Letters

Manufacturer’s Name

Letters

Manufacturer’s Name

AB

AN

AP

AT

BQ

BU

BY

GI

GK

HX

IS

JC

Abbott Australasia Pty Ltd

Amgen Australasia Pty Ltd

AstraZeneca Pty Ltd

Actelion Pharmaceuticals Australia

Pty Ltd

Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd

Bausch & Lomb A Division of Bausch & Lomb (Australia) Pty Ltd

Boehringer Ingelheim Pty Limited

Gilead Sciences Pty Ltd

GlaxoSmithKline Australia Pty Ltd

Hexal Australia Pty Ltd

Ipsen Pty Ltd

Janssen-Cilag Pty Ltd

MK

MX

NV

OA

PF

PI

PU

PS

RO

SC

SH

WY

ZT

Merck Sharp & Dohme (Australia) Pty Ltd

Mayne Pharma Pty Ltd

Novartis Pharmaceuticals Australia Pty Ltd

Orphan Australia Pty Ltd

Pfizer Pty Limited

Pharmion Pty Ltd

Pharmacia Products Pharmacia & Upjohn Pty Limited

Pharmacia & Upjohn Pty Limited

Roche Products Pty Ltd

Schering Pty Ltd

Schering-Plough Pty Ltd

Wyeth Pharmaceuticals Division of Wyeth Australia Pty Limited

Synthon AU Pty Ltd

Abacavir Sulfate

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 Sulfate 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 Sulfate 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

Adefovir Dipivoxil

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

(1) Repeatedly elevated (greater than 1.2 times the upper limit of normal) 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 (HBe antigen positive and/or serum HBV DNA positive)

(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

Patients receiving treatment with adefovir dipivoxil subsidised under the Pharmaceutical Benefits Scheme (PBS) must receive that treatment as monotherapy, except in the following circumstances:

(i) patients who are not immunocompromised may receive concomitant treatment with lamivudine for the initial 3 months of PBS-subsidised adefovir dipivoxil therapy

(ii) patients who are immunocompromised may receive concomitant treatment with lamivudine for the initial 12 months of PBS-subsidised adefovir dipivoxil therapy

Amprenavir

Treatment of human immunodeficiency virus infection in patients who have:

(a) failed treatment with other protease inhibitors; or

(b) experienced treatment-limiting toxicity with other protease inhibitors

Apomorphine Hydrochloride

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

Atazanavir Sulfate

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 Dihydrate

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 Monohydrate

Initial treatment, for up to six months, of adult patients who have not received prior treatment with iloprost trometamol or epoprostenol 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 copy of a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, 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, 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 is being commenced on bosentan monohydrate treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment 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 or epoprostenol 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 copy of a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, 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, 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 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 copy of a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate or epoprostenol sodium 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 is being commenced on bosentan monohydrate treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment 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 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 copy of a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate or epoprostenol sodium 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  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; 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 or epoprostenol 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 or epoprostenol 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 or epoprostenol 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; 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 or epoprostenol 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 or epoprostenol 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 or epoprostenol 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 

Continuing PBS-subsidised treatment, for up to 6 months, of 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, who have received approval for initial PBS-subsidised treatment with bosentan monohydrate and have completed the initial treatment course, 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, 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 and pulmonary arterial hypertension secondary to 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 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

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 ampoule and solution concentrate for I.V. infusion 250 mg in 5 mL ampoule:

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

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 Mesylate

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 Mesylate

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

Disodium Pamidronate

In respect of the concentrated injection 15 mg in 5 mL, injection set containing 4 vials powder for I.V. infusion 15 mg and 4 ampoules solvent 5 mL, concentrated injection 30 mg in 10 mL, injection set containing 2 vials powder for I.V. infusion 30 mg and 2 ampoules solvent 10 mL, and concentrated injection 60 mg in 10 mL:

Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy

In respect of the concentrated injection 90 mg in 10 mL and injection set containing 1 vial powder for I.V. infusion 90 mg and 1 ampoule solvent 10 mL:

Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy

Multiple myeloma

Bone metastases from breast cancer

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 Hydrochloride, 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 Monohydrate

In respect of  the tablet 0.5 mg:

Patients aged 16 years or older 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) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (HBe antigen positive and/or HBV DNA positive)

(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

Patients receiving treatment with entecavir monohydrate subsidised under the Pharmaceutical Benefits Scheme (PBS) must receive that treatment as monotherapy

In respect of  the tablet 1 mg:

Patients aged 16 years or older with chronic hepatitis B who have failed lamivudine therapy and who satisfy all of the following criteria:

(1) Repeatedly elevated (greater than 1.2 times the upper limit of normal) 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 (HBe antigen positive and/or serum HBV DNA positive)

(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

Patients receiving treatment with entecavir monohydrate subsidised under the Pharmaceutical Benefits Scheme (PBS) must receive that treatment as monotherapy

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 Sodium

Initial treatment, for up to six months, of adult patients who have not received prior treatment with bosentan monohydrate or iloprost trometamol 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 copy of a signed patient acknowledgment form 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, 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 is being commenced on epoprostenol sodium treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment 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 or iloprost trometamol 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 copy of a signed patient acknowledgment form 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, 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 PBS-subsidised supply for continuing treatment, for up to 6 months, of adult patients who were receiving treatment with epoprostenol sodium prior to 1 August 2006, who have not received prior treatment with bosentan monohydrate or iloprost trometamol 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 or IV primary pulmonary hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

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

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

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; or

(b) for patients who have received 6 or more months of epoprostenol sodium treatment at the time of application -  a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results, as measured both at the time that the patient commenced treatment with epoprostenol sodium and at the time of application, from a RHC composite assessment plus ECHO composite assessment plus 6MWT, or, where results as at commencement of treatment are not available for all 3 of the tests or where it is, or was at commencement of treatment, not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability:

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

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) the date of commencement of epoprostenol sodium treatment; and

(3) a copy of a signed patient acknowledgment form 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, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(4) 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 epoprostenol sodium 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 epoprostenol sodium 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 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 patients aged less than 18 years who were receiving treatment with epoprostenol sodium prior to 1 August 2006, who have not received prior treatment with bosentan monohydrate 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 or IV primary pulmonary hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

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

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

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; or

(b) for patients who have received 6 or more months of epoprostenol sodium treatment at the time of application -  a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results, as measured both at the time that the patient commenced treatment with epoprostenol sodium and at the time of application, from a RHC composite assessment plus ECHO composite assessment plus 6MWT, or, where results as at commencement of treatment are not available for all 3 of the tests or where it is, or was at commencement of treatment, not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability:

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

(ii) RHC composite assessment plus 6MWT; or

(iii) RHC composite assessment alone; or

(iv) ECHO composite assessment plus 6MWT; or

(v) ECHO composite assessment alone; and

(2) the date of commencement of epoprostenol sodium treatment; and

(3) a copy of a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium or bosentan monohydrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(4) 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 epoprostenol sodium 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 epoprostenol sodium 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 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 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 copy of a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium or bosentan monohydrate 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 is being commenced on epoprostenol sodium treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment 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 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 copy of a patient acknowledgment form, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium or bosentan monohydrate 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 or iloprost trometamol; 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 or bosentan monohydrate, 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 or bosentan monohydrate, 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 or bosentan monohydrate;

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; 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 or bosentan monohydrate, 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 or bosentan monohydrate, 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 or bosentan monohydrate;

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, for up to 6 months, of patients with World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension 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

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

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 patients 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 patients with non-myeloid malignancies who have had myeloablative or myelosuppressive therapy

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

Patients receiving marrow-ablative chemotherapy and subsequent bone marrow transplantation

Patients with non-myeloid malignancies receiving marrow-ablative chemotherapy and subsequent autologous blood progenitor cell transplantation

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

Acute lymphoblastic leukaemia

Ewing’s sarcoma

Germ cell tumours

Infants and children with CNS tumours

Neuroblastoma

Non-Hodgkin’s lymphoma (intermediate or high grade)

Osteosarcoma

Relapsed Hodgkin’s disease

Rhabdomyosarcoma

Patients with breast cancer receiving standard dose adjuvant chemotherapy who have 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

Patients receiving first-line chemotherapy for Hodgkin’s disease who have 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

Patients receiving chemotherapy for myeloma who have 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

Patients 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)

Patients 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))

Patients 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))

Fosamprenavir Calcium

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 Sodium

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

Cytomegalovirus retinitis in severely immunocompromised patients

Ganciclovir 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

Iloprost Trometamol

Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with bosentan monohydrate or epoprostenol 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 copy of a signed patient acknowledgment form 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, 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 is being commenced on iloprost trometamol treatment due to an adverse event while on vasodilator treatment or a contraindication to vasodilator treatment 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 or epoprostenol 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 copy of a signed patient acknowledgment form 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, 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 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; 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 or epoprostenol 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 or epoprostenol 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 or epoprostenol 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, for up to 6 months, of adult patients with World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, pulmonary arterial hypertension secondary to connective tissue disease or drug-induced pulmonary arterial hypertension, 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 Sulfate

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

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

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

(b) who, where the patient has received non-PBS-subsidised treatment with etanercept or infliximab, have not received non-PBS-subsidised treatment with infliximab prior to 1 March 2004; and

(c) who have at least 2 of the following:

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

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

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

 (d) who have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), in combination with an appropriate exercise program, for a total period of at least 3 months, unless:

(i) treatment with NSAIDs is contraindicated according to the relevant Therapeutic Goods Administration (TGA)-approved Product Information, in which case the patient is exempt from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or

(ii) adverse events of a severity necessitating permanent treatment withdrawal develop during the relevant period of use of 2 NSAIDs, in which case the patient may be exempted from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or

(iii) the patient is unable to complete the minimum exercise program, in which case the patient is exempt from completing the exercise component of the combined NSAID and exercise treatment regimen specified above; or

(iv) the patient has had a break in PBS-subsidised therapy with etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months, instead of the combined NSAID and exercise regimen specified above; and

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

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

where the following conditions apply:

failure to achieve an adequate response is demonstrated by:

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

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

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

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

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

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

where the patient is exempted from the minimum 3 months of treatment with at least 2 NSAIDs because treatment with NSAIDs is contraindicated, the authority application includes evidence supporting the contraindication;

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

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

the application for authorisation is made in writing and includes:

(a) a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes the following:

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

(ii) a copy of the completed BASDAI Assessment Form; and

(iii) a copy of the signed patient acknowledgment form; and

(iv) a copy of the exercise program self-certification form detailing the program followed and the dates over which it was followed; and

(b) confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed in the self-certification form;

a course of initial treatment commencing a treatment cycle is limited to a maximum of 6 weeks of treatment

Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis and who, in this treatment cycle, have received prior PBS-subsidised treatment with etanercept or with infliximab for this condition as ‘new’ patients and have not failed PBS-subsidised therapy with infliximab more than once; and

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

where a ‘new’ patient is one who was not ‘grandfathered’ onto PBS-subsidised treatment with either etanercept or infliximab; and

where to be ‘grandfathered’ onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is ‘grandfathered’ onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is ‘grandfathered’ onto etanercept); and

where the following conditions apply:

patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient’s first treatment cycle;

the authority application is made in writing and includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form;

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

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

(ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course;

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment

Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of treatment with infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS) as 'new' patients, who have 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 etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and

where to be 'grandfathered' onto PBS-subsdidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and

where the following conditions apply:

patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle;

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

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

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

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

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

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

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

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

(ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course;

the application for authorisation is made in writing and includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form, including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; unless the application is the first application for continuing PBS-subsidised treatment immediately following a course of PBS-subsidised therapy initiating, or recommencing, infliximab treatment and is for a single dose only, in which case the authority application may be made by telephone following submission of the above-mentioned application form by facsimile;

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

Commencement of a treatment cycle with an initial PBS-subsidised course of infliximab for continuing treatment, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were receiving treatment with infliximab prior to 1 March 2004; and

(a) who are receiving treatment with infliximab at the time of application; and

(b) who have not received prior PBS-subsidised treatment with etanercept; and

(c) whose Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is less than or equal to 5 on a 0-10 scale; and

(d) who have:

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

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

(iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and

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

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab,
 

and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

the BASDAI assessment and the ESR and CRP measurements are no more than 1 month old at the time of application;

the application for authorisation is made in writing and includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes the following:

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

(ii) a copy of the completed BASDAI Assessment Form; and

(iii) a copy of the signed patient acknowledgment 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 a course of 24 weeks of therapy in total may be submitted by telephone;

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

Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were ‘grandfathered’ onto PBS-subsidised treatment with etanercept or infliximab and who have not failed PBS-subsidised therapy with infliximab more than once; and

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

where to be ‘grandfathered’ onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is ‘grandfathered’ onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is ‘grandfathered’ onto etanercept); and

where the following conditions apply:

patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient’s first treatment cycle;

the authority application is made in writing and includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form;

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

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

(ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course;

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment

Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab, who have received 6 weeks or more of PBS-subsidised treatment with infliximab, who have 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 etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and

where the following conditions apply:

patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle;

response to treatment is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, and:

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

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

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

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

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

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

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

(ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course;

the application for authorisation is made in writing and includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; unless the application is the first application for continuing PBS-subsidised treatment immediately following a course of PBS-subsidised therapy initiating, or recommencing, infliximab treatment and is for a single dose only, in which case the authority application may be made by telephone following submission of the above-mentioned application form by facsimile;

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

Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:

(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or

(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and

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

(i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or

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

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

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

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

where the following conditions apply:

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

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

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

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

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

where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;

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

a course of treatment is limited to a maximum of 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

Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

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

where the following conditions apply:

patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient’s first bDMARD treatment cycle;

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly, unless the patient commenced PBS-subsidised treatment with infliximab prior to 1 December 2004 and received concomitant methotrexate at a dose of less than 7.5 mg weekly, in which case the patient may continue to receive PBS-subsidised treatment with infliximab in combination with methotrexate at this lower dose for the duration of their first bDMARD treatment cycle;

patients are eligible to commence therapy with infliximab within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of infliximab therapy specified below, if applicable;

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 if:

(i) they have demonstrated an adequate response 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 when the most recent course of PBS-subsidised treatment was an initial 22 week course;  and

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

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

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

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

the authority application is made in writing and includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient’s response to their most recent course of infliximab therapy;

a course of treatment 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

Commencement of infliximab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with infliximab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 November 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to infliximab treatment as specified in the criteria for continuing PBS-subsidised treatment with infliximab detailed below; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

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

where the following conditions apply:

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

the authority application is made in writing and contains sufficient information to determine the patient’s eligibility for treatment and the date of assessment of the patient;

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

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

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

(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with infliximab; and

where bDMARD means a drug included in the following list of drugs:

adalimumab, anakinra, etanercept or infliximab; and

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

where the following conditions apply:

patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient’s first bDMARD treatment cycle;

the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly, unless the patient commenced PBS-subsidised treatment with infliximab prior to 1 December 2004 and received concomitant methotrexate at a dose of less than 7.5 mg weekly, in which case the patient may continue to receive PBS-subsidised treatment with infliximab in combination with methotrexate at this lower dose for the duration of their first bDMARD treatment cycle;

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

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

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

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

the authority application is made in writing and includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with 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 an initial 22 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

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

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

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

(1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and

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

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

(4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and

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

where biological agent means adalimumab or etanercept or infliximab; and

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

where the following conditions apply:

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

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

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

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

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

if intolerance to treatment with the regimens specified at (3) 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

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 with a record of rheumatoid factor negative status within the last 12 months; and

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

(3) have not failed treatment with 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

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 with a record of rheumatoid factor negative status within the last 12 months; 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

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

(1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and

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

Interferon Alfa-2a

Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase

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) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (Hbe antigen positive and/or HBV DNA positive)

(3) Are not 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)

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

Interferon Alfa-2b

Adjunctive therapy of malignant melanoma following surgery in patients with nodal involvement

Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase

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) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (Hbe antigen positive and/or HBV DNA positive)

(3) Are not 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)

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

Interferon Gamma-1b

Treatment of chronic granulomatous disease in patients with frequent and severe infections despite adequate prophylaxis with antimicrobial agents

Lamivudine

In respect of the tablet 100 mg and oral solution 5 mg per mL, 240 mL:

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) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (Hbe antigen positive and/or HBV DNA positive)

(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 150 mg, tablet 300 mg and oral solution 10 mg per mL, 240 mL:

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

Lamivudine with Zidovudine

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

Lanreotide Acetate

In respect of the powder for suspension for injection equivalent to 30 mg lanreotide with diluent ampoule:

Active acromegaly in patients with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:

(a) after failure of other therapy including dopamine agonists; or

(b) as interim treatment in patients awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or

(c) where surgery and radiotherapy are contraindicated

Treatment is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF1) after lanreotide acetate withdrawal for at least 4 weeks (6 weeks after last dose).  Lanreotide acetate should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy

Treatment is to cease if there has been failure to lower IGF1 after 3 months’ treatment

In respect of the injection equivalent to 60 mg lanreotide in single dose pre-filled syringe, injection equivalent to 90 mg lanreotide in single dose pre-filled syringe and injection equivalent to 120 mg lanreotide in single dose pre-filled syringe:

Active acromegaly in patients with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:

(a) after failure of other therapy including dopamine agonists; or

(b) as interim treatment in patients awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or

(c) where surgery and radiotherapy are contraindicated

Treatment is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF1) after lanreotide acetate withdrawal for at least 4 weeks (8 weeks after last dose).  Lanreotide acetate should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy

Treatment is to cease if there has been failure to lower IGF1 after 3 months’ treatment

Patients with a histologically-confirmed diagnosis of a functional carcinoid tumour, experiencing on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persists despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and for whom surgery or antineoplastic therapy has failed or is inappropriate

Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 120 mg every 28 days. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

Lenograstim

Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for reinfusion into patients with non-myeloid malignancies who have had myeloablative or myelosuppressive therapy

Mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic transplantation to facilitate harvest of such cells in healthy donors

Patients with non-myeloid malignancies receiving marrow-ablative chemotherapy and subsequent peripheral blood progenitor cell or bone marrow transplantation

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

Acute lymphoblastic leukaemia

Ewing’s sarcoma

Infants and children with CNS tumours

Neuroblastoma

Non-Hodgkin’s lymphoma (intermediate or high grade)

Osteosarcoma

Relapsed Hodgkin’s disease

Rhabdomyosarcoma

Patients with breast cancer receiving standard dose adjuvant chemotherapy who have 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

Patients receiving first-line chemotherapy for Hodgkin’s disease who have 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

Lopinavir with Ritonavir

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

Mycophenolate Mofetil

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

Mycophenolate Mofetil with Water - Purified BP

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

Mycophenolate Sodium

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

Nelfinavir Mesylate

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

Nevirapine

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

Octreotide Acetate

In respect of the injection equivalent to 50 micrograms octreotide in 1 mL, injection equivalent to 100 micrograms octreotide in 1 mL and injection equivalent to 500 micrograms octreotide in 1 mL:

Active acromegaly in patients with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and:

(a) after failure of other therapy including dopamine agonists; or

(b) as interim treatment in patients awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or

(c) where surgery and radiotherapy are contraindicated

Treatment is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF1) after octreotide withdrawal for at least 4 weeks. Octreotide should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy

Treatment is to cease if there has been failure to lower IGF1 after 3 months of treatment at a dose of 100 micrograms 3 times daily

Patients with a histologically-confirmed diagnosis of a functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma), experiencing on average over 1 week, 3 or more episodes per day of diarrhoea or flushing, which persists despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and for whom surgery or antineoplastic therapy has failed or is inappropriate

Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

In respect of the injection (modified release) equivalent to 10 mg octreotide, vial and diluent syringe, injection (modified release) equivalent to 20 mg octreotide, vial and diluent syringe and injection (modified release) equivalent to 30 mg octreotide, vial and diluent syringe:

Patients with acromegaly who are controlled on Sandostatin subcutaneous injections

Treatment is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF1) after octreotide acetate withdrawal for at least 4 weeks (8 weeks after the last dose)

Octreotide acetate should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy

Treatment is to cease if there has been failure to lower IGF1 after 3 months of treatment

Patients with a histologically-confirmed diagnosis of a functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) and who are controlled on Sandostatin subcutaneous injections

Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with Sandostatin subcutaneous injections. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

Pegfilgrastim

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

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

Acute lymphoblastic leukaemia

Ewing’s sarcoma

Germ cell tumours

Infants and children with CNS tumours

Neuroblastoma

Non-Hodgkin’s lymphoma (intermediate or high grade)

Osteosarcoma

Relapsed Hodgkin’s disease

Rhabdomyosarcoma

Patients with breast cancer receiving standard dose adjuvant chemotherapy who have 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

Patients receiving first-line chemotherapy for Hodgkin’s disease who have 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

Patients receiving chemotherapy for myeloma who have 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

Peginterferon Alfa-2a

~RBTA~Monotherapy in patients with chronic hepatitis B and compensated liver disease who satisfy all of the following criteria:

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

(2) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (HBe antigen positive and/or HBV DNA positive);

(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;

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

(5) Are not 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)

Treatment is limited to 1 course of treatment for a duration of up to 48 weeks

Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa  or peginterferon alfa treatment for hepatitis C and have a contraindication to ribavirin, who satisfy all of the following criteria:

(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);

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

The treatment course is limited to up to 48 weeks

Patients may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop

Peginterferon Alfa-2b

Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and have a contraindication to ribavirin, who satisfy all of the following criteria:

(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);

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

The treatment course is limited to up to 48 weeks

Patients may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop

Ribavirin and Peginterferon Alfa-2a

Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:

(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);

(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant

For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks

Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. An HCV RNA assay at week 12 is unnecessary for genotype 2 or 3 patients because of the high likelihood of early viral response by week 12

Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12

Ribavirin and Peginterferon Alfa-2b

Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:

(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);

(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant

For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks

Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. An HCV RNA assay at week 12 is unnecessary for genotype 2 or 3 patients because of the high likelihood of early viral response by week 12

Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12

Rifabutin

Treatment of Mycobacterium avium complex infections in human immunodeficiency virus-positive patients

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

Ritonavir

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

Saquinavir

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

Saquinavir Mesylate

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

Sirolimus

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

Stavudine

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

Stavudine with Water - Purified BP

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

Tacrolimus

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

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

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

Tenofovir Disoproxil Fumarate

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

Tenofovir Disoproxil Fumarate

with 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

Thalidomide

Relapsed or refractory multiple myeloma in patients who have failed at least 1 other treatment

Valaciclovir Hydrochloride

Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease

Valganciclovir Hydrochloride

Cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome

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

Zidovudine

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

Zoledronic Acid

Multiple myeloma

Bone metastases from breast cancer

Bone metastases from hormone-resistant prostate cancer, with demonstration of biochemical progession of disease despite maximal therapy with hormone treatments

Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy

Abacavir Sulfate

Tablet equivalent to 300 mg abacavir

Oral

GK

Oral solution equivalent to 20 mg abacavir per mL, 240 mL

Oral

GK

Abacavir Sulfate with Lamivudine

Tablet equivalent to 600 mg abacavir-300 mg

Oral

GK

Abacavir Sulfate with Lamivudine and Zidovudine

Tablet equivalent to 300 mg abacavir-150 mg-300 mg

Oral

GK

Adefovir Dipivoxil

Tablet 10 mg

Oral

GI

Amprenavir

Capsule 150 mg

Oral

GK

Oral solution 15 mg per mL, 240 mL

Oral

GK

Apomorphine Hydrochloride

Injection 10 mg in 1 mL

Injection

MX

Atazanavir Sulfate

Capsule equivalent to 150 mg atazanavir

Oral

BQ

Capsule equivalent to 200 mg atazanavir

Oral

BQ

Azithromycin Dihydrate

Tablet equivalent to 600 mg azithromycin

Oral

PF

Baclofen

Intrathecal injection 10 mg in 5 mL

Injection

NV

Intrathecal injection 10 mg in 20 mL

Injection

NV

Bosentan Monohydrate

Tablet equivalent to 62.5 mg bosentan

Oral

AT

Tablet equivalent to 125 mg bosentan

Oral

AT

Cidofovir

Solution for I.V. infusion 375 mg (anhydrous) in 5 mL single use vial

Injection

PU

Clarithromycin

Tablet 250 mg

Oral

AB

Tablet 500 mg

Oral

AB

Clozapine

Tablet 25 mg

Oral

MX, NV, ZT

Tablet 50 mg

Oral

MX

Tablet 100 mg

Oral

MX, NV, ZT

Tablet 200 mg

Oral

MX

Cyclosporin

Solution concentrate for I.V. infusion 50 mg in 1 mL ampoule

Injection

NV

Solution concentrate for I.V. infusion 250 mg in 5 mL ampoule

Injection

NV

Capsule 10 mg

Oral

NV

Capsule 25 mg

Oral

HX, NV

Capsule 50 mg

Oral

HX, NV

Capsule 100 mg

Oral

HX, NV

Oral liquid 100 mg per mL, 50 mL

Oral

NV

Darbepoetin Alfa

Injection 10 micrograms in 0.4 mL pre-filled syringe

Injection

AN

Injection 20 micrograms in 0.5 mL pre-filled syringe

Injection

AN

Injection 20 micrograms in 0.5 mL pre-filled injection pen

Injection

AN

Injection 30 micrograms in 0.3 mL pre-filled syringe

Injection

AN

Injection 40 micrograms in 0.4 mL pre-filled syringe

Injection

AN

Injection 40 micrograms in 0.4 mL pre-filled injection pen

Injection

AN

Injection 50 micrograms in 0.5 mL pre-filled syringe

Injection

AN

Injection 60 micrograms in 0.3 mL pre-filled syringe

Injection

AN

Injection 60 micrograms in 0.3 mL pre-filled injection pen

Injection

AN

Injection 80 micrograms in 0.4 mL pre-filled syringe

Injection

AN

Injection 80 micrograms in 0.4 mL pre-filled injection pen

Injection

AN

Injection 100 micrograms in 0.5 mL pre-filled syringe

Injection

AN

Injection 100 micrograms in 0.5 mL pre-filled injection pen

Injection

AN

Injection 150 micrograms in 0.3 mL pre-filled syringe

Injection

AN

Injection 150 micrograms in 0.3 mL pre-filled injection pen

Injection

AN

Deferasirox

Tablet, dispersible, 125 mg

Oral

NV

Tablet, dispersible, 250 mg

Oral

NV

Tablet, dispersible, 500 mg

Oral

NV

Deferiprone

Tablet 500 mg

Oral

OA

Delavirdine Mesylate

Tablet 100 mg

Oral

PF

Desferrioxamime Mesylate

Powder for injection 500 mg vial

Injection

MX, NV

Powder for injection 2 g vial

Injection

MX, NV

Didanosine

Capsule 125 mg (containing enteric coated beadlets)

Oral

BQ

Capsule 200 mg (containing enteric coated beadlets)

Oral

BQ

Capsule 250 mg (containing enteric coated beadlets)

Oral

BQ

Capsule 400 mg (containing enteric coated beadlets)

Oral

BQ

Disodium Pamidronate

Concentrated injection 15 mg in 5 mL

Injection

MX

Concentrated injection 30 mg in 10 mL

Injection

MX

Concentrated injection 60 mg in 10 mL

Injection

MX

Concentrated injection 90 mg in 10 mL

Injection

MX

Injection set containing 4 vials powder for I.V. infusion 15 mg and 4 ampoules solvent 5 mL

Injection

NV

Injection set containing 2 vials powder for I.V. infusion 30 mg and 2 ampoules solvent 10 mL

Injection

NV

Injection set containing 1 vial powder for I.V. infusion 90 mg and 1 ampoule solvent 10 mL

Injection

NV

Dornase Alfa

Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL ampoule

Inhalation

RO

Doxorubicin Hydrochloride, Pegylated Liposomal

Suspension for I.V. infusion 20 mg in 10 mL vial

Injection

SH

Efavirenz

Capsule 200 mg

Oral

MK

Tablet 600 mg

Oral

MK

Oral solution 30 mg per mL, 180 mL

Oral

MK

Emtricitabine

Capsule 200 mg

Oral

GI

Enfuvirtide

Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs)

Injection

RO

Entecavir Monohydrate

Tablet 0.5 mg

Oral

BQ

Tablet 1 mg

Oral

BQ

Epoetin Alfa

Injection 1,000 units in 0.5 mL pre-filled syringe

Injection

JC

Injection 2,000 units in 0.5 mL pre-filled syringe

Injection

JC

Injection 3,000 units in 0.3 mL pre-filled syringe

Injection

JC

Injection 4,000 units in 0.4 mL pre-filled syringe

Injection

JC

Injection 5,000 units in 0.5 mL pre-filled syringe

Injection

JC

Injection 6,000 units in 0.6 mL pre-filled syringe

Injection

JC

Injection 8,000 units in 0.8 mL pre-filled syringe

Injection

JC

Injection 10,000 units in 1 mL pre-filled syringe

Injection

JC

Injection 20,000 units in 0.5 mL pre-filled syringe

Injection

JC

Injection 40,000 units in 1 mL pre-filled syringe

Injection

JC

Epoetin Beta

Injection 1,000 units in 0.3 mL pre-filled syringe

Injection

RO

Injection 2,000 units in 0.3 mL pre-filled syringe

Injection

RO

Injection 3,000 units in 0.3 mL pre-filled syringe

Injection

RO

Injection 4,000 units in 0.3 mL pre-filled syringe

Injection

RO

Injection 5,000 units in 0.3 mL pre-filled syringe

Injection

RO

Injection 6,000 units in 0.3 mL pre-filled syringe

Injection

RO

Injection 10,000 units in 0.6 mL pre-filled syringe

Injection

RO

Injection 20,000 units in 0.6 mL pre-filled syringe

Injection

RO

Injection 30,000 units in 0.6 mL pre-filled syringe

Injection

RO

Epoprostenol Sodium

Powder for I.V. infusion equivalent to 500 micrograms epoprostenol with 1 vial diluent 50 mL

Injection

GK

Powder for I.V. infusion equivalent to 1.5  mg epoprostenol with 2 vials diluent 50 mL

Injection

GK

Etanercept

Injection set containing 4 vials powder for injection 25 mg and  4 pre-filled syringes solvent 1 mL

Injection

WY

Everolimus

Tablet 0.25 mg

Oral

NV

Tablet 0.5 mg

Oral

NV

Tablet 0.75 mg

Oral

NV

Filgrastim

Injection 300 micrograms in 0.5 mL single use pre-filled syringe

Injection

AN

Injection 300 micrograms in 1 mL vial

Injection

AN

Injection 480 micrograms in 0.5 mL single use pre-filled syringe

Injection

AN

Injection 480 micrograms in 1.6 mL vial

Injection

AN

Fosamprenavir Calcium

Tablet equivalent to 700 mg fosamprenavir

Oral

GK

Oral liquid equivalent to 50 mg fosamprenavir per mL, 225 mL

Oral

GK

Foscarnet Sodium

I.V. infusion 24 mg per mL, 250 mL bottle

Injection

AP

Ganciclovir

Intravitreal implant 4.5 mg

Intravitreal implantation

BU

Ganciclovir Sodium

Powder for I.V. infusion equivalent to 500 mg ganciclovir, vial

Injection

RO

Iloprost Trometamol

Solution for inhalation equivalent to 20 micrograms iloprost in 2 mL ampoule

Inhalation

SC

Indinavir Sulfate

Capsule equivalent to 100 mg indinavir

Oral

MK

Capsule equivalent to 200 mg indinavir

Oral

MK

Capsule equivalent to 400 mg indinavir

Oral

MK

Infliximab

Powder for I.V. infusion 100 mg vial

Injection

SH

Interferon Alfa-2a

Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe

Injection

RO

Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe

Injection

RO

Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe

Injection

RO

Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe

Injection

RO

Interferon Alfa-2b

Solution for injection 10,000,000 I.U. in 1 mL single dose vial

Injection

SH

Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen

Injection

SH

Solution for injection 18,000,000 I.U. in 3 mL single dose vial

Injection

SH

Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial

Injection

SH

Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen

Injection

SH

Solution for injection 60,000,000 I.U. in 1.2 mL multi-dose injection pen

Injection

SH

Interferon Gamma-1b

Injection 2,000,000 I.U. in 0.5 mL vial

Injection

BY

Lamivudine

Tablet 100 mg

Oral

GK

Oral solution 5 mg per mL, 240 mL

Oral

GK

Tablet 150 mg

Oral

GK

Tablet 300 mg

Oral

GK

Oral solution 10 mg per mL, 240 mL

Oral

GK

Lamivudine with Zidovudine

Tablet 150 mg-300 mg

Oral

GK

Lanreotide Acetate

Powder for suspension for injection equivalent to 30 mg lanreotide with diluent ampoule

Injection

IS

Injection equivalent to 60 mg lanreotide in single dose pre-filled syringe

Injection

IS

Injection equivalent to 90 mg lanreotide in single dose pre-filled syringe

Injection

IS

Injection equivalent to 120 mg lanreotide in single dose pre-filled syringe

Injection

IS

Lenograstim

Powder for injection 13,400,000 I.U. (105 micrograms) vial

Injection

MX

Powder for injection 33,600,000 I.U. (263 micrograms) vial

Injection

MX

Lopinavir with Ritonavir

Capsule 133.3 mg-33.3 mg

Oral

AB

Tablet 200 mg-50 mg

Oral

AB

Oral liquid 400 mg-100 mg per 5 mL, 60 mL

Oral

AB

Mycophenolate Mofetil

Capsule 250 mg

Oral

RO

Tablet 500 mg

Oral

RO

Mycophenolate Mofetil with Water - Purified BP

Powder for oral suspension 1 g per 5 mL, 165 mL

Oral

RO

Mycophenolate Sodium

Tablet (enteric coated) equivalent to 180 mg mycophenolic acid

Oral

NV

Tablet (enteric coated) equivalent to 360 mg mycophenolic acid

Oral

NV

Nelfinavir Mesylate

Tablet equivalent to 250 mg nelfinavir

Oral

RO

Oral powder equivalent to 50 mg nelfinavir per g, 144 g

Oral

RO

Nevirapine

Tablet 200 mg

Oral

BY

Octreotide Acetate

Injection  equivalent to 50 micrograms octreotide in 1 mL

Injection

NV

Injection  equivalent to 100 micrograms octreotide in 1 mL

Injection

NV

Injection equivalent to 500 micrograms octreotide in 1 mL

Injection

NV

Injection (modified release) equivalent to 10 mg octreotide, vial and diluent syringe

Injection

NV

Injection (modified release) equivalent to 20 mg octreotide, vial and diluent syringe

Injection

NV

Injection (modified release) equivalent to 30 mg octreotide, vial and diluent syringe

Injection

NV

Pegfilgrastim

Injection 6 mg in 0.6 mL single use pre-filled syringe

Injection

AN

Peginterferon Alfa-2a

Injection 135 micrograms in 0.5 mL single use pre-filled syringe

Injection

RO

Injection 180 micrograms in 0.5 mL single use pre-filled syringe

Injection

RO

Peginterferon Alfa-2b

Powder for injection 50 micrograms with diluent in single use injection pen

Injection

SH

Powder for injection 80 micrograms with diluent in single use injection pen

Injection

SH

Powder for injection 100 micrograms with diluent in single use injection pen

Injection

SH

Powder for injection 120 micrograms with diluent in single use injection pen

Injection

SH

Powder for injection 150 micrograms with diluent in single use injection pen

Injection

SH

Ribavirin and Peginterferon   Alfa-2a

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Oral (tablets) and injection (injections)

RO

Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Oral (tablets) and injection (injections)

RO

Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Oral (tablets) and injection (injections)

RO

Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Oral (tablets) and injection (injections)

RO

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms

Oral (tablets) and injection (injections)

RO

Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms

Oral (tablets) and injection (injections)

RO

Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms

Oral (tablets) and injection (injections)

RO

Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms

Oral (tablets) and injection (injections)

RO

Ribavirin and Peginterferon   Alfa-2b

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Oral (capsules) and injection (injections)

SH

Rifabutin

Capsule 150 mg

Oral

PS

Ritonavir

Capsule 100 mg

Oral

AB

Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL

Oral

AB

Saquinavir

Soft gelatin capsule 200 mg

Oral

RO

Saquinavir Mesylate

Capsule equivalent to 200 mg saquinavir

Oral

RO

Tablet equivalent to 500 mg saquinavar  

Oral

RO

Sirolimus

Tablet 1 mg

Oral

WY

Tablet 2 mg

Oral

WY

Oral solution 1 mg per mL, 60 mL

Oral

WY

Stavudine

Capsule 20 mg

Oral

BQ

Capsule 30 mg

Oral

BQ

Capsule 40 mg

Oral

BQ

Stavudine with Water - Purified BP

Powder for oral solution 1 mg per mL, 200 mL

Oral

BQ

Tacrolimus

Capsule 500 micrograms

Oral

JC

Capsule 1 mg

Oral

JC

Capsule 5 mg

Oral

JC

Tenofovir Disoproxil Fumarate

Tablet 300 mg

Oral

GI

Tenofovir Disoproxil Fumarate

with Emtricitabine

Tablet 300 mg-200 mg

Oral

GI

Thalidomide

Capsule 50 mg

Oral

PI

Valaciclovir Hydrochloride

Tablet equivalent to 500 mg valaciclovir

Oral

GK

Valganciclovir Hydrochloride

Tablet equivalent to 450 mg valganciclovir

Oral

RO

Zidovudine

Capsule 100 mg

Oral

GK

Syrup 10 mg per mL, 200 mL bottle

Oral

GK

Capsule 250 mg

Oral

GK

Zoledronic Acid

Injection concentrate for I.V. infusion 4 mg in 5 mL vial

Injection

NV

Column 1

Name of highly specialised drug

Column 2

Form (strength, type, size, etc.)

Enfuvirtide

Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs)

Ribavirin and Peginterferon Alfa-2a

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 135 micrograms

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms

Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms

Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms

Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms

Ribavirin and Peginterferon Alfa-2b

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent

Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent

Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent

Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Column 1

Name of highly specialised drug

Column 2

Form (strength, type, size, etc.)

Column 3

Brand

Column 4

Relevant quantity or number of units

Column 5

Commonwealth Price

Column 6

Price claimed by manufacturer

Cyclosporin

Capsule 25 mg

NV

30

$41.63

$42.62

Capsule 50 mg

NV

30

$86.60

$87.67

Capsule 100 mg

NV

30

$176.45

$177.53

Desferrioxamine Mesylate

Powder for injection 500 mg vial

NV

10

$99.00

$107.19

Powder for injection 2 g vial

NV

1

$39.60

$40.00