1618 – Testing of tumour prostate tissue to detect BRCA1/2 pathogenic gene variants in men with metastatic castration-resistant prostate cancer to help determine eligibility for PBS olaparib

Page last updated: 03 September 2021

Application Detail

Description of Medical Service

The proposed medical service is testing of prostate tumour tissue to detect BRCA1/2 (BReast CAncer gene) gene variants in men with metastatic castration-resistant prostate cancer to determine eligibility for treatment with olaparib.

Description of Medical Condition

When localised, prostate cancer can be cured with surgery or radiotherapy, but some patients will relapse with either overt metastases or an isolated rise in prostate-specific antigen. There is also a proportion of men who have metastases when the prostate cancer is first diagnosed. Prostate cancer is termed ‘castrate resistant’ when the disease progresses despite continuous androgen deprivation therapy. After this, further treatment is needed to maintain disease control.

This application concerns the metastatic disease, which is a small part of the overall disease and is furthermore targeted at those patients with genetic mutations in their homologous recombination repair (HRR) genes. A small percentage of prostate tumours have loss of function mutations in candidate genes involved in HRR of DNA. BRCA1, BRCA2, or ATM are the most well characterised and/or frequently mutated HRR genes in prostate cancer. The overall mutation frequency for these three genes together range from 13% to 26.5% in metastatic castration resistant prostate cancer

Reason for Application

New MBS item

Medical Service Type

Investigative

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1381 KB)
Application Form (Word 280 KB)

Consultation Survey

Consultation Survey (PDF 561 KB)
Consultation Survey (Word 68 KB)

PICO Confirmation

PICO Confirmation (PDF 1552 KB)
PICO Confirmation (Word 1194 KB)

Assessment Report

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Public Summary Document

Public Summary Document (PDF 1026 KB)
Public Summary Document (Word 1651 KB)

Meetings for this Application

PASC

17 April 2020

ESC

11-12 February 2021

MSAC

31 March - 1 April 2021
25-26 November 2021