1716 – Germline BRCA mutation test to detect BRCA1 or BRCA2 mutations in patients with HER2- negative high risk early breast cancer to determine eligibility for PBS-listed olaparib treatment

New MBS item.

Germline BRCA mutation testing to detect the presence of a BRCA1 or BRCA2 gene variant in a patient with, HER2-negative, high risk early breast cancer.

Type: Investigative technology

In Australia, breast cancer is the most common cancer affecting women and early breast cancer includes Stages I-IIIa. Patients with a germline BRCA gene variant are typically younger than the overall breast cancer population. 

Patients with triple negative breast cancer (TNBC) are known to have a higher risk of tumours presenting with a BRCA mutation. TNBC refers to breast cancer that does not present with the three most common types of receptors known to fuel breast cancer growth (estrogen, progesterone, and the human epidermal growth factor receptor 2 gene (HER-2)). This form of cancer tends to be more aggressive than other breast cancer sub-types, with a poor prognosis, and is more likely to affect younger, pre-menopausal women.

• PASC consultation: Expedited – bypassing PASC
• MSAC consultation: Closed Friday 10 February 2023

• PASC meeting: Bypassing PASC
• ESC meeting: Bypassing ESC
• MSAC meeting: 
  • 30–31 March 2023
  • 23–24 November 2023