Late stage metastatic breast cancer
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Authority to supply lapatinib ditosylate (Tykerb®) for treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive late stage breast cancer through the Pharmaceutical Benefits Scheme (PBS) under Section 85 arrangements of the National Health Act 1953.
Restriction details
The Schedule of Pharmaceutical Benefits outlines restrictions for prescribing lapatinib.
Lapatinib is not PBS subsidised when used in combination with Commonwealth subsidised trastuzumab (Herceptin®).
If disease progression occurs, the prescribing doctor must contact Medicare Australia within one week and lapatinib treatment must be stopped immediately. Call 1800 700 270** and select option 1 (hours of operation 8 am to 5 pm EST Monday to Friday) or lodge the Continuing or stopping PBS subsidised treatment for late stage metastatic breast cancer (Form 4214) [PDF, 188Kb]
to notify Medicare Australia of the date of disease progression during lapatinib treatment and to declare that lapatinib treatment has stopped.
Initial treatment
All patients wanting to start treatment with lapatinib must have:
- disease progression despite treatment with trastuzumab for metastatic disease
- cardiac function tested by a suitable method, e.g. Echocardiogram (ECHO) or Multiple Gated Acquisition scan (MUGA)
- lapatinib treatment in combination with capecitabine
- demonstrated Human Epidermal Growth Factor Receptor 2 (HER2) positivity by In-Situ Hybridisation (ISH).
Patients are eligible for continuation treatment until there is evidence of disease progression.
Continuing treatment
Applications may be made for continuing treatment for patients who have not experienced disease progression. Patients must have cardiac function tested by a suitable method at three monthly intervals throughout lapatinib treatment.
Item details
Dose
Lapatinib is available as 250 mg tablets taken as a once daily dose of 1250 mg.
Initial application
Prescriptions should be written for a quantity of 140 tablets with two repeats.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Test requirements
A copy of the pathology report confirming the presence of HER2 gene amplification by ISH must be provided and from an approved pathology authority.
Cardiac function must be tested by a suitable method, for example, ECHO or MUGA, before seeking the initial authority approval and then at three monthly intervals during treatment.
Toxicity criteria and severity descriptors
The attached toxicity criteria and severity descriptors should be used to assess a patient’s inability to tolerate taxane treatment if this is required to be demonstrated.
Lapatinib – late stage breast cancer - toxicity criteria and severity descriptors [PDF, 24Kb]
Lodgement
All initial applications must be in writing. Please send all written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
Hobart Tasmania 7001
(No stamp required if posted in Australia)
For more information please call 1800 700 270** and select option 1 (8 am to 5 pm EST Monday to Friday).
** Call charges apply from mobile or pay phones only.
Application forms
- Initial PBS subsidised treatment for patients with late stage metastatic breast cancer [PDF, 182Kb] (Form 4213)
Lodge this form for a patient starting initial PBS subsidised treatment with lapatinib. The patient and prescriber acknowledgements must be completed. - Continuing or stopping PBS subsidised treatment for late stage metastatic breast cancer [PDF, 188Kb] (Form 4214)
Lodge this form for a patient continuing PBS subsidised treatment with lapatinib. This form may also be used as notification for patients who have had treatment with lapatinib stopped due to progression of their disease.
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Last updated: 8 April, 2011