Drug

Date Subsidised

PBAC Clinical Indications and other Restrictions

Cidofovir
(Vistide)

1 October 1998

Revised
Nov 2002

Treatment of cytomegalovirus retinitis in patients with AIDS.

Cinacalcet hydrochloride (Sensipar)

Please note – Cinacalcet will also be listed under s.85 from 1 July for maintenance therapy. Please refer to the Schedule of Pharmaceutical Benefits for details.

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

NOTE:
During the titration phase, intact PTH should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved. During the titration phase, approval will be limited to sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

During the maintenance phase, approval will be limited to provide sufficient quantity for 4 weeks treatment up to a maximum of 6 months supply for doses between 30 and 180 mg per day according to the patient's response and tolerability. Intact PTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.

"Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.

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

NOTE:
During the titration phase, intact PTH should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved. During the titration phase, approval will be limited to sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

During the maintenance phase, approval will be limited to provide sufficient quantity for 4 weeks treatment up to a maximum of 6 months supply for doses between 30 and 180 mg per day according to the patient's response and tolerability. Intact PTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.

"Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.

Clarithromycin (Klacid)

1 May 1996

Revised October 1999

Clozapine (Clozaril, Clopine)

Revised 1 February 2004

Cyclosporin
(Sandimmun)

1 Jan 1991

For use by organ or tissue transplant recipients.

CAUTION:
Careful monitoring of patients is mandatory.

Amended February 2004

Management of rejection in patients following organ or tissue transplantation, under the supervision and direction of a transplant unit. 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 patients with nephrotic syndrome in patients in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired;
(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.

Condition of funding for Rheumatoid Arthritis: The Australian Government requires patient numbers specific to this indication as a condition of funding.

CAUTION:
Careful monitoring of patients is mandatory.

1 May 2003

Amended 1 May 2004

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

Note: With the amended indication for darbepoetin from 1 May 2004 it should be noted that patients receiving subsidised treatment prior to this date will be eligible to continue to receive subsidised treatment.

Darunavir
(Prezista)

Treatment, in combination with other antiretroviral agents, and co-administered with 100mg ritonavir twice daily, of HIV infection in an antiretroviral experienced patient with:
(a) evidence of HIV replication (viral load greater than 10,000 copies per ml); and/or
(b) CD4 cell counts of less than 500 per cubic millimetre.
A patient must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens which have included:
(i) at least 1 non-nucleoside reverse transcriptase inhibitor; and
(ii) at least 1 nucleoside reverse transcriptase inhibitor; and
(iii) at least 2 protease inhibitors.

Deferiprone (Ferriprox)

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

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

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 or in whom desferrioxamine has proven ineffective.

Delavirdine Mesylate (Rescriptor)

1 July 1998

Treatment of HIV infection in patients with:
(a) CD4 counts of less than 500 per cubic millimetre; or
(b) viral load greater than 10,000 copies per mL.

Desferrioxamine
(Desferal,Mayne)

1 July 1995.

Price Change Jan 2001, Nov 2001

Disorders of erythropoiesis associated with treatment related chronic iron overload.

*A Brand Premium of $8.19 applies on the Desferal 500 mg brand. A Brand Premium of $0.40 applies on the Desferal 2g brand. Both brands may not be available in all hospitals.

Didanosine (DDI)

1 July 1992

Amended 1 February 2004

Disodium Pamidronate (Aredia, Pamisol)
Codes: 6289B, 6223M

Amended 1 February 2003

Amended 1 December 2006

Multiple myeloma.
Bone metastases from breast cancer.

NOTE:
The concentrated injection and powder for I.V. infusion (after reconstitution) are bioequivalent.

Amended 1 February 2003

Amended 1 December 2006

Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy.

NOTE:
The concentrated injection and powder for I.V. infusion (after reconstitution) are bioequivalent.

Dornase Alfa
(Pulmozyme)

1 January 1996

Revised October 2000

Price increase Nov 2002

Revised  1 November 2009

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 HSD program, the following conditions must be met:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In order for the patient to be eligible for participation in the HSD program, the following conditions must be met:

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

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

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

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

NOTE:
It is highly desirable that all patients be included in the national cystic fibrosis patient data-base.

Doxorubicin hydrochloride pegylated liposomal (Caelyx)

1 Jan 1999

Treatment of AIDS-related Kaposi's sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive mucocutaneous or visceral involvement.

Efavirenz (Stocrin)

October 99

Amended 1 February 2004

Treatment of HIV 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.

Treatment, in combination with other antiretroviral agents, of HIV infection in antiretroviral experienced patients with treatment failure characterised by:

(a) evidence of HIV replication, despite ongoing therapy; or

(b) treatment-limiting toxicity to previous antiretroviral agents.

Patients must have failed previous treatment with 3 different antiretroviral regimens. At least 1 of each of the following classes of antiretroviral drugs must have been attempted:

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

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

(iii) at least 1 protease inhibitor.

6455R Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections

1 December 2006

Amended 1 July 2008

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

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

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

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

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

NOTE:
PBS-subsidised entecavir monohydrate must be used as monotherapy.

Entecavir Monohydrate (Baraclude) 9603K Tablet 1 mg

1 December 2006

Amended 1 March 2008

Amended 1 July 2008

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

(1)(a) Repeatedly elevated  serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance;

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

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

NOTE:
Patients should have undergone a liver biopsy at some point since initial diagnosis to obtain histological evidence of chronic hepatitis. PBS-subsidised entecavir monohydrate must be used as monotherapy.

Epoetin alfa (Eprex)

Amended 1 May 2004

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

Note: With the amended indication for epoetin from 1 May 2004 it should be noted that patients receiving subsidised treatment prior to this date will be eligible to continue to receive subsidised treatment.