1554 - Testing of tumour tissue or blood to detect somatic or germline BRCA1 or BRCA2 gene mutations, in a patient with newly diagnosed, advanced (FIGO stage III-IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy).

Page last updated: 29 October 2018

Application Detail

Status

Open

Description of Medical Service

Germline BRCA1 or BRCA 2 testing to determine eligibility for olaparib maintenance therapy in patients with platinum sensitive, relapsed high grade serous ovarian cancer (HGSOC) was listed on the MBS (Item 73295) and PBS (Items 11034R and 11050N) since 1 February 2017 (refer co-dependent MSAC/PBAC Application 1380). Subsequently, germline gene mutation testing, including BRCA1 and BRCA 2 testing at diagnosis of ovarian cancer in patients at >10% risk of having a pathogenic gene mutation became available on the MBS from November 2017 (Item 73296).
MSAC Application 1538 is currently being evaluated to include tumour tissue testing to detect somatic BRCA1 or BRCA 2 gene mutations to determine eligibility for olaparib maintenance therapy in patients with platinum sensitive, relapsed high grade serous ovarian cancer (HGSOC) and who have tested negative to germline BRCA 1 or BRCA 2 mutations. Application 1538 will be considered at the August 2019 PASC meeting.
This application for blood and tumour tissue testing to detect germline or somatic BRCA1 or BRCA2 gene mutations (referred to as BRCA mutation in this Application), is for newly diagnosed, advanced (FIGO stage III-IV), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, who do not met the eligibility criteria of MBS item 73295 or MBS item 73296, to determine PBS eligibility for olaparib as first-line maintenance therapy.

Description of Medical Condition

Ovarian cancer is the eighth most commonly diagnosed type of cancer for women in Australia, with an estimated 1613 new cases in 2018.1 The 5-year relative survival for women with ovarian cancer in Australia is low at 44.4%.1 The most common and most aggressive histological subtype is high-grade serous ovarian cancer (HGSOC). Patients with fallopian tube or primary peritoneal cancer have similar serous features and are usually treated as for ovarian cancer. HGSOC is difficult to diagnose in its early stages as there are no effective tests for early detection, and symptoms tend to be vague and non-specific (e.g. bloating, fatigue and abdominal pain) so most women are diagnosed when their disease is advanced and widespread. Standard first line treatment of HGSOC is platinum-based chemotherapy.2 Ovarian cancer is a highly chemo-sensitive tumour type, but more than 70% of women with advanced disease who initially respond to first-line chemotherapy will eventually relapse and require re-treatment. BRCA1 and BRCA2 mutational loss of function is a primary driver of ovarian cancer.
1 Australian Institute of Health and Welfare Cancer in Australia 2017.
2 Cancer Australia 2014 First line chemotherapy for the treatment of women with epithelial ovarian cancer.

Reason for Application

Amendment to existing MBS item(s)

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application Form (Word 396 KB)
Application Form (PDF 1095 KB)

Consultation Survey

Consultation Survey (Word 508 KB)
Consultation Survey (PDF 308 KB)

PICO Confirmation

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Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

6-7 December 2018

ESC

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MSAC

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