1507.1 – Germline BRCA mutation testing in patients with locally advanced or metastatic HER2-negative breast cancer to determine eligibility for PBS-listed olaparib treatment

MSAC–PBAC co-dependent submission.

Germline BRCA mutation testing to detect the presence of a BRCA1 or BRCA2 gene variant in a patient with locally advanced or metastatic HER2-negative breast cancer.

Type: Investigative technology

In Australia, breast cancer is the most common cancer affecting women. A personal history of breast cancer or family history are contributing risk factors with approximately 5 to 10% of breast cancers due to a strong family history or genetic mutation, such as in BRCA1 or BRCA2 gene.

Breast cancer is classified as hormone receptor (HR)-positive if the cancer cells have receptors for the hormones estrogen and progesterone, which suggests the cancer cells receive signals from these hormones that promote their growth.

Human epidermal growth factor receptor 2 (HER2) -negative breast cancers have cells that contain little to no HER-2 protein, so they tend to grow more slowly and have a better outlook than HER-2-positive cancers.

A HER-2-negative diagnosis means that the cancer will not benefit from therapies that target the HER-2 protein. Testing for germline BRCA mutation informs treatment choices and outcomes.

• PASC consultation: Expedited – bypassing PASC
• MSAC consultation: Closed Friday 14 June 2024

• PASC meeting: Bypassing PASC
• ESC meeting: Bypassing ESC
• MSAC meeting: 1–2 August 2024