Chronic myeloid leukaemia (CML)–dasatinib
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Authority to supply dasatinib through the Pharmaceutical Benefits Scheme (PBS) under the Section 85 Arrangements of the National Health Act 1953.
Dasatinib is available as a PBS subsidised therapy for the treatment of patients with chronic myeloid leukaemia (CML), in any disease phase, bearing the Philadelphia chromosome or expressing the transcript BCR-ABL and who have active disease (as defined by current bone marrow pathology) and who have failed an adequate trial of imatinib mesylate.
Restriction details
Either of the following two restrictions must apply before approval will be granted to prescribe dasatinib under the PBS:
- initial treatment for patients of CML who have failed an adequate trial of imatinib mesylate
or - continuing treatment for patients of CML.
The Schedule of Pharmaceutical Benefits outlines the restrictions for prescribing dasatinib.
View a full transcript of the dasatinib restriction details
.
Dasatinib will only be PBS subsidised for patients with CML who are not receiving concomitant PBS subsidised imatinib mesylate, nilotinib or interferon alfa therapy.
Item details
Dose
The maximum dose that can be prescribed is 140 mg per day.
Dasatinib is available in a tablet form presented as one of the following:
- dasatinib 20 mg tablets in a pack size of 60
- dasatinib 50 mg tablets in a pack size of 60
- dasatinib 70 mg tablets in a pack size of 60.
Patients should be started on a dose of dasatinib of 140 mg per day. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy, irrespective of the daily dasatinib dose received.
| Dasatinib prescriptions—a guide to quantity and repeats | ||||
|---|---|---|---|---|
| Daily dose | Tablet strength | Authority prescription | Quantity | Maximum number |
| 100 mg | 2 x 50 mg tablet | dasatinib 50 mg tablets | 60 | 5 |
| 140 mg | 2 x 70 mg tablets | dasatinib 70 mg tablets | 60 | 5 |
| or | ||||
| 2 x 50 mg tablet | dasatinib 50 mg tablets | 60 | 5 | |
| and | and | |||
| 2 x 20 mg tablets | dasatinib 20 mg tablets | 60 | 5 | |
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.
Initial application: A pathology report conducted on bone marrow which confirms that the patient has active disease and supporting pathology to demonstrate failure to an adequate trial of imatinib mesylate must be submitted.
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 dasatinib, 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
- 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 Fluroescence In Situ Hybridisation (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.
Toxicity and severity descriptors
To ensure that the eligibility of patients can be fully assessed, a comprehensive list of imatinib mesylate toxicity and severity descriptors [PDF, 138Kb]
which should be used in conjunction with the application when demonstrating a Grade 3 or 4 non-haematological toxicity that is imatinib related. The toxicity must be of a severity to necessitate permanent treatment withdrawal.
Lodgement
All initial and continuing application requests must be in writing and sent to:
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 dasatinib supporting information form, which for initial applications only includes signed patient and prescriber acknowledgements
- all relevant pathology reports to support current criteria.
For assistance 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
- Chronic myeloid leukaemia—dasatinib PBS authority application supporting information form—initial treatment—(Form 4190) [PDF, 220Kb]
Lodge this form for a patient starting initial PBS subsidised treatment of chronic myeloid leukaemia with dasatinib. The patient and prescriber acknowledgements must also be completed. - Chronic myeloid leukaemia—dasatinib PBS authority application supporting information form—continuing treatment—(Form 4191) [PDF, 194Kb]
Lodge this form for a patient continuing PBS subsidised treatment of chronic myeloid leukaemia with dasatinib.
Important: The information on this website is correct at the time of publishing and is subject to change.
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Last updated: 11 August, 2008