What's new?

July 2014

Improvements will be made to the way some PBS medicines are processed under the Highly Specialised Drugs Programme from 1 July 2015.

Chronic myeloid leukaemia (CML)

Authority to supply tyrosine kinase inhibitor (TKI) agents through the Pharmaceutical Benefits Scheme (PBS) under Section 85 Arrangements of the National Health Act 1953.

TKI agents are available as PBS subsidised therapy for the treatment of patients with chronic myeloid leukaemia (CML), expressing the Philadelphia chromosome or the transcript—BCR-ABL—and who have a primary diagnosis of CML.  TKI agents which are approved for this condition are dasatinib, imatinib mesylate and nilotinib only.

Restriction details

There are eight 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

View a full transcript of the Schedule of Pharmaceutical BenefitsExternal link (the Schedule) restriction details.

Notes on switching between TKI agents

Patients are eligible for PBS subsidised treatment with only one TKI agent at any time and mustn’t be receiving concomitant interferon alfa therapy.  Eligible patients can only swap between TKI agents if they haven’t failed PBS subsidised treatment with that agent before.

From 1 April 2012, a patient can be prescribed any TKI agent within the initial 18 month treatment period as long as the patient hasn’t 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 and third-line agents for eligible patients who have trialled imatinib mesylate as first 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 aren’t responding.

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 100mg (base) daily.

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 400mg (base) daily.

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 first-line TKI agent, patients should start on a dose of nilotinib of 300 mg twice daily.

Patient eligibility

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

Who is eligible for the PBS?

Pathology reports

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

Chronic phase patients

All initial applications must be submitted in writing and must include all relevant pathology reports.

Lodgement

Chronic phase CML

All initial application requests must be made in writing.

The first imatinib mesylate continuing application must be made in writing.  Further applications for continuing treatment can be made by calling 1800 700 270* and selecting option 3, Monday to Friday 8am to 5pm EST.  Patients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than one per cent 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. Requests for continuing prescriptions (imatinib mesylate only) can be made in writing or by calling 1800 700 270* and selecting option 3, Monday to Friday 8am to 5pm EST.

All written applications can be sent to:

Department of Human Services
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001

(No stamp required if posted in Australia)

For more information please call 1800 700 270* and select option 3, Monday to Friday 8am to 5pm EST.

* Call charges apply from mobile or pay phones only.

Application forms

Some documents on this page may require the free Adobe PDF reader.

Last updated: 28 November, 2014