The PBS subsidises trastuzumab for patients with human epidermal growth factor receptor 2 (HER2) positive early breast cancer or HER2 positive locally advanced breast cancer.
The PBS can subsidise treatment with trastuzumab under both section 85 of the National Health Act 1953, and the section 100 arrangements for the Efficient Funding of Chemotherapy, for patients with:
- HER2 positive early breast cancer, or
- HER2 positive locally advanced breast cancer
There are separate arrangements for the treatment of metastatic breast cancer.
Patients must meet the relevant criteria in the restrictions and be eligible for the PBS.
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing trastuzumab.
Patients must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
You must provide a copy of the pathology report confirming the presence of HER2 gene amplification by in situ hybridisation (ISH) 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 3 months during treatment.
Make all initial applications for authority approval to prescribe trastuzumab for the treatment of HER2 positive early breast cancer or HER2 positive locally advanced breast cancer in writing and:
- upload through Health Professional Online Services, or
- post to the PBS Complex Drugs Programs address
All applications must include:
- the authority prescription form
- the Early breast cancer Initial PBS authority application supporting information form
- any relevant attachments
The prescription must clearly specify if the IV or SC route of administration is requested.
To be eligible for continuing treatment the patient must have a left ventricular ejection fraction (LVEF) of 45% and not have symptomatic heart failure.
To apply for continuing treatment call the PBS Complex Drugs Programs enquiry line.
For more information contact the PBS Complex Drugs Programs enquiry line.