Azacitidine

The Pharmaceutical Benefits Scheme subsidises azacitidine for patients with myelodysplastic syndrome, chronic myelomonocytic leukaemia or acute myeloid leukaemia.

For patients with myelodysplastic syndrome, chronic myelomonocytic leukaemia or acute myeloid leukaemia, treatment with azacitidine (Vidaza®) can be subsidised through the Pharmaceutical Benefits Scheme (PBS), under section 100 of the National Health Act 1953.

Authority to supply azacitidine (Vidaza®) is required for the treatment of:

  • myelodysplastic syndrome classified as Intermediate-2 or high risk according to the International Prognostic Scoring System (IPSS), or
  • chronic myelomonocytic leukaemia, 10% to 29% marrow blasts without myeloproliferative disorder, or
  • acute myeloid leukaemia with 20% to 30% marrow blasts and multi-lineage dysplasia, acccording to World Health Organisation (WHO) Classification

Section 100 arrangements

These items are only available to a patient who is attending either:

  • an approved private hospital
  • a public participating hospital or
  • a public hospital
    and is either a
  • day admitted patient
  • non-admitted patient or
  • patient on discharge

These items are not available as a PBS benefit for in-patients of the hospital. The hospital provider number must be included on the application form.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing azacitidine. If disease progression occurs, the prescribing doctor must stop treatment with azacitidine.

Initial treatment

All patients starting treatment with azacitidine must have 1 of the following:

  • myelodysplastic syndrome classified as intermediate-2 or high risk according to the International Prognostic Scoring System, or
  • chronic myelomonocytic leukaemia, 10% to 29% marrow blasts without myeloproliferative disorder, or
  • acute myeloid leukaemia with 20% to 30% marrow blasts and multilineage dysplasia, according to World Health Organization classification

Continuing treatment

Patients are eligible for continuing treatment until there is evidence of disease progression. For more information on applying to continue treatment for patients who have not experienced disease progression, contact us on the Complex Drug Enquiry line.

Schedule item details

Dose - Azacitidine is available as a 100 mg vial.

Azacitidine is a category X medicine and must not be given to pregnant women. Pregnancy must be avoided during treatment.

Initial application

Prescriptions should be written for a sufficient quantity of vials to treat the patient with a dose of 75 mg per m2. No more than 3 cycles will be authorised.

Continuing application

Prescriptions should be written for a sufficient quantity of vials to treat the patient at a dose of 75 mg per m2. No more than 6 cycles will be authorised.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.

Lodging an application

Lodge the Azacitidine Initial PBS authority application form (PB079) for a patient starting initial PBS-subsidised treatment with azacitidine. The patient and prescriber acknowledgements must be completed.

All initial applications must be submitted in writing and must include:

  • a copy of the bone marrow biopsy report showing that the patient has myelodysplastic syndrome, chronic myelomonocytic leukaemia or acute myeloid leukaemia
  • a copy of the full blood examination
  • for myelodysplastic syndrome, a copy of the pathology report detailing the cytogenetics that show intermediate-2 or high-risk disease according to the International Prognostic Scoring System

Further information

For more information contact us on the Complex Drug Enquiry line or to lodge an application go to the Register to prescribe on the contact us page.

Page last updated: 8 November 2016

This information was printed Monday 5 December 2016 from humanservices.gov.au/health-professionals/enablers/azacitidine It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.