National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (No. PB 63 of 2010)

Abacavir

3309

Treatment of human immunodeficiency virus infection in patients with CD4 cell counts of less than 500 per cubic millimetre

3310

Treatment of human immunodeficiency virus infection in patients with viral load of greater than 10,000 copies per mL

Abacavir with Lamivudine

3311

Treatment of human immunodeficiency virus infection in patients over 12 years of age, weighing 40 kg or more, with CD4 cell counts of less than 500 per cubic millimetre

3312

Treatment of human immunodeficiency virus infection in patients over 12 years of age, weighing 40 kg or more, with viral load of greater than 10,000 copies per mL

Abacavir with Lamivudine and Zidovudine

3311

Treatment of human immunodeficiency virus infection in patients over 12 years of age, weighing 40 kg or more, with CD4 cell counts of less than 500 per cubic millimetre

3312

Treatment of human immunodeficiency virus infection in patients over 12 years of age, weighing 40 kg or more, with viral load of greater than 10,000 copies per mL

Abatacept

Rheumatoid arthritis —  initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)

Initial PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, 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 received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and

(c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:

(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:

— hydroxychloroquine at a dose of at least 200 mg daily; or

— leflunomide at a dose of at least 10 mg daily; or

— sulfasalazine at a dose of at least 2 g daily; or

(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose —  at least 3 months continuous treatment with each of at least 2 of the following DMARDs:

— hydroxychloroquine at a dose of at least 200 mg daily; and/or

— leflunomide at a dose of at least 10 mg daily; and/or

— sulfasalazine at a dose of at least 2 g daily; or

(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above —  at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:

— azathioprine at a dose of at least 1 mg/kg per day; and/or

— cyclosporin at a dose of at least 2 mg/kg/day; and/or

— sodium aurothiomalate at a dose of 50 mg weekly; and

where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and

where the following conditions apply:

if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;

the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;

the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;

if the requirement to trial 6 months of intensive DMARD therapy with at least
2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;

failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:

(a) 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

(b) either:

(i) a total active joint count of at least 20 active (swollen and tender) joints; or

(ii) at least 4 active joints from the following list of major joints:

— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or

— shoulder and/or hip (assessed as active if there is 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);

the joint count and ESR and/or CRP are determined at the completion of the
6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;

if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;

the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;

a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with abatacept for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;

a course of initial treatment is limited to a maximum of 16 weeks of treatment;

if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Rheumatoid arthritis —  initial treatment 2
(change or recommencement after a break of less than 12 months)

Initial PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, 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 biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous
12 months and are eligible to receive further bDMARD therapy; and

(c) have not failed previous PBS-subsidised treatment with abatacept for this condition; and

where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and

where the following conditions apply:

patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;

patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with abatacept are not eligible to commence treatment with abatacept 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 is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;

where a patient has received PBS-subsidised treatment with abatacept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS-subsidised abatacept treatment;

the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised abatacept treatment is a
16-week initial treatment course, is made following a minimum of 12 weeks of therapy;

a course of initial treatment is limited to a maximum of 16 weeks of treatment;

if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Rheumatoid arthritis —  continuing treatment

Continuing PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, 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 abatacept; and

(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with abatacept; and

where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and

where the following conditions apply:

an adequate response to treatment is defined as:

(a) 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

(b) either of the following:

(i) 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

(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or

— shoulder and/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 an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;

the authority application is made in writing and 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 abatacept;

the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

if the most recent course of abatacept therapy is 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;

if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

a course of continuing treatment is limited to a maximum of 24 weeks of treatment;

if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

Adalimumab

Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)

Initial treatment commencing a treatment cycle, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years:

(a) who has severe active juvenile idiopathic arthritis; and

(b) whose parent or authorised guardian has signed a patient acknowledgement; and

(c) who has not received PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and

(d) who has demonstrated either:

(i) severe intolerance of, or toxicity due to, methotrexate; or

(ii) failure to achieve an adequate response to 1 or more of the following treatment regimens:

— oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or

— oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; and

where bDMARD means adalimumab or etanercept; and

where the following conditions apply:

severe intolerance is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours;

toxicity is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis;

if treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application provides details of the contraindication;

if intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, the authority application provides details of this toxicity;

failure to achieve an adequate response is indicated by the following criteria and must be demonstrated in all patients at the time of the authority application:

(a) an active joint count of at least 20 active (swollen and tender) joints; or

(b) at least 4 active joints from the following list:

(i) elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or

(ii) shoulder, cervical spine and/or hip (assessed as active if there is 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);

the joint count assessment is performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and an acknowledgement signed by a parent or authorised guardian;

a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 12 months have elapsed between the date the last PBS-subsidised bDMARD was stopped and the date of the first application under the new treatment cycle;

a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;

if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)

Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years who:

(a) has a documented history of severe active juvenile idiopathic arthritis; and

(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and

(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and

where the following conditions apply:

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;

where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS-subsidised adalimumab treatment;

the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;

a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;

if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Juvenile idiopathic arthritis — initial treatment 3

Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years who:

(a) has a documented history of severe active juvenile idiopathic arthritis; and

(b) was receiving treatment with adalimumab prior to 1 March 2010; and

(c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and

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

where the following conditions apply:

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and an acknowledgement signed by a parent or authorised guardian;

the course of treatment is limited to a maximum of 24 weeks of treatment;

if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;

a patient is eligible for PBS-subsidised treatment under the above criteria once only

Juvenile idiopathic arthritis — continuing treatment

Continuing PBS-subsidised treatment with adalimumab within an ongoing treatment cycle, by a rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient:

(a) who has a documented history of severe active juvenile idiopathic arthritis; and

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

(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle was with adalimumab; and

where bDMARD means adalimumab or etanercept; and

where the following conditions apply:

an adequate response to treatment is defined as:

(i) 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

(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or

— shoulder, cervical spine and/or hip (assessed as active if there is 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);

the same joints assessed to establish baseline joint count at the commencement of an initial course of treatment are assessed to determine response to that course, and subsequent courses, of treatment;

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;

the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

if the most recent course of adalimumab therapy is 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;

if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;

a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;

if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

Adefovir

3313

Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:

(1) (a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or

(b) Repeatedly elevated HBV DNA levels 1 log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance;

(2) Female patients of childbearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.

Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Ambrisentan

Initial treatment 1
(new patients)

Initial PBS-subsidised treatment with ambrisentan of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:

(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or

(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and

where the patient has failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a signed patient and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and

(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment 2
(new patients)

Initial PBS-subsidised treatment with ambrisentan of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:

(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or

(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; or

(c) WHO Functional Class IV primary pulmonary hypertension; or

(d) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a signed patient and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment
(previous treatment not PBS-subsidised)

Initial PBS-subsidised treatment with ambrisentan of patients who were receiving treatment with ambrisentan prior to 1 December 2009 and who have been assessed by a physician from a designated hospital to have:

(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension; or

(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; or

(c) WHO Functional Class IV primary pulmonary hypertension; or

(d) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) for patients who have received less than 6 months of ambrisentan treatment at the time of application — a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT) at the time treatment with ambrisentan was commenced, or, where results from all 3 of the tests are not available or it was not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) the date of commencement of ambrisentan treatment; and

(3) a signed patient acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(4) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

for patients who have received less than 6 months of non-PBS-subsidised ambrisentan treatment at the time of application — the maximum duration of treatment which will be authorised under this criterion is sufficient to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised therapy;

if the duration of treatment authorised for the written application under this criterion is less than that to which the patient is entitled, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete the maximum allowable duration of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment
(change or re-commencement for all patients)

Initial treatment with ambrisentan of patients:

(a) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence PBS-subsidised ambrisentan after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with ambrisentan; or

(b) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with an alternate PAH agent other than ambrisentan; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and

(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and

(3) the results of the patient’s response to treatment with their last course of PBS-subsidised PAH agent; and

(4) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Continuing treatment
(all patients)

Continuing PBS-subsidised treatment with ambrisentan of patients who have received approval for initial PBS-subsidised treatment with ambrisentan and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of ambrisentan treatment; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) ECHO composite assessment plus 6MWT; or

(iv) RHC composite assessment alone; or

(v) ECHO composite assessment alone; and

(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Definitions

For the purpose of PBS-subsidised supply of ambrisentan for the circumstances specified above:

“PAH agent” means ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium

Primary pulmonary hypertension and pulmonary arterial hypertension secondary to connective tissue disease are defined as:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or

(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or

(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function

Response to ambrisentan or prior vasodilator treatment is defined:

(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iv) for patients aged less than 18 years – as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital

Apomorphine

3314

Parkinson's disease in patients severely disabled by motor fluctuations which do not respond to other therapy

Atazanavir

3315

Treatment, in combination with 2 or more other antiretroviral drugs, of human immunodeficiency virus infection in patients with CD4 cell counts of less than 500 per cubic millimetre

3316

Treatment, in combination with 2 or more other antiretroviral drugs, of human immunodeficiency virus infection in patients with viral load of greater than 10,000 copies per mL

Azithromycin

3317

Prophylaxis against Mycobacterium avium complex infections in human immunodeficiency virus-positive patients with CD4 cell counts of less than 75 per cubic millimetre

Baclofen

3318

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity of cerebral origin

3319

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to multiple sclerosis

3320

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to spinal cord injury

3321

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to spinal cord disease

Bosentan

Initial treatment 1
(new adult patient)

Initial PBS-subsidised treatment with bosentan monohydrate of adult patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:

(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or

(b) WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and

where the patient has failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a signed patient and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and

(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;

the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;

if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;

determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment 2
(new adult patient)

Initial PBS-subsidised treatment with bosentan monohydrate of adult patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:

(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or

(b) WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; or

(c) WHO Functional Class IV primary pulmonary hypertension; or

(d) WHO Functional Class IV pulmonary arterial hypertension secondary to scleroderma; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a signed patient and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;

the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;

if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;

determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment 1
(new patient under 18 years of age)

Initial PBS-subsidised treatment with bosentan monohydrate of patients aged less than 18 years who have not received prior PBS-subsidised treatment with a PAH agent, who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO), and who have failed to respond to 6 or more weeks of appropriate prior vasodilator treatment unless intolerance or a contraindication to such treatment exists; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a patient and prescriber acknowledgment, signed by the parent or authorised guardian, indicating that they understand and acknowledge that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and

(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;

the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;

if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;

determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment 2
(new patient under 18 years of age)

Initial PBS-subsidised treatment with bosentan monohydrate of patients aged less than 18 years who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:

(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or

(b) WHO Functional Class IV primary pulmonary hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a patient and prescriber acknowledgment, signed by the parent or authorised guardian, indicating that they understand and acknowledge that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;

the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;

if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;

determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment
(new patient)

Initial PBS-subsidised treatment with bosentan monohydrate of a patient who has been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III or IV pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology); and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a signed patient and prescriber acknowledgment (and signed by the parent or authorised guardian for patients under 18 years of age) indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;

the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;

if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;

determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment
(change or re-commencement for adult patients)

Initial treatment with bosentan monohydrate of adult patients:

(a) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology), who wish to re-commence PBS-subsidised bosentan monohydrate after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or

(b) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with an alternate PAH agent other than bosentan monohydrate; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and

(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and

(3) the results of the patient’s response to treatment with their last course of PBS-subsidised PAH agent; and

(4) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;

the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;

if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;

determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment
(change or re-commencement for patients under 18 years of age)

Initial treatment with bosentan monohydrate of patients aged less than 18 years:

(a) who have primary pulmonary hypertension, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology), who wish to re-commence PBS-subsidised bosentan monohydrate after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or

(b) who have primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with a PAH agent other than bosentan monohydrate; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and

(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and

(3) the results of the patient’s response to treatment with their last course of PBS-subsidised PAH agent; and

(4) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;

the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;

if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;

determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Continuing treatment
(all patients)

Continuing PBS-subsidised treatment with bosentan monohydrate of patients who have received approval for initial PBS-subsidised treatment with bosentan monohydrate and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of bosentan monohydrate treatment; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) ECHO composite assessment plus 6MWT; or

(iv) RHC composite assessment alone; or

(v) ECHO composite assessment alone; and

(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Cessation of treatment
(all patients)

Final PBS-subsidised supply to allow for gradual cessation of treatment for patients with World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma, or WHO Functional Class III or IV pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology), who have not responded to bosentan monohydrate therapy; and

where the following conditions apply:

the authority application may be submitted by telephone;

the supply authorised under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient to allow gradual dose reduction over a period of 1 month

Definitions

For the purpose of PBS-subsidised supply of bosentan monohydrate for the circumstances specified above:

“PAH agent” means ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium

Primary pulmonary hypertension, pulmonary arterial hypertension secondary to scleroderma and pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology) are defined as:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or

(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or

(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function

Response to bosentan monohydrate or prior vasodilator treatment is defined:

(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iv) for patients aged less than 18 years – as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital

Cidofovir

3322

Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome

Cinacalcet

3323

Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with intact parathyroid hormone (iPTH) of at least 50 pmol per L, not responding to conventional therapy

3324

Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with intact parathyroid hormone (iPTH) of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L, not responding to conventional treatment

Clarithromycin

3325

Treatment of Mycobacterium avium complex infections

Clozapine

3326

Schizophrenia in patients who are non-responsive to other neuroleptic agents

3327

Schizophrenia in patients who are intolerant of other neuroleptic agents

Cyclosporin

In respect of the solution concentrate for I.V. infusion 50 mg in 1 mL: 

3333

For use by organ or tissue transplant recipients

In respect of the capsule 10 mg, capsule 25 mg, capsule 50 mg, capsule 100 mg and oral liquid 100 mg per mL, 50 mL:

3328

Management of rejection in patients following organ or tissue transplantation, under the supervision and direction of a transplant unit, where management includes initiation, stabilisation and review of therapy as required

3329

Management (which includes initiation, stabilisation and review of therapy) by dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate

3330

Management (which includes initiation, stabilisation and review of therapy) by dermatologists of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life

3331

Management (which includes initiation, stabilisation and review of therapy) by nephrologists of patients with nephrotic syndrome in patients in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired

3332

Management (which includes initiation, stabilisation and review of therapy) by rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate

Darbepoetin Alfa

3334

Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia

Darunavir

3335

Treatment, in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir twice daily, of human immunodeficiency virus (HIV) infection in an antiretroviral experienced patient with:

(a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and/or

(b) CD4 cell counts of less than 500 per cubic millimetre.

A patient must have failed previous treatment with, or have resistance to, 1 antiretroviral regimen

Deferasirox

3336

Chronic iron overload in adults, adolescents and children 6 years and older associated with disorders of erythropoiesis

3337

Chronic iron overload in paediatric patients aged 2 to 5 years, associated with disorders of erythropoiesis, who are intolerant to desferrioxamine mesylate or in whom desferrioxamine mesylate has proven ineffective

Deferiprone

3338

Iron overload in patients with thalassaemia major who are unable to take desferrioxamine mesylate therapy 

3339

Iron overload in patients with thalassaemia major in whom desferrioxamine mesylate therapy has proven ineffective

Desferrioxamine

3340

Disorders of erythropoiesis associated with treatment-related chronic iron overload

Didanosine

3309

Treatment of human immunodeficiency virus infection in patients with CD4 cell counts of less than 500 per cubic millimetre

3310

Treatment of human immunodeficiency virus infection in patients with viral load of greater than 10,000 copies per mL

Dornase Alfa

3344

Patient 5 years of age or older

Use by cystic fibrosis patients who satisfy all of the following criteria: 

(1) are 5 years of age or older;

(2) have a FVC greater than 40% predicted for age, gender and height;

(3) have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);

(4) are participating in a 4 week trial as detailed below or have achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to dornase alfa treatment) after a 4 week trial.

In order for patients to be eligible for participation in the highly specialised drugs (HSD) program, the following conditions must be met:

(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;

(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;

(3) Prior to dornase alfa therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;

(4) Initial therapy is limited to 4 weeks' treatment with dornase alfa at a dose of 2.5 mg daily;

(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to dornase alfa treatment) are eligible for continued subsidy under the HSD program at a dose of 2.5 mg daily;

(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 2.5 mg daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;

(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that dornase alfa treatment is continuing to produce worthwhile benefits. (Dornase alfa therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;

(8) Other aspects of treatment, such as physiotherapy, must be continued;

(9) Where there is documented evidence that a patient already receiving dornase alfa therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period)

3345

Patient less than 5 years of age

Treatment of cystic fibrosis in a patient less than 5 years of age who has:

(1) A severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring frequent hospital admissions more frequently than 3 times per year; or

(2) Significant bronchiectasis on chest high resolution computed tomography scan; or

(3) Severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or

(4) Severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy.

In order for the patient to be eligible for participation in the highly specialised drugs (HSD) program, the following conditions must be met:

(1) The patient must be assessed at a cystic fibrosis clinic/centre which is under the supervision of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis, and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;

(2) Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. Further reassessments are to be undertaken and documented yearly

3346

Patient 5 years of age or older (commenced treatment at age of less than 5 years)

Continuation of treatment of cystic fibrosis in a patient 5 years of age or older, who initiated treatment with dornase alfa at an age of less than 5 years and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

3347

Patient less than 5 years of age (treatment initiated prior to 1 November 2009)

Treatment of cystic fibrosis in a patient less than 5 years of age who initiated treatment with dornase alfa prior to 1 November 2009 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team, documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Doxorubicin - Pegylated Liposomal

3348

Treatment of acquired immunodeficiency syndrome-related Kaposi's sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive mucocutaneous involvement

3349

Treatment of acquired immunodeficiency syndrome-related Kaposi's sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive visceral involvement

Efavirenz

3309

Treatment of human immunodeficiency virus infection in patients with CD4 cell counts of less than 500 per cubic millimetre

3310

Treatment of human immunodeficiency virus infection in patients with viral load of greater than 10,000 copies per mL

Emtricitabine

3309

Treatment of human immunodeficiency virus infection in patients with CD4 cell counts of less than 500 per cubic millimetre

3310

Treatment of human immunodeficiency virus infection in patients with viral load of greater than 10,000 copies per mL

Enfuvirtide

3350

Treatment, in combination with other antiretroviral agents, of human immunodeficiency virus (HIV) infection in antiretroviral experienced patients with treatment failure characterised by evidence of HIV replication despite ongoing therapy; and

where the patient has failed previous treatment with 3 different antiretroviral regimens; and

where the patient's previous treatment has included at least 1 non-nucleoside reverse transcriptase inhibitor, at least 1 nucleoside reverse transcriptase inhibitor and at least 1 protease inhibitor

3351

Treatment, in combination with other antiretroviral agents, of human immunodeficiency virus (HIV) infection in antiretroviral experienced patients with treatment failure characterised by treatment-limiting toxicity to previous antiretroviral agents; and

where the patient has failed previous treatment with 3 different antiretroviral regimens; and

where the patient's previous treatment has included at least 1 non-nucleoside reverse transcriptase inhibitor, at least 1 nucleoside reverse transcriptase inhibitor and at least 1 protease inhibitor

Entecavir

In respect of the tablet containing entecavir monohydrate 0.5 mg:

3352

Patients with chronic hepatitis B who satisfy all of the following criteria:

(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);

(2) (a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or

(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;

(3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.

Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

In respect of the tablet containing entecavir monohydrate 1 mg:

3353

Patients with chronic hepatitis B who have failed lamivudine therapy and who satisfy all of the following criteria:

(1) (a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or

(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance;

(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.

Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Epoetin Alfa

3334

Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia

Epoetin Beta

3334

Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia

Epoprostenol

Initial treatment
(new adult patients)

Initial PBS-subsidised treatment with epoprostenol sodium of adult patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class IV primary pulmonary hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a signed patient and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment
(new patients under 18 years of age)

Initial PBS-subsidised treatment with epoprostenol sodium of patients aged less than 18 years who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class IV primary pulmonary hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) a patient acknowledgment, signed by the parent or authorised guardian and the prescriber, indicating that they understand and acknowledge that PBS-subsidised treatment with PAH agents will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment
(change or re-commencement for all adult patients)

Initial PBS-subsidised treatment with epoprostenol sodium of adult patients:

(a) who have primary pulmonary hypertension, who wish to re-commence PBS-subsidised epoprostenol sodium after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with epoprostenol sodium; or

(b) who have World Health Organisation (WHO) Functional Class IV primary pulmonary hypertension and who have received prior treatment with a PBS-subsidised PAH agent other than epoprostenol sodium; or

(c) who have WHO Functional Class III primary pulmonary hypertension and who have failed to respond to a prior PBS-subsidised PAH agent; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and

(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and

(3) the results of the patient’s response to treatment with their last course of PBS-subsidised PAH agent; and

(4) for WHO Functional Class III patients, where this is the first application for epoprostenol sodium, assessment details of the PBS-subsidised PAH agent they have failed to respond to; and

(5) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment
(change or re-commencement for all patients under 18 years of age)

Initial PBS-subsidised treatment with epoprostenol sodium of patients aged less than 18 years:

(a) who have primary pulmonary hypertension, who wish to re-commence PBS-subsidised epoprostenol sodium after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with epoprostenol sodium; or

(b) who have World Health Organisation (WHO) Functional Class IV primary pulmonary hypertension and who have received prior treatment with a PBS-subsidised PAH agent other than epoprostenol sodium; or

(c) who have WHO Functional Class III primary pulmonary hypertension and who have failed to respond to a prior PBS-subsidised PAH agent; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and

(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and

(3) the results of the patient’s response to treatment with their last course of PBS-subsidised PAH agent; and

(4) for WHO Functional Class III patients, where this is the first application for epoprostenol sodium, assessment details of the PBS-subsidised PAH agent they have failed to respond to; and.

(5) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Continuing treatment
(all patients)

Continuing PBS-subsidised treatment with epoprostenol sodium of patients who have received approval for initial PBS-subsidised treatment with epoprostenol sodium and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of epoprostenol sodium treatment; and

where the following conditions apply:

the authority application is made in writing and includes:

(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:

(i) RHC composite assessment plus ECHO composite assessment; or

(ii) RHC composite assessment plus 6MWT; or

(iii) ECHO composite assessment plus 6MWT; or

(iv) RHC composite assessment alone; or

(v) ECHO composite assessment alone; and

(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;

a maximum of 6 months of treatment will be authorised under this criterion;

if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;

determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Definitions

For the purpose of PBS-subsidised supply of epoprostenol sodium for the circumstances specified above:

“PAH agent” means ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium

Primary pulmonary hypertension is defined as:

(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or

(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or

(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function

Response to epoprostenol sodium or prior vasodilator treatment is defined:

(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iv) for patients aged less than 18 years – as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital

Etanercept

In respect of the injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL:

Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)

Initial treatment commencing a treatment cycle, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years:

(a) who has severe active juvenile idiopathic arthritis; and

(b) whose parent or authorised guardian has signed a patient acknowledgement; and

(c) who has not received PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and

(d) who has demonstrated either:

(i) severe intolerance of, or toxicity due to, methotrexate; or

(ii) failure to achieve an adequate response to 1 or more of the following treatment regimens:

— oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or

— oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; and

where bDMARD means adalimumab or etanercept; and

where the following conditions apply:

severe intolerance is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours;

toxicity is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis;

if treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application provides details of the contraindication;

if intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, the authority application provides details of this toxicity;

failure to achieve an adequate response is indicated by the following criteria and must be demonstrated in all patients at the time of the authority application:

(a) an active joint count of at least 20 active (swollen and tender) joints; or

(b) at least 4 active joints from the following list:

(i) elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or

(ii) shoulder, cervical spine and/or hip (assessed as active if there is 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);

the joint count assessment is performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and an acknowledgement signed by a parent or authorised guardian;

a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of etanercept provided a minimum of 12 months have elapsed between the date the last PBS-subsidised bDMARD was stopped and the date of the first application under the new treatment cycle;

a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;

if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)

Initial PBS-subsidised treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years who:

(a) has a documented history of severe active juvenile idiopathic arthritis; and

(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and

(c) has not failed PBS-subsidised therapy with etanercept for this condition more than once in the current treatment cycle; and

where the following conditions apply:

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;

where a patient has received PBS-subsidised treatment with etanercept in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS-subsidised etanercept treatment;

the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;

a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;

if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Juvenile idiopathic arthritis — continuing treatment

Continuing PBS-subsidised treatment with etanercept within an ongoing treatment cycle, by a rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient:

(a) who has a documented history of severe active juvenile idiopathic arthritis; and

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

(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle was with etanercept; and

where bDMARD means adalimumab or etanercept; and

where the following conditions apply:

an adequate response to treatment is defined as:

(i) 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

(ii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or

— shoulder, cervical spine and/or hip (assessed as active if there is 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);

the same joints assessed to establish baseline joint count at the commencement of an initial course of treatment are assessed to determine response to that course, and subsequent courses, of treatment;

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;

the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

if the most recent course of etanercept therapy is 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;

if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;

a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;

if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

In respect of the injections 50 mg in 1 mL single use pre-filled syringes, 4 and the injection 50 mg in 1 mL single use auto-injector, 4:

Juvenile idiopathic arthritis — continuing treatment
(patient 18 years or older)

Continuing PBS-subsidised treatment with etanercept within an ongoing treatment cycle, by a rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient 18 years or older:

(a) who has a documented history of severe active juvenile idiopathic arthritis; and

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

(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle was with etanercept; and

where bDMARD means adalimumab or etanercept; and

where the following conditions apply:

an adequate response to treatment is defined as:

(i) 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

(ii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or

— shoulder, cervical spine and/or hip (assessed as active if there is 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);

the same joints assessed to establish baseline joint count at the commencement of an initial course of treatment are assessed to determine response to that course, and subsequent courses, of treatment;

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;

the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

if the most recent course of etanercept therapy is 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;

if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;

a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;

if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

Etravirine

3354

Treatment, in combination with other antiretroviral agents, of human immunodeficiency virus (HIV) infection in an antiretroviral experienced patient with:

(a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and/or

(b) CD4 cell counts of less than 500 per cubic millimetre.

A patient must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens which have included:

(i) at least 1 non-nucleoside reverse transcriptase inhibitor; and

(ii) at least 1 nucleoside reverse transcriptase inhibitor; and

(iii) at least 1 protease inhibitor

Everolimus

3355

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required

3356

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required

Filgrastim

3357

For use in a patient undergoing induction and consolidation therapy for acute myeloid leukaemia

3358

Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy

3359

Mobilisation of peripheral blood progenitor cells, in a normal volunteer, for use in allogeneic transplantation

3360

A patient receiving marrow-ablative chemotherapy and subsequent bone marrow transplantation

3361

A patient with a non-myeloid malignancy receiving marrow-ablative chemotherapy and subsequent autologous peripheral blood progenitor cell transplantation

3362

A patient with breast cancer receiving standard dose adjuvant chemotherapy who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned

3363

A patient receiving chemotherapy for B-cell chronic lymphocytic leukaemia with fludarabine and cyclophosphamide who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned

3364

A patient receiving first-line chemotherapy for Hodgkin disease who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned

3365

A patient receiving chemotherapy for myeloma who has had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned

3366

A patient with severe congenital neutropenia (absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, and in whom a bone marrow examination has shown evidence of maturational arrest of the neutrophil lineage)

3367

A patient with severe chronic neutropenia (absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, or evidence of neutrophil dysfunction, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months))

3368

A patient with chronic cyclic neutropenia (absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months))

3369

A patient with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned

3370

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia

3371

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide)

3372

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours

3373

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours

3374

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma

3375

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen)

3376

A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease

3377