1618 – Testing of blood to detect germline BRCA1 or BRCA2 gene mutations, in patients with metastatic pancreatic cancer, to determine eligibility for PBS olaparib

Page last updated: 05 March 2020

Application Detail

Description of Medical Service

SCENARIO 1 (preferred medical service): The proposed medical service is testing of prostate tumour tissue to detect BRCA1/2 (BReast CAncer gene) or ATM (Ataxia-Telangiesctasia Mutated) gene mutations in men with metastatic castration-resistant prostate cancer to determine eligibility for treatment with olaparib.

SCENARIO 2 (alternative medical service): An alternative medical service to the above is testing of prostate tumour tissue to detect BRCA 1 or BRCA 2 gene mutations 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

-

Assessment Report

-

Public Summary Document

-

Meetings for this Application

PASC

16-17 April 2020

ESC

-

MSAC

-