Description of Medical ServiceGermline 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.