1507 - Germline BRCA mutation testing to determine eligibility for olaparib treatment in patients with locally advanced or metastatic HER2 negative breast cancer (either hormone receptor positive or triple negative)

Page last updated: 04 May 2018

Application Detail



Description of Medical Service

Germline BRCA mutation testing is currently well established in Australia especially for familial risk assessment and more recently to determine patient eligibility for olaparib in the ovarian cancer population. Publically (state) funded BRCA genetic testing is available through public and some private Familial Cancer Centres (FCC) across Australia to those families who meet certain criteria. Self-funded gene testing can be arranged through a patient’s general practitioner and available through private laboratories.

Germline mutations in BRCA1 or BRCA2 are present in around 5% of breast cancers overall, and the eviQ guidelines currently recommend BRCAm testing in individuals with: TNBC age ≤ 50; high-grade non-mucinous ovarian cancer age ≤ 70; non-mucinous ovarian cancer, any age + family history; OR known BRCA mutation in a relativeBRCA testing is not routinely recommended for all women diagnosed with the disease. Testing for germline BRCA mutation informs treatment choices and outcomes and will ensure that targeted products such as olaparib are used for indications where patients are eligible for treatment and will get the most benefit. In addition, BRCA mutation testing can help identify and address increased cancer risk in family members through surveillance or prophylactic surgery. This co-dependent submission requests public funding for germline BRCA mutation testing to determine eligibility of olaparib treatment in patients with locally advanced or metastatic HER2 negative breast cancer (which are either hormone receptor positive or triple negative). It is proposed that only patients who are germline BRCA mutation positive and have received prior treatment with anthracycline and taxane and are refractory to hormone therapy will be eligible for olaparib treatment.

Description of Medical Condition

In Australia, breast cancer is the most common cancer affecting women. In 2017, it is estimated that 17,586 women and 144 men will be diagnosed with breast cancer . On average, 48 Australians are diagnosed with breast cancer each day. The risk of being diagnosed with breast cancer increases with age, with 78% of new cases of breast cancer developing in women over the age of 50. 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. Women with a BRCA1 or BRCA2 mutation are believed to have an intermediate risk of developing breast cancer. The average cumulative risks of developing breast cancer by 70 years old has been reported as 57‒65% for BRCA1 mutation carriers and 45‒49% for BRCA2 mutation carriers.

Reason for Application

Amendment to MBS item

Medical Service Type


Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application Form (Word 171 KB)
Application Form (PDF 938 KB)

Consultation Survey

Consultation Survey (Word 508 KB)
Consultation Survey (PDF 307 KB)

PICO Confirmation

PICO Confirmation (Word 202 KB)
PICO Confirmation (PDF 850 KB)

Assessment Report


Public Summary Document


Meetings for this Application


8 December 2017