Chronic myeloid leukaemia (CML)–imatinib mesylate
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Authority to supply imatinib mesylate (Glivec®) through the Pharmaceutical Benefits Scheme (PBS) under Section 85 Arrangements of the National Health Act 1953.
Imatinib mesylate is 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.
Restriction details
There are six restrictions, one of which a patient must satisfy before approval will be granted to prescribe imatinib mesylate. These restrictions are:
- initial treatment for patients in the chronic phase of CML
- continuing treatment for patients in the chronic phase of CML
- initial treatment for patients in the accelerated phase of CML
- continuing treatment for patients in the accelerated phase of CML
- initial treatment for patients in the blast phase of CML
- continuing treatment of patients in the blast phase of CML
View a full transcript of the Schedule of Pharmaceutical Benefits
(the Schedule) restriction details.
Imatinib will only be PBS subsidised for patients with chronic meyloid leukaemia who are not receiving concomitant PBS subsidised dasatinib, nilotinib or interferon alfa therapy.
Item details
Dose
The maximum dose that can be prescribed is 800 mg per day.
imatinib mesylate is available in tablet form.
- imatinib mesylate 100 mg tablets in a pack size of 60
- imatinib mesylate 400 mg tablets in a pack size of 30
Patients should start on a dose of imatinib mesylate of 400 mg daily and be maintained on a minimum dose of imatinib mesylate of 400 mg daily. Continuing therapy is dependent on patients demonstrating a response to imatinib therapy, irrespective of the daily imatinib dose received.
| Imatinib Mesylate prescriptions—a guide to quantity and repeats | |||||
|---|---|---|---|---|---|
| Chronic phase | Daily dose | Tablet strength | Authority prescription | Quantity | Maximum number |
| 400 mg | 1 x 400 mg tablet | imatinib mesylate 400 mg tablets | 30 | 5 | |
| 4 x 100 mg tablets | imatinib mesylate 100 mg tablets | 120 | 5 | ||
| 600 mg† | 6 x 100 mg tablets | imatinib mesylate 100 mg tablets | 180 | 5 | |
| or | |||||
| 1 x 400 mg tablet | imatinib mesylate 400 mg tablets | 30 | 5 | ||
| and | |||||
| 2 x 100 mg tablets | imatinib mesylate 100 mg tablets | 60 | 5 | ||
| 800 mg | 2 x 400 mg tablets | imatinib mesylate 400 mg tablets | 60 | 5 | |
| 8 x 100 mg tablets | imatinib mesylate 100 mg tablets | 240 | 5 | ||
| Accelerated or blast phase | 400 mg | 1 x 400 mg tablet | imatinib mesylate 400 mg tablets | 30 | 2 |
| 4 x 100 mg tablets | imatinib mesylate 100 mg tablets | 120 | 2 | ||
| 600 mg† | 6 x 100 mg tablets | imatinib mesylate 100 mg tablets | 180 | 2 | |
| or | |||||
| 1 x 400 mg tablet | imatinib mesylate 400 mg tablets | 30 | 2 | ||
| and | |||||
| 2 x 100 mg tablets | imatinib mesylate 100 mg tablets | 60 | 2 | ||
| 800 mg | 2 x 400 mg tablets | imatinib mesylate 400 mg tablets | 60 | 2 | |
| 8 x 100 mg tablets | imatinib mesylate 100 mg tablets | 240 | 2 | ||
†Important: it is essential that a separate authority prescription is written for each strength of imatinib mesylate tablet
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Pathology reports
All applicable pathology reports must be provided from an Approved Australian Pathology Authority.
Chronic phase patients
Initial application: A pathology report conducted on peripheral blood or bone marrow which confirms eligibility for treatment.
Continuing application: A cytogenetic analysis on bone marrow or quantitive Polymerase Chain Reaction (qPCR) on peripheral blood must be performed:
- between 10 and 12 months of initial treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than one per cent has been demonstrated may receive authorisation for a further 12 months of treatment
- within 18 months of initial treatment with imatinib mesylate in patients who have failed to demonstrate a major cytogenetic response or peripheral blood BCR-ABL level of less than one percent at between 10 and 12 months (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than one per cent is demonstrable by 18 months may also receive authorisation for a further 12 months of treatment); and
- at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than one per cent has been sustained
Definitions of response:
- a major cytogenic response is defined as less than 35 per cent Philadelphia positive bone marrow cells
- a peripheral blood BCR-ABL level of less than one per cent on the international scale (Blood 108: 28-37, 2006 ) also indicates a response, at least the biological equivalent of a major cytogenetic response.
For bone marrow analyses where standard karyotyping conducted at the time of continuing application is not informative, a copy of a cytogenetic analysis conducted on bone marrow using using fluorescent in situ hydridisation (FISH) with BCR-ABL specific probe must be submitted with the application. A copy of the non-informative standard karyotype analysis must be included with the application.
Accelerated and blast phase patients
Initial application: A pathology report conducted on peripheral blood or bone marrow which confirms the presence of Philadelphia chromosome or the transcript BCR-ABL and a pathology report or details and dates of assessment confirming diagnosis of accelerated or blast phase.
Continuing application: May be made by phone or in writing.
Lodgement
Chronic phase CML
All initial and continuing application requests must be in writing.
See flow chart [PDF, 103Kb]
for details of when to submit forms and cytogenetic analysis.
Accelerated phase and blast phase CML
Applications for initial approvals must be in writing. Requests for continuing prescriptions may be submitted in writing or may be obtained by calling 1800 700 270* and selecting option 3 (8 am to 5 pm EST Monday to Friday).
The postal address for all written applications is:
Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
GPO Box 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
Please ensure that all written applications for authorisation include:
- a completed authority prescription form
- a completed imatinib mesylate supporting information form, which includes for initial chronic phase applications only, signed patient and prescriber acknowledgements
- all relevant pathology reports to support current criteria.
For more information please call 1800 700 270* and select option 3 (8 am to 5 pm EST Monday to Friday).
* Call charges apply from mobile or pay phones only.
Application forms
- Initial treatment—chronic phase—chronic myeloid leukaemia (Form 4076) [PDF, 49Kb]
Lodge this form for a patient starting initial PBS subsidised treatment in the chronic phase of chronic myeloid leukaemia. The patient and prescriber acknowledegments must also be completed. - Continuing treatment—chronic phase—chronic myeloid leukaemia (Form 4077) [PDF, 47Kb]
Lodge this form for a patient continuing PBS subsidised treatment in the chronic phase of chronic myeloid leukaemia. - Initial treatment—accelerated phase—chronic myeloid leukaemia (Form 4066) [PDF, 45Kb]
Lodge this form for a patient undergoing initial PBS subsidised treatment in the accelerated phase of chronic myeloid leukaemia. - Initial treatment—blast phase—chronic myeloid leukaemia (Form 4074) [PDF, 45Kb]
Lodge this form for a patient undergoing initial PBS subsidised treatment in the blast phase of chronic myeloid leukaemia.
Important: the information on this website is correct at the time of publishing and is subject to change.
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Last updated: 16 September, 2008