Early breast cancer
The Pharmaceutical Benefits Scheme subsidises trastuzumab for patients with HER2-positive early breast cancer or HER2-positive locally advanced breast cancer.
Treatment with trastuzumab (Herceptin®) can be subsidised through the Pharmaceutical Benefit Scheme (PBS) under both section 100 (efficient funding of chemotherapy) and section 85 of the National Health Act 1953 for patients with:
- human epidermal growth factor receptor 2 (HER2) positive early breast cancer, or
- HER2 positive locally advanced breast cancer
There are separate arrangements for the treatment of metastatic breast cancer.
Schedule restriction details
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing trastuzumab (Herceptin®).
All patients seeking initial treatment must meet the criteria as indicated in the restrictions and must:
- have had their cardiac function tested by a suitable method and must have a left ventricular ejection fraction (LVEF) of greater than or equal to 45 per cent and not have symptomatic heart failure
- start trastuzumab (Herceptin®) treatment while receiving chemotherapy, and
- demonstrate human epidermal growth factor receptor 2 (HER2 positivity by in-situ hybridisation (ISH)
Patients are eligible for 52 weeks of PBS-subsidised treatment.
All patients for continuing treatment must have their cardiac function tested every 3 months by a suitable method and must have a LVEF of greater than or equal to 45 per cent and not have symptomatic heart failure.
Schedule item details
Dose – Trastuzumab (Herceptin®) is available as either intravenous (IV) infusion or subcutaneous (SC) injection.
The prescription must clearly specify whether the IV or SC route of administration is requested.
For patients receiving intravenous trastuzumab
You must specify on the prescription the dose to be administered in milligrams per infusion. The prescription must be written for 1 infusion plus the approved number of repeats, if applicable.
The initial loading dose depends on the patient's weight. It is calculated as follows:
- for dosing once a week: 4 mg per kg, or
- for dosing every 3 weeks: 8 mg per kg
The continuing treatment dose depends on the patient's weight. It is calculated as follows:
- for dosing once a week: 2 mg per kg. Up to 11 repeats may be requested, or
- for dosing every 3 weeks: 6 mg per kg. Up to 3 repeats may be requested
For patients receiving subcutaneous trastuzumab
The dose for patients is one SC injection every 3 weeks. The prescription must be written for one 600 mg injection – as dose is irrespective of weight – and no repeats may be requested.
The continuing dose is one SC injection every 3 weeks. The prescription must be written for one 600 mg injection – as dose is irrespective of weight – and up to 3 repeats may be requested.
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.
A copy of the pathology report confirming the presence of HER2 gene amplification by ISH must be provided and must be from an approved pathology authority.
Cardiac function must be tested by a suitable method such as an echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) before seeking the initial authority approval, and then every three months during treatment.
Lodging an application
All initial application requests must be made in writing. Send written applications to the Complex Drugs address on the contact us page.
Please ensure that all written applications for initial PBS authorisations include:
- a completed authority prescription form
- a completed Early breast cancer Initial PBS authority application Supporting information form (PB094) that includes the patient and prescriber acknowledgements, and
- a pathology report confirming HER2 gene amplification
Applications for continuing treatment may be made in writing or may be obtained by contacting us on the Complex Drugs enquiry line.
For more information contact the Complex Drugs Programs enquiry line.