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

Page last updated: 26 July 2023

Application Detail

Description of Medical Service

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.

Description of Medical Condition

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.

Reason for Application

New MBS item

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1607 KB)
Application Form (Word 258 KB)

Consultation Survey

Consultation Survey (PDF 660 KB)
Consultation Survey (Word 27 KB)

PASC Consultation
Expedited - Bypassing PASC

MSAC Consultation
MSAC consultation input closed Friday, 10 February 2023.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation


Assessment Report


Public Summary Document

Public Summary Document (PDF 884 KB)
Public Summary Document (Word 369 KB)

Meetings for this Application


Bypassing PASC


Bypassing ESC


30-31 March 2023
23-24 November 2023