Leukaemia - chronic myeloid leukaemia

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

Patient eligibility

The 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 experience toxicity and have not 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
  • 150mg nilotinib is only available as first line therapy and 200mg nilotinib is only available for second and third line therapy
  • nilotinib is PBS listed for patients in blast crisis
  • ponatinib is available after a trial of dasatinib or nilotinib provided patients meet the relevant restriction criteria.

Applications

First line treatment

Apply for authority approval to prescribe PBS subsidised TKI agents for first line treatment of CML in writing and either:

‘Chronic phase’ initial applications for dasatinib or nilotinib must include the completed:

‘Accelerated or blast phase’ initial applications for imatinib must include the completed:

To apply for initial PBS subsidised imatinib treatment, for all phases, call the PBS Complex Drugs Programs enquiry line.

Second or third line treatment

Apply for authority approval to prescribe PBS subsidised dasatinib or nilotinib for second or third line treatment of CML in writing and either:

 All applications must include the completed:

Initial ponatinib treatment

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

All applications must include the completed:

Continuing treatment

Apply for authority approval to continue PBS subsidised dasatinib or nilotinib to treat CML in writing and either:

First continuing applications for dasatinib or nilotinib must include the completed:

After we approve the first continuing application for first line treatment, subsequent continuing applications can be made by calling the PBS Complex Drugs Programs enquiry line.

After we approve the first continuing application for ponatinib treatment, subsequent continuing applications can be made by calling the PBS Complex Drugs Programs enquiry line.

First continuing authority applications for imatinib can be made by calling PBS Complex Drugs Program enquiry line. Subsequent continuing PBS subsidised treatment with imatinib is Authority Required (Streamlined). It doesn’t need authority approval from us for listed quantities and repeats.

More information

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

Page last updated: 1 November 2019