Chronic myeloid leukaemia
The Pharmaceutical Benefits Scheme (PBS) subsidises tyrosine kinase inhibitor agents for patients with chronic myeloid leukaemia.
Patients with chronic myeloid leukaemia can be treated with tyrosine kinase inhibitor agents, where applicable, if they:
- express the Philadelphia chromosome or the transcript BCR-ABL, and
- have a primary diagnosis of CML
TKI agents approved for this condition are:
- imatinib mesylate
- nilotinib, and
This is defined in the restrictions through the PBS. The treatment falls under Section 85 of the National Health Act 1953.
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing TKI agents to patients.
Switching between TKI agents
Dasatinib, imatinib mesylate, and nilotinib
Patients are eligible for PBS subsidised treatment with 1 TKI agent at any time and must not be receiving concomitant interferon alpha therapy at the same time.
Eligible patients can swap between TKI agents if they experience toxicity and provided they have not previously failed PBS subsidised treatment with that agent.
A patient can be prescribed any TKI agent in the initial 18 month treatment period, as long as they have not failed to respond to any of the TKI agents.
Imatinib mesylate is only available as a first line TKI agent. Dasatinib and nilotinib are available as first, second line agents and are only available as third line agents for eligible patients who have trialled imatinib mesylate 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
- have failed an adequate treatment trial with imatinib mesylate, dasatinib or nilotinib, and are expressing the T315i mutation
Lodging an application
All initial applications must be made in writing and include all relevant pathology reports. Send all written applications to the PBS Complex Drugs Programs address.
Applications for continuing treatment with imatinib mesylate can be made by contacting the PBS Complex Drugs Programs enquiry line.
Applications for continuing treatment with dasatinib, nilotinib and ponatinib must be made in writing.
Chronic phase CML
For a patient starting initial PBS subsidised treatment in the chronic phase of CML submit:
For a patient starting initial PBS subsidised treatment with ponatinib submit:
For a patient continuing PBS subsidised treatment in the chronic phase of CML submit:
For a patient starting second or third line PBS subsidised treatment in the chronic phase of CML with dasatinib or nilotinib submit:
Accelerated phase and blast phase CML
For a patient undergoing initial PBS subsidised treatment in the accelerated or blast phase of chronic myeloid leukaemia:
- Chronic myeloid leukaemia Initial PBS authority application Imatinib mesylate, accelerated or blast phase application form (PB082)
For more information contact the PBS Complex Drugs Programs enquiry line.