Chronic myeloid leukaemia

The Pharmaceutical Benefits Scheme (PBS) subsidises tyrosine kinase inhibitor agents for patients with chronic myeloid leukaemia (CML).

Treatment with some tyrosine kinase inhibitor (TKI) agents can be subsidised through the PBS under section 85 of the National Health Act 1953 for patients with chronic myeloid leukaemia (CML).

These TKI agents are:

  • dasatinib
  • imatinib mesylate
  • nilotinib, and
  • ponatinib

Patient eligibility

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

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing TKI agents to patients.

Patients with CML can be treated with TKI agents, where applicable, if they:

  • express the Philadelphia chromosome or the transcript BCR-ABL tyrosine kinase, and
  • have a primary diagnosis of CML

Switching between TKI agents

Dasatinib, imatinib mesylate, and nilotinib

Patients are eligible for PBS subsidised treatment with 1 TKI agent at any time.

Patients can be prescribed any one of imatinib mesilate, dasatinib, nilotinib in the initial 18 months of treatment.

Eligible patients can swap between TKI agents if they experience toxicity and have not failed PBS subsidised treatment with that agent in the past.

  • Imatinib mesilate is only available as a first line TKI agent
  • Dasatinib and nilotinib are available as first and second line therapy. They are available as third line therapy for eligible patients who have trialled imatinib mesilate as first line
  • Nilotinib is not approved for patients in blast crisis

Ponatinib is available for patients who:

  • have failed an adequate treatment trial or are intolerant to both nilotinib and dasatinib, or
  • have failed a treatment trial with imatinib mesilate, dasatinib or nilotinib, and are expressing the T315i mutation

Applications

Initial treatment – Ponatinib

Make initial treatment application in writing for authority approval, to prescribe ponatinib for the treatment of chronic myeloid leukaemia and:

All applications for ponatinib must include a completed:

Initial First line treatment – Dasatinib, imatinib mesilate or nilotinib

Make a first line initial treatment application in writing for authority approval, to prescribe imatinib mesilate, dasatinib, or nilotinib, for the treatment of chronic phase of chronic myeloid leukaemia and:

All initial first line applications for imatinib mesilate, dasatinib and nilotinib must include a completed:

Initial Second or Third line treatment – Dasatinib or nilotinib

Make a second or third line initial treatment application in writing for authority approval, to prescribe:

  • Dasatinib for chronic phase, accelerated phase, or blast phase of chronic myeloid leukaemia, or
  • Nilotinib for chronic or accelerate phase of chronic myeloid leukaemia

and

All applications for dasatinib and nilotinib must include a completed:

Continuing treatment

Make applications for continuing authority in writing to prescribe:

  • Imatinib mesilate, dasatinib, or nilotinib for first line treatment of chronic phase chronic myeloid leukaemia
  • Dasatinib and nilotinib for second or third line treatment, or
  • Ponatinib

and

All applications must include:

Subsequent continuing treatment

Subsequent continuing authority requests for imatinib mesilate, dasatinib, or nilotinib, for first line treatment of chronic phase of chronic myeloid leukaemia, can be made over the phone by contacting the PBS Complex Drugs Programs enquiry line on 1800 700 270.

An application for subsequent continuing subsidised treatment with ponatinib, or second or third line treatment with dasatinib or nilotinib, must be in writing and include:

Further information

For more information contact the PBS Complex Drugs Programs enquiry line.

Page last updated: 7 February 2017

This information was printed Monday 20 February 2017 from humanservices.gov.au/health-professionals/enablers/chronic-myeloid-leukaemia 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.