Leukaemia - chronic myeloid leukaemia

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

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 1 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.

  • Imatinib 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 as first line.
  • Nilotinib is not approved for patients in blast crisis.
  • Patient’s may trial ponatinib at any time given they meet the relevant prescription 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, imatinib or nilotinib must include the completed:

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

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 TKI agents to treat CML in writing and either:  

First continuing applications for TKI agents 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.

More information

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

Page last updated: 1 May 2019

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