Early breast cancer

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.

Patient eligibility

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 receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.

Test requirements

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.

Applications

Initial 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:

All applications must include:

The prescription must clearly specify if the IV or SC route of administration is requested.

Continuing treatment

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.

Further information

For more information contact the PBS Complex Drugs Programs enquiry line.

Page last updated: 27 August 2017