Leukaemia - chronic myeloid leukaemia

The PBS subsidises tyrosine kinase inhibitor agents for patients with chronic myeloid leukaemia.

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with tyrosine kinase inhibitor (TKI) agents under the National Health Act 1953, section 85 for patients with chronic myeloid leukaemia (CML).

Where the term TKI agents appear it refers to:

  • dasatinib
  • imatinib
  • nilotinib
  • ponatinib.

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 TKI agents.

Treatment specifics

Patients are eligible for PBS subsidised treatment with one TKI agent at any time.

Eligible patients can swap between TKI agents if they both:

  • experience toxicity or intolerance 
  • haven't failed PBS subsidised treatment with that agent in the past.

Availability of TKI agents:

  • imatinib is only available as a first line therapy
  • dasatinib is available as first, second and third line therapy
  • nilotinib 150mg is only available as first line therapy and nilotinib 200mg is only available for second and third line therapy
  • ponatinib is available after a trial of dasatinib or nilotinib provided patients meet the relevant restriction criteria.

From 1 March 2022, ponatinib is the only TKI requiring written authority approval.

Authority Applications

Applying for initial treatment

Apply for initial authority approval to prescribe PBS subsidised ponatinib to treat CML in writing and either:

All written applications must include the completed:

Apply for initial authority approval to prescribe PBS subsidised dasatinib, imatinib or nilotinib treatment, for all lines and phases either:

  • in real time using the Online PBS Authorities system
  • by calling the PBS Complex Drugs Programs enquiry line.

Applying for continuing treatment

Apply for first continuing authority approval to prescribe PBS subsidised ponatinib to treat CML in writing and either:

First continuing applications for ponatinib must include the completed:

After we approve the first continuing application for ponatinib treatment, subsequent continuing applications can be made either:

  • in real time using the Online PBS Authorities system
  • by calling the PBS Complex Drugs Programs enquiry line.

Continuing PBS subsidised treatment with dasatinib, imatinib or nilotinib is Authority Required (Streamlined). It doesn’t need authority approval from us for the listed quantities and repeats.

More information

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

Page last updated: 3 March 2022