COMMONWEALTH OF AUSTRALIA
Instrument number PB 4 of 2010
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, ADRIANA PLATONA, 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 2 February 2010
ADRIANA PLATONA
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 March 2010.
2 Amendment of PB 113 of 2008
Schedule 1 amends PB 113 of 2008.
Schedule 1 Amendments
[1] Schedule 1, item dealing with Adalimumab
under the headings:
Chronic plaque psoriasis (whole body) — initial treatment 1
Chronic plaque psoriasis (whole body) — initial treatment 2
Chronic plaque psoriasis (whole body) — initial treatment 3
Chronic plaque psoriasis (whole body) — continuing treatment
Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
Chronic plaque psoriasis (face, hand, foot) — initial treatment 3
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
omit from the column headed “Circumstances”:
where biological agent means adalimumab, 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
and substitute:
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
[2] Schedule 1, item dealing with Albendazole
omit from the columns in the order indicated:
In respect of the tablet 200 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
2446
Treatment of whipworm infestation in an Aboriginal or a Torres Strait Islander person
1525
Treatment of tapeworm infestation
and substitute:
In respect of the tablet 200 mg:
In compliance with authority procedures set out in subparagraph 14 (d):
2446
Treatment of whipworm infestation in an Aboriginal or a Torres Strait Islander person
1388
Strongyloidiasis
3241
Treatment of hookworm infestation
1525
Treatment of tapeworm infestation
[3] Schedule 1, item dealing with Alendronic Acid
omit from the columns in the order indicated:
1392
Symptomatic Paget's disease of bone
and substitute:
3256
Symptomatic Paget disease of bone
[4] Schedule 1, item dealing with Bicalutamide
omit text from the column headed “Circumstances” and substitute in the columns in the order indicated:
In compliance with authority procedures set out in subparagraph 14 (d):
3247
Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy
[5] Schedule 1, item dealing with Candesartan with Hydrochlorothiazide
omit text from the column headed “Circumstances” and substitute:
In respect of the tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg:
Hypertension in patients who are not adequately controlled with 16 mg candesartan cilexetil
In respect of the tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg and tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg:
Hypertension in a patient who is not adequately controlled with monotherapy
[6] Schedule 1, item dealing with Clopidogrel
omit all details from Column 2 and Column 3 and substitute:
In compliance with authority procedures set out in subparagraph 14 (d):
1719
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin
1720
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
1721
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
1722
Prevention of recurrence of myocardial infarction or unstable angina in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin
1723
Prevention of recurrence of myocardial infarction or unstable angina in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
1724
Prevention of recurrence of myocardial infarction or unstable angina in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
3245
Treatment of acute coronary syndromes (myocardial infarction or unstable angina) in combination with aspirin
3146
Treatment in combination with aspirin following cardiac stent insertion
[7] Schedule 1, item dealing with Clopidogrel with aspirin
omit all details from Column 2 and Column 3 and substitute:
In compliance with authority procedures set out in subparagraph 14 (d):
3246
Treatment of acute coronary syndromes (myocardial infarction or unstable angina)
3219
Treatment following cardiac stent insertion
1722
Prevention of recurrence of myocardial infarction or unstable angina in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin
[8] Schedule 1, item dealing with Etanercept
under the headings:
Chronic plaque psoriasis (whole body) — initial treatment 1
Chronic plaque psoriasis (whole body) — initial treatment 2
Chronic plaque psoriasis (whole body) — continuing treatment
Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
omit from the column headed “Circumstances”:
where biological agent means adalimumab, 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
and substitute:
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
[9] Schedule 1, item dealing with Etidronic Acid
omit from the columns in the order indicated:
1849
Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to lack of efficacy
1850
Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to unacceptable side effects
and substitute:
3257
Symptomatic Paget disease of bone when salcatonin has been found to be unsatisfactory due to lack of efficacy
3258
Symptomatic Paget disease of bone when salcatonin has been found to be unsatisfactory due to unacceptable side effects
[10] Schedule 1, item dealing with Fluconazole
omit from the column headed “Circumstances”:
Secondary prophylaxis of oropharyngeal candidiasis in immunosuppressed patients
and substitute:
Prophylaxis of oropharyngeal candidiasis in immunosuppressed patients
[11] Schedule 1, item dealing with Gefitinib
omit from the column headed “Circumstances”:
(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
and substitute:
(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
[12] Schedule 1, item dealing with Glucose Indicator—Blood
(a) insert in the column headed “Circumstances” after “(Accu-Chek Integra),”:
test strips, 50 (Accu-Chek Mobile),
(b) omit from the column headed “Circumstances”:
test strips, 50 (Glucoboy),
[13] Schedule 1, item dealing with Goserelin
omit text from the column headed “Circumstances” and substitute in the columns in the order indicated:
In respect of the subcutaneous implant 3.6 mg (as acetate) in pre-filled injection syringe:
In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate
Hormone-dependent locally advanced (equivalent to stage III) or metastatic (equivalent to stage IV) breast cancer in pre-menopausal women
Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months' uninterrupted therapy
Hormone-dependent breast cancer as an alternative to adjuvant chemotherapy in peri- or pre-menopausal women
In respect of the subcutaneous implant (long acting) 10.8 mg (as acetate) in pre-filled injection syringe:
In compliance with authority procedures set out in subparagraph 14 (d):
3229
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate
[14] Schedule 1, item dealing with Goserelin and Bicalutamide
omit from the column headed “Circumstances”:
Metastatic (equivalent to stage D) prostatic carcinoma in patients for whom a combination of an antiandrogen and a gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist is required
and substitute in the columns in the order indicated:
3239
Metastatic (equivalent to stage D) prostatic carcinoma in patients for whom a combination of an antiandrogen and a gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist is required
[15] Schedule 1, item dealing with Imatinib
(a) omit from the column headed “Circumstances” under the heading “Gastrointestinal stromal tumour” (first occurring):
(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim; and
(iv) for patients who commenced treatment with imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour prior to 1 December 2004, the date on which therapy with imatinib mesylate was commenced
and substitute:
(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim
(b) omit from the column headed “Circumstances” under the heading “Gastrointestinal stromal tumour” (second occurring):
Continuing PBS-subsidised treatment, at a dose of up to 600 mg per day, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour who have previously been issued with an authority prescription for this drug
and substitute:
Continuing PBS-subsidised treatment, at a dose of up to 600 mg per day, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour who have previously been issued with an authority prescription for this drug, and where the patient has not failed to respond, or is not intolerant, to imatinib
[16] Schedule 1, omit item dealing with Influenza Vaccine
[17] Schedule 1, item dealing with Lapatinib
omit from the column headed “Circumstances”:
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Initial treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer who was receiving treatment with lapatinib prior to 1 May 2008, and where the authority application includes:
(a) a pathology report demonstrating that HER2 positivity has been demonstrated by in situ hybridisation (ISH); and
(b) a signed patient acknowledgment; and
(c) the date the patient commenced non-PBS-subsidised treatment with lapatinib
[18] Schedule 1, item dealing with Memantine
omit from the column headed “Circumstances”:
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
[19] Schedule 1, after item dealing with Naratriptan
insert in the columns in the order indicated:
Nebivolol
In compliance with authority procedures set out in subparagraph 14 (d):
3234
Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor or angiotensin II antagonist, if tolerated
[20] Schedule 1, item dealing with Olanzapine
omit from the column headed “Circumstances”:
In respect of the powder for injection 210 mg (as pamoate monohydrate) with diluent and powder for injection 300 mg (as pamoate monohydrate) with diluent:
and substitute:
In respect of the powder for injection 210 mg (as pamoate monohydrate) with diluent, powder for injection 300 mg (as pamoate monohydrate) with diluent and powder for injection 405 mg (as pamoate monohydrate) with diluent:
[21] Schedule 1, item dealing with Pamidronic Acid
omit from the columns in the order indicated:
1392
Symptomatic Paget's disease of bone
and substitute:
3256
Symptomatic Paget disease of bone
[22] Schedule 1, item dealing with Risedronic Acid
omit from the columns in the order indicated:
1392
Symptomatic Paget's disease of bone
and substitute:
3256
Symptomatic Paget disease of bone
[23] Schedule 1, after item dealing with Rivastigmine
insert in the columns in the order indicated:
Rizatriptan
In compliance with authority procedures set out in subparagraph 14 (d):
3233
Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics
[24] Schedule 1, item dealing with Salcatonin
omit from the columns in the order indicated:
1392
Symptomatic Paget's disease of bone
and substitute:
3256
Symptomatic Paget disease of bone
[25] Schedule 1, item dealing with Terbinafine
omit all details from Column 2 and Column 3 and substitute:
In respect of the tablet 250 mg (as hydrochloride):
In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of a dermatophyte infection in an Aboriginal or a Torres Strait Islander person where topical treatment has failed
Treatment of a dermatophyte infection in a patient aged up to 18 years inclusive where topical treatment and griseofulvin have failed
Proximal or extensive (greater than 80% nail involvement) onychomycosis due to dermatophyte infection where topical treatment has failed, where the infection is proven by microscopy or culture and confirmed by an Approved Pathology Authority not more than 12 months prior to the date of the authority application and where the date of the pathology report is included in the authority application
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):
2354
Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
3243
Treatment of a fungal or a yeast infection in a patient aged up to 18 years inclusive
[26] Schedule 1, item dealing with Tiludronic Acid
omit from the columns in the order indicated:
1392
Symptomatic Paget's disease of bone
and substitute:
3256
Symptomatic Paget disease of bone
[27] Schedule 1, after item dealing with Trifluoperazine
insert in the columns in the order indicated:
Triglycerides, long chain with glucose polymer
Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae
[28] Schedule 1, after item dealing with Ursodeoxycholic Acid
insert in the columns in the order indicated:
Ustekinumab
Chronic plaque psoriasis (whole body) — initial treatment 3
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 ustekinumab for continuing treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with ustekinumab prior to 26 November 2009; and
(b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with ustekinumab; and
(c) have signed a patient and prescriber 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 restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with ustekinumab of psoriasis affecting the whole body; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 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 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 Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of ustekinumab therapy) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
the most recent PASI assessment is no more than 1 month old at the time of application;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):
Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and were receiving non-PBS-subsidised treatment with ustekimumab prior to 26 November 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with ustekinumab 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
Chronic plaque psoriasis (whole body) — continuing treatment
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 ustekinumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with ustekinumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 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 ustekinumab 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 pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 28-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with ustekinumab;
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;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):
Continuing treatment as systemic monotherapy (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 ustekinumab 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
Chronic plaque psoriasis (face, hand, foot) — initial treatment 3
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 ustekinumab for continuing treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with ustekinumab prior to 26 November 2009; and
(b) whose disease, prior to treatment with ustekinumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and
(c) who have signed a patient and prescriber 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 restriction for continuing treatment of psoriasis affecting the face, hand or foot; and
(d) who have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with ustekinumab of psoriasis affecting the face, hand or foot; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 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 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 Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of ustekinumab therapy) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
the most recent PASI assessment is no more than 1 month old at the time of application;
the PASI assessment is performed on the same affected body area as assessed at baseline or prior to initiation of ustekinumab treatment;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):
Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy (other than methotrexate) 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 were receiving non-PBS-subsidised treatment with ustekinumab prior to 26 November 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with ustekinumab 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
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
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 ustekinumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with ustekinumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 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 ustekinumab 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 pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 28-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with ustekinumab;
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;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):
Continuing treatment as systemic monotherapy (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 ustekinumab 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
Chronic plaque psoriasis (whole body) — initial treatment 1
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 and prescriber 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 restriction for continuing treatment of psoriasis affecting the whole body; 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 adalimumab, etanercept, infliximab or ustekinumab; 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 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 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 demonstrated 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 and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 28 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 ustekinumab for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total
Chronic plaque psoriasis (whole body) — initial treatment 2
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Initial treatment, or recommencement of treatment, with ustekinumab 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 ustekinumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 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 who have previously demonstrated a response to PBS-subsidised treatment with ustekinumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised ustekinumab 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 28 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 ustekinumab 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 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
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 and prescriber 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 restriction for continuing treatment of psoriasis affecting the face, hand or foot; 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 adalimumab, etanercept, infliximab or ustekinumab; 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 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 is demonstrated 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 and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 28 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 ustekinumab for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
In compliance with authority procedures set out in subsubparagraph 14 (d) (i):
Initial treatment, or recommencement of treatment, with ustekinumab 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 ustekinumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 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 who have previously demonstrated a response to PBS-subsidised treatment with ustekinumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised ustekinumab 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 28 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 ustekinumab 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 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total
[29] Schedule 1A, after item dealing with Methadone
insert in the columns in the order indicated:
Methylnaltrexone
In compliance with authority procedures set out in subparagraph 14 (d):
Initial supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has failed to respond to laxatives
First continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone
Second and subsequent continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone, and where consultation with a palliative care specialist or service has occurred
Continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone
