1658.1 – Testing of tumour tissue to determine a positive homologous recombination deficiency status in women newly diagnosed with advanced (FIGO stage III-IV) high grade epithelial ovarian, fallopian tube or primary peritoneal cancer for access to PBS olaparib

New MBS item.

The applicant has described the proposed service to detect a positive homologous recombination deficiency (HRD) status in tumour material from a patient diagnosed with advanced (FIGOIII-IV), high-grade serous or high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, including BRCA 1 or BRCA2 pathogenic or likely pathogenic gene variants, to determine if requirements are fulfilled for access to olaparib, under the Pharmaceutical Benefits Scheme (PBS).

Type: Investigative

Homologous recombination deficiency is caused by impaired DNA repair mechanisms, such as a pathogenic or likely pathogenic BRCA gene variant, which are considered to be a primary driver of ovarian cancer. All women with a BRCA variant are HRD positive, but BRCA pathogenic gene variant is not the only cause of HRD. Deficiencies in HRD are predictive for response to Poly (ADP-ribose) polymerases (PARP) inhibitors such as olaparib, and testing tumour tissue for HRD at diagnosis can identify all patients with High-grade serous ovarian carcinoma likely to achieve a treatment benefit with PARP inhibitors. This application requests a new MBS item for HRD testing which will detect HRD and BRCA status in patients with advanced ovarian cancer to determine eligibility for treatment with olaparib, in combination with bevacizumab. Olaparib is currently listed on the PBS for treatment of ovarian, fallopian tube or primary peritoneal cancer (with BRCA variants), and MBS items are currently available to detect BRCA gene variant status to determine eligibility for olaparib treatment (MBS items 73295, 73301). However, recent evidence shows that women who have HRD positive, BRCA wild-type ovarian cancer would also benefit from treatment with olaparib in combination with bevacizumab.

• MSAC consultation: Closed Friday 10 February 2023

• PASC meeting: Bypassing PASC
• ESC meeting: 9 to 10 February 2023
• MSAC meeting: 30 to 31 March 2023