PBS Declaration 85COMMONWEALTH OF AUSTRALIA National Health Act 1953 PHARMACEUTICAL BENEFITS DECLARATION UNDER SUBSECTION 85(2) No. PB 31 of 2006 I, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to subsection 85(2) of the National Health Act 1953, hereby make the following Declaration: 1. This declaration commences on 1 August 2006. 2. Declaration No. PB 14 of 2006 under subsection 85(2) of the National Health Act 1953 made on 24 March 2006 with effect from 1 April 2006 is repealed. 3. In this Declaration: “Act” means the National Health Act 1953; “base-priced drug” means — (a) in relation to ranitidine hydrochloride (tablet, effervescent, equivalent to 150 mg ranitidine or syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine hydrochloride (tablet equivalent to 150 mg ranitidine or tablet equivalent to 300 mg ranitidine); or (b) in relation to amlodipine besylate or lercanidipine hydrochloride or nifedipine (tablet 20 mg (controlled release)): felodipine or nifedipine (tablet 10 mg or tablet 20 mg or tablet 30 mg (controlled release) or tablet 60 mg (controlled release)); or (c) in relation to ramipril: captopril or enalapril maleate or fosinopril sodium or lisinopril or perindopril arginine or perindopril erbumine or quinapril hydrochloride or trandolapril; “electronic communication” has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999; “extemporaneously-prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit; “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia; “PBS” means Pharmaceutical Benefits Scheme; “palliative care patient”, in relation to a circumstance specified in Schedule 1A, means a patient with an active, progressive, far-advanced disease, and for whom the prognosis is limited and the focus of care is the quality of life; “ready-prepared pharmaceutical benefit” means a drug or medicinal preparation in respect of which there is in force a determination under subsection 85(6) of the Act; “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
4. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 1 or 1A and the circumstances (if any) specified in column 2 of Schedule 1 or 1A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a medical practitioner. 4A. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 2 and the circumstances (if any) specified in column 2 of Schedule 2 opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a participating dental practitioner. 5. A medicinal preparation composed of a compound that includes a pharmaceutical benefit the name of which is specified in column 1 of Schedule 3, other than a compound the name of which is specified in column 2 of that Schedule opposite the name of that pharmaceutical benefit, is not a medicinal preparation to which Part VII of the Act applies, unless the name of that pharmaceutical benefit is also specified in Schedule 4, in which case the provisions of paragraphs 7 and 8 apply. 6. Part VII of the Act does not apply in relation to a medicinal preparation composed of a compound that includes a ready-prepared pharmaceutical benefit, other than a pharmaceutical benefit the name of which is specified in column 1 of Schedule 3. 7. Part VII of the Act applies in relation to medicinal preparations composed of one or more of the drugs or medicinal preparations the names of which are specified in Schedule 4. 8. Part VII of the Act applies in relation to medicinal preparations composed of one or more of the drugs or medicinal preparations the names of which are specified in Schedule 4 with the addition of one or more of the substances the names of which are specified in Schedule 5. 9. The substances the names of which are specified in Schedule 5 are additives for the purposes of paragraph 85(2)(b) of the Act. 10. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in Schedule 6. 11. The drugs and medicinal preparations the names of which are specified in Schedule 6 are additional pharmaceutical benefits made available under arrangements provided for by section 100 of the Act. 12. Where circumstances are specified in column 2 of Schedule 1, 1A, 2 or 4 opposite the name of a pharmaceutical benefit specified in column 1 of any of those Schedules, that pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act. 13. Where circumstances are specified in column 2 of Schedule 4 opposite the name of a pharmaceutical benefit specified in column 1 of that Schedule, those circumstances are also specified in relation to any medicinal preparation containing that pharmaceutical benefit. 14. Subject to paragraph 16, the following circumstances are specified in relation to each relevant pharmaceutical benefit for the purposes of section 88A of the Act: (a) where a class of persons is specified in column 2 of Schedule 1, 1A, 2 or 4 — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;
(b) where a disease or condition is specified in column 2 of Schedule 1, 1A, 2 or 4 — (i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or (ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons; (c) where a purpose is specified in column 2 of Schedule 1, 1A, 2 or 4 — that the pharmaceutical benefit is to be supplied for that purpose; (d) where it is specified in column 2 of Schedule 1 or 1A that compliance with authority procedures set out in subparagraph 14(d) is required — that a medical practitioner has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit: (i) by preparing and signing the prescription: (A) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or (B) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubsubparagraph (A); or (C) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or (D) by a method approved in writing by the Secretary; or (ii) by submitting the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i); or (iii) where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (ii) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO; or (iv) by submitting the prescription by giving the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i). 14A. For the purposes of subsubparagraph 14(d)(i), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees. 15. Subject to paragraph 15B, the authorisation of a prescription submitted under subparagraph 14(d) may be made: (a) if the prescription was submitted in accordance with subsubparagraph 14(d)(i) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:
(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or (ii) in any other case: (A) by returning it to the medical practitioner; or (B) by sending it to the person in respect of whom it was prepared; or (b) if the prescription was submitted in accordance with subsubparagraph 14(d)(ii) — orally, at the time the Medicare Australia CEO is given details of the prescription; or (c) if the prescription was submitted in accordance with subsubparagraph 14(d)(iv) — by the Medicare Australia CEO sending his or her authorisation, by electronic communication, to the medical practitioner. 15A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 15(b) or (c): (a) the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; and (b) the medical practitioner must: (i) mark that number on the prescription; and (ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised. 15B. Notwithstanding paragraph 15, if the prescription was submitted in accordance with subsubparagraph 14(d)(iii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO. 16. Where the circumstances “For use in accordance with paragraph 16” are specified in column 2 of Schedule 1, the circumstances specified for the purpose of subparagraph 14(c) are that the pharmaceutical benefit is to be supplied for the treatment of a patient who, after dietary therapy, qualifies for the supply of the benefit in accordance with the following table:
Category of patient
Lipid level
(1) patients with existing coronary heart disease
cholesterol greater than 4 mmol per L
(2) patients, not in category (1), with 1 or more of the following: diabetes mellitus; familial hypercholesterolaemia; family history of cardiovascular disease (first degree relative less than 60 years of age); hypertension; peripheral vascular disease
cholesterol greater than 6.5 mmol per L; or cholesterol greater than 5.5 mmol per L and high density lipoprotein less than 1 mmol per L
(3) patients, not in category (1) or (2), with high density lipoprotein level less than 1 mmol per L
cholesterol greater than 6.5 mmol per L
(4) patients, not in category (1), (2) or (3), being men over 34 but less than 76 years of age or post-menopausal women less than 76 years of age
cholesterol greater than 7.5 mmol per L; or triglyceride greater than 4 mmol per L
(5) patients, not in category (1), (2), (3) or (4)
cholesterol greater than 9 mmol per L; or triglyceride greater than 8 mmol per L
Abciximab
In compliance with authority procedures set out in subparagraph 14 (d):
Patients undergoing percutaneous coronary balloon angioplasty
Patients undergoing percutaneous coronary atherectomy
Patients undergoing percutaneous coronary stent placement
Acamprosate Calcium
In compliance with authority procedures set out in subparagraph 14 (d):
For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence
Acarbose
—
Acetazolamide
—
Acetylcysteine Sodium
Bronchiectasis
Cystic fibrosis
Aciclovir
In respect of the eye ointment 30 mg per g, 4.5 g:
Herpes simplex keratitis
In respect of the tablet 200 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Moderate to severe initial genital herpes
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
In respect of the tablet 800 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of patients with herpes zoster within 72 hours of the onset of the rash
Herpes zoster ophthalmicus
Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L)
Acitretin
In compliance with authority procedures set out in subparagraph 14 (d):
Severe intractable psoriasis
Severe forms of disorders of keratinisation
Adalimumab
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: (i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or
(ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of treatment is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with adalimumab within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of adalimumab therapy specified below, if applicable; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised adalimumab treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of adalimumab therapy; a course of treatment is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 November 2004, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to an inability to receive concomitant methotrexate, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with adalimumab; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with adalimumab; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of adalimumab therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and (3) have not failed treatment with adalimumab during the current Treatment Cycle; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) were receiving treatment with adalimumab prior to 16 March 2006; and (3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply: the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form; the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Adrenaline
In compliance with authority procedures set out in subparagraph 14 (d):
Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where the name of the specialist consulted is included in the authority application
Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis
Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis, where the patient has previously been issued with an authority prescription for this drug
Adrenaline Acid Tartrate
—
Albendazole
In respect of the tablet 200 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of tapeworm infestation
In respect of the tablet 400 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used
Alendronate Sodium
In respect of the tablet equivalent to 70 mg alendronic acid:
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
In respect of the tablet equivalent to 40 mg alendronic acid:
In compliance with authority procedures set out in subparagraph 14 (d):
Symptomatic Paget's disease of bone
Alendronate Sodium with Colecalciferol
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
"Alfaré"
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 3 months, for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a soy protein as the principal formula, and where the date of birth of the patient is included in the authority application
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children aged 2 years and over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Biliary atresia
Chronic liver failure with fat malabsorption
Chylous ascites
Chylothorax
Cystic fibrosis
Enterokinase deficiency
Proven fat malabsorption
Severe diarrhoea of greater than 2 weeks' duration in infants under the age of 4 months, where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome
Allopurinol
—
Alprazolam
In compliance with authority procedures set out in subparagraph 14 (d):
Panic disorder where other treatments have failed or are inappropriate
Aluminium Hydroxide - Dried with Magnesium Hydroxide
—
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide
—
Amantadine Hydrochloride
Parkinson's disease which is not drug induced
Amiloride Hydrochloride
—
Aminoglutethimide
—
Amiodarone Hydrochloride
Severe cardiac arrhythmias
Amisulpride
In compliance with authority procedures set out in subparagraph 14 (d):
Schizophrenia
Amitriptyline Hydrochloride
—
Amlodipine Besylate
—
Amoxycillin Trihydrate
In respect of the tablet, chewable, equivalent to 250 mg amoxycillin, capsule equivalent to 250 mg amoxycillin, capsule equivalent to 500 mg amoxycillin and sachet containing oral powder equivalent to 3 g amoxycillin:
—
In respect of the tablet equivalent to 1 g amoxycillin:
Acute exacerbations of chronic bronchitis
Amoxycillin Trihydrate with Potassium Clavulanate
Infections where resistance to amoxycillin trihydrate is suspected
Infections where resistance to amoxycillin trihydrate is proven
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP
Infections where resistance to amoxycillin trihydrate is suspected
Infections where resistance to amoxycillin trihydrate is proven
Amoxycillin Trihydrate with Water - Purified BP
—
Amphotericin
—
Ampicillin Sodium
—
Ampicillin Trihydrate
—
Anakinra
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: (i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or (ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgement form; a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with anakinra within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of anakinra therapy specified below, if applicable; unless this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, in which case the patient is eligible to commence therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with anakinra within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised anakinra treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of anakinra therapy; a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 July 2004 and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment
Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 December 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with anakinra; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with anakinra; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; if this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, the patient is eligible to continue PBS-subsidised therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of anakinra therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Anastrozole
Treatment of hormone-dependent breast cancer in post-menopausal women
Apraclonidine Hydrochloride
Short-term reduction of intra-ocular pressure in patients already on maximally tolerated anti-glaucoma therapy
Aprepitant
In compliance with authority procedures set out in subparagraph 14 (d):
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where the cytotoxic chemotherapy to be administered to the patient includes any of the following agents:
altretamine;
carmustine;
cisplatin, when a single dose constitutes a cycle of chemotherapy;
cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
dacarbazine;
procarbazine, when a single dose constitutes a cycle of chemotherapy;
streptozocin
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer where cyclophosphamide and an anthracycline are to be co-administered, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy
Aripiprazole
In compliance with authority procedures set out in subparagraph 14 (d):
Schizophrenia
Aspirin
—
Atenolol
—
Atorvastatin Calcium
For use in accordance with paragraph 16
Atovaquone
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy
Atropine Sulfate
—
Auranofin
—
Azathioprine
—
Azithromycin Dihydrate
Uncomplicated urethritis due to Chlamydia trachomatis
Uncomplicated cervicitis due to Chlamydia trachomatis
Trachoma
Azithromycin Dihydrate with Water - Purified BP
Trachoma
Baclofen
—
Balsalazide Sodium
In compliance with authority procedures set out in subparagraph 14 (d):
Ulcerative colitis where hypersensitivity to sulfonamides exists
Ulcerative colitis where intolerance to sulfasalazine exists
"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)
Treatment of carcinoma in situ of the urinary bladder
"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)
Primary and relapsing superficial urothelial carcinoma of the bladder
Beclomethasone Dipropionate
In respect of the pressurised inhalation 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation 100 micrograms per dose, 200 doses (CFC-free formulation):
—
In respect of the pressurised inhalation in breath actuated device 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation in breath actuated device 100 micrograms per dose, 200 doses (CFC-free formulation):
Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug
Benzathine Penicillin
—
Benzhexol Hydrochloride
—
Benztropine Mesylate
—
Benzydamine Hydrochloride
Radiation induced mucositis
Benzyl Benzoate
—
Benzylpenicillin Sodium
—
Betamethasone Acetate with Betamethasone Sodium Phosphate
Alopecia areata
For local intra-articular or peri-articular infiltration
Granulomata, dermal
Keloid
Lichen planus hypertrophic
Lichen simplex chronicus
Lupus erythematosus, chronic discoid
Necrobiosis lipoidica
Uveitis
Betamethasone Dipropionate
Treatment of corticosteroid-responsive dermatoses
Betamethasone Valerate
Treatment of corticosteroid-responsive dermatoses
Betaxolol Hydrochloride
—
Bethanechol Chloride
—
Bicalutamide
In compliance with authority procedures set out in subparagraph 14 (d):
Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy
Bifonazole
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
Bimatoprost
—
Biperiden Hydrochloride
—
Bisacodyl
Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
Patients receiving palliative care
Terminal malignant neoplasia
Anorectal congenital abnormalities
Megacolon
Bisoprolol Fumarate
In compliance with authority procedures set out in subparagraph 14 (d):
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated
Bivalirudin Trifluoroacetate
In compliance with authority procedures set out in subparagraph 14 (d):
Patients undergoing non-emergency percutaneous coronary intervention
Bleomycin Sulfate
Germ cell neoplasms
Lymphoma
Brimonidine Tartrate
—
Brimonidine Tartrate with Timolol Maleate
Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL
Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL
Brinzolamide
—
Bromocriptine Mesylate
In respect of the tablet equivalent to 2.5 mg bromocriptine:
Prevention of the onset of lactation in the puerperium for medical reasons
Acromegaly
Parkinson's disease
Pathological hyperprolactinaemia where surgery is not indicated
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
Pathological hyperprolactinaemia where radiotherapy is not indicated
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
In respect of the capsule equivalent to 5 mg bromocriptine and capsule equivalent to 10 mg bromocriptine:
Acromegaly
Parkinson's disease
Pathological hyperprolactinaemia where surgery is not indicated
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
Pathological hyperprolactinaemia where radiotherapy is not indicated
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
Budesonide
In respect of the powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses, powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses and powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses:
—
In respect of the nebuliser suspension 500 micrograms in 2 mL single dose units, 30 and nebuliser suspension 1 mg in 2 mL single dose units, 30:
In compliance with authority procedures set out in subparagraph 14 (d):
Severe chronic asthma in patients who require long-term steroid therapy and who are unable to use other forms of inhaled steroid therapy
Budesonide with Eformoterol Fumarate Dihydrate
Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide
Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide
Buprenorphine
Chronic severe disabling pain not responding to non-narcotic analgesics
Bupropion Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where details of the program are specified in the authority application
Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who are entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application
Completion of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where the patient has previously been issued with an authority prescription for commencement of treatment with this drug
Busulfan
—
Cabergoline
In respect of the tablet 500 micrograms:
Prevention of the onset of lactation in the puerperium for medical reasons
In compliance with authority procedures set out in subparagraph 14 (d):
Pathological hyperprolactinaemia where surgery is not indicated
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
Pathological hyperprolactinaemia where radiotherapy is not indicated
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
In respect of the tablet 1 mg, tablet 2 mg and tablet 4 mg:
Parkinson's disease
Calcipotriol
Chronic stable plaque type psoriasis vulgaris
Calcitriol
In compliance with authority procedures set out in subparagraph 14 (d):
Hypocalcaemia due to renal disease
Hypoparathyroidism
Hypophosphataemic rickets
Vitamin D-resistant rickets
Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
Calcium Carbonate
In compliance with authority procedures set out in subparagraph 14 (d):
Hyperphosphataemia associated with chronic renal failure
Calcium Citrate
In compliance with authority procedures set out in subparagraph 14 (d):
Hyperphosphataemia associated with chronic renal failure
Calcium Folinate
In respect of the injection equivalent to 50 mg folinic acid in 5 mL and injection equivalent to 100 mg folinic acid in 10 mL:
—
In respect of the tablet equivalent to 15 mg folinic acid:
Antidote to folic acid antagonists
Candesartan Cilexetil
—
Candesartan Cilexetil with Hydrochlorothiazide
Hypertension in patients who are not adequately controlled with 16 mg candesartan cilexetil
Capecitabine
In compliance with authority procedures set out in subparagraph 14 (d):
Advanced breast cancer after failure of prior therapy which includes a taxane and an anthracycline
Advanced breast cancer where therapy with a taxane or an anthracycline is contraindicated
Advanced breast cancer in combination with docetaxel after failure of prior anthracycline-containing chemotherapy
Treatment of advanced or metastatic colorectal cancer
Adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour
"Caprilon"
Chylous ascites
Chylothorax
Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders
Captopril
In respect of the tablet 12.5 mg, tablet 25 mg and tablet 50 mg:
—
In respect of the oral solution 5 mg per mL, 95 mL:
For patients unable to take a solid dose form of an angiotensin-converting enzyme inhibitor
Carbamazepine
—
Carbimazole
—
"Carbohydrate Free Mixture"
Patients with intractable seizures requiring treatment with a ketogenic diet
Glucose transport protein defects
Pyruvate dehydrogenase deficiency
Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance
Carbomer 974
In compliance with authority procedures set out in subparagraph 14 (d):
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Carbomer 980
In respect of the ocular lubricating gel 2 mg per g, 10 g:
Severe dry eye syndrome, including Sjogren's syndrome
In respect of the eye drops 2 mg per g, single dose units 0.6 mL, 30:
In compliance with authority procedures set out in subparagraph 14 (d):
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Carboplatin
—
Carmellose Sodium
In respect of the eye drops 5 mg per mL, 15 mL and eye drops 10 mg per mL, 15 mL:
Severe dry eye syndrome, including Sjogren's syndrome
In respect of the eye drops 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops 5 mg per mL, single dose units 0.4 mL, 30, eye drops 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel 10 mg per mL, single dose units 0.6 mL, 28:
In compliance with authority procedures set out in subparagraph 14 (d):
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Carmustine
Newly-diagnosed glioblastoma multiforme as an adjunct to surgery and radiation
Carvedilol
In respect of the pack containing 30 tablets 3.125 mg, 30 tablets 6.25 mg and 10 tablets 12.5 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated
In respect of the tablet 3.125 mg, tablet 6.25 mg, tablet 12.5 mg and tablet 25 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated
Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002
Cefaclor Monohydrate
—
Cefaclor Monohydrate with Water - Purified BP
—
Cefepime Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of febrile neutropenia
Cefotaxime Sodium
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Ceftriaxone Sodium
In respect of the powder for injection equivalent to 250 mg ceftriaxone:
Gonorrhoea
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
In respect of the powder for injection equivalent to 500 mg ceftriaxone, powder for injection equivalent to 1 g ceftriaxone and powder for injection equivalent to 2 g ceftriaxone:
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Cefuroxime Axetil
—
Celecoxib
Symptomatic treatment of osteoarthritis
Symptomatic treatment of rheumatoid arthritis
Cephalexin
—
Cephalexin with Water - Purified BP
—
Cephalothin Sodium
—
Cephazolin Sodium
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Chlorambucil
—
Chloramphenicol
—
Chlorpromazine Hydrochloride
—
Chlorthalidone
—
Cholestyramine
—
Chorionic Gonadotrophin
In respect of the injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL:
Anovulatory infertility
For the treatment of infertility in males due to hypogonadotrophic hypogonadism
For the treatment of infertility in males associated with isolated luteinising hormone deficiency
For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation
For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty
Cryptorchism not due to organic obstruction in boys over 12 months of age
In respect of the injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL:
Anovulatory infertility
For the treatment of infertility in males due to hypogonadotrophic hypogonadism
For the treatment of infertility in males associated with isolated luteinising hormone deficiency
For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation
For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty
Ciclesonide
—
Cimetidine
—
Ciprofloxacin Hydrochloride
In respect of the tablet equivalent to 250 mg ciprofloxacin:
Gonorrhoea
In compliance with authority procedures set out in subparagraph 14 (d):
Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients
Bacterial gastroenteritis in severely immunocompromised patients
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials
In respect of the tablet equivalent to 500 mg ciprofloxacin and tablet equivalent to 750 mg ciprofloxacin:
In compliance with authority procedures set out in subparagraph 14 (d):
Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients
Bacterial gastroenteritis in severely immunocompromised patients
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials
In respect of the eye drops equivalent to 3 mg ciprofloxacin per mL, 5 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Bacterial keratitis
Cisplatin
—
Citalopram Hydrobromide
Major depressive disorders
Cladribine
In compliance with authority procedures set out in subparagraph 14 (d):
Hairy cell leukaemia
Clarithromycin
—
Clindamycin Hydrochloride
Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin
Clomiphene Citrate
Anovulatory infertility
Patients undergoing in-vitro fertilisation
Clomipramine Hydrochloride
Cataplexy associated with narcolepsy
Obsessive-compulsive disorder
Phobic disorders in adults
Clonazepam
In respect of the injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent):
Epilepsy
In respect of the tablet 500 micrograms, tablet 2 mg and oral liquid 2.5 mg per mL, 10 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Neurologically proven epilepsy
Clonidine Hydrochloride
—
Clopidogrel Hydrogen Sulfate
In compliance with authority procedures set out in subparagraph 14 (d):
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events:
in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
Prevention of recurrence of myocardial infarction or unstable angina:
in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
Clotrimazole
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
Coal Tar - Prepared
—
Codeine Phosphate
—
Codeine Phosphate with Paracetamol
—
Colchicine
—
Colestipol Hydrochloride
—
Copper Sulfate
—
Cortisone Acetate
—
Cyclophosphamide
—
Cyclosporin
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate, where therapy remains under the supervision and direction of a dermatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the dermatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life, where therapy remains under the supervision and direction of a dermatologist or specialised unit reviewing the patient and where the name of the dermatologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with nephrotic syndrome in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired, where therapy remains under the supervision and direction of a nephrologist or specialised unit reviewing the patient and where the name of the nephrologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate, where therapy remains under the supervision and direction of a rheumatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the rheumatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Management (which includes initiation, stabilisation and review of therapy) by dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate
Management (which includes initiation, stabilisation and review of therapy) by dermatologists of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life
Management (which includes initiation, stabilisation and review of therapy) by rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate
Cyproheptadine Hydrochloride
Prevention of migraine
Cyproterone Acetate
In respect of the tablet 50 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Moderate to severe androgenisation, of which acne alone is not a sufficient indication, in non-pregnant women
Advanced carcinoma of the prostate
To reduce drive in sexual deviations in males
In respect of the tablet 100 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Advanced carcinoma of the prostate
To reduce drive in sexual deviations in males
Cytarabine
—
Dalteparin Sodium
—
Danazol
In compliance with authority procedures set out in subparagraph 14 (d):
Endometriosis, visually proven
Hereditary angio-oedema
Treatment, for up to 6 months, of intractable primary menorrhagia
Treatment, for up to 6 months, of severe benign (fibrocystic) breast disease or mastalgia associated with severe symptomatic benign breast disease in patients refractory to other treatments
Dantrolene Sodium
Treatment of chronic spasticity
Dapsone
—
Desmopressin Acetate
In respect of the intranasal solution 100 micrograms per mL, 2.5 mL dropper bottle:
In compliance with authority procedures set out in subparagraph 14 (d):
Cranial diabetes insipidus
In respect of the tablet 200 micrograms and nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Primary nocturnal enuresis:
in patients aged 6 years or older who are refractory to an enuresis alarm, where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose
in patients aged 6 years or older for whom an enuresis alarm is contraindicated, where the reason for the contraindication is included in the authority application, and where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose
Cranial diabetes insipidus
Dexamethasone
—
Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin
—
Dexamethasone Sodium Phosphate
—
Dexamphetamine Sulfate
In compliance with authority procedures set out in subparagraph 14 (d):
Use in attention deficit hyperactivity disorder, in accordance with State/Territory law
Narcolepsy
"Dialamine"
Gyrate atrophy of the choroid and retina
Urea cycle disorders
Diazepam
—
Diclofenac Sodium
In respect of the suppository 100 mg:
—
In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated):
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the eye drops 1 mg per mL, 5 mL:
Inhibition of intraoperative miosis
Dicloxacillin Sodium
In respect of the powder for injection equivalent to 500 mg dicloxacillin and powder for injection equivalent to 1 g dicloxacillin:
—
In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin:
Serious staphylococcal infections
"Digestelact"
In compliance with authority procedures set out in subparagraph 14 (d):
Acute lactose intolerance in children aged 1 year and over, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose
Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Digoxin
—
Dihydroergotamine Mesylate
—
Diltiazem Hydrochloride
—
Diphenoxylate Hydrochloride with Atropine Sulfate
—
Diphtheria and Tetanus Vaccine - Adsorbed
—
Diphtheria and Tetanus Vaccine - Adsorbed (Diluted)
—
Dipivefrine Hydrochloride
—
Dipyridamole
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events:
in patients receiving therapy with low-dose aspirin
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
Dipyridamole with Aspirin
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events
Disodium Etidronate
In compliance with authority procedures set out in subparagraph 14 (d):
Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to lack of efficacy
Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to unacceptable side effects
Heterotopic ossification
Disodium Etidronate and Calcium Carbonate
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
Disodium Pamidronate
In compliance with authority procedures set out in subparagraph 14 (d):
Symptomatic Paget's disease of bone
Disopyramide
—
Docetaxel
In compliance with authority procedures set out in subparagraph 14 (d):
Advanced breast cancer after failure of prior therapy which includes an anthracycline
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Locally advanced or metastatic non-small cell lung cancer
Docusate Sodium with Bisacodyl
Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
Patients receiving palliative care
Terminal malignant neoplasia
Anorectal congenital abnormalities
Megacolon
Dolasetron Mesylate
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy
Domperidone
—
Donepezil Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more who demonstrate improvement in cognitive function following initial therapy, as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination, or a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale, for patients with a Mini-Mental State Examination baseline score of at least 25 points, where the relevant result from the Mini-Mental State Examination or the Alzheimer's Disease Assessment Scale, cognitive sub-scale, is included in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more and with demonstrated improvement in cognitive function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial therapy, based on a rating of very much improved or much improved on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less and with demonstrated improvement in function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Dorzolamide Hydrochloride
—
Dorzolamide Hydrochloride with Timolol Maleate
Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL
Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL
Dothiepin Hydrochloride
—
Doxepin Hydrochloride
—
Doxorubicin Hydrochloride
—
Doxorubicin Hydrochloride - Pegylated Liposomal
In compliance with authority procedures set out in subparagraph 14 (d):
Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen
Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane
Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated
Doxycycline Hydrochloride
In respect of the tablet equivalent to 100 mg doxycycline and capsule equivalent to 100 mg doxycycline (containing enteric coated pellets):
—
In respect of the tablet equivalent to 50 mg doxycycline and capsule equivalent to 50 mg doxycycline (containing enteric coated pellets):
Bronchiectasis in patients aged 8 years or older
Chronic bronchitis in patients aged 8 years or older
Severe acne
Doxycycline Monohydrate
In respect of the tablet equivalent to 100 mg doxycycline:
—
In respect of the tablet equivalent to 50 mg doxycycline:
Bronchiectasis in patients aged 8 years or older
Chronic bronchitis in patients aged 8 years or older
Severe acne
Drotrecogin Alfa (Activated)
In compliance with authority procedures set out in subparagraph 14 (d):
Adult patients with severe sepsis who have a high risk of death as determined by acute dysfunction in at least 2 organs or modified Acute Physiology and Chronic Health Evaluation II score of at least 25, where acute organ dysfunction is defined as follows:
For cardiovascular-system dysfunction, an arterial systolic blood pressure of less than or equal to 90 mmHg or mean arterial pressure of less than or equal to 70 mmHg for at least 1 hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic blood pressure of greater than or equal to 90 mmHg or a mean arterial pressure of greater than or equal to 70 mmHg;
For kidney dysfunction, urine output of less than 0.5 mL per kg of body weight per hour for 1 hour despite adequate fluid resuscitation;
For respiratory-system dysfunction, a ratio of partial pressure of oxygen in arterial blood (in mmHg) to the percentage of oxygen in the inspired air (expressed as a decimal) of less than or equal to 250;
For haematologic dysfunction, a platelet count of less than 80,000 per cubic millimetre or which has decreased by 50 percent in the previous 3 days;
In the case of unexplained metabolic acidosis, a pH of less than or equal to 7.30 or a base deficit of greater than or equal to 5.0 mmol per L in association with a plasma lactate level of greater than 1.5 times the upper limit of the normal value for the reporting laboratory
"Duocal"
Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae
Dydrogesterone
—
"Easiphen"
Phenylketonuria
Efalizumab
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrable in the patient at the time of the authority application; a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; the most recent PASI assessment is no more than 1 month old at the time of application; if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Adminstration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with efalizumab as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis; and (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and (c) have not failed PBS-subsidised therapy with efalizumab for the treatment of this condition more than once in the current Treatment Cycle; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who have previously demonstrated a response to PBS-subsidised treatment with efalizumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised efalizumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept and wish to transfer to treatment with efalizumab are not eligible to commence treatment with efalizumab until they have completed a period free from biological agent treatment of at least 12 weeks duration, immediately following cessation of the etanercept treatment course; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; a course of initial treatment within a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, with efalizumab as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with efalizumab prior to 10 November 2005; and (b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with efalizumab; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form;
the most recent PASI assessment is no more than 1 month old at the time of application; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and (c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to efalizumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, after at least 12 weeks of efalizumab treatment, when compared with the baseline value for this Treatment Cycle established prior to biological agent treatment; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and (ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams along with the date of the assessment of the patient's condition; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have severe chronic plaque psoriasis of the face or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is demonstrable in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; the most recent PASI assessment is no more than 1 month old at the time of application; if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with efalizumab as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and (c) have not failed PBS-subsidised therapy with efalizumab for the treatment of this condition more than once in the current Treatment Cycle; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply: patients who have previously demonstrated a response to PBS-subsidised treatment with efalizumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised efalizumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept and wish to transfer to treatment with efalizumab are not eligible to commence treatment with efalizumab until they have completed a period free from biological agent treatment of at least 12 weeks duration, immediately following cessation of the etanercept treatment course; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment; a course of initial treatment within a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, with efalizumab as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with efalizumab prior to 10 November 2005; and (b) whose disease, prior to treatment with efalizumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and (c) who have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) who have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and where biological agent means efalizumab or etanercept; and
where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) a copy of the signed patient acknowledgement form; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment score; the most recent PASI assessment is no more than 1 month old at the time of application; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; (c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and where biological agent means efalizumab or etanercept; and
where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to efalizumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline values established prior to biological agent treatment; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline value established prior to biological agent treatment; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and (ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Eformoterol Fumarate Dihydrate
Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids
Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids
"EleCare"
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Enalapril Maleate
—
Enalapril Maleate with Hydrochlorothiazide
Hypertension in patients who are not adequately controlled with 20 mg enalapril maleate
"Energivit"
Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae
Enoxaparin Sodium
—
Entacapone
In compliance with authority procedures set out in subparagraph 14 (d):
Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect
Epirubicin Hydrochloride
—
Eplerenone
In compliance with authority procedures set out in subparagraph 14 (d):
Initial therapy subsidised under the Pharmaceutical Benefits Scheme (PBS) for heart failure with a left ventricular ejection fraction of 40% or less occurring within 3 to 14 days following an acute myocardial infarction, where the date of the acute myocardial infarction is included in the authority application, and where the treatment commences within 14 days of the acute myocardial infarction or continues treatment which was commenced in a hospital within 14 days of the acute myocardial infarction
Continuation of therapy for heart failure with a left ventricular ejection fraction of 40% or less occurring following an acute myocardial infarction, where the patient has previously been issued with a PBS authority prescription for eplerenone
Eprosartan Mesylate
—
Eprosartan Mesylate with Hydrochlorothiazide
Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or eprosartan mesylate monotherapy
Eptifibatide Acetate
In compliance with authority procedures set out in subparagraph 14 (d):
Patients undergoing non-urgent percutaneous intervention with intracoronary stenting
Erythromycin
—
Erythromycin Ethyl Succinate
—
Erythromycin Ethyl Succinate with Water - Purified BP
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Erythromycin Lactobionate
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Escitalopram Oxalate
Major depressive disorders
In compliance with authority procedures set out in subparagraph 14 (d):
Major depressive disorders, where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Major depressive disorders, where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
Esomeprazole Magnesium Trihydrate
In respect of the tablet (enteric coated), equivalent to 20 mg esomeprazole:
Initial treatment of gastric ulcer
Maintenance of healed gastro-oesophageal reflux disease
In respect of the tablet (enteric coated), equivalent to 40 mg esomeprazole:
Healing of gastro-oesophageal reflux disease
Esomeprazole Magnesium Trihydrate and Clarithromycin and Amoxycillin Trihydrate
Eradication of Helicobacter pylori associated with peptic ulcer disease
Etanercept
In respect of the injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL:
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrable in the patient at the time of the authority application; a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Adminstration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with etanercept as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis; and (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and (c) have not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who have previously demonstrated a response to PBS-subsidised treatment with etanercept within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent 12-week course of PBS-subsidised etanercept treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; a course of initial treatment within a Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, with etanercept as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of etanercept for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with etanercept prior to 16 March 2006; and (b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with etanercept; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with etanercept; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of etanercept therapy) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form; the most recent PASI assessment is no more than 1 month old at the time of application; the course of treatment is limited to a maximum of 12 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis, who were receiving non-PBS-subsidised treatment with etanercept prior to 16 March 2006, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, after at least 12 weeks of etanercept treatment, when compared with the baseline value for this Treatment Cycle established prior to biological agent treatment; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless the assessment of response is conducted at the completion of the 12-week treatment course and is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased; patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept are not eligible to commence further treatment with etanercept until they have completed a period free from biological agent therapy of at least 12 weeks duration, immediately following cessation of that course of treatment;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams along with the date of the assessment of the patient's condition; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have severe chronic plaque psoriasis of the face or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply: failure to achieve an adequate response is demonstrable in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application; if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with etanercept as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and (c) have not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle; and
where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who have previously demonstrated a response to PBS-subsidised treatment with etanercept within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent 12-week course of PBS-subsidised etanercept treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; a course of initial treatment within a Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, with etanercept as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of etanercept for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with etanercept prior to 16 March 2006; and (b) whose disease, prior to treatment with etanercept, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and (c) who have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) who have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with etanercept; and
where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of etanercept therapy) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment score; the most recent PASI assessment is no more than 1 month old at the time of application; the course of treatment is limited to a maximum of 12 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who were receiving non-PBS-subsidised treatment with etanercept prior to 16 March 2006, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means efalizumab or etanercept; and
where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, after at least 12 weeks of etanercept treatment, as compared to the baseline values established prior to biological agent treatment; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, after at least 12 weeks of etanercept treatment, as compared to the baseline value established prior to biological agent treatment; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless the assessment of response is conducted at the completion of the 12-week treatment course and is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased; patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept are not eligible to commence further treatment with etanercept until they have completed a period free from biological agent therapy of at least 12 weeks duration, immediately following cessation of that course of treatment; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: (i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or (ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with etanercept within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised etanercept treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy; a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and
where the following conditions apply: failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with etanercept; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of etanercept therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient
Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and where the following conditions apply: the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment commencing a treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: (a) who have not received any treatment with either etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with either of these drugs, have not received PBS-subsidised treatment with etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and (b) who, where the patient has received non-PBS-subsidised treatment with etanercept or infliximab, have not received non-PBS-subsidised treatment with etanercept prior to 1 July 2004; and
(c) who have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; and (d) who have documented confirmation of human leucocyte antigen B27 (HLA-B27) positive status; and (e) who have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), in combination with an appropriate exercise program, for a total period of at least 3 months, unless: (i) treatment with NSAIDs is contraindicated according to the relevant Therapeutic Goods Administration (TGA)-approved Product Information, in which case the patient is exempt from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or (ii) adverse events of a severity necessitating permanent treatment withdrawal develop during the relevant period of use of 2 NSAIDs, in which case the patient may be exempted from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or (iii) the patient is unable to complete the minimum exercise program, in which case the patient is exempt from completing the exercise component of the combined NSAID and exercise treatment regimen specified above; or (iv) the patient has had a break in PBS-subsidised therapy with etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months, instead of the combined NSAID and exercise regimen specified above; and (f) who have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with etanercept and with infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is demonstrated by: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reasons why a higher dose cannot be used; where the patient is exempted from the minimum 3 months of treatment with at least 2 NSAIDs because treatment with NSAIDs is contraindicated, the authority application includes evidence supporting the contraindication; an appropriate minimum exercise program includes stretch and range of motion exercises 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; the application for authorisation includes: (a) a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HLA-B27; and (iii) a copy of the completed BASDAI Assessment Form; and (iv) a copy of the signed patient acknowledgement form; and (v) a copy of the exercise program self-certification form detailing the program followed and the dates over which it was followed; and (b) confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed in the self-certification form; a course of initial treatment commencing a treatment cycle is limited to a maximum of 6 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis and who, in this treatment cycle, have received prior PBS-subsidised treatment with etanercept or with infliximab for this condition as 'new' patients and have not failed PBS-subsidised therapy with etanercept more than once; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and
where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; the authority application includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form; the application is accompanied by the results of the patient's most recent course of PBS-subsidised etanercept or infliximab therapy, where: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and (ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who have not failed PBS-subsidised therapy with etanercept more than once; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and
where the following conditions apply: patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; the authority application includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form; the application is accompanied by the results of the patient's most recent course of PBS-subsidised etanercept or infliximab therapy, where: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and (ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of treatment with etanercept subsidised under the Pharmaceutical Benefits Scheme (PBS) as 'new' patients, who have demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline; all measurements provided are no more than 1 month old at the time of application; the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured for all subsequent continuing treatment applications for the patient; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and (ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course; the application for authorisation includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form, including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept as 'new' patients for a period of less than 24 weeks (other than a prescription for the first 4 weeks of continuing treatment immediately following an initial treatment course), and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment, for up to 4 weeks, within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks of initial PBS-subsidised treatment with etanercept as 'new' patients immediately prior to this course of therapy and who, at the time of application, meet the criteria for continuing treatment with etanercept as specified above, and where a completed copy of the appropriate PBS Authority Application - Supporting Information Form (which includes a copy of the completed BASDAI Assessment Form) is submitted to the Medicare Australia CEO by facsimile
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a treatment cycle with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were receiving treatment with etanercept prior to 1 July 2004; and (a) who are receiving treatment with etanercept at the time of application; and (b) who have not received prior PBS-subsidised treatment with infliximab; and
(c) who have documented confirmation of human leucocyte antigen B27 (HLA-B27) positive status; and (d) whose Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is less than or equal to 5 on a 0-10 scale; and (e) who have: (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and (f) who have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with etanercept and with infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where the following conditions apply: the BASDAI assessment and the ESR and CRP measurements are no more than 1 month old at the time of application; the application for authorisation includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HLA-B27; and (iii) a copy of the completed BASDAI Assessment Form; and (iv) a copy of the signed patient acknowledgement form; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were receiving non-PBS-subsidised treatment with etanercept prior to 1 July 2004 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab, who have received 6 weeks or more of PBS-subsidised treatment with etanercept, who have demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; response to treatment is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, and: (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; all measurements provided are no more than 1 month old at the time of application; the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured for all subsequent continuing treatment applications for the patient; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and (ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course; the application for authorisation includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing PBS-subsidised treatment with etanercept for a period of less than 24 weeks (other than a prescription for the first 4 weeks of continuing treatment immediately following an initial treatment course), and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment, for up to 4 weeks, within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of initial PBS-subsidised treatment with etanercept as 'grandfathered' patients immediately prior to this course of therapy and who, at the time of application, meet the criteria for continuing treatment with etanercept as specified above, and where a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form (which includes a copy of the completed BASDAI Assessment Form) is submitted to the Medicare Australia CEO by facsimile
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity: the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgement form; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and (3) have not failed treatment with etanercept during the current Treatment Cycle; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16 week initial treatment course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) were receiving treatment with etanercept prior to 17 March 2005; and (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and
where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In respect of the injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL:
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrable in the patient at the time of the authority application; a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Adminstration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with etanercept as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis; and (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and (c) have not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who have previously demonstrated a response to PBS-subsidised treatment with etanercept within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent 12-week course of PBS-subsidised etanercept treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; a course of initial treatment within a Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, with etanercept as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of etanercept for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with etanercept prior to 16 March 2006; and (b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with etanercept; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with etanercept; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of etanercept therapy) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form; the most recent PASI assessment is no more than 1 month old at the time of application; the course of treatment is limited to a maximum of 12 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis, who were receiving non-PBS-subsidised treatment with etanercept prior to 16 March 2006, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, after at least 12 weeks of etanercept treatment, when compared with the baseline value for this Treatment Cycle established prior to biological agent treatment; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless the assessment of response is conducted at the completion of the 12-week treatment course and is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased; patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept are not eligible to commence further treatment with etanercept until they have completed a period free from biological agent therapy of at least 12 weeks duration, immediately following cessation of that course of treatment;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams along with the date of the assessment of the patient's condition; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have severe chronic plaque psoriasis of the face or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply: failure to achieve an adequate response is demonstrable in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application; if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, or recommencement of treatment, with etanercept as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and (c) have not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle; and
where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who have previously demonstrated a response to PBS-subsidised treatment with etanercept within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent 12-week course of PBS-subsidised etanercept treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; a course of initial treatment within a Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, with etanercept as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of etanercept for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with etanercept prior to 16 March 2006; and (b) whose disease, prior to treatment with etanercept, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and (c) who have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) who have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with etanercept; and
where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of etanercept therapy) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) a copy of the signed patient acknowledgement form; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment score; the most recent PASI assessment is no more than 1 month old at the time of application; the course of treatment is limited to a maximum of 12 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who were receiving non-PBS-subsidised treatment with etanercept prior to 16 March 2006, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means efalizumab or etanercept; and
where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, after at least 12 weeks of etanercept treatment, as compared to the baseline values established prior to biological agent treatment; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, after at least 12 weeks of etanercept treatment, as compared to the baseline value established prior to biological agent treatment; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless the assessment of response is conducted at the completion of the 12-week treatment course and is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased; patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept are not eligible to commence further treatment with etanercept until they have completed a period free from biological agent therapy of at least 12 weeks duration, immediately following cessation of that course of treatment; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 12 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: (i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or (ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgement form; a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with etanercept within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised etanercept treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy; a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and
where the following conditions apply: failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with etanercept; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of etanercept therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient
Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and where the following conditions apply: the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
Ethacrynic Acid
Patients hypersensitive to other oral diuretics
Ethosuximide
—
Etonogestrel
—
Etoposide
—
Etoposide Phosphate
—
Everolimus
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Exemestane
Treatment of hormone-dependent advanced breast cancer in post-menopausal women with disease progression following treatment with tamoxifen citrate
Ezetimibe
In compliance with authority procedures set out in subparagraph 14 (d):
For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is contraindicated
For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is unsuitable because the patient developed a clinically important product-related adverse event during treatment with a statin and required discontinuation of all statin treatment, and where a clinically important product-related adverse event is defined as follows:
Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin
Homozygous sitosterolaemia
Treatment, in combination with an HMG CoA reductase inhibitor (statin), of patients with homozygous familial hypercholesterolaemia whose cholesterol level, after dietary therapy, is greater than 6.5 mmol per L, or greater than 5.5 mmol per L in patients with a high density lipoprotein level of less than 1 mmol per L, or greater that 4 mmol per L in patients with existing coronary heart disease
Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease whose cholesterol levels are inadequately controlled with a statin, where inadequate control with a statin is defined as a cholesterol level greater than 4 mmol per L after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application
Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with diabetes mellitus whose cholesterol levels are inadequately controlled with a statin, where inadequate control with a statin is defined as a cholesterol level greater than 6.5 mmol per L (or greater than 5.5 mmol per L in patients with a high density lipoprotein level less than 1 mmol per L) after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application
Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with peripheral vascular disease whose cholesterol levels are inadequately controlled with a statin, where inadequate control with a statin is defined as a cholesterol level greater than 6.5 mmol per L (or greater than 5.5 mmol per L in patients with a high density lipoprotein level less than 1 mmol per L) after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application
Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with heterozygous familial hypercholesterolaemia whose cholesterol levels are inadequately controlled with a statin, where inadequate control with a statin is defined as a cholesterol level greater than 6.5 mmol per L (or greater than 5.5 mmol per L in patients with a high density lipoprotein level less than 1 mmol per L) after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application
Continuing treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease or diabetes mellitus or peripheral vascular disease or heterozygous familial hypercholesterolaemia whose cholesterol levels were inadequately controlled with a statin, where the patient has previously been issued with an authority prescription for this drug
Ezetimibe with Simvastatin
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, in conjunction with dietary therapy and exercise, of patients with coronary heart disease whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), where inadequate control with a statin is defined as a cholesterol level greater than 4 mmol per L after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application
Initial treatment, in conjunction with dietary therapy and exercise, of patients with diabetes mellitus whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), where inadequate control with a statin is defined as a cholesterol level greater than 6.5 mmol per L (or greater than 5.5 mmol per L in patients with a high density lipoprotein level less than 1 mmol per L) after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application
Initial treatment, in conjunction with dietary therapy and exercise, of patients with peripheral vascular disease whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), where inadequate control with a statin is defined as a cholesterol level greater than 6.5 mmol per L (or greater than 5.5 mmol per L in patients with a high density lipoprotein level less than 1 mmol per L) after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application
Initial treatment, in conjunction with dietary therapy and exercise, of patients with heterozygous familial hypercholesterolaemia whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), where inadequate control with a statin is defined as a cholesterol level greater than 6.5 mmol per L (or greater than 5.5 mmol per L in patients with a high density lipoprotein level less than 1 mmol per L) after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application
Continuing treatment of patients with coronary heart disease or diabetes mellitus or peripheral vascular disease or heterozygous familial hypercholesterolaemia whose cholesterol levels were inadequately controlled with an HMG CoA reductase inhibitor (statin), where the patient has previously been issued with an authority prescription for this item or the combination of ezetimibe and 40 mg or greater of a statin
Treatment of patients with homozygous familial hypercholesterolaemia whose cholesterol level, after dietary therapy, is greater than 6.5 mmol per L, or greater than 5.5 mmol per L in patients with a high density lipoprotein level of less than 1 mmol per L, or greater than 4 mmol per L in patients with existing coronary heart disease
Famciclovir
In respect of the tablet 125 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
In respect of the tablet 250 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of patients with herpes zoster within 72 hours of the onset of the rash
Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
In respect of the tablet 500 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of immunocompromised patients with herpes zoster within 72 hours of the onset of the rash
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes in immunocompromised patients, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Famotidine
—
Felodipine
—
Fenofibrate
For use in accordance with paragraph 16
Fentanyl
Chronic severe disabling pain not responding to non-narcotic analgesics
Ferrous Fumarate with Folic Acid
—
Ferrous Sulfate
—
Flecainide Acetate
Serious supra-ventricular cardiac arrhythmias
Serious ventricular cardiac arrhythmias where treatment is initiated in a hospital (in-patient or out-patient)
Flucloxacillin Magnesium with Water - Purified BP
Serious staphylococcal infections
Flucloxacillin Sodium
In respect of the powder for injection equivalent to 500 mg flucloxacillin and powder for injection equivalent to 1 g flucloxacillin:
—
In respect of the capsule equivalent to 250 mg flucloxacillin and capsule equivalent to 500 mg flucloxacillin:
Serious staphylococcal infections
Fluconazole
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of cryptococcal meningitis in patients unable to take or tolerate amphotericin
Maintenance therapy in patients with cryptococcal meningitis and immunosuppression
Treatment of oropharyngeal candidiasis in immunosuppressed patients
Treatment of oesophageal candidiasis in immunosuppressed patients
Secondary prophylaxis of oropharyngeal candidiasis in immunosuppressed patients
Treatment of serious and life-threatening candida infections in patients unable to tolerate amphotericin
Fludrocortisone Acetate
—
Fluorometholone
—
Fluorometholone Acetate
—
Fluorouracil
—
Fluoxetine Hydrochloride
Major depressive disorders
Obsessive-compulsive disorder
Flupenthixol Decanoate
—
Fluphenazine Decanoate
—
Flurbiprofen Sodium
—
Flutamide
In compliance with authority procedures set out in subparagraph 14 (d):
Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy
Fluticasone Propionate
—
Fluticasone Propionate with Salmeterol Xinafoate
Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate
Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate
Fluvastatin Sodium
For use in accordance with paragraph 16
Fluvoxamine Maleate
Major depressive disorders
Obsessive-compulsive disorder
Folic Acid
—
Follitropin Alfa
In respect of the injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL and the injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL:
Anovulatory infertility
In respect of the injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL, injection 300 I.U. in 0.5 mL multi-dose cartridge, injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL, injection 450 I.U. in 0.75 mL multi-dose cartridge and injection 900 I.U. in 1.5 mL multi-dose cartridge:
Anovulatory infertility
In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis
Follitropin Beta
Anovulatory infertility
In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis
Fondaparinux Sodium
In compliance with authority procedures set out in subparagraph 14 (d):
Prevention of venous thromboembolic events in patients undergoing major hip surgery
Prevention of venous thromboembolic events in patients undergoing total knee replacement
Fosinopril Sodium
—
Fosinopril Sodium with Hydrochlorothiazide
Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or fosinopril sodium monotherapy
Fotemustine
In compliance with authority procedures set out in subparagraph 14 (d):
Metastatic malignant melanoma
Framycetin Sulfate
—
Frusemide
—
Gabapentin
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs
Galantamine Hydrobromide
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more who demonstrate improvement in cognitive function following initial therapy, as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination, or a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale, for patients with a Mini-Mental State Examination baseline score of at least 25 points, where the relevant result from the Mini-Mental State Examination or the Alzheimer's Disease Assessment Scale, cognitive sub-scale, is included in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more and with demonstrated improvement in cognitive function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial therapy, based on a rating of very much improved or much improved on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less and with demonstrated improvement in function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Gefitinib
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment subsidised under the Pharmaceutical Benefits Scheme (PBS), as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a World Health Organisation (WHO) performance status of 2 or less, and: (a) in whom disease progression has occurred following treatment with at least 1 chemotherapy agent; and (b) where there is evidence that the patient has at least 1 activating mutation of the epidermal growth factor receptor (EGFR) gene in tumour material, unless: (i) the patient commenced treatment with gefitinib prior to 1 July 2004, in which case, although an attempt must be made to test for the presence of an activating mutation of the EGFR gene, the patient is exempt from meeting this requirement; or
(ii) the patient commenced treatment with gefitinib between 1 July 2004 and 27 September 2004, in which case a test for the presence of an activating mutation of the EGFR gene with a negative result does not render the patient ineligible if a radiological assessment of the patient which is less than 1 month old at the date of the authority application demonstrates that disease progression has not occurred while the patient has been on gefitinib therapy; and where the following conditions apply: the presence of a mutation is demonstrated by analysis of the DNA sequence of the EGFR gene; the authority application includes the following: (i) a completed copy of the appropriate Gefitinib (Iressa) PBS Authority Application - Supporting Information Form; and (ii) details of the prior chemotherapy including the names of drugs and date of the most recent treatment cycle; and (iii) details of the patient's WHO performance status; and (iv) a copy of the pathology report from an Approved Pathology Authority providing the result of the test for the presence of an activating mutation, or mutations, of the EGFR gene; and (v) where the patient is claiming exemption from the requirement to test positive for the presence of an activating mutation of the EGFR gene on the basis that treatment with gefitinib commenced between 1 July 2004 and 27 September 2004 and a radiological assessment within the month prior to the application shows disease progression has not occurred while on gefitinib therapy, a copy of that radiological assessment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii):
Continuing treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a World Health Organisation performance status of 2 or less, where the patient has previously been issued with an authority prescription for gefitinib
Gelatin - Succinylated
—
Gemcitabine Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Advanced breast cancer in combination with paclitaxel after failure of prior therapy which includes an anthracycline
Advanced epithelial ovarian cancer, in combination with carboplatin, in patients who relapse more than 6 months after platinum-based therapy
Locally advanced or metastatic non-small cell lung cancer
Locally advanced or metastatic adenocarcinoma of the pancreas
Locally advanced or metastatic bladder cancer, when used in combination with cisplatin
Gemfibrozil
For use in accordance with paragraph 16
Gentamicin Sulfate
In respect of the injection equivalent to 80 mg gentamicin in 2 mL ampoule:
—
In respect of the eye drops equivalent to 3 mg gentamicin per mL, 5 mL:
Invasive ocular infection
Perioperative use in ophthalmic surgery
Suspected pseudomonal eye infection
Gestrinone
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months' uninterrupted therapy
Glatiramer Acetate
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient
Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy
Glibenclamide
—
Gliclazide
—
Glimepiride
—
Glipizide
—
Glucagon Hydrochloride
—
Glucose
—
Glucose and Ketone Indicator—Urine
—
Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
—
Glucose Indicator—Blood
In respect of the electrode strips, 50 (Advantage II), electrode strips, 50 (Freestyle Papillon), electrode strips, 50 (Glucocard 01 Sensor), electrode strips, 50 (GlucoCare), electrode strips, 50 (GlucoCare Super Sensor), electrode strips, 50 (GlucoMen Sensor), electrode strips, 50 (Omnitest EZ), electrode strips, 50 (TrueTrack), discs containing electrode sensors, 10 sensors per disc, 5, electrode strips, 100 (Optium glucose), electrode strips, 100 (SofTact), electrode strips, 100 (TrueSense), reagent strips, 50 (Accu-Chek Active), reagent strips, 50 (Accu-Chek Go), reagent strips, 51 (Accu-Chek Integra), reagent strips, 50 (Betachek), reagent strips, 50 (CareSens), reagent strips, 50 (Glucoflex-R), reagent strips, 50 (Glucostix) and reagent strips, 50 (SensoCard):
—
In respect of the electrode strips, 50 (Ascensia Elite) and electrode strips, 100 (Precision Plus):
In compliance with authority procedures set out in subparagraph 14 (d):
Patients who have previously received this product as a pharmaceutical benefit
Patients who have purchased a meter to be used with this product prior to 1 August 2003
Glucose Indicator—Urine
—
Glycerol
Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
Patients receiving palliative care
Terminal malignant neoplasia
Anorectal congenital abnormalities
Megacolon
Glyceryl Trinitrate
—
Goserelin Acetate
In respect of the subcutaneous implant equivalent to 3.6 mg goserelin in pre-filled injection syringe:
In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate
Hormone-dependent locally advanced (equivalent to stage III) or metastatic (equivalent to stage IV) breast cancer in pre-menopausal women
Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months' uninterrupted therapy
In respect of the subcutaneous implant (long acting) equivalent to 10.8 mg goserelin in pre-filled injection syringe:
In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate
Granisetron Hydrochloride
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy
In compliance with authority procedures set out in subparagraph 14 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Griseofulvin
—
Haloperidol
—
Haloperidol Decanoate
—
"HCU express"
Pyridoxine non-responsive homocystinuria
"HCU gel"
Pyridoxine non-responsive homocystinuria
Heparin Sodium
—
Hexamine Hippurate
—
Homatropine Hydrobromide
—
Hydralazine Hydrochloride
—
Hydrochlorothiazide
—
Hydrochlorothiazide with Amiloride Hydrochloride
—
Hydrochlorothiazide with Triamterene
—
Hydrocortisone
In respect of the tablet 4 mg and tablet 20 mg:
—
In respect of the cream 10 mg per g, 50 g:
Treatment of corticosteroid-responsive dermatoses
Hydrocortisone Acetate
In respect of the eye ointment 5 mg per g, 5 g and eye ointment 10 mg per g, 5 g:
—
In respect of the cream 10 mg per g, 30 g, cream 10 mg per g, 50 g, ointment 10 mg per g, 30 g and ointment 10 mg per g, 50 g:
Treatment of corticosteroid-responsive dermatoses
In respect of the rectal foam 90 mg per applicatorful, 14 applications, aerosol 21.1 g:
Proctitis
Ulcerative colitis
Hydrocortisone Sodium Succinate
—
Hydromorphone Hydrochloride
In respect of the injection 2 mg in 1 mL ampoule, injection 10 mg in 1 mL ampoule, injection 50 mg in 5 mL ampoule and injection 500 mg in 50 mL vial:
—
In respect of the tablet 2 mg, tablet 4 mg, tablet 8 mg and oral liquid 1 mg per mL, 473 mL:
Severe disabling pain not responding to non-narcotic analgesics
Hydroxocobalamin
Pernicious anaemia
Other proven vitamin B12 deficiencies
Prophylaxis after gastrectomy
Hydroxychloroquine Sulfate
—
Hydroxyurea
—
Hypromellose
Severe dry eye syndrome, including Sjogren's syndrome
Hypromellose with Carbomer 980
Severe dry eye syndrome, including Sjogren's syndrome
Hypromellose 2900 with Dextran 70
In compliance with authority procedures set out in subparagraph 14 (d):
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Hypromellose 4500 with Dextran 70
Severe dry eye syndrome, including Sjogren's syndrome
Ibuprofen
In respect of the tablet 400 mg:
—
In respect of the tablet 200 mg:
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Idarubicin Hydrochloride
Acute myelogenous leukaemia
Ifosfamide
Relapsed or refractory germ cell tumours following first-line chemotherapy
Relapsed or refractory sarcomas following first-line chemotherapy
Imipramine Hydrochloride
—
Indapamide Hemihydrate
—
Indomethacin
In respect of the suppository 100 mg:
—
In respect of the capsule 25 mg:
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Influenza Vaccine (Split Virion) - Inactivated
Persons at special risk of adverse consequences from infections of the lower respiratory tract
Insect Allergen Extract—Honey Bee Venom
—
Insect Allergen Extract—Paper Wasp Venom
—
Insect Allergen Extract—Yellow Jacket Venom
—
Insulin - Isophane
—
Insulin - Neutral
—
Insulin - Neutral with Insulin - Isophane
—
Insulin Aspart
—
Insulin Aspart with Insulin Aspart Protamine Suspension
—
Insulin Lispro
—
Insulin Lispro with Insulin Lispro Protamine Suspension
—
Interferon Alfa-2a
In respect of the injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe:
In compliance with authority procedures set out in subparagraph 14 (d):
Hairy cell leukaemia
Myeloproliferative disease with excessive thrombocytosis
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
In respect of the injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe, injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe and injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe:
In compliance with authority procedures set out in subparagraph 14 (d):
Myeloproliferative disease with excessive thrombocytosis
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Interferon Alfa-2b
In respect of the solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen:
In compliance with authority procedures set out in subparagraph 14 (d):
Hairy cell leukaemia
Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
In respect of the solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen:
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Interferon Beta-1a
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient
Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy
Interferon Beta-1b
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient
Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy
Ipratropium Bromide
In respect of the pressurised inhalation 21 micrograms per dose, 200 doses (CFC-free formulation):
—
In respect of the nebuliser solution 250 micrograms (anhydrous) in 1 mL single dose units, 30, nebuliser solution 500 micrograms (anhydrous) in 1 mL single dose units, 30 and nebuliser solution 250 micrograms (anhydrous) per mL, 20 mL:
Asthma in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer
Chronic obstructive pulmonary disease in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer
Irbesartan
—
Irbesartan with Hydrochlorothiazide
Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or irbesartan monotherapy
Irinotecan Hydrochloride Trihydrate
In compliance with authority procedures set out in subparagraph 14 (d):
Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less
Iron Polymaltose Complex
—
Iron Sucrose
In compliance with authority procedures set out in subparagraph 14 (d):
Iron deficiency anaemia, when used in combination with either epoetin alfa or darbepoetin alfa, in patients undergoing chronic haemodialysis who have had a documented hypersensitivity reaction to iron polymaltose and in whom continued intravenous iron therapy is appropriate
Isoniazid
—
Isosorbide Dinitrate
—
Isosorbide Mononitrate
—
Isotretinoin
In compliance with authority procedures set out in subparagraph 14 (d):
Severe cystic acne not responsive to other therapy
Itraconazole
In compliance with authority procedures set out in subparagraph 14 (d):
Systemic aspergillosis
Systemic sporotrichosis
Systemic histoplasmosis
Treatment and maintenance therapy in patients with Acquired Immunodeficiency Syndrome who have disseminated pulmonary histoplasmosis infection
Treatment and maintenance therapy in patients with Acquired Immunodeficiency Syndrome who have chronic pulmonary histoplasmosis infection
Treatment of oropharyngeal candidiasis in immunosuppressed patients
Treatment of oesophageal candidiasis in immunosuppressed patients
Ivermectin
In compliance with authority procedures set out in subparagraph 14 (d):
Onchocerciasis
Strongyloidiasis
"Karicare De-Lact"
In compliance with authority procedures set out in subparagraph 14 (d):
Acute lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose
Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Ketoconazole
In respect of the tablet 200 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Symptomatic genital candidiasis recurring after treatment of at least 2 episodes with topical therapy
Oral candidiasis in severely immunocompromised persons where topical therapy has failed
Systemic or deep mycoses where other forms of therapy have failed
In respect of the cream 20 mg per g, 30 g, shampoo 10 mg per g, 100 mL and shampoo 20 mg per g, 60 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
"Ketonex-1"
Maple syrup urine disease
"Ketonex-2"
Maple syrup urine disease
Ketoprofen
In respect of the suppository 100 mg:
—
In respect of the capsule 200 mg (sustained release):
Chronic arthropathies (including osteoarthritis) with an inflammatory component
"Kindergen"
In compliance with authority procedures set out in subparagraph 14 (d):
Infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet
Labetalol Hydrochloride
—
Lactulose
Hepatic coma or precoma (chronic porto-systemic encephalopathy)
Constipation in patients with malignant neoplasia
Lamotrigine
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs
Lansoprazole
In respect of the capsule 30 mg:
Initial treatment of peptic ulcer
Gastro-oesophageal reflux disease
Scleroderma oesophagus
In respect of the sachet containing granules for oral suspension, 30 mg per sachet:
Initial treatment of peptic ulcer
Gastro-oesophageal reflux disease
Scleroderma oesophagus
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of peptic ulcer, in patients unable to take a solid dose form of a proton pump inhibitor
Gastro-oesophageal reflux disease, in patients unable to take a solid dose form of a proton pump inhibitor
Scleroderma oesophagus, in patients unable to take a solid dose form of a proton pump inhibitor
In respect of the capsule 15 mg:
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Latanoprost
—
Latanoprost with Timolol Maleate
Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL or latanoprost eye drops
Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL or latanoprost eye drops
Leflunomide
In respect of the pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Initiation treatment of severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective and where the authority application is made by a consultant physician
In respect of the tablet 10 mg and tablet 20 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Initiation treatment of severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective and where the authority application is made by a consultant physician
Ongoing leflunomide therapy for severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective
Lercanidipine Hydrochloride
—
Letrozole
Treatment of hormone-dependent advanced breast cancer in post-menopausal women
Leuprorelin Acetate
In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate
Levetiracetam
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
Levobunolol Hydrochloride
—
Levodopa with Benserazide Hydrochloride
—
Levodopa with Carbidopa
In respect of the tablet 100 mg-25 mg (anhydrous) and tablet 250 mg-25 mg (anhydrous):
—
In respect of the tablet 200 mg-50 mg (anhydrous) (modified release):
In compliance with authority procedures set out in subparagraph 14 (d):
Parkinson's disease where fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor
Levodopa with Carbidopa and Entacapone
In compliance with authority procedures set out in subparagraph 14 (d):
Parkinson's disease in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect
Parkinson's disease in patients stabilised on concomitant treatment with levodopa—decarboxylase inhibitor combinations and entacapone
Levonorgestrel
In respect of the tablets 30 micrograms, 28:
—
In respect of the intrauterine drug delivery system 52 mg:
Contraception
Levonorgestrel with Ethinyloestradiol
—
Lignocaine Hydrochloride
—
Lincomycin Hydrochloride
—
Liothyronine Sodium
In compliance with authority procedures set out in subparagraph 14 (d):
Management of patients with thyroid cancer
Replacement therapy for hypothyroid patients who have documented intolerance to thyroxine sodium
Replacement therapy for hypothyroid patients who have documented resistance to thyroxine sodium
Initiation of thyroid therapy in severely hypothyroid patients
Lisinopril
—
Lithium Carbonate
—
"Locasol"
In compliance with authority procedures set out in subparagraph 14 (d):
Hypercalcaemia in children under the age of 4 years
Loperamide Hydrochloride
—
"Lophlex"
Phenylketonuria
"Lophlex LQ"
Phenylketonuria
Lumiracoxib
Symptomatic treatment of osteoarthritis
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Constipation in patients with malignant neoplasia
"Mapleflex"
Maple syrup urine disease
Medroxyprogesterone Acetate
In respect of the tablet 5 mg, tablet 10 mg, injection 50 mg in 1 mL vial and injection 150 mg in 1 mL vial:
—
In respect of the tablet 500 mg:
Hormone-dependent advanced breast cancer
In respect of the tablet 100 mg, tablet 200 mg and tablet 250 mg:
Hormone-dependent breast cancer
Endometrial cancer
Mefenamic Acid
Dysmenorrhoea
Menorrhagia
Megestrol Acetate
Hormone-dependent advanced breast cancer
Meloxicam
Symptomatic treatment of osteoarthritis
Melphalan
—
Mercaptopurine
—
Mesalazine
In respect of the suppositories 1 g, 28:
Acute episode of mild to moderate ulcerative proctitis
In respect of the tablet 250 mg and tablet 500 mg (enteric coated):
In compliance with authority procedures set out in subparagraph 14 (d):
Ulcerative colitis where hypersensitivity to sulfonamides exists
Ulcerative colitis where intolerance to sulfasalazine exists
Crohn's disease where hypersensitivity to sulfonamides exists
Crohn's disease where intolerance to sulfasalazine exists
In respect of the sachet containing granules, 500 mg per sachet and sachet containing granules, 1 g per sachet:
In compliance with authority procedures set out in subparagraph 14 (d):
Ulcerative colitis where hypersensitivity to sulfonamides exists
Ulcerative colitis where intolerance to sulfasalazine exists
In respect of the enemas 1 g in 100 mL, 7, enemas 2 g in 60 mL, 7, enemas 4 g in 60 mL, 7 and rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g:
In compliance with authority procedures set out in subparagraph 14 (d):
Acute episode of mild to moderate ulcerative colitis
Mesna
Adjunctive therapy for use with ifosfamide or high dose cyclophosphamide
"Metabolic Mineral Mixture"
Metabolic disorders
Metformin Hydrochloride
—
Metformin Hydrochloride with Glibenclamide
—
Methadone Hydrochloride
Severe disabling pain not responding to non-narcotic analgesics
Methotrexate
—
Methyldopa
—
Methylphenidate Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Use in attention deficit hyperactivity disorder, in accordance with State/Territory law
Methylprednisolone Aceponate
In respect of the cream 1 mg per g, 15 g, ointment 1 mg per g, 15 g and fatty ointment 1 mg per g, 15 g:
Treatment of corticosteroid-responsive dermatoses
In respect of the lotion 1 mg per g, 20 g:
Eczema
Methylprednisolone Acetate
For local intra-articular or peri-articular infiltration
Methylprednisolone Sodium Succinate
—
Methysergide Maleate
—
Metoclopramide Hydrochloride
—
Metoprolol Succinate
In compliance with authority procedures set out in subparagraph 14 (d):
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated
Metoprolol Tartrate
—
Metronidazole
In respect of the tablet 200 mg, tablet 400 mg and suppositories 500 mg, 10:
—
In respect of the I.V. infusion 500 mg in 100 mL:
Prophylaxis in large bowel surgery
Treatment, in a hospital, of acute anaerobic sepsis
Metronidazole Benzoate
—
Mexiletine Hydrochloride
—
Mianserin Hydrochloride
Severe depression
Miconazole
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
Miconazole Nitrate
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
"Minaphlex"
Phenylketonuria
Minocycline Hydrochloride
In respect of the capsule equivalent to 100 mg minocycline:
—
In respect of the tablet equivalent to 50 mg minocycline:
Severe acne not responding to other tetracyclines
Minoxidil
In compliance with authority procedures set out in subparagraph 14 (d):
Severe refractory hypertension where treatment with minoxidil was initiated in a hospital (in-patient or out-patient)
Mirtazapine
Major depressive disorders
Misoprostol
In compliance with authority procedures set out in subparagraph 14 (d):
Reduction in the incidence of gastrointestinal complications in patients who have a history of peptic ulcer disease and in whom non-steroidal anti-inflammatory drug therapy is essential
Duodenal ulcer (including pyloric and stomal ulcers), proven by current or prior x-ray, endoscopy or surgery, where the date on which, and the method by which, the ulcer was proven are included in the authority application
Gastric ulcer, proven by x-ray, endoscopy or surgery within the previous 2 years, where the date on which, and the method by which, the ulcer was proven are included in the authority application
Mitozantrone Hydrochloride
—
Moclobemide
Major depressive disorders
Modafinil
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Initial treatment, by a qualified sleep medicine practitioner or neurologist, of patients with narcolepsy where: (i) intolerance to dexamphetamine sulfate of a severity necessitating permanent treatment withdrawal develops; or (ii) therapy with dexamphetamine sulfate poses an unacceptable medical risk, as indicated by the presence of any 1 of the following: (a) a psychiatric disorder; (b) a cardiac disorder; (c) a history of substance abuse; (d) glaucoma; (e) any other absolute contraindication to dexamphetamine sulfate as specified in the Therapeutic Goods Administration-approved Product Information; and where the patient meets the following definition of narcolepsy: excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months, and: (i) a definite history of cataplexy and a Multiple Sleep Latency Test (MSLT), conducted following at least 6 hours of sleep, with a mean sleep latency less than or equal to 8 minutes; or (ii) a MSLT, conducted following at least 6 hours of sleep, with a mean sleep latency less than or equal to 8 minutes and 2 or more sleep onset rapid eye movement (REM) periods; and where the following conditions apply: the MSLT is preceded by nocturnal polysomnography; the polysomnography test and the MSLT are conducted by, or under the supervision of, a qualified sleep medicine practitioner; polygraph records and sleep reports are available for audit by the Medicare Australia CEO; the authority application includes the following: (a) a completed copy of the appropriate Modafinil (Modavigil) PBS Authority Application - Supporting Information Form; and (b) the result and date of the polysomnography test; and (c) the results and date of the MSLT; and (d) details of the contraindication or intolerance to dexamphetamine sulfate; the results of the polysomnography test and the MSLT which are included in the authority application are no more than 5 years old at the time of application
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii):
Continuing treatment of narcolepsy, where the patient has previously been issued with an authority prescription for this drug
Mometasone Furoate
Treatment of corticosteroid-responsive dermatoses
"Monogen"
Chylous ascites
Chylothorax
Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders
Hyperlipoproteinaemia type 1
Long chain fatty acid oxidation disorders
Montelukast Sodium
In respect of the tablet, chewable, equivalent to 4 mg montelukast:
In compliance with authority procedures set out in subparagraph 14 (d):
First-line preventer medication, as the single preventer agent for children aged from 2 to less than 6 years with frequent episodic or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium
In respect of the tablet, chewable, equivalent to 5 mg montelukast:
In compliance with authority procedures set out in subparagraph 14 (d):
First-line preventer medication, as the single preventer agent for children aged from 6 to less than 15 years with frequent episodic or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium
Morphine Hydrochloride
Severe disabling pain not responding to non-narcotic analgesics
Morphine Sulfate
In respect of the injection 10 mg in 1 mL ampoule, injection 15 mg in 1 mL ampoule and injection 30 mg in 1 mL ampoule:
—
In respect of the tablet 10 mg and tablet 20 mg:
Severe disabling pain due to cancer not responding to non-narcotic analgesics
In respect of the tablet 30 mg:
Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 15 mg (controlled release), tablet 30 mg (controlled release), tablet 60 mg (controlled release), tablet 100 mg (controlled release), capsule 10 mg (containing sustained release pellets), capsule 20 mg (containing sustained release pellets), capsule 30 mg (controlled release), capsule 50 mg (containing sustained release pellets), capsule 60 mg (controlled release), capsule 90 mg (controlled release), capsule 100 mg (containing sustained release pellets), capsule 120 mg (controlled release), sachet containing controlled release granules for oral suspension, 20 mg per sachet, sachet containing controlled release granules for oral suspension, 30 mg per sachet, sachet containing controlled release granules for oral suspension, 60 mg per sachet and sachet containing controlled release granules for oral suspension, 100 mg per sachet:
Chronic severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet 200 mg (controlled release) and sachet containing controlled release granules for oral suspension, 200 mg per sachet:
In compliance with authority procedures set out in subparagraph 14 (d):
Chronic severe disabling pain due to cancer
Morphine Tartrate
—
Moxifloxacin Hydrochloride
In respect of the solution for I.V. infusion equivalent to 400 mg moxifloxacin in 250 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of radiologically-confirmed, severe community-acquired pneumonia, requiring admission to an intensive care or high dependency unit, in patients greater than 12 years old with a history of hypersensitivity to penicillin
In respect of the tablet equivalent to 400 mg moxifloxacin:
In compliance with authority procedures set out in subparagraph 14 (d):
Oral treatment, following initial intravenous treatment with moxifloxacin hydrochloride, of radiologically-confirmed, severe community-acquired pneumonia, requiring admission to an intensive care or high dependency unit, in patients greater than 12 years old with a history of hypersensitivity to penicillin
Radiologically-confirmed, severe community-acquired pneumonia requiring hospitalisation, in patients greater than 12 years old with a history of hypersensitivity to penicillin
Radiologically-confirmed, community-acquired pneumonia in patients greater than 12 years old with a history of immediate hypersensitivity to penicillin (as defined by urticaria, angioedema, bronchospasm or anaphylaxis within 1 hour of drug administration)
Moxonidine
Hypertension in patients receiving concurrent antihypertensive therapy
"MSUD AID III"
Maple syrup urine disease
"MSUD Analog"
Maple syrup urine disease
"MSUD Express"
Maple syrup urine disease
"MSUD Maxamaid"
Maple syrup urine disease
"MSUD Maxamum"
Maple syrup urine disease
"MSUD-gel"
Maple syrup urine disease
Mycophenolate Mofetil
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Mycophenolate Mofetil with Water - Purified BP
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Mycophenolate Sodium
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate sodium, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Nafarelin Acetate
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 6 months, of visually proven endometriosis
Subsequent treatment, for up to 6 months, of visually proven endometriosis, where 2 years or more have elapsed since the end of the previous course and where a recent bone density assessment has been made and where the date of the assessment is included in the authority application
Naloxone Hydrochloride
—
Naltrexone Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence
Nandrolone Decanoate
In compliance with authority procedures set out in subparagraph 14 (d):
Monotherapy for osteoporosis where other treatment has failed, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient
Monotherapy for osteoporosis where other treatment is not tolerated, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient
Monotherapy for osteoporosis where other treatment is contraindicated, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient
Patients receiving PBS-subsidised therapy with this drug for osteoporosis prior to 1 February 2004
Patients on long-term treatment with corticosteroids
Naproxen
In respect of the tablet 250 mg, tablet 500 mg, tablet 750 mg (sustained release) and tablet 1 g (sustained release):
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the oral suspension 125 mg per 5 mL, 474 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Chronic arthropathies (including osteoarthritis) with an inflammatory component in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Bone pain due to malignant disease in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Naproxen Sodium
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Naratriptan Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated
Nedocromil Sodium
—
"Neocate"
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
"Neocate Advance"
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Neomycin Sulfate
—
Neomycin Undecenoate with Bacitracin Zinc
—
Nicorandil
—
Nifedipine
—
Nilutamide
In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostatic carcinoma, when used in conjunction with surgical orchidectomy
Nitrazepam
—
Nitrofurantoin
—
Nizatidine
—
Norethisterone
—
Norethisterone with Ethinyloestradiol
—
Norethisterone with Mestranol
—
Norfloxacin
In compliance with authority procedures set out in subparagraph 14 (d):
Acute bacterial enterocolitis
Complicated urinary tract infection
Nortriptyline Hydrochloride
Major depression where other antidepressant therapy has failed
Major depression where other antidepressant therapy is contraindicated
Nystatin
In respect of the tablet 500,000 units, capsule 500,000 units and oral suspension 100,000 units per mL, 24 mL:
—
In respect of the cream 100,000 units per g, 15 g:
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
Oestradiol
In respect of the tablet 2 mg and vaginal tablets 25 micrograms, 15:
—
In respect of the transdermal patches 390 micrograms, 8, transdermal patches 2 mg, 4, transdermal patches 2 mg, 8, transdermal patches 585 micrograms, 8, transdermal patches 3.28 mg, 8, transdermal patches 780 micrograms, 8, transdermal patches 3.8 mg, 4, transdermal patches 4 mg, 8, transdermal patches 4.33 mg, 8, transdermal patches 1.17 mg, 8, transdermal patches 5.7 mg, 4, transdermal patches 6.57 mg, 8, transdermal patches 1.56 mg, 8, transdermal patches 7.6 mg, 4, transdermal patches 8 mg, 8 and transdermal patches 8.66 mg, 8:
For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens
Oestradiol and Oestradiol with Dydrogesterone
—
Oestradiol and Oestradiol with Norethisterone Acetate
In respect of the pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg:
—
In respect of the pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg:
For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens
Oestradiol Hemihydrate
For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens
Oestradiol Hemihydrate and Oestradiol Hemihydrate with Norethisterone Acetate
For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens
Oestradiol Hemihydrate with Norethisterone Acetate
In respect of the tablets equivalent to 1 mg oestradiol with 500 micrograms norethisterone acetate, 28 and tablets equivalent to 2 mg oestradiol with 1 mg norethisterone acetate, 28:
—
In respect of the transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate, 8 and transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate, 8:
For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens
Oestradiol Valerate
—
Oestradiol Valerate and Oestradiol Valerate with Cyproterone Acetate
—
Oestriol
—
Oestrogens—Conjugated
—
Oestrogens—Conjugated with Medroxyprogesterone Acetate
—
Ofloxacin
In compliance with authority procedures set out in subparagraph 14 (d):
Bacterial keratitis
Olanzapine
In compliance with authority procedures set out in subparagraph 14 (d):
Schizophrenia
Maintenance treatment of bipolar I disorder
Olsalazine Sodium
In compliance with authority procedures set out in subparagraph 14 (d):
Ulcerative colitis where hypersensitivity to sulfonamides exists
Ulcerative colitis where intolerance to sulfasalazine exists
Omeprazole
Initial treatment of peptic ulcer
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Omeprazole and Clarithromycin and Amoxycillin Trihydrate
Eradication of Helicobacter pylori associated with peptic ulcer disease
Omeprazole Magnesium
In respect of the tablet equivalent to 20 mg omeprazole:
Initial treatment of peptic ulcer
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
In respect of the tablet equivalent to 10 mg omeprazole:
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Ondansetron
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy
In compliance with authority procedures set out in subparagraph 14 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Ondansetron Hydrochloride Dihydrate
In respect of the tablet equivalent to 4 mg ondansetron, tablet equivalent to 8 mg ondansetron, I.V. injection equivalent to 4 mg ondansetron in 2 mL ampoule and I.V. injection equivalent to 8 mg ondansetron in 4 mL ampoule:
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy
In compliance with authority procedures set out in subparagraph 14 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
In respect of the syrup equivalent to 4 mg ondansetron per 5 mL, 50 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Oxaliplatin
In compliance with authority procedures set out in subparagraph 14 (d):
Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil sodium and calcium folinate
Adjuvant treatment of stage III (Dukes C) colon cancer, in combination with fluorouracil sodium and calcium folinate, following complete resection of the primary tumour
Oxandrolone
In compliance with authority procedures set out in subparagraph 14 (d):
Promotion of growth in girls with Turner syndrome where the date of confirmation of diagnosis is included in the authority application
Promotion of growth in boys of short stature with delayed bone maturation where the date of confirmation of diagnosis is included in the authority application
Oxazepam
—
Oxcarbazepine
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of partial epileptic seizures and primary generalised tonic-clonic seizures, which are not controlled satisfactorily by other anti-epileptic drugs
Oxprenolol Hydrochloride
—
Oxybutynin Hydrochloride
Detrusor overactivity where propantheline bromide has failed
Oxycodone Hydrochloride
In respect of the tablet 5 mg, capsule 5 mg, capsule 10 mg, capsule 20 mg and oral solution 5 mg per 5 mL, 250 mL:
Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 20 mg (controlled release), tablet 40 mg (controlled release) and tablet 80 mg (controlled release):
Chronic severe disabling pain not responding to non-narcotic analgesics
Oxycodone Pectinate
Severe disabling pain not responding to non-narcotic analgesics
Paclitaxel
In compliance with authority procedures set out in subparagraph 14 (d):
Adjuvant treatment of node-positive, oestrogen receptor negative, breast cancer administered sequentially to doxorubicin hydrochloride and cyclophosphamide
Advanced breast cancer after failure of prior therapy which includes an anthracycline
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Primary treatment of ovarian cancer in combination with a platinum compound
Locally advanced or metastatic non-small cell lung cancer
Pancreatic Extract
—
Pancrelipase
—
Pantoprazole Sodium Sesquihydrate
In respect of the tablet (enteric coated), equivalent to 40 mg pantoprazole:
Initial treatment of peptic ulcer
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
In respect of the tablet (enteric coated), equivalent to 20 mg pantoprazole:
Gastro-oesophageal reflux disease
Paracetamol
In respect of the tablet 500 mg, oral liquid 120 mg per 5 mL, 100 mL and oral liquid 240 mg per 5 mL, 200 mL:
—
In respect of the tablet 665 mg (modified release):
Relief of persistent pain associated with osteoarthritis
Paraffin - Soft White with Paraffin - Liquid
—
Paroxetine Hydrochloride
Major depressive disorders
Obsessive-compulsive disorder
Panic disorder
Pemetrexed Disodium Heptahydrate
In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with paclitaxel or docetaxel is contraindicated
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where intolerance to treatment with either docetaxel or paclitaxel has developed
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with either docetaxel or paclitaxel has been unsuccessful
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where transfer to docetaxel or paclitaxel is likely to result in adverse clinical consequences
Penicillamine
—
"Pepti-Junior"
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 3 months, for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a soy protein as the principal formula, and where the date of birth of the patient is included in the authority application
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children aged 2 years and over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Biliary atresia
Chronic liver failure with fat malabsorption
Chylous ascites
Cystic fibrosis
Enterokinase deficiency
Proven fat malabsorption
Severe diarrhoea of greater than 2 weeks' duration in infants under the age of 4 months, where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome
Pergolide Mesylate
Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations
Perhexiline Maleate
In compliance with authority procedures set out in subparagraph 14 (d):
Angina not responding to other therapy
Pericyazine
—
Perindopril Arginine
—
Perindopril Erbumine
—
Perindopril Erbumine with Indapamide Hemihydrate
Hypertension in patients who are not adequately controlled with either indapamide hemihydrate or perindopril monotherapy
Permethrin
—
Pethidine Hydrochloride
Short-term treatment of acute pain
Phenelzine Sulfate
Depression where all other anti-depressant therapy has failed or is inappropriate
"Phenex-1"
Phenylketonuria
"Phenex-2"
Phenylketonuria
Phenobarbitone
Epilepsy
Phenobarbitone Sodium
Epilepsy
Phenoxybenzamine Hydrochloride
Phaeochromocytoma
Neurogenic urinary retention
Phenoxymethylpenicillin Benzathine
—
Phenoxymethylpenicillin Potassium
—
Phenytoin
—
Phenytoin Sodium
—
"Phlexy-10"
Phenylketonuria
"Phlexy-10 Drink Mix"
Phenylketonuria
Pilocarpine Hydrochloride
—
Pimecrolimus
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of facial or eyelid atopic dermatitis in patients aged between 3 months and 18 years who have 1 or more of the following contraindications to topical corticosteroids:
perioral dermatitis;
periorbital dermatitis;
rosacea;
epidermal atrophy;
dermal atrophy;
allergy to topical corticosteroids;
cataracts;
glaucoma;
raised intraocular pressure; and
where the authority application includes the patient's date of birth, a description of the contraindication to topical corticosteroids, and, where the authority approval is sought on the basis of topical corticosteroid allergy, the date and outcome of epicutaneous patch testing; and
where a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for this purpose
Short-term (up to 3 weeks) intermittent treatment of atopic dermatitis of the face or eyelids in patients aged between 3 months and 18 years who fail to achieve satisfactory disease control with intermittent topical corticosteroid therapy and where more than 3 months have passed since the initial diagnosis of atopic dermatitis; and
where failure to achieve satisfactory disease control with intermittent topical corticosteroid therapy is manifest by:
failure of the facial skin to clear despite at least 2 weeks of topical hydrocortisone 1% applied every day; or
failure of the facial skin to clear despite at least 1 week of a moderate or potent topical corticosteroid applied every day; or
clearing of the facial skin with at least 2 weeks of topical hydrocortisone 1% applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; or
clearing of the facial skin with at least 1 week of a moderate or potent topical corticosteroid applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; and
where the authority application includes the patient's date of birth, the duration of atopic dermatitis since initial diagnosis, and the name, quantity and duration of topical corticosteroid therapy used on the face or eyelids in the last month; and
where a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for this purpose
Pindolol
—
Pioglitazone Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Initiation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetes mellitus patients in whom a combination of metformin hydrochloride and a sulfonylurea is contraindicated or not tolerated, and:
(a) who have glycosylated haemoglobin (HbA1c) greater than 7%; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months, where blood glucose monitoring over a 2 week period shows blood glucose levels greater than 10 mmol per L in more than 20% of tests; and
where the date of the HbA1c measurement or the most recent blood glucose level, whichever is applicable in the circumstance, is included in the authority application and is no greater than 4 months old at the time of application
Continuation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetes mellitus patients where the patient has previously been issued with an authority prescription for pioglitazone hydrochloride or rosiglitazone maleate
Initiation of therapy, in combination with insulin, in type 2 diabetes mellitus patients who, despite treatment with insulin and oral anti-diabetic agents, or with insulin alone where metformin hydrochloride is contraindicated, have either:
(a) glycosylated haemoglobin (HbA1c) greater than 7%; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolyic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months, blood glucose levels greater than 10 mmol per L in more than 20% of tests conducted during blood glucose monitoring over a 2 week period; and
where the date of the HbA1c measurement or the most recent blood glucose level, whichever is applicable in the circumstance, is included in the authority application and is no greater than 4 months old at the time of application
Continuation of therapy, in combination with insulin, in type 2 diabetes mellitus patients where the patient has previously been issued with an authority prescription for pioglitazone hydrochloride or rosiglitazone maleate
Piperazine Oestrone Sulfate
—
Piroxicam
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Pizotifen Malate
—
"PK AID II"
Phenylketonuria
"PK Max"
Phenylketonuria
"PKU Express Liquid"
Phenylketonuria
"PKU-gel"
Phenylketonuria
"PKU-Express"
Phenylketonuria
Pneumococcal Vaccine - Polyvalent
Splenectomised persons over 2 years of age
Persons with Hodgkin's disease
Persons at high risk of pneumococcal infections
Polyethylene Glycol 400 with Propylene Glycol
Severe dry eye syndrome, including Sjogren's syndrome
Polygeline
—
Polyvinyl Alcohol
Severe dry eye syndrome, including Sjogren's syndrome
Potassium Chloride
—
Potassium Chloride with Potassium Bicarbonate
—
Pravastatin Sodium
For use in accordance with paragraph 16
Prazosin Hydrochloride
—
Prednisolone
—
Prednisolone Acetate with Phenylephrine Hydrochloride
Corneal grafts
Uveitis
Prednisolone Sodium Phosphate
In respect of the oral solution equivalent to 5 mg prednisolone per mL, 30 mL and enema, retention, equivalent to 20 mg prednisolone in 100 mL:
—
In respect of the suppositories equivalent to 5 mg prednisolone, 10:
Proctitis
Ulcerative colitis
Prednisone
—
Primidone
—
"Pro-Phree"
Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae
Probenecid
—
Procaine Penicillin
—
Prochlorperazine
—
Prochlorperazine Maleate
—
Prochlorperazine Mesylate
—
Promethazine Hydrochloride
—
Propantheline Bromide
Detrusor overactivity
Propranolol Hydrochloride
—
Propylthiouracil
—
Pyrantel Embonate
—
Pyridostigmine Bromide
—
Pyrimethamine
—
Quetiapine Fumarate
In compliance with authority procedures set out in subparagraph 14 (d):
Schizophrenia
Quinagolide Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Pathological hyperprolactinaemia where surgery is not indicated
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
Pathological hyperprolactinaemia where radiotherapy is not indicated
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
Quinapril Hydrochloride
—
Quinapril Hydrochloride with Hydrochlorothiazide
Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or quinapril hydrochloride monotherapy
Quinidine Bisulfate
—
Quinine Bisulfate
In compliance with authority procedures set out in subparagraph 14 (d):
Malaria
Quinine Sulfate
In compliance with authority procedures set out in subparagraph 14 (d):
Malaria
Rabeprazole Sodium
In respect of the tablet 20 mg (enteric coated):
Initial treatment of peptic ulcer
Gastro-oesophageal reflux disease
Scleroderma oesophagus
In respect of the tablet 10 mg (enteric coated):
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Raloxifene Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
Raltitrexed
In compliance with authority procedures set out in subparagraph 14 (d):
For use as a single agent in the treatment of advanced colorectal cancer
Ramipril
—
Ranitidine Hydrochloride
—
"RCF"
Patients with intractable seizures requiring treatment with a ketogenic diet
Glucose transport protein defects
Pyruvate dehydrogenase deficiency
Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance
Reboxetine Mesilate
Major depressive disorders
Reteplase
Treatment of acute myocardial infarction within 6 hours of onset of attack
Rifampicin
In respect of the capsule 150 mg and capsule 300 mg:
Prophylaxis of meningococcal disease in close contacts and carriers
Prophylactic treatment of contacts of patients with Haemophilus influenzae type B
In compliance with authority procedures set out in subparagraph 14 (d):
Leprosy in adults
In respect of the syrup 100 mg per 5 mL, 60 mL:
Prophylaxis of meningococcal disease in close contacts and carriers
Prophylactic treatment of contacts of patients with Haemophilus influenzae type B
Riluzole
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of amyotrophic lateral sclerosis, as diagnosed by a neurologist, in patients aged 75 years or less with disease duration of 2 years or less who have at least 60 percent of predicted forced vital capacity within 2 months prior to commencing riluzole therapy, and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow, and where the date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) are included in the authority application
Initial PBS-subsidised treatment of amyotrophic lateral sclerosis for patients receiving treatment with riluzole prior to 1 March 2003 who would have qualified under the initial treatment criteria for PBS subsidy and where the date of diagnosis, date of commencement of riluzole treatment and the date and results of spirometry (in terms of percent of predicted forced vital capacity) are included in the authority application
Continuing treatment of amyotrophic lateral sclerosis in patients who have previously been issued with an authority prescription for this drug and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow
Risedronate Sodium
In respect of the tablet 5 mg and tablet 35 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
In respect of the tablet 30 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Symptomatic Paget's disease of bone
Risedronate Sodium and Calcium Carbonate
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
Risperidone
In respect of the tablet 0.5 mg and tablet 0.5 mg (orally disintegrating):
In compliance with authority procedures set out in subparagraph 14 (d):
Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful
Schizophrenia
In respect of the tablet 1 mg and tablet 1 mg (orally disintegrating):
In compliance with authority procedures set out in subparagraph 14 (d):
Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful
Schizophrenia
Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder
In respect of the tablet 2 mg, tablet 2 mg (orally disintegrating), tablet 3 mg, tablet 4 mg and oral solution 1 mg per mL, 100 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Schizophrenia
Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder
In respect of the oral solution 1 mg per mL, 30 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful
In respect of the I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL, I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL and I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Schizophrenia
Rituximab
In compliance with authority procedures set out in subparagraph 14 (d):
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Rivastigmine Hydrogen Tartrate
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more who demonstrate improvement in cognitive function following initial therapy, as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination, or a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale, for patients with a Mini-Mental State Examination baseline score of at least 25 points, where the relevant result from the Mini-Mental State Examination or the Alzheimer's Disease Assessment Scale, cognitive sub-scale, is included in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more and with demonstrated improvement in cognitive function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial therapy, based on a rating of very much improved or much improved on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less and with demonstrated improvement in function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Rosiglitazone Maleate
In compliance with authority procedures set out in subparagraph 14 (d):
Initiation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetes mellitus patients in whom a combination of metformin hydrochloride and a sulfonylurea is contraindicated or not tolerated, and:
(a) who have glycosylated haemoglobin (HbA1c) greater than 7%; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months, where blood glucose monitoring over a 2 week period shows blood glucose levels greater than 10 mmol per L in more than 20% of tests; and
where the date of the HbA1c measurement or the most recent blood glucose level, whichever is applicable in the circumstance, is included in the authority application and is no greater than 4 months old at the time of application
Continuation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetes mellitus patients where the patient has previously been issued with an authority prescription for rosiglitazone maleate or pioglitazone hydrochloride
Initiation of therapy, in combination with metformin hydrochloride and a sulfonylurea, in type 2 diabetes mellitus patients who, despite maximally tolerated doses of metformin hydrochloride and a sulfonylurea, have either:
(a) glycosylated haemoglobin (HbA1c) greater than 7%; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months, blood glucose levels greater than 10 mmol per L in more than 20% of tests conducted during blood glucose monitoring over a 2 week period; and
where the date of the HbA1c measurement or the most recent blood glucose level, whichever is applicable in the circumstance, is included in the authority application and is no greater than 4 months old at the time of application
Continuation of therapy, in combination with metformin hydrochloride and a sulfonylurea, in type 2 diabetes mellitus patients where the patient has previously been issued with an authority prescription for rosiglitazone maleate or pioglitazone hydrochloride
Initiation of therapy, in combination with insulin, in type 2 diabetes mellitus patients who, despite treatment with insulin and oral anti-diabetic agents, or insulin alone where metformin hydrochloride is contraindicated, have either:
(a) glycosylated haemoglobin (HbA1c) greater than 7%; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolyic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months, blood glucose levels greater than 10 mmol per L in more than 20% of tests conducted during blood glucose monitoring over a 2 week period; and
where the date of the HbA1c measurement or the most recent blood glucose level, whichever is applicable in the circumstance, is included in the authority application and is no greater than 4 months old at the time of application
Continuation of therapy, in combination with insulin, in type 2 diabetes mellitus patients where the patient has previously been issued with an authority prescription for rosiglitazone maleate or pioglitazone hydrochloride
Roxithromycin
—
"S-26 LF"
In compliance with authority procedures set out in subparagraph 14 (d):
Acute lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose
Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Salbutamol Sulfate
In respect of the oral solution equivalent to 2 mg salbutamol per 5 mL, 150 mL, capsule containing powder for oral inhalation equivalent to 200 micrograms salbutamol (for use in Ventolin Rotahaler) and pressurised inhalation equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation):
—
In respect of the pressurised inhalation in breath actuated device equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation):
Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug
In respect of the nebuliser solution equivalent to 2.5 mg salbutamol in 2.5 mL single dose units, 30, nebuliser solution equivalent to 5 mg salbutamol in 2.5 mL single dose units, 30 and nebuliser solution equivalent to 5 mg salbutamol per mL, 30 mL:
Asthma in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer
Chronic obstructive pulmonary disease in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer
Salcatonin
In compliance with authority procedures set out in subparagraph 14 (d):
Symptomatic Paget's disease of bone
Treatment initiated in a hospital (in-patient or out-patient) of hypercalcaemia
Salmeterol Xinafoate
Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids
Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids
Selegiline Hydrochloride
Late stage Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations
Sertraline Hydrochloride
Major depressive disorders
Obsessive-compulsive disorder
Panic disorder where other treatments have failed or are inappropriate
Silver Sulfadiazine with Chlorhexidine Gluconate
Prevention and treatment of infection in partial or full skin thickness loss due to burns
Prevention and treatment of infection in partial or full skin thickness loss due to epidermolysis bullosa
Stasis ulcers
Simvastatin
For use in accordance with paragraph 16
Sirolimus
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with sirolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Sodium Acid Phosphate
In compliance with authority procedures set out in subparagraph 14 (d):
Familial hypophosphataemia
Hypercalcaemia
Hypophosphataemic rickets
Vitamin D-resistant rickets
Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
—
Sodium Aurothiomalate
—
Sodium Chloride
—
Sodium Chloride with Glucose
—
Sodium Chloride with Potassium Chloride and Calcium Chloride
—
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
—
Sodium Clodronate Tetrahydrate
Maintenance treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy
Multiple myeloma
Bone metastases from breast cancer
Sodium Cromoglycate
In respect of the capsule containing powder for oral inhalation 20 mg (for use in Intal Spinhaler or Intal Halermatic), solution for inhalation 20 mg in 2 mL ampoule, pressurised inhalation 1 mg per dose, 200 doses, pressurised inhalation 1 mg per dose, 200 doses (CFC-free formulation) and pressurised inhalation 5 mg per dose, 112 doses (CFC-free formulation):
—
In respect of the eye drops 20 mg per mL, 10 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Vernal kerato-conjunctivitis
Sodium Fusidate
For use in combination with another antibiotic in the treatment of proven serious staphylococcal infections
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
—
Sodium Valproate
—
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
Patients receiving palliative care
Terminal malignant neoplasia
Anorectal congenital abnormalities
Megacolon
Sotalol Hydrochloride
Severe cardiac arrhythmias
Spironolactone
—
Sterculia with Frangula Bark
Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
Patients receiving palliative care
Terminal malignant neoplasia
Anorectal congenital abnormalities
Megacolon
Sucralfate
—
Sulfacetamide Sodium
—
Sulfasalazine
—
Sulindac
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Sulthiame
—
Sumatriptan
In compliance with authority procedures set out in subparagraph 14 (d):
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated
Sumatriptan Succinate
In compliance with authority procedures set out in subparagraph 14 (d):
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated
Tacrolimus
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy of patients with liver transplants following initiation and stabilisation of treatment with tacrolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with tacrolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Tamoxifen Citrate
Treatment of hormone-dependent breast cancer
Telmisartan
—
Telmisartan with Hydrochlorothiazide
Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or telmisartan monotherapy
Temazepam
—
Temozolomide
In respect of the capsule 5 mg, capsule 20 mg and capsule 100 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Glioblastoma multiforme concomitantly with radiotherapy
Recurrence of anaplastic astrocytoma following standard therapy
Recurrence of glioblastoma multiforme following standard therapy
Glioblastoma multiforme following radiotherapy
In respect of the capsule 250 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Recurrence of anaplastic astrocytoma following standard therapy
Recurrence of glioblastoma multiforme following standard therapy
Glioblastoma multiforme following radiotherapy
Tenecteplase
Treatment of acute myocardial infarction within 12 hours of onset of attack
Terbinafine Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Proximal or extensive (greater than 80% nail involvement) onychomycosis due to dermatophyte infection where topical treatment has failed, where the infection is proven by microscopy or culture and confirmed by an Approved Pathology Authority not more than 12 months prior to the date of the authority application and where the date of the pathology report is included in the authority application
Terbutaline Sulfate
In respect of the injection 500 micrograms in 1 mL ampoule and powder for oral inhalation in breath actuated device 500 micrograms per dose, 200 doses:
—
In respect of the nebuliser solution 5 mg in 2 mL single dose units, 30:
Asthma in patients unable to use this drug delivered from a breath actuated device
Chronic obstructive pulmonary disease in patients unable to use this drug delivered from a breath actuated device
Testosterone
In compliance with authority procedures set out in subparagraph 14 (d):
Androgen deficiency in males with established pituitary or testicular disorders
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age
Testosterone Enanthate
In compliance with authority procedures set out in subparagraph 14 (d):
Androgen deficiency in males with established pituitary or testicular disorders
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age
Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate
In compliance with authority procedures set out in subparagraph 14 (d):
Androgen deficiency in males with established pituitary or testicular disorders
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate
In compliance with authority procedures set out in subparagraph 14 (d):
Androgen deficiency in males with established pituitary or testicular disorders
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age
Testosterone Undecanoate
In compliance with authority procedures set out in subparagraph 14 (d):
Androgen deficiency in males with established pituitary or testicular disorders
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age
Tetrabenazine
In compliance with authority procedures set out in subparagraph 14 (d):
Hyperkinetic extrapyramidal disorders
Tetracosactrin
—
Theophylline
—
Thiamine Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Prophylaxis of thiamine deficiency in an Aboriginal or a Torres Strait Islander person
Thioguanine
—
Thioridazine Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Management of patients with schizophrenia who have failed to respond adequately to treatment with appropriate courses of at least 2 other antipsychotic drugs, at an adequate dose and for an adequate duration, because of insufficient effectiveness
Management of patients with schizophrenia who have failed to respond adequately to treatment with appropriate courses of at least 2 other antipsychotic drugs, at an adequate dose and for an adequate duration, because of the inability to achieve an effective dose due to intolerable adverse effects from those drugs
Thiotepa
—
Thyroxine Sodium
—
Tiagabine Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs
Tiaprofenic Acid
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Ticarcillin Sodium with Potassium Clavulanate
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Ticlopidine Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events:
in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
Patients established on this drug as a pharmaceutical benefit prior to 1 November 1999
Tiludronate Disodium
In compliance with authority procedures set out in subparagraph 14 (d):
Symptomatic Paget's disease of bone
Timolol Maleate
—
Tinidazole
—
Tiotropium Bromide Monohydrate
For the long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease
Tirofiban Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Patients with high risk unstable angina who have new transient or persistent ST-T ischaemic changes and anginal pain lasting longer than 20 minutes
Patients with high risk unstable angina who have new transient or persistent ST-T ischaemic changes and repetitive episodes of angina at rest or during minimal exercise in the previous 12 hours
Patients with non-Q-wave myocardial infarction
Tobramycin
Invasive ocular infection
Perioperative use in ophthalmic surgery
Suspected pseudomonal eye infection
Tobramycin Sulfate
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Topiramate
In respect of the tablet 25 mg, tablet 50 mg, tablet 100 mg and tablet 200 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
In respect of the capsule 15 mg, capsule 25 mg and capsule 50 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid form dose of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
Topotecan Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Toremifene Citrate
Treatment of hormone-dependent metastatic breast cancer in post-menopausal patients
Tramadol Hydrochloride
In respect of the capsule 50 mg:
For acute pain where aspirin or paracetamol alone is inappropriate or has failed
For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the tablet 100 mg (sustained release), tablet 150 mg (sustained release), tablet 200 mg (sustained release) and oral drops 100 mg per mL, 10 mL:
For pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the injection 100 mg in 2 mL ampoule:
Short-term treatment of acute pain
Trandolapril
—
Tranexamic Acid
—
Tranylcypromine Sulfate
—
Travoprost
—
Triamcinolone Acetonide
In respect of the injection 10 mg in 1 mL ampoule:
Alopecia areata
For local intra-articular or peri-articular infiltration
Granulomata, dermal
Keloid
Lichen planus hypertrophic
Lichen simplex chronicus
Lupus erythematosus, chronic discoid
Necrobiosis lipoidica
Psoriasis
In respect of the cream 200 micrograms per g, 100 g and ointment 200 micrograms per g, 100 g:
Treatment of corticosteroid-responsive dermatoses
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
—
Trifluoperazine Hydrochloride
—
Triglycerides Oil - Medium Chain
In compliance with authority procedures set out in subparagraph 14 (d):
Chylous ascites
Chylothorax
Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders
Hyperlipoproteinaemia type 1
Intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect, requiring a ketogenic diet
Long chain fatty acid oxidation disorders
Trimethoprim
—
Trimethoprim with Sulfamethoxazole
—
Tropisetron Hydrochloride
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy
"TYR gel"
Tyrosinaemia
"TYR Express"
Tyrosinaemia
Ursodeoxycholic Acid
In compliance with authority procedures set out in subparagraph 14 (d):
Primary biliary cirrhosis
Valaciclovir Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Moderate to severe initial genital herpes
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Treatment of patients with herpes zoster within 72 hours of the onset of the rash
Herpes zoster ophthalmicus
Vancomycin Hydrochloride
In respect of the powder for injection equivalent to 500 mg (500,000 I.U.) vancomycin activity:
Prophylaxis of endocarditis in patients hypersensitive to penicillin
Endophthalmitis
Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic
In respect of the capsule equivalent to 125 mg (125,000 I.U.) vancomycin activity and capsule equivalent to 250 mg (250,000 I.U.) vancomycin activity:
In compliance with authority procedures set out in subparagraph 14 (d):
Antibiotic associated pseudomembranous colitis due to Clostridium difficile which is unresponsive to metronidazole
Antibiotic associated pseudomembranous colitis due to Clostridium difficile where there is intolerance to metronidazole
Venlafaxine Hydrochloride
Major depressive disorders
Verapamil Hydrochloride
—
Vigabatrin
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs
Vinblastine Sulfate
—
Vincristine Sulfate
—
Vinorelbine Tartrate
In respect of the capsule equivalent to 20 mg vinorelbine and capsule equivalent to 30 mg vinorelbine:
In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced or metastatic non-small cell lung cancer
In respect of the solution for I.V. infusion equivalent to 10 mg vinorelbine in 1 mL and solution for I.V. infusion equivalent to 50 mg vinorelbine in 5 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Advanced breast cancer after failure of prior therapy which includes an anthracycline
Locally advanced or metastatic non-small cell lung cancer
Warfarin Sodium
—
"XMET Analog"
For infants and very young children with pyridoxine non-responsive homocystinuria
"XMET Maxamaid"
Pyridoxine non-responsive homocystinuria
"XMET Maxamum"
Pyridoxine non-responsive homocystinuria
"XMTVI Analog"
Methylmalonic acidaemia
Propionic acidaemia
"XMTVI Asadon"
Methylmalonic acidaemia
Propionic acidaemia
"XMTVI Maxamaid"
Methylmalonic acidaemia
Propionic acidaemia
"XMTVI Maxamum"
Methylmalonic acidaemia
Propionic acidaemia
"XP Analog"
Phenylketonuria
"XP Analog LCP"
Phenylketonuria
"XP Maxamaid"
Phenylketonuria
"XP Maxamum"
Phenylketonuria
"XPhen, Tyr Analog"
Tyrosinaemia
"XPhen, Tyr Maxamaid"
Tyrosinaemia
"XPhen, Tyr Maxamum"
Tyrosinaemia
"XPTM Tyrosidon"
Tyrosinaemia
Zolmitriptan
In compliance with authority procedures set out in subparagraph 14 (d):
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated
Zuclopenthixol Decanoate
—
Benzydamine Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where a painful mouth is a problem
Initial supply, for up to 4 months, for palliative care patients where a painful mouth is a problem
Continuing supply for palliative care patients where a painful mouth is a problem, and where consultation with a palliative care specialist or service has occurred
Bisacodyl
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Carmellose Sodium
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where dry mouth is a symptom
Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom
Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred
Clonazepam
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients for the prevention of epilepsy
Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy
Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred
Diazepam
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where anxiety is a problem
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Diclofenac Sodium
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Docusate Sodium with Bisacodyl
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Glycerol
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Hyoscine Butylbromide
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where colicky pain is a symptom
Initial supply, for up to 4 months, for palliative care patients where colicky pain is a symptom
Continuing supply for palliative care patients where colicky pain is a symptom, and where consultation with a palliative care specialist or service has occurred
Ibuprofen
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Indomethacin
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Lactulose
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Morphine Sulfate
In respect of the tablet 10 mg and tablet 20 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply, for up to 1 month, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics
Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
In respect of the tablet 200 mg (controlled release):
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply, for up to 1 month, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics
Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Naproxen
In respect of the tablet 250 mg, tablet 500 mg, tablet 750 mg (sustained release) and tablet 1 g (sustained release):
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
In respect of the oral suspension 125 mg per 5 mL, 474 mL:
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Continuing supply for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent, and where consultation with a palliative care specialist or service has occurred
Naproxen Sodium
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Nitrazepam
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where insomnia is a problem
Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem
Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred
Oxazepam
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where anxiety is a problem
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Paracetamol
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated
Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated
Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred
Promethazine Hydrochloride
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where nausea and/or vomiting is a problem
Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem
Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Sterculia with Frangula Bark
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Sulindac
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Temazepam
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where insomnia is a problem
Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem
Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred
Adrenaline Acid Tartrate
—
Amoxycillin Trihydrate
—
Amoxycillin Trihydrate with Potassium Clavulanate
Infections where resistance to amoxycillin trihydrate is suspected
Infections where resistance to amoxycillin trihydrate is proven
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP
Infections where resistance to amoxycillin trihydrate is suspected
Infections where resistance to amoxycillin trihydrate is proven
Amoxycillin Trihydrate with Water - Purified BP
—
Amphotericin
—
Ampicillin Sodium
—
Ampicillin Trihydrate
—
Aspirin
—
Atropine Sulfate
—
Benzathine Penicillin
—
Benztropine Mesylate
—
Benzydamine Hydrochloride
Radiation induced mucositis
Benzylpenicillin Sodium
—
Betamethasone Acetate with Betamethasone Sodium Phosphate
For local intra-articular or peri-articular infiltration
Keloid
Lichen planus hypertrophic
Carbamazepine
—
Cefaclor Monohydrate
—
Cefaclor Monohydrate with Water - Purified BP
—
Cefotaxime Sodium
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Cefuroxime Axetil
—
Cephalexin
—
Cephalexin with Water - Purified BP
—
Cephalothin Sodium
—
Chloramphenicol
—
Clindamycin Hydrochloride
Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin
Codeine Phosphate
—
Codeine Phosphate with Paracetamol
—
Diazepam
—
Diclofenac Sodium
In respect of the suppository 100 mg:
—
In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated):
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Dicloxacillin Sodium
In respect of the powder for injection equivalent to 500 mg dicloxacillin and powder for injection equivalent to 1 g dicloxacillin:
—
In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin:
Serious staphylococcal infections
Doxycycline Hydrochloride
—
Doxycycline Monohydrate
—
Erythromycin
—
Erythromycin Ethyl Succinate
—
Erythromycin Ethyl Succinate with Water - Purified BP
—
Erythromycin Lactobionate
—
Flucloxacillin Magnesium with Water - Purified BP
Serious staphylococcal infections
Flucloxacillin Sodium
In respect of the powder for injection equivalent to 500 mg flucloxacillin and powder for injection equivalent to 1 g flucloxacillin:
—
In respect of the capsule equivalent to 250 mg flucloxacillin and capsule equivalent to 500 mg flucloxacillin:
Serious staphylococcal infections
Glucagon Hydrochloride
—
Glucose
—
Glyceryl Trinitrate
—
Hydrocortisone Acetate
Treatment of corticosteroid-responsive dermatoses
Hydrocortisone Sodium Succinate
For use in a hospital
Hydromorphone Hydrochloride
In respect of the injection 2 mg in 1 mL ampoule, injection 10 mg in 1 mL ampoule and injection 50 mg in 5 mL ampoule:
—
In respect of the tablet 2 mg, tablet 4 mg, tablet 8 mg and oral liquid 1 mg per mL, 473 mL:
Severe disabling pain not responding to non-narcotic analgesics
Ibuprofen
In respect of the tablet 400 mg:
—
In respect of the tablet 200 mg:
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Indomethacin
In respect of the suppository 100 mg:
—
In respect of the capsule 25 mg:
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Ketoprofen
In respect of the suppository 100 mg:
—
In respect of the capsule 200 mg (sustained release):
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Lignocaine Hydrochloride
—
Lincomycin Hydrochloride
—
Methylprednisolone Acetate
For local intra-articular or peri-articular infiltration
Metoclopramide Hydrochloride
—
Metronidazole
In respect of the tablet 200 mg, tablet 400 mg and suppositories 500 mg, 10:
—
In respect of the I.V. infusion 500 mg in 100 mL:
Treatment, in a hospital, of acute anaerobic sepsis
Metronidazole Benzoate
—
Morphine Hydrochloride
Severe disabling pain not responding to non-narcotic analgesics
Morphine Sulfate
In respect of the injection 10 mg in 1 mL ampoule, injection 15 mg in 1 mL ampoule and injection 30 mg in 1 mL ampoule:
—
In respect of the tablet 30 mg:
Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 15 mg (controlled release), tablet 30 mg (controlled release), tablet 60 mg (controlled release), tablet 100 mg (controlled release), capsule 10 mg (containing sustained release pellets), capsule 20 mg (containing sustained release pellets), capsule 30 mg (controlled release), capsule 50 mg (containing sustained release pellets), capsule 60 mg (controlled release), capsule 90 mg (controlled release), capsule 100 mg (containing sustained release pellets), capsule 120 mg (controlled release), sachet containing controlled release granules for oral suspension, 20 mg per sachet, sachet containing controlled release granules for oral suspension, 30 mg per sachet, sachet containing controlled release granules for oral suspension, 60 mg per sachet and sachet containing controlled release granules for oral suspension, 100 mg per sachet:
Chronic severe disabling pain not responding to non-narcotic analgesics
Naloxone Hydrochloride
—
Naproxen
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Naproxen Sodium
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Nitrazepam
—
Nystatin
—
Oxazepam
—
Oxycodone Hydrochloride
In respect of the tablet 5 mg, capsule 5 mg, capsule 10 mg, capsule 20 mg and oral solution 5 mg per 5 mL, 250 mL:
Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 20 mg (controlled release), tablet 40 mg (controlled release) and tablet 80 mg (controlled release):
Chronic severe disabling pain not responding to non-narcotic analgesics
Oxycodone Pectinate
Severe disabling pain not responding to non-narcotic analgesics
Paracetamol
—
Pethidine Hydrochloride
Short-term treatment of acute pain
Phenoxymethylpenicillin Benzathine
—
Phenoxymethylpenicillin Potassium
—
Piroxicam
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Procaine Penicillin
—
Prochlorperazine
—
Prochlorperazine Maleate
—
Prochlorperazine Mesylate
—
Promethazine Hydrochloride
—
Sodium Chloride
—
Sodium Chloride with Glucose
—
Sulindac
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Temazepam
—
Ticarcillin Sodium with Potassium Clavulanate
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Tramadol Hydrochloride
In respect of the capsule 50 mg:
For acute pain where aspirin or paracetamol alone is inappropriate or has failed
For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the tablet 100 mg (sustained release), tablet 150 mg (sustained release), tablet 200 mg (sustained release) and oral drops 100 mg per mL, 10 mL:
For pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the injection 100 mg in 2 mL ampoule:
Short-term treatment of acute pain
Triamcinolone Acetonide
For local intra-articular or peri-articular infiltration
Keloid
Lichen planus hypertrophic
Trimethoprim with Sulfamethoxazole
—
Vancomycin Hydrochloride
Prophylaxis of endocarditis in patients hypersensitive to penicillin
Abacavir Sulfate
Abacavir Sulfate with Lamivudine
Abacavir Sulfate with Lamivudine and Zidovudine
Alendronate Sodium
Alendronate Sodium with Colecalciferol
Aluminium Hydroxide - Dried
Aluminium Hydroxide - Dried with Magnesium Hydroxide
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide
Amiloride Hydrochloride
Hydrochlorothiazide with Amiloride Hydrochloride
Amoxycillin Trihydrate
Amoxycillin Trihydrate with Potassium Clavulanate
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP
Amoxycillin Trihydrate with Water - Purified BP
Aspirin
Dipyridamole with Aspirin
Atropine Sulfate
Diphenoxylate Hydrochloride with Atropine Sulfate
Azithromycin Dihydrate
Azithromycin Dihydrate with Water - Purified BP
Bacitracin Zinc
Neomycin Undecenoate with Bacitracin Zinc
Benserazide Hydrochloride
Levodopa with Benserazide Hydrochloride
Betamethasone Acetate
Betamethasone Acetate with Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate
Betamethasone Acetate with Betamethasone Sodium Phosphate
Bisacodyl
Docusate Sodium with Bisacodyl
Brimonidine Tartrate
Brimonidine Tartrate with Timolol Maleate
Budesonide
Budesonide with Eformoterol Fumarate Dihydrate
Buprenorphine Hydrochloride
Buprenorphine Hydrochloride with Naloxone Hydrochloride
Calcium Carbonate
Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
Calcium Chloride
Sodium Chloride with Potassium Chloride and Calcium Chloride
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
Candesartan Cilexetil
Candesartan Cilexetil with Hydrochlorothiazide
Carbidopa
Levodopa with Carbidopa
Levodopa with Carbidopa and Entacapone
Carbomer 980
Hypromellose with Carbomer 980
Cefaclor Monohydrate
Cefaclor Monohydrate with Water - Purified BP
Cephalexin
Cephalexin with Water - Purified BP
Chlorhexidine Gluconate
Silver Sulfadiazine with Chlorhexidine Gluconate
Codeine Phosphate
Codeine Phosphate with Paracetamol
Colecalciferol
Alendronate Sodium with Colecalciferol
Cyproterone Acetate
Oestradiol Valerate with Cyproterone Acetate
Dexamethasone Sodium Metasulfobenzoate
Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin
Dextran 70
Hypromellose 2900 with Dextran 70
Hypromellose 4500 with Dextran 70
Diphenoxylate Hydrochloride
Diphenoxylate Hydrochloride with Atropine Sulfate
Dipyridamole
Dipyridamole with Aspirin
Docusate Sodium
Docusate Sodium with Bisacodyl
Dorzolamide Hydrochloride
Dorzolamide Hydrochloride with Timolol Maleate
Dydrogesterone
Oestradiol with Dydrogesterone
Eformoterol Fumarate Dihydrate
Budesonide with Eformoterol Fumarate Dihydrate
Emtricitabine
Tenofovir Disoproxil Fumarate with Emtricitabine
Enalapril Maleate
Enalapril Maleate with Hydrochlorothiazide
Entacapone
Levodopa with Carbidopa and Entacapone
Eprosartan Mesylate
Eprosartan Mesylate with Hydrochlorothiazide
Erythromycin Ethyl Succinate
Erythromycin Ethyl Succinate with Water - Purified BP
Ethinyloestradiol
Levonorgestrel with Ethinyloestradiol
Norethisterone with Ethinyloestradiol
Ezetimibe
Ezetimibe with Simvastatin
Ferrous Fumarate
Ferrous Fumarate with Folic Acid
Flucloxacillin Magnesium
Flucloxacillin Magnesium with Water - Purified BP
Fluticasone Propionate
Fluticasone Propionate with Salmeterol Xinafoate
Folic Acid
Ferrous Fumarate with Folic Acid
Fosinopril Sodium
Fosinopril Sodium with Hydrochlorothiazide
Framycetin Sulfate
Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin
Frangula Bark
Sterculia with Frangula Bark
Glibenclamide
Metformin Hydrochloride with Glibenclamide
Glucose
Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
Sodium Chloride with Glucose
Gramicidin
Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Hydrochlorothiazide
Candesartan Cilexetil with Hydrochlorothiazide
Enalapril Maleate with Hydrochlorothiazide
Eprosartan Mesylate with Hydrochlorothiazide
Fosinopril Sodium with Hydrochlorothiazide
Hydrochlorothiazide with Amiloride Hydrochloride
Hydrochlorothiazide with Triamterene
Irbesartan with Hydrochlorothiazide
Quinapril Hydrochloride with Hydrochlorothiazide
Telmisartan with Hydrochlorothiazide
Hypromellose
Hypromellose with Carbomer 980
Hypromellose 2900
Hypromellose 2900 with Dextran 70
Hypromellose 4500
Hypromellose 4500 with Dextran 70
Indapamide Hemihydrate
Perindopril Erbumine with Indapamide Hemihydrate
Insulin - Isophane
Insulin - Neutral with Insulin - Isophane
Insulin - Neutral
Insulin - Neutral with Insulin - Isophane
Insulin Aspart
Insulin Aspart with Insulin Aspart Protamine Suspension
Insulin Aspart Protamine Suspension
Insulin Aspart with Insulin Aspart Protamine Suspension
Insulin Lispro
Insulin Lispro with Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension
Insulin Lispro with Insulin Lispro Protamine Suspension
Irbesartan
Irbesartan with Hydrochlorothiazide
Lamivudine
Abacavir Sulfate with Lamivudine
Abacavir Sulfate with Lamivudine and Zidovudine
Lamivudine with Zidovudine
Latanoprost
Latanoprost with Timolol Maleate
Levodopa
Levodopa with Benserazide Hydrochloride
Levodopa with Carbidopa
Levodopa with Carbidopa and Entacapone
Levonorgestrel
Levonorgestrel with Ethinyloestradiol
Lopinavir
Lopinavir with Ritonavir
Macrogol 3350
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Magnesium Chloride
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Magnesium Hydroxide
Aluminium Hydroxide - Dried with Magnesium Hydroxide
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide
Magnesium Trisilicate
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide
Medroxyprogesterone Acetate
Oestrogens—Conjugated with Medroxyprogesterone Acetate
Mestranol
Norethisterone with Mestranol
Metformin Hydrochloride
Metformin Hydrochloride with Glibenclamide
Mycophenolate Mofetil
Mycophenolate Mofetil with Water - Purified BP
Naloxone Hydrochloride
Buprenorphine Hydrochloride with Naloxone Hydrochloride
Neomycin Sulfate
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Neomycin Undecenoate
Neomycin Undecenoate with Bacitracin Zinc
Norethisterone
Norethisterone with Ethinyloestradiol
Norethisterone with Mestranol
Norethisterone Acetate
Oestradiol with Norethisterone Acetate
Oestradiol Hemihydrate with Norethisterone Acetate
Nystatin
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Oestradiol
Oestradiol with Dydrogesterone
Oestradiol with Norethisterone Acetate
Oestradiol Hemihydrate
Oestradiol Hemihydrate with Norethisterone Acetate
Oestradiol Valerate
Oestradiol Valerate with Cyproterone Acetate
Oestrogens—Conjugated
Oestrogens—Conjugated with Medroxyprogesterone Acetate
Paracetamol
Codeine Phosphate with Paracetamol
Paraffin - Liquid
Paraffin - Soft White with Paraffin - Liquid
Paraffin - Soft White
Paraffin - Soft White with Paraffin - Liquid
Perindopril Erbumine
Perindopril Erbumine with Indapamide Hemihydrate
Phenylephrine Hydrochloride
Prednisolone Acetate with Phenylephrine Hydrochloride
Polyethylene Glycol 400
Polyethylene Glycol 400 with Propylene Glycol
Potassium Bicarbonate
Potassium Chloride with Potassium Bicarbonate
Potassium Chloride
Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Potassium Chloride with Potassium Bicarbonate
Sodium Chloride with Potassium Chloride and Calcium Chloride
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
Potassium Clavulanate
Amoxycillin Trihydrate with Potassium Clavulanate
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP
Ticarcillin Sodium with Potassium Clavulanate
Prednisolone Acetate
Prednisolone Acetate with Phenylephrine Hydrochloride
Propylene Glycol
Polyethylene Glycol 400 with Propylene Glycol
Quinapril Hydrochloride
Quinapril Hydrochloride with Hydrochlorothiazide
Ritonavir
Lopinavir with Ritonavir
Salmeterol Xinafoate
Fluticasone Propionate with Salmeterol Xinafoate
Silver Sulfadiazine
Silver Sulfadiazine with Chlorhexidine Gluconate
Simvastatin
Ezetimibe with Simvastatin
Sodium Acetate
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Sodium Acid Citrate
Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
Sodium Alginate
Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
Sodium Bicarbonate
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
Sodium Chloride
Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Sodium Chloride with Glucose
Sodium Chloride with Potassium Chloride and Calcium Chloride
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
Sodium Citrate
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Sodium Gluconate
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Sodium Lactate
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
Sodium Lauryl Sulfoacetate
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Sorbitol
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Stavudine
Stavudine with Water - Purified BP
Sterculia
Sterculia with Frangula Bark
Sulfamethoxazole
Trimethoprim with Sulfamethoxazole
Telmisartan
Telmisartan with Hydrochlorothiazide
Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate with Emtricitabine
Testosterone Decanoate
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate
Testosterone Isocaproate
Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate
Testosterone Phenylpropionate
Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate
Testosterone Propionate
Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate
Ticarcillin Sodium
Ticarcillin Sodium with Potassium Clavulanate
Timolol Maleate
Brimonidine Tartrate with Timolol Maleate
Dorzolamide Hydrochloride with Timolol Maleate
Latanoprost with Timolol Maleate
Triamcinolone Acetonide
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Triamterene
Hydrochlorothiazide with Triamterene
Trimethoprim
Trimethoprim with Sulfamethoxazole
Water - Purified BP
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP
Amoxycillin Trihydrate with Water - Purified BP
Azithromycin Dihydrate with Water - Purified BP
Cefaclor Monohydrate with Water - Purified BP
Cephalexin with Water - Purified BP
Erythromycin Ethyl Succinate with Water - Purified BP
Flucloxacillin Magnesium with Water - Purified BP
Mycophenolate Mofetil with Water - Purified BP
Stavudine with Water - Purified BP
Zidovudine
Abacavir Sulfate with Lamivudine and Zidovudine
Lamivudine with Zidovudine
Acacia BP, powdered — Acetic Acid (33 per cent) BP — Alum BP — Aluminium Acetate Solution BP — Aqueous Cream APF For use only as a base combined with active ingredients Ascorbic Acid BP For use only as an ingredient of ferrous sulfate mixtures Aspirin BP — Belladonna Tincture BP — Benzocaine BP — Benzoic Acid BP — Benzoin Tincture, Compound BP — Boric Acid, Olive Oil and Zinc Oxide Ointment QHF — Calcium Hydroxide BP — Cetomacrogol Cream, Aqueous APF For use only as a base combined with active ingredients Cetrimide Cream, Aqueous APF For use only as a base combined with active ingredients Chlorhexidine Cream, Aqueous APF For use only as a base combined with active ingredients Citric Acid Monohydrate BP — Coal Tar BP — Coal Tar Solution BP — Cocaine Hydrochloride BP — Coconut Oil BP — Codeine Phosphate BP May only be prescribed in linctuses, mixtures and mixtures for children Collodion, Flexible BP — Dithranol BP — Emulsifying Ointment BP For use only as a base combined with active ingredients Ephedrine Hydrochloride BP May only be prescribed in nasal instillations Ferrous Sulfate BP — Formaldehyde Solution BP — Gentian Alkaline Mixture APF — Glycerol BP — Iodine BP — Kaolin Mixture BPC 1968 — Kaolin and Opium Mixture APF 14 — Lactic Acid BP — Lavender Oil, Spike BPC 1968 — Levomenthol BP — Liquorice Liquid Extract BP — Magnesium Carbonate, Light BP — Magnesium Sulfate BP May only be prescribed for other than oral use Magnesium Trisilicate BP — Menthol, Racemic BP — Methyl Hydroxybenzoate BP — Paraffin, Hard BP — Paraffin, Light Liquid BP — Paraffin, Liquid BP May only be prescribed for other than oral use Paraffin, Soft White BP — Paraffin, Soft Yellow BP — Phenobarbitone Sodium BP May only be prescribed for the treatment of epilepsy Phenol, Liquefied BP Not available for ear drops Podophyllum Resin BP — Potassium Citrate BP — Potassium Iodide BP — Potassium Permanganate BP — Propylene Glycol BP — Propyl Hydroxybenzoate BP — Red Syrup APF 15 — Resorcinol BP — Salicylic Acid BP — Simple Ointment (white) BP For use only as a base combined with active ingredients Simple Ointment (yellow) BP For use only as a base combined with active ingredients Sodium Bicarbonate BP — Sodium Chloride BP — Sodium Citrate BP — Starches BP — Sulfur, Precipitated BP 1980 — Syrup BP — Talc, Purified BP, sterilised — Thymol BP — Thymol Mouth Wash, Compound APF 15 — Tragacanth BP, powdered — Tragacanth Powder, Compound BP 1980 — Trichloroacetic Acid BP 1980 — Triethanolamine BP — Water for Injections, sterilised BP May only be prescribed in eye drops and eye lotions Water, Purified BP — Wool Alcohols Ointment (white) BP For use only as a base combined with active ingredients Wool Alcohols Ointment (yellow) BP For use only as a base combined with active ingredients Wool Fat BP — Wool Fat, Hydrous BP — Zinc Cream BP For use only as a base combined with active ingredients Zinc Oxide BP — Zinc Sulfate BP —
SCHEDULE 5 — ADDITIVES Acetone BP Anise Water, Concentrated BP Boric Acid BP Castor Oil BP Chlorhexidine Acetate BP Chloroform BP Ethanol (96 per cent) BP Ethanols, Dilute BP Ether, Solvent BP Eucalyptus Oil BP Honey, Purified BP 1993 Industrial Methylated Spirit BP Olive Oil BP Peppermint Oil BP Peppermint Water, Concentrated APF Pholcodine Citrate Syrup BPC 1959 Sodium Thiosulfate BP
Abacavir Sulfate
Abacavir Sulfate with Lamivudine
Abacavir Sulfate with Lamivudine and Zidovudine
Adefovir Dipivoxil
Amprenavir
Apomorphine Hydrochloride
Atazanavir Sulfate
Bosentan Monohydrate
Botulinum Toxin Type A Purified Neurotoxin Complex
Buprenorphine Hydrochloride
Buprenorphine Hydrochloride with Naloxone Hydrochloride
Charcoal - Activated
Cidofovir
Clostridium Botulinum Type A Toxin—Haemagglutinin Complex
Clozapine
Darbepoetin Alfa
Deferiprone
Delavirdine Mesylate
Desferrioxamine Mesylate
Didanosine
Dornase Alfa
Efavirenz
Emtricitabine
Enfuvirtide
Epoetin Alfa
Epoetin Beta
Epoprostenol Sodium
Filgrastim
Fosamprenavir Calcium
Foscarnet Sodium
Ganciclovir
Ganciclovir Sodium
Iloprost Trometamol
Imatinib Mesylate
Indinavir Sulfate
Infliximab
Interferon Gamma-1b
Lamivudine
Lamivudine with Zidovudine
Lanreotide Acetate
Lenograstim
Lopinavir with Ritonavir
Nelfinavir Mesylate
Nevirapine
Octreotide Acetate
Pegfilgrastim
Peginterferon Alfa-2a
Peginterferon Alfa-2b
Progesterone
Ribavirin and Peginterferon Alfa-2a
Ribavirin and Peginterferon Alfa-2b
Rifabutin
Ritonavir
Saquinavir
Saquinavir Mesylate
Somatropin
Stavudine
Stavudine with Water - Purified BP
Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate with Emtricitabine
Thalidomide
Valganciclovir Hydrochloride
Zidovudine
Zoledronic Acid
Dated this 26th day of July 2006.
JOAN CORBETT
Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
