Application Detail

Description of Medical Service

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).

Description of Medical Condition

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.

Reason for Application

New MBS item

Medical Service Type

Investigative

Previous Application Number/s

1658

Associated Documentation

Application Form

Refer to MSAC Application 1658

Consultation Survey

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

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

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Assessment Report

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Public Summary Document

Public Summary Document (PDF 833 KB)
Public Summary Document (Word 395 KB)

Meetings for this Application

PASC

Bypassing PASC

ESC

9-10 February 2023

MSAC

30-31 March 2023