Chronic myeloid leukaemia (CML)–nilotinib
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Authority to supply nilotinib (Tasigna®) through the Pharmaceutical Benefits Scheme (PBS) under the Section 85 Arrangements of the National Health Act 1953.
Nilotinib is available as a PBS subsidised therapy for the treatment of patients with chronic myeloid leukaemia (CML), in chronic or accelerated phases, 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 nilotinib 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 who have received treatment with PBS subsidised nilotinib.
The Schedule of Pharmaceutical Benefitsoutlines the restrictions for prescribing nilotinib.
View a full transcript of the nilotinib restriction details
.
Nilotinib will only be PBS subsidised for patients with CML who are not receiving concomitant PBS subsidised imatinib mesylate, dasatinib or interferon alfa therapy.
Item details
Dose
The maximum dose that can be prescribed is 400 mg twice daily nilotinib is available in a capsule form presented as a pack size of 112.
Patients should be started on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy, irrespective of the daily nilotinib dose received.
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 quantitative polymerase chain reaction (qPCR) on peripheral blood must be performed:
- Between 10 and 12 months of initial treatment with nilotinib, 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.
- 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 Fluorescence 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 criteria and severity descriptors [PDF, 77Kb]
which should be used in conjunction with the application when demonstrating a Grade 3 or 4 non-haematological toxicity that is imatinib mesylate related, is attached. 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 applications for authorisation include:
- a completed authority prescription form
- a completed nilotinib supporting information form (which includes, for initial applications only, 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—nilotinib PBS authority application supporting information form—initial treatment [PDF, 210Kb]—(Form 4216)
Lodge this form for a patient starting initial PBS subsidised treatment of chronic myeloid leukaemia with nilotinib. The patient and prescriber acknowledgements must also be completed. - Chronic myeloid leukaemia—nilotinib PBS authority application supporting information form—continuing treatment [PDF, 194Kb]—(Form 4217)
Lodge this form for a patient continuing PBS subsidised treatment of chronic myeloid leukaemia with nilotinib.
Important: The information on this website is correct at the time of publishing and is subject to change.
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Last updated: 1 August, 2008