National Health Act 1953 - Special Arrangements under subsection 100(1) - highly specialised drugs program (No. PB 120 of 2008)

Abacavir

Treatment of human immunodeficiency virus infection in patients with:

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Abacavir with Lamivudine

Treatment of human immunodeficiency virus infection in patients over 12 years of age, weighing 40 kg or more, with:

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Abacavir with Lamivudine and Zidovudine

Treatment of human immunodeficiency virus infection in patients over 12 years of age, weighing 40 kg or more, with:

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

  Abatacept

Rheumatoid arthritis

Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

(a) have severe active rheumatoid arthritis; and

(b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and

(c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

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

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

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

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;

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

if less than 16 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply 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, or recommencement of treatment, with abatacept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

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

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

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

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;

patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with abatacept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:

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

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

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and

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

patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with 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 and, in the case of patients recommencing therapy with abatacept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised abatacept therapy;

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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Rheumatoid arthritis

Commencement of abatacept treatment in a bDMARD Treatment Cycle with an initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of an adult who:

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

(b) was receiving treatment with abatacept prior to 1 November 2007; and

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

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

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

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, a subsequent authority application for a supply 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

Rheumatoid arthritis

Continuing treatment with abatacept within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:

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

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

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

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;

an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

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

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

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

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

the authority application 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, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of abatacept therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

the patient has not failed to demonstrate response to a course of PBS-subsidised abatacept 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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

Adefovir

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

Apomorphine

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

Atazanavir

Treatment, in combination with 2 or more other antiretroviral drugs, of human immunodeficiency virus infection in patients with:

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Azithromycin

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

Baclofen

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

(1) of cerebral origin; or

(2) due to multiple sclerosis; or

(3) due to spinal cord injury; or

(4) due to spinal cord disease

Bosentan

Initial treatment, for up to six months, of adult patients who have not received prior treatment with iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and:

(a) who have been assessed by a physician from a designated hospital to have 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) unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or

(b) who have been assessed by a physician from a designated hospital to have 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 unless RHC is contraindicated on clinical grounds, and who have 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 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 is contraindicated 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 acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension, pulmonary arterial hypertension secondary to scleroderma or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology), or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, 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 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy 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, for up to 6 months, of adult patients who have not received prior treatment with iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) 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) unless RHC is contraindicated on clinical grounds; 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 unless RHC is contraindicated on clinical grounds; 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 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 is contraindicated 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 acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension, pulmonary arterial hypertension secondary to scleroderma or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology), or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy 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, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS), 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, normal 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 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 is contraindicated 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, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate for primary pulmonary hypertension 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 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy 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, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) 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 dysfunction 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 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 is contraindicated 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, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy 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, for up to 6 months, 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 is contraindicated 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 acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension, pulmonary arterial hypertension secondary to scleroderma or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology), or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy 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 PBS-subsidised supply for continuing treatment, for up to 6 months, of a patient who was receiving treatment with bosentan monohydrate prior to 1 August 2008 and who has been assessed by a physician from a designated hospital to have 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 is contraindicated 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 acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension, pulmonary arterial hypertension secondary to scleroderma or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology), or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

for patients who have received less than 6 months of bosentan monohydrate treatment at the time of application – the supply authorised under this criterion provides sufficient to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised therapy;

for patients who have received 6 or more months of bosentan monohydrate treatment at the time of application – the supply authorised under this criterion provides for up to 6 months of therapy;

if the supply initially authorised under this criterion is less than that to which the patient is entitled, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete the maximum allowable duration 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, for up to 6 months, of adult patients:

(a) who have 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, who wish to re-commence bosentan monohydrate treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or

(b) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with iloprost trometamol, sildenafil citrate or sitaxentan sodium; or

(c) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; 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 the first authorisation for PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium;

the first supply authorised 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 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, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy 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, for up to 6 months, of patients aged less than 18 years:

(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, who wish to re-commence bosentan monohydrate treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or

(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium or sildenafil citrate; 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 the first authorisation for PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised bosentan monohydrate, epoprostenol sodium or sildenafil citrate;

the first supply authorised 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 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, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy 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 PBS-subsidised treatment with bosentan monohydrate, for up to 6 months, 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), unless results from all 3 of the tests were included in the application for initial treatment and subsequent ECHO composite assessment and 6MWT results demonstrate stability or improvement of disease in which case RHC composite assessment can be omitted, or, where results from all 3 of the tests specified above were not able to be included in the application for initial treatment, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that, unless contraindicated on clinical grounds, the test results submitted include results from the same tests as were included in the application for initial treatment:

(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 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy 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

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 is 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 and no longer

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

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

Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome

Cinacalcet

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

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

Treatment of Mycobacterium avium complex infections

Clozapine

Schizophrenia in patients who are: 

(a) non-responsive to other neuroleptic agents; or

(b) intolerant of other neuroleptic agents

Cyclosporin

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

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:

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

Management, which includes initiation, stabilisation and review of therapy, by:

(1) dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate

(2) 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

(3) nephrologists of 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

(4) 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

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

Treatment, in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir twice daily, of 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 2 protease inhibitors.

Deferasirox

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

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

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

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

Delavirdine

Treatment of human immunodeficiency virus infection in patients with:

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Desferrioxamine

Disorders of erythropoiesis associated with treatment-related chronic iron overload

Didanosine

Treatment of human immunodeficiency virus infection in patients with: 

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Dornase Alfa

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 drug 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 highly specialised drug 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 highly specialised drug 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)

Doxorubicin - Pegylated Liposomal

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

(a) extensive mucocutaneous involvement; or

(b) extensive visceral involvement

Efavirenz

Treatment of human immunodeficiency virus infection in patients with: 

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Emtricitabine

Treatment of human immunodeficiency virus infection in patients with: 

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Enfuvirtide

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 previously failed 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

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

where the patient has previously failed 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:

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:

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

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

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, for up to six months, of adult patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have 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) unless RHC is contraindicated on clinical grounds, and who have 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 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 is contraindicated 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 acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, 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 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) 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) unless RHC is contraindicated on clinical grounds; 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 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 is contraindicated 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 acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

Initial treatment, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with bosentan monohydrate or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and 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, normal 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 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 is contraindicated 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, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate for primary pulmonary hypertension 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 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

Initial treatment, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with bosentan monohydrate or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) 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 dysfunction 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 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 is contraindicated 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, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

Initial treatment, for up to 6 months, of adult patients:

(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, who wish to re-commence epoprostenol sodium treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with epoprostenol sodium; or

(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium; 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 the first authorisation for PBS-subsidised treatment with epoprostenol sodium, iloprost trometamol, bosentan monohydrate, sildenafil citrate or sitaxentan sodium, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with epoprostenol sodium, iloprost trometamol, bosentan monohydrate, sildenafil citrate or sitaxentan sodium, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised epoprostenol sodium, iloprost trometamol, bosentan monohydrate, sildenafil citrate or sitaxentan sodium;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

Initial treatment, for up to 6 months, of patients aged less than 18 years:

(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, who wish to re-commence epoprostenol sodium treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with epoprostenol sodium; or

(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate or sildenafil citrate; 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 the first authorisation for PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised epoprostenol sodium, bosentan monohydrate or sildenafil citrate;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

Continuing PBS-subsidised treatment with epoprostenol sodium, for up to 6 months, 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), unless results from all 3 of the tests were included in the application for initial treatment and subsequent ECHO composite assessment and 6MWT results demonstrate stability or improvement of disease in which case RHC composite assessment can be omitted, or, where results from all 3 of the tests specified above were not able to be included in the application for initial treatment, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that, unless contraindicated on clinical grounds, the test results submitted include results from the same tests as were included in the application for initial treatment:

(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 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

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

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:

Initial treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years who have severe active polyarticular course juvenile chronic arthritis and whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment; and who have 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, alone or in combination with corticosteroids, for a minimum of 3 months;

unless treatment with methotrexate alone or in combination with another disease modifying anti-rheumatic drug is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance develops during the period of use such that permanent withdrawal is necessary and a suitably effective treatment regimen cannot be implemented, in which case the patient is exempted from demonstrating an inadequate response within the time period specified above; 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;

failure to achieve an adequate response to either of the above treatment regimens is demonstrated by:

(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 or ankle (assessed as swollen and tender); or

(ii) shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)

where the authority application includes the information used to determine the patient's eligibility according to the above criteria and the date of joint assessment

Initial PBS-subsidised supply for continuing treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients receiving treatment with etanercept prior to 1 December 2002, whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment

Continuing PBS-subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients who have demonstrated an adequate response to treatment with etanercept as manifested by:

(a) an active joint count of fewer than 10 active (swollen and tender) joints; or

(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or

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

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

(ii) shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and

where the following conditions apply:

the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; and

patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; and

applications for re-treatment of patients who have previously ceased treatment with etanercept due to having achieved and sustained complete remission of disease for 12 or more months are subject to the conditions applying to initial treatment and will not be authorised until a period of 12 months has elapsed since cessation of the previous treatment; and

authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course

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

Continuing PBS-subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients 18 years or older who have demonstrated an adequate response to treatment with etanercept as manifested by:

(a) an active joint count of fewer than 10 active (swollen and tender) joints; or

(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or

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

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

(ii) shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and

where the following conditions apply:

the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; and

patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; and

applications for re-treatment of patients who have previously ceased treatment with etanercept due to having achieved and sustained complete remission of disease for 12 or more months are subject to the conditions applying to initial treatment and will not be authorised until a period of 12 months has elapsed since cessation of the previous treatment; and

authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course

Everolimus

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for: 

(a) prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required; or

(b) prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required

Filgrastim

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

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

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

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

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

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

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

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

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

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)

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))

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))

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

(a) acute lymphoblastic leukaemia; or

(b) breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide); or

(c) germ cell tumours; or

(d) infants and children with CNS tumours; or

(e) neuroblastoma; or

(f) non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen); or

(g) relapsed Hodgkin disease; or

(h) sarcoma

Fosamprenavir

Treatment, in combination with 2 or more other antiretroviral drugs, of human immunodeficiency virus infection in patients with:

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Foscarnet

Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome

Treatment of aciclovir-resistant herpes simplex virus infection in immunocompromised patients with human immunodeficiency virus infection

Ganciclovir

In respect of the intravitreal implant 4.5 mg:

Cytomegalovirus retinitis in severely immunocompromised patients

In respect of the powder for I.V. infusion 500 mg (as sodium):

Cytomegalovirus retinitis in severely immunocompromised patients

Prophylaxis of cytomegalovirus disease in bone marrow transplant patients at risk of cytomegalovirus disease

Prophylaxis of cytomegalovirus disease in solid organ transplant patients at risk of cytomegalovirus disease

Ibandronic acid

Bone metastases from breast cancer

Iloprost

Initial treatment, for up to 6 months, of patients who have not received prior treatment with bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and:

(a) who have been assessed by a physician from a designated hospital to have 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) unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or

(b) who have been assessed by a physician from a designated hospital to have 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 unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or

(c) who have been assessed by a physician from a designated hospital to have WHO Functional Class III drug-induced pulmonary arterial hypertension, and a mean right atrial pressure of 8 mmHg or less as measured by RHC unless RHC is contraindicated on clinical grounds, and who have 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 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 is contraindicated 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 acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, 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 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

Initial treatment, for up to 6 months, of patients who have not received prior treatment with bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) 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) unless RHC is contraindicated on clinical grounds; 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 unless RHC is contraindicated on clinical grounds; or

(c) WHO Functional Class III drug-induced pulmonary arterial hypertension and a mean right atrial pressure greater than 8 mmHg as measured by RHC unless RHC is contraindicated on clinical grounds; or

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

(e) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; or

(f) WHO Functional Class IV drug-induced pulmonary arterial 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 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 is contraindicated 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 acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

Initial treatment, for up to 6 months, of patients:

(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, WHO Functional Class III or IV drug-induced pulmonary arterial hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence iloprost trometamol treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with iloprost trometamol; or

(b) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate; or

(c) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; or

(d) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with sildenafil citrate; or

(e) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with sitaxentan sodium; 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 the first authorisation for PBS-subsidised treatment with iloprost trometamol, bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with iloprost trometamol, bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised iloprost trometamol, bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium;

the supply authorised under this criterion provides for up to a maximum of 6 months of treatment;

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

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

Continuing PBS-subsidised treatment with iloprost trometamol, for up to 6 months, of patients who have received approval for initial PBS-subsidised treatment with iloprost trometamol and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of iloprost trometamol 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), unless results from all 3 of the tests were included in the application for initial treatment and subsequent ECHO composite assessment and 6MWT results demonstrate stability or improvement of disease in which case RHC composite assessment can be omitted, or, where results from all 3 of the tests specified above were not able to be included in the application for initial treatment, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that, unless contraindicated on clinical grounds, the test results submitted include results from the same tests as were included in the application for initial treatment:

(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 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

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

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

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

Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension and pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma 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 iloprost trometamol 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

Indinavir

Treatment of human immunodeficiency virus infection in patients with:

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

Infliximab

Ankylosing spondylitis

Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:

(a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and

(b) who has at least 2 of the following:

(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or

(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or

(iii) limitation of chest expansion relative to normal values for age and gender; and

(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and

(d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response is demonstrated by:

(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and

(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;

both ESR and CRP measurements are included in the authority application and are no more than 1 month old;

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

the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;

if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;

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

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

an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;

if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;

the application for authorisation is made in writing and includes:

(a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and

(ii) a completed BASDAI Assessment Form; and

(iii) a signed patient acknowledgment form; and

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

a course of initial treatment commencing a treatment cycle is limited to a maximum of 18 weeks of treatment;

if less than 18 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 18 weeks of therapy in total may be submitted by telephone

Ankylosing spondylitis

Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with infliximab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

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

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

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

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

(b) (i) if the course of therapy is an 18 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

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

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

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 18 weeks of treatment;

if less than 18 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 18 weeks of therapy in total may be submitted by telephone

Ankylosing spondylitis

Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with infliximab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with infliximab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

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

response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:

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

(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or

(c) an ESR or CRP measurement reduced by at least 20% from baseline;

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

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

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

all measurements provided are no more than 1 month old at the time of application; 

the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;

patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

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

(b) (i) if the course of therapy is an 18 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

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

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

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

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

Rheumatoid arthritis

Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

(a) have severe active rheumatoid arthritis; and

(b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and

(c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with

leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

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

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

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

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 22 weeks of treatment;

if less than 22 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

Rheumatoid arthritis

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

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

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

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

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;

patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle; 

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with infliximab within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:

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

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

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 22-week initial treatment course; and

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

patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with infliximab are not eligible to commence treatment with infliximab 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 and, in the case of patients recommencing therapy with infliximab in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised infliximab therapy;

a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 22 weeks of treatment;

if less than 22 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

Rheumatoid arthritis

Continuing treatment with infliximab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:

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

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

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

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a

maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; 

patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;

an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

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

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

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

(b) if the course of therapy is a 22-week initial treatment course, the assessment of response is made following a minimum of 12 weeks 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 infliximab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of infliximab therapy was a 22-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

the patient has not failed to demonstrate response to a course of PBS-subsidised infliximab 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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

Psoriatic arthritis

Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have severe active psoriatic arthritis; and

(2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and

(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to

demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and

(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

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

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (3) develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 22 weeks of treatment;

if less than 22 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete 22 weeks of uninterrupted therapy may be submitted by telephone

Psoriatic arthritis

Initial treatment, or recommencement of treatment, with infliximab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

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

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

 (3) have not failed treatment with infliximab during the current Treatment Cycle; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with infliximab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:

(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with infliximab, to their most recent course of PBS-subsidised infliximab treatment; and

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

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 22 week initial treatment course; and

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

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

a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 22 weeks of treatment;

if less than 22 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete 22 weeks of uninterrupted therapy may be submitted by telephone

Psoriatic arthritis

Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of infliximab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

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

(2) were receiving treatment with infliximab prior to 16 March 2006; and

(3) have demonstrated a response to infliximab treatment as specified in the criteria for continuing PBS-subsidised treatment with infliximab; and

(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and 

where the following conditions apply:

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

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

if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete 24 weeks of uninterrupted therapy may be submitted by telephone;

patients are eligible for PBS-subsidised treatment under the above criteria once only

Psoriatic arthritis

Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:

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

(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with infliximab; and

(3) who, at the time of application, demonstrate an adequate response to treatment with infliximab; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to treatment with infliximab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

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

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with infliximab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of infliximab therapy was a 22 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

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

if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete 24 weeks of uninterrupted therapy may be submitted by telephone

Crohn disease

Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:

(a)  has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and

(b)  has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and

(c)  has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(d)  has failed to achieve an adequate response to prior systemic therapy including:

(i)  a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and

(ii)  immunosuppressive therapy including:

– azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

– 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

– methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens mentioned at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

failure to achieve an adequate response is indicated by a severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as assessed, and is demonstrated in the patient at the time of the authority application;

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

the most recent CDAI assessment is no more than 1 month old at the time of application;

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient’s condition; and

(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and

(iii) the signed patient acknowledgement;

a course of initial treatment commencing a treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

Crohn disease

Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient who:

(a) has a documented history of severe refractory Crohn disease; and

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

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

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and

(ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment; and

to demonstrate a response to treatment the application is accompanied by the results of the patient’s most recent course of adalimumab or infliximab therapy where:

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

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

(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);

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

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

Crohn disease

Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:

(a)  has a documented history of severe refractory Crohn disease; and

(b)  has demonstrated or sustained an adequate response to treatment with infliximab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150;

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient’s condition;

the CDAI assessment is no more than 1 month old at the time of application;

the CDAI assessment of the patient’s response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 3 dose initial course, the assessment is made up to 12 weeks after the first dose (6 weeks following the third dose);

where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab, despite demonstrating a response as defined above;

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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response

Crohn disease

Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:

(a)  has confirmed Crohn disease defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and

(b)  has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy; and

(c)  has evidence of intestinal inflammation; and

(d)  has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and

(e)  has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(f)  has failed to achieve an adequate response to prior systemic drug therapy including:

(i)  a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and

(ii) immunosuppressive therapy including:

– azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

– 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

– methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

if treatment with any of the drugs mentioned at (f) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens mentioned at (f) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:

(a)  have evidence of intestinal inflammation, including:

(i)  blood: higher than normal platelet count, or, 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/or

(ii)  faeces: higher than normal lactoferrin or calprotectin level; and/or

(iii)  diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or

(b)  be assessed clinically as being in a high faecal output state; and/or

(c)  be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of infliximab;

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

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

(i)  details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and

(ii)  reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and

(iii)  date of the most recent clinical assessment; and

(iv)  the signed patient acknowledgement;

all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;

a course of initial treatment commencing a treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

Crohn disease

Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient who:

(a) has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease; and

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

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

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

(i) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criteria, if relevant; and

(ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment;

to demonstrate a response to treatment the application is accompanied by the results of the patient’s most recent course of adalimumab or infliximab therapy where:

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

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

(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);

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

the same baseline criterion used to determine response to an initial course of infliximab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

Crohn disease

Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:

(a)  has a documented history of severe refractory Crohn disease with intestinal inflammation and with short gut syndrome or with an ileostomy or colostomy; and

(b)  has demonstrated or sustained an adequate response to treatment with infliximab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as:

(a)  improvement of intestinal inflammation as demonstrated by:

(i)  blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or

(ii)  faeces: normalisation of lactoferrin or calprotectin level; and/or

(iii)  evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or

(b)  reversal of high faecal output state; or

(c)  avoidance of the need for surgery or total parenteral nutrition (TPN);

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy or the date of clinical assessment;

the patient’s assessment is no more than 1 month old at the time of application;

the assessment of the patient’s response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 3 dose initial course, the assessment is made up to 12 weeks after the first dose (6 weeks following the third dose);

where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab, despite demonstrating a response as defined above;

the same baseline criterion used to determine response to an initial course of infliximab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;

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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response

Crohn disease

Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:

(a)  has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and

(b)  has extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; and

(c)  has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and

(d)  has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(e)  has failed to achieve an adequate response to prior systemic therapy including:

(i)  a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and

(ii)  immunosuppressive therapy including:

– azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

– 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

– methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

if treatment with any of the drugs mentioned at (e) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens mentioned at (e) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:

(a)  have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and/or

(b)  have evidence of active intestinal inflammation, including:

(i)  blood: higher than normal platelet count, or, 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/or

(ii)  faeces: higher than normal lactoferrin or calprotectin level; and/or

(iii)  diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or

(c)  be assessed clinically as being in a high faecal output state; and/or

(d)  be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of infliximab;

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

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

(i)  details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and

(ii)  (1) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; or

(2) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the dates of assessment of the patient’s condition, if relevant; and

(iii)  date of the most recent clinical assessment; and

(iv)  the signed patient acknowledgement;

all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;

a course of initial treatment commencing a treatment cycle is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

Crohn disease

Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, or consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:

(a)  has a documented history of severe refractory Crohn disease with extensive intestinal inflammation affecting more than 50 cm of the small intestine; and

(b)  has demonstrated or sustained an adequate response to treatment with infliximab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as:

(a)  a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or

(b)  improvement of intestinal inflammation as demonstrated by:

(i)  blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or

(ii)  faeces: normalisation of lactoferrin or calprotectin level; and/or

(iii)  evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or

(c)  reversal of high faecal output state; or

(d)  avoidance of the need for surgery or total parenteral nutrition (TPN);

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient’s condition; or

(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy; or

(iii) the date of clinical assessment;

all assessments are no more than 1 month old at the time of application;

the assessment of the patient’s response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 3 dose initial course, the assessment is made up to 12 weeks after the first dose (6 weeks following the third dose);

where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab, despite demonstrating a response as defined above;

the same baseline criterion used to determine response to an initial course of infliximab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;

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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response

Crohn disease

Commencement of a treatment cycle with an initial PBS-subsidised course of infliximab for continuing treatment, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:

(a)  has a documented history of severe refractory Crohn disease and was receiving treatment with infliximab prior to 7 March 2007; and

(b)  had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with infliximab; and

(c)  has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(d)  has demonstrated or sustained an adequate response to treatment with infliximab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150;

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient’s condition; and

(ii) the signed patient acknowledgment;

the current CDAI assessment is no more than 1 month old at the time of application;

the baseline CDAI assessment is from immediately prior to commencing treatment with infliximab;

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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

a patient may qualify for PBS-subsidised treatment under this restriction once only

Crohn disease

Commencement of a treatment cycle with an initial PBS-subsidised course of infliximab for continuing treatment, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:

(a)  has a documented history of severe refractory Crohn disease and was receiving treatment with infliximab prior to 7 March 2007; and

(b)  (1) has a history of extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; or

(2) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy with a documented history of intestinal inflammation; and

(c)  has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

(d)  has demonstrated or sustained an adequate response to treatment with infliximab according to the criteria included in the relevant continuation restriction; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to infliximab treatment is defined as:

(a)  a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or

(b)  improvement of intestinal inflammation as demonstrated by:

(i)  blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or

(ii)  faeces: normalisation of lactoferrin or calprotectin level; and/or

(iii)  evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or

(c)  reversal of high faecal output state; or

(d)  avoidance of the need for surgery or total parenteral nutrition (TPN);

the same criteria used to determine an inadequate response to prior treatment at baseline are used to determine response to treatment and eligibility for continuing therapy, according to the criteria included in the continuing treatment restriction;

the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

(i)  (1) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet, where relevant, including the date of the assessment of the patient’s condition; or

(2) the reports and dates of the current and baseline pathology or diagnostic imaging test(s) in order to assess response to therapy; or

(3) the date of clinical assessment(s); and