Azacitidine
Through the Pharmaceutical Benefits Scheme (PBS), under Section 100 arrangements 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 per cent to 29 per cent marrow blasts without myeloproliferative disorder), or
- acute myeloid leukaemia with 20 per cent to 30 per cent 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 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:
- myelodysplastic syndrome classified as Intermediate-2 or high risk according to the IPSS, or
- chronic myelomonocytic leukaemia (10 per cent to 29 per cent marrow blasts without myeloproliferative disorder), or
- acute myeloid leukaemia with 20 per cent to 30 per cent marrow blasts and multi-lineage dysplasia, acccording to World Health Organisation (WHO) Classification.
Patients are eligible for continuing treatment until there is evidence of disease progression.
Continuing treatment
For more information on applying to continue treatment for patients who have not experienced disease progression:
Call 1800 700 270* (Option 3) Available Monday to Friday 8.00am to 5.00pm EST.
Item details
Dose
Azacitidine is available as 100mg vial.
Note: 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 dose the patient at 75mg/m2 of azacitidine. No more than three cycles will be authorised.
Continuing application
Prescriptions should be written for a sufficient quantity of vials to dose the patient at a maximum of 75mg/m2 of azacitidine. No more than six cycles will be authorised.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Test requirements
All initial applications must include:
- a copy of the bone marrow biospy report demonstrating the patient has myelodysplastic syndrome, chronic myelomonocytic leukaemia or acute myeloid leukaemia, and
- a copy of the full blood examination, and
- for myelodysplastic syndrome, a copy of the pathology report detailing the cytogenetics demonstrating intermediate-2 or high risk disease according to the IPSS.
Lodgement
All initial applications must be submitted in writing. Send all written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
Hobart Tasmania 7001
(No stamp required if posted in Australia)
For more information
Call 1800 700 270* (Option 3) Available Monday to Friday 8.00am to 5.00pm EST
Application forms
- Initial PBS subsidised treatment (Form 4487) [PDF, 200Kb]
Lodge this form for a patient starting initial PBS subsidised treatment with azacitidine. The patient and prescriber acknowledgements must be completed.
*Call charges apply from mobile or pay phones only.
Important: the information on this website is correct at the time of publishing and is subject to change.
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Last updated: 28 February, 2011