Chronic myeloid leukaemia

The PBS subsidises tyrosine kinase inhibitor (TKI) 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 mesilate
  • 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.

Switching between TKI agents

Dasatinib, imatinib mesilate, and nilotinib

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

Patients can be prescribed any one of dasatinib, imatinib mesilate or 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 therapy
  • Dasatinib and nilotinib are available as first, second and third line therapy. They are only 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

Applications

Dasatinib, imatinib mesilate or nilotinib first line treatment applications:

Initial treatment:

Make all initial applications for authority approval to prescribe dasatinib, imatinib mesilate or nilotinib for first line treatment of CML and:

Chronic phase:

All initial applications for dasatinib, imatinib mesilate or nilotinib for chronic phase of CML must include a completed:

Accelerated or blast phase:

All initial applications for imatinib mesilate for accelerated or blast phase of CML must include a completed:

Continuing treatment:

Make all first continuing applications for authority approval to prescribe dasatinib, imatinib mesilate or nilotinib for first line treatment of CML in writing and:

All first continuing applications for dasatinib, imatinib mesilate or nilotinib must include a completed:

Subsequent continuing applications for first line treatment can be made by calling the PBS Complex Drugs Programs enquiry line.

Dasatinib or nilotinib second or third line treatment applications:

Initial applications:

Make all initial applications for authority approval to prescribe dasatinib or nilotinib for second or third line treatment of CML and:

All initial applications for dasatinib for chronic, accelerated or blast phase, or nilotinib for chronic or accelerated phase of CML must include a completed:

Continuing treatment

Make all continuing applications for authority approval to prescribe dasatinib or nilotinib for second or third line treatment of CML in writing and:

All continuing applications for dasatinib or nilotinib must include a completed:

Ponatinib treatment applications:

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

Initial treatment:

Make all initial applications for authority approval to prescribe ponatinib for the treatment of CML in writing and:

All initial applications for ponatinib must include a completed:

Continuing treatment:

Make all continuing applications for authority approval to prescribe ponatinib for the treatment of CML in writing and:

All continuing applications for ponatinib must include a completed:

Further information

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

Page last updated: 27 August 2017