Leukaemia - acute myeloid leukaemia

The PBS subsidises azacitidine, decitabine+cedazuridine and midostaurin for patients with acute myeloid leukaemia (AML).

Please note: You’ll get an immediate assessment when you request PBS authorities online.

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with azacitidine (injection) and midostaurin under the National Health Act 1953, section 100 and subsidises treatment with azacitidine (tablet) and decitabine+cedazuridine under the National Health Act, section 85 for patients with AML.

Patients must be eligible for the PBS and meet the relevant restriction criteria.

The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing azacitidine, decitabine+cedazuridine and midostaurin.

Section 100 arrangements

Midostaurin and azacitidine (injection)

These items are only PBS-subsidised for non-admitted patients, day admitted patients or patients on discharge who are attending:

  • an approved private hospital
  • a public hospital.

These items aren’t PBS-subsidised for hospital in-patients. You must include the hospital name and provider number on the authority application form.

Authority applications

Azacitidine (injection)

Applying for initial treatment

Applications for initial authority approval to prescribe PBS-subsidised azacitidine injection to treat AML can be made either:

Applying for continuing treatment

Continuing PBS-subsidised treatment with azacitidine injection is Authority Required (Streamlined). You don’t need authority approval from us for the listed quantities and repeats.

Azacitidine (tablet)

Applying for initial treatment following intensive induction chemotherapy

Applications for initial authority approval to prescribe PBS-subsidised azacitidine (tablet) to treat AML can be made either:

Applying for continuing treatment following intensive induction chemotherapy

Applications for continuing authority approval to prescribe PBS-subsidised azacitidine (tablet) to treat AML can be made either:

Applying for continuing treatment - dose escalation therapy

Applications for continuing authority approval to prescribe PBS-subsidised azacitidine (tablet) - dose escalation therapy - to treat AML can be made either in:

All written applications must include the completed:

Decitabine+cedazuridine

Applying for initial treatment

Applications for initial authority approval to prescribe PBS-subsidised decitabine+cedazuridine to treat AML can be made either:

Applying for continuing treatment

Continuing PBS-subsidised treatment with decitabine+cedazuridine is Authority Required (Streamlined). You don’t need authority approval from us for the listed quantities and repeats.

Midostaurin

Applying for induction and consolidation treatment

Applications for induction and consolidation authority approval to prescribe PBS-subsidised midostaurin to treat AML can be made either:

Applying for initial maintenance treatment

Applications for initial maintenance authority approval to prescribe PBS-subsidised midostaurin to treat AML can be made either in:

All written applications must include the completed:

Applying for continuing maintenance treatment

Applications for continuing maintenance authority approval to prescribe PBS-subsidised midostaurin to treat AML can be made either:

More information

Call the PBS Complex Drugs Programs enquiry line for more information.

Page last updated: 3 October 2023.
QC 46846