COMMONWEALTH OF AUSTRALIA
Instrument number PB 59 of 2008
Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953
Amendment determination under subsection 85(2A) of the National Health Act 1953
I, ANDREW MITCHELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.
Dated                                                                           3 JUNE            2008
 
 
 
ANDREW MITCHELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
 
Amendment declaration and determination — drugs and medicinal preparations
1              Commencement
                This instrument commences on 1 July 2008.
2              Amendment of PB 88 of 2007
                Schedule 1 amends PB 88 of 2007.
Schedule 1        Amendments
 
[1]       Schedule 1, item dealing with Adalimumab
omit all text from “Column 3” and substitute:
 
 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Initial treatment commencing 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 who:

 
 
 (a) have severe active rheumatoid arthritis; and

 
 
 (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD 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 bDMARD treatment for this condition was approved; and

 
 
 (c) 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 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

 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; 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 (c) 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);

 
 
 all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

 
 
 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 (c) 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 (c) 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 Rheumatoid 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 signed patient acknowledgment;

 
 
 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 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, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

 
 
 (a) have a documented history of severe active rheumatoid arthritis; and

 
 
 (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and

 
 
 (c) have not failed previous PBS-subsidised treatment with adalimumab during this Treatment Cycle; and

 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; 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 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;

 
 
 patients are eligible to receive further bDMARD therapy within this 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;

 
 
 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 provided that:

 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, 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; and

 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

 
 
 patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;

 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with adalimumab in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised adalimumab therapy;

 
 
 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 bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, 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):
Continuing treatment with adalimumab 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:

 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and

 
 
 (b) who have demonstrated an adequate response to treatment with adalimumab; and

 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and

 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; 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 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;

 
 
 
 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;

 
 
 a patient 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:

 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;

 
 
 the authority application includes a completed copy of the appropriate Rheumatoid 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;

 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised adalimumab in this Treatment Cycle;

 
 
 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 bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, 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

 
 
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; 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 either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily 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 methotrexate or sulfasalazine or leflunomide, 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 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; 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; 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 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; 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 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; 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 with adalimumab 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 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

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:

 
 
 (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, 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 has 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

 
 
 (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, 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; and

 
 
 (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and 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 adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, 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 each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, 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 reason 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 reason why a higher dose cannot be used;

 
 
 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;

 
 
 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;

 
 
 an appropriate minimum exercise program includes stretch and range of motion exercises at least 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 Ankylosing Spondylitis 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 completed BASDAI Assessment Form; and

 
 
 (iii) a signed patient acknowledgment form; and

 
 
 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;

 
 
 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 treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has 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 treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with adalimumab; 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 adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, 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 each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

 
 
 where the following conditions apply:

 
 
 a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

 
 
 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;

 
 
 the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:

 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and

 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

 
 
 
 if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;

 
 
 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 treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has 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 treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and

 
 
 (a) who is receiving treatment with adalimumab at the time of application; and

 
 
 (b) who has not received prior PBS-subsidised treatment with infliximab or etanercept; and

 
 
 (c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0-10 scale or improved by at least 2 from baseline; and

 
 
 (d) who has:

 
 
 (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

 
 
 (e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and 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 adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, 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 each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, 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 provided are no more than 1 month old at the time of application;

 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis 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 completed BASDAI Assessment Form; and

 
 
 (iii) a 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 treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab 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 treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; 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 adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, 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 each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

 
 
 where the following conditions apply:

 
 
 a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

 
 
 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;

 
 
 if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS-subsidised treatment and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:

 
 
 (a) an ESR measurement no greater than 25 mm per hour; or

 
 
 (b) a CRP measurement no greater than 10 mg per L;

 
 
 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 and supplied 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:

 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

 
 
 (b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment;

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with 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 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 treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab 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

[2]       Schedule 1, item dealing with Calcipotriol
omit all text from “Column 3” and substitute:
 
 
 
In respect of the ointment 50 micrograms per g, 30g and cream
50 micrograms (as monohydrate) per g, 30 g
Chronic stable plaque type psoriasis vulgaris
In respect of the scalp solution 50 micrograms (as monohydrate) per mL, 30 mL:
Chronic stable plaque type psoriasis vulgaris of the scalp
[3]       Schedule 1, after item dealing with Cimetidine
insert in the columns in the order indicated:
 
Cinacalcet
 
In compliance with authority procedures set out in subparagraph 14 (d):
Maintenance therapy, following initiation and stabilisation of treatment with cinacalcet, of a patient with chronic kidney disease on dialysis who has a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment
[4]       Schedule 1, after item dealing with Cyproterone
insert in the columns in the order indicated:
 
Cystine with carbohydrate
 
Pyridoxine non-responsive homocystinuria
[5]       Schedule 1, item dealing with Donepezil
omit all text from “Column 3” and substitute:
 
 
 
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
 
 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 includes the baseline scores submitted with the first application 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' duration in total

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, and where:

 
 
 (1) improvement in cognitive function is demonstrated by:

 
 
 (a) in the case of patients with a baseline MMSE or SMMSE score of 10 or more and less than 25 — an increase of at least 2 points from baseline on the MMSE or SMMSE; or

 
 
 (b) in the case of patients with a baseline MMSE or SMMSE score of at least 25 points — an increase of at least 2 points from baseline on the MMSE or SMMSE, or, if a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) was submitted with the application for initial treatment, a decrease of at least 4 points from baseline on the ADAS-Cog; and

 
 
 (2) the relevant result from the MMSE, SMMSE or ADAS-Cog is included in the authority application for continuing treatment

 
 
 In compliance with authority procedures set out in subparagraph 14 (d):
 Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

 
 
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups 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 an MMSE or SMMSE test;

 
 
 Intellectual (developmental or acquired) disability;

 
 
 Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE 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, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 includes the information submitted with the first application 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' duration in total

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying 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 an MMSE or SMMSE test;

 
 
 Intellectual (developmental or acquired) disability;

 
 
 Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;

 
 
 Prominent dysphasia, out of proportion to other cognitive and functional impairment

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 PBS-subsidised 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, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

 
[6]       Schedule 1, item dealing with Etanercept
omit all text from “Column 3” and substitute:
 
 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Initial treatment as systemic monotherapy (other than methotrexate), 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 indicating 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, 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 chronic plaque psoriasis 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 each of the 3 biological agents once, 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 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) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets 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) the signed patient acknowledgement;

 
 
 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 (other than methotrexate), 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 (other than methotrexate), 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 in the current Treatment Cycle; and

 
 
 where biological agent means efalizumab, 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 chronic plaque psoriasis 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 each of the 3 biological agents once, 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) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets 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 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):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept as systemic monotherapy (other than methotrexate), 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):
Continuing treatment as systemic monotherapy (other than methotrexate), 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, 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 chronic plaque psoriasis 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 each of the 3 biological agents once, 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, 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;

 
 
 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 the course of treatment ceased;

 
 
 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 response assessment is undertaken and submitted to the Medicare Australia CEO within the timeframes specified above;

 
 
 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 PBS-subsidised 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 the completed Psoriasis Area and Severity Index (PASI) calculation sheet 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 (other than methotrexate), 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 (other than methotrexate), 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 indicating 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, 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 chronic plaque psoriasis 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 each of the 3 biological agents once, 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) 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) the signed patient acknowledgement;

 
 
 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 (other than methotrexate), 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 (other than methotrexate), 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 in the current Treatment Cycle; and

 
 
 where biological agent means efalizumab, 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 chronic plaque psoriasis 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 each of the 3 biological agents once, 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) 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 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):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept as systemic monotherapy (other than methotrexate), 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):
Continuing treatment as systemic monotherapy (other than methotrexate), 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; and

 
 
 (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and

 
 
 where biological agent means efalizumab, 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 chronic plaque psoriasis 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 each of the 3 biological agents once, 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, 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, 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;

 
 
 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 the course of treatment ceased;

 
 
 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 response assessment is undertaken and submitted to the Medicare Australia CEO within the timeframes specified above;

 
 
 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 PBS-subsidised 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 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 (other than methotrexate), 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 commencing 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 who:

 
 
 (a) have severe active rheumatoid arthritis; and

 
 
 (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD 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 bDMARD treatment for this condition was approved; and

 
 
 (c) 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 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

 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; 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 (c) 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);

 
 
 
 all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

 
 
 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 (c) 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 (c) 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 Rheumatoid 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 signed patient acknowledgment;

 
 
 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 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, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

 
 
 (a) have a documented history of severe active rheumatoid arthritis; and

 
 
 (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and

 
 
 (c) have not failed previous PBS-subsidised treatment with etanercept during this Treatment Cycle; and

 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; 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 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;

 
 
 patients are eligible to receive further bDMARD therapy within this 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;

 
 
 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 provided that:

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, 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;

 
 
 patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;

 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised etanercept therapy;

 
 
 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 bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, 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):
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):
Continuing treatment with etanercept 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:

 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and

 
 
 (b) who have demonstrated an adequate response to treatment with etanercept; and

 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and

 
 
 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; 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 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;

 
 
 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;

 
 
 a patient 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:

 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;

 
 
 the authority application includes a completed copy of the appropriate Rheumatoid 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;

 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised etanercept in this Treatment Cycle;

 
 
 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 bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, 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 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

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
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 an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:

 
 
 (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, 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 has 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

 
 
 (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, 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; and

 
 
 (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and 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 adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, 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 each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, 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 reason 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 reason why a higher dose cannot be used;

 
 
 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;

 
 
 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;

 
 
 an appropriate minimum exercise program includes stretch and range of motion exercises at least 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 Ankylosing Spondylitis 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 completed BASDAI Assessment Form; and

 
 
 (iii) a signed patient acknowledgment form; and

 
 
 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;

 
 
 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 treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has 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 treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy 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 adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, 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 each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

 
 
 where the following conditions apply:

 
 
 a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

 
 
 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;

 
 
 the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:

 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and

 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

 
 
 if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;

 
 
 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 treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has 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):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has 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 adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, 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 each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

 
 
 where the following conditions apply:

 
 
 
 a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

 
 
 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;

 
 
 if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:

 
 
 (a) an ESR measurement no greater than 25 mm per hour; or

 
 
 (b) a CRP measurement no greater than 10 mg per L;

 
 
 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 and supplied 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:

 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with 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 an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing 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):
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; 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 either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily 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 methotrexate or sulfasalazine or leflunomide, 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

 
 
 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 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; 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 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; 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 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; 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 with etanercept 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 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

[7]       Schedule 1, item dealing with Galantamine
omit all text from “Column 3” and substitute:
 
 
 
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 includes the baseline scores submitted with the first application 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' duration in total

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, and where:

 
 
 (1) improvement in cognitive function is demonstrated by:

 
 
 (a) in the case of patients with a baseline MMSE or SMMSE score of 10 or more and less than 25 — an increase of at least 2 points from baseline on the MMSE or SMMSE; or

 
 
 (b) in the case of patients with a baseline MMSE or SMMSE score of at least 25 points — an increase of at least 2 points from baseline on the MMSE or SMMSE, or, if a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) was submitted with the application for initial treatment, a decrease of at least 4 points from baseline on the ADAS-Cog; and

 
 
 (2) the relevant result from the MMSE, SMMSE or ADAS-Cog is included in the authority application for continuing treatment

 
 
 In compliance with authority procedures set out in subparagraph 14 (d):
 Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

 
 
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups 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 an MMSE or SMMSE test;

 
 
 Intellectual (developmental or acquired) disability;

 
 
 Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE 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, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 includes the information submitted with the first application 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' duration in total

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying 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 an MMSE or SMMSE test;

 
 
 Intellectual (developmental or acquired) disability;

 
 
 Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;

 
 
 Prominent dysphasia, out of proportion to other cognitive and functional impairment

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 PBS-subsidised 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, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

[8]       Schedule 1, item dealing with Gefitinib
omit all text from “Column 3” and substitute:
 
 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Initial PBS-subsidised treatment, 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, where:

 
 
 (1) disease progression has occurred following treatment with at least 1 chemotherapy agent; and

 
 
 (2) there is evidence that the patient has an activating mutation, or mutations, of the epidermal growth factor receptor (EGFR) gene in tumour material, and the mutation(s) are demonstrated by analysis of the DNA sequence of the EGFR gene; and

 
 
 (3) 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 name(s) of drug(s) 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 providing evidence of the presence of activating mutation(s) of the EGFR gene from an Approved Pathology Authority

 
 
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

[9]       Schedule 1, after item dealing with Melphalan
insert in the columns in the order indicated:
 
Memantine
 
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline MMSE or SMMSE is included in the authority application

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Continuation of initial treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, 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 includes the baseline scores submitted with the first application 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' duration in total

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline MMSE or SMMSE is included in the authority application

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Continuing treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14 who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, where improvement in cognitive function is demonstrated by an increase of at least 2 points from baseline on the MMSE or SMMSE, and where the relevant result from the MMSE or SMMSE is included in the authority application for continuing treatment

 
 
 In compliance with authority procedures set out in subparagraph 14 (d):
 Continuing treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14 and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

 
 
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups 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 an MMSE or SMMSE test;

 
 
 Intellectual (developmental or acquired) disability;

 
 
 Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE 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, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 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 includes the information submitted with the first application 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' duration in total

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying 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 an MMSE or SMMSE test;

 
 
 Intellectual (developmental or acquired) disability;

 
 
 Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;

 
 
 Prominent dysphasia, out of proportion to other cognitive and functional impairment

 
 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Continuing treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial PBS-subsidised therapy, based on a rating of "very much improved" or "much improved" on the Clinicians Interview Based Impression of Change (CIBIC) 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, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

 
 
In compliance with authority procedures set out in subparagraph 14 (d):
 Continuing treatment, as the sole PBS-subsidised therapy, of a patient commenced on memantine prior to 1 March 2008

[10]     Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone
omit from “Column 3”(twice occurring):
4.33 mg
and substitute:
780 micrograms
[11]     Schedule 1, item dealing with Rivastigmine
omit all text from “Column 3” and substitute:
 

 
 
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 includes the baseline scores submitted with the first application 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' duration in total

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, and where:

 
 
 (1) improvement in cognitive function is demonstrated by:

 
 
 (a) in the case of patients with a baseline MMSE or SMMSE score of 10 or more and less than 25 — an increase of at least 2 points from baseline on the MMSE or SMMSE; or

 
 
 (b) in the case of patients with a baseline MMSE or SMMSE score of at least 25 points — an increase of at least 2 points from baseline on the MMSE or SMMSE, or, if a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) was submitted with the application for initial treatment, a decrease of at least 4 points from baseline on the ADAS-Cog; and

 
 
 (2) the relevant result from the MMSE, SMMSE or ADAS-Cog is included in the authority application for continuing treatment

 
 
 In compliance with authority procedures set out in subparagraph 14 (d):
 Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

 
 
In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups 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 an MMSE or SMMSE test;

 
 
 Intellectual (developmental or acquired) disability;

 
 
 Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE 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, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 includes the information submitted with the first application 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' duration in total

 
 
 In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
 Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying 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 an MMSE or SMMSE test;

 
 
 Intellectual (developmental or acquired) disability;

 
 
 Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;

 
 
 Prominent dysphasia, out of proportion to other cognitive and functional impairment

 
 
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Continuing treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) 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 PBS-subsidised 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, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment

[12]     Schedule 1, item dealing with Sevelamer
omit from “Column 3”(twice occurring):
an adult
and substitute:
a patient
[13]     Schedule 1, item dealing with Terbinafine
(a) insert as first line in “Column 3”:
 
 
 
In respect of the tablet 250 mg (as hydrochloride):
(b) after existing text insert in the columns in the order indicated:
 
 
 
 
 
In respect of the cream containing terbinafine hydrochloride 10 mg 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

2354

 
[14]     Schedule 1, after item dealing with Tropisetron
insert in the columns in the order indicated:
 
Tyrosine with carbohydrate
 
Phenylketonuria
[15]     Schedule 6
insert in alphabetical order:
Natalizumab
[16]     Schedule 6
insert in alphabetical order:
Raltegravir