Chronic myeloid leukaemia (CML)

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

For patients with chronic myeloid leukaemia (CML) who express the Philadelphia chromosome or the transcript BCR-ABL, and who have a primary diagnosis of CML, tyrosine kinase inhibitor (TKI) agents can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under Section 85 of the National Health Act 1953.

TKI agents approved for this condition are dasatinib, imatinib mesylate and nilotinib only.

Restriction details

There are 8 restrictions, one of which a patient must satisfy before approval will be granted to prescribe a TKI agent. These restrictions are:

  1. initial first-line treatment for patients in the chronic phase of CML
  2. initial second-line treatment for patients in the chronic phase of CML
  3. initial third-line treatment for patients in the chronic phase of CML
  4. continuing treatment for patients in the chronic phase of CML
  5. initial treatment for patients in the accelerated phase of CML
  6. continuing treatment for patients in the accelerated phase of CML
  7. initial treatment for patients in the blast phase of CML
  8. continuing treatment of patients in the blast phase of CML

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

Notes on switching between TKI agents

Patients are eligible for PBS subsidised treatment with only 1 TKI agent at any time and must not be receiving concomitant interferon alpha therapy at the same time. Eligible patients can only swap between TKI agents if they have not failed PBS-subsidised treatment with that agent before.

A patient can be prescribed any TKI agent within the initial 18-month treatment period, as long as the patient has not failed to respond to any of the TKI agents.

Imatinib mesylate is only available as a 1st-line TKI agent. Dasatinib and nilotinib are available as 1st, 2nd and 3rd-line agents for eligible patients who have trialled imatinib mesylate as 1st line.

Nilotinib is not approved for patients in blast crisis.

During the initial 18-month treatment period, a patient can only switch between approved TKI agents if they are intolerant, not because they are not responding.

Schedule item details

Dose - Dasatinib is available as:

  • 20 mg tablets in a pack size of 60
  • 50 mg tablets in a pack size of 60
  • 70 mg tablets in a pack size of 60
  • 100 mg tablets in a pack size of 30

Patients should start on a dose of dasatinib of at least 100 mg (base) daily.

Dose - Imatinib mesylate is available as:

  • 100 mg tablets in a pack size of 60
  • 400 mg tablets in a pack size of 30

Patients should start on a dose of imatinib mesylate of at least 400 mg (base) daily.

Dose - Nilotinib is available as:

  • 150 mg capsules in a pack size of 120
  • 200 mg capsules in a pack size of 120

When nilotinib is used as a 1st-line TKI agent, patients should start on a dose of nilotinib of 300 mg twice daily.

Lodging an application

Chronic phase CML

All initial application requests must be made in writing and must include all relevant pathology reports. Send all written applications to the Complex drugs address on the contact us page.

All applicable pathology reports must be provided from an Approved Australian Pathology Authority.

The first imatinib mesylate continuing application must be made in writing. Further applications for continuing treatment can be made by contacting us on the Complex Drug Enquiry line. Patients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% to have continuing treatment.

All dasatinib and nilotinib continuing applications must be made in writing.

Accelerated phase and blast phase CML

Initial applications must be made in writing. Send all written applications to the Complex drugs address on the contact us page.

Further information

For more information contact us on the Complex Drug Enquiry line.