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

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1459 KB)
Application Form (Word 542 KB)

Consultation Survey

Consultation Survey (PDF 560 KB)
Consultation Survey (Word 71 KB)

PASC Consultation
PASC consultation closed

MSAC Consultation
MSAC consultation input closed Friday, 10 June 2022 for it to be considered by MSAC at its July 2022 meeting.

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

PICO Confirmation (PDF 1635 KB)
PICO Confirmation (Word 736 KB)

Assessment Report

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Public Summary Document

Public Summary Document (PDF 1468 KB)
Public Summary Document (Word 908 KB)

Meetings for this Application

PASC

15-16 April 2021
12-13 August 2021

ESC

9-10 June 2022

MSAC

28-29 July 2022