Application Detail

Description of Medical Service

Germline BRCA mutation testing to detect the presence of a BRCA1 or BRCA2 gene variant in a patient with locally advanced or metastatic HER2-negative breast cancer.

Description of Medical Condition

In Australia, breast cancer is the most common cancer affecting women. A personal history of breast cancer or family history are contributing risk factors with approximately 5 to 10% of breast cancers due to a strong family history or genetic mutation, such as in BRCA1 or BRCA2 gene. Breast cancer is classified as hormone receptor (HR)-positive if the cancer cells have receptors for the hormones estrogen and progesterone, which suggests the cancer cells receive signals from these hormones that promote their growth. Human epidermal growth factor receptor 2 (HER2) -negative breast cancers have cells that contain little to no HER-2 protein, so they tend to grow more slowly and have a better outlook than HER-2-positive cancers. A HER-2-negative diagnosis means that the cancer will not benefit from therapies that target the HER-2 protein. Testing for germline BRCA mutation informs treatment choices and outcomes.

Reason for Application

MSAC-PBAC co-dependent submission

Medical Service Type

Investigative technology

Previous Application Number/s

1507

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 168 KB)
Application Summary (Word 31 KB)
1507 Application Form (PDF 494 KB)
1507 Application Form (Word 153 KB)

Consultation Survey

Consultation Survey (PDF 182 KB)
Consultation Survey (Word 33 KB)

PASC Consultation
Expedited - Bypassing PASC

MSAC Consultation
MSAC consultation closed Friday, 14 June 2024.

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

1507 Ratified PASC Outcome (PDF 167 KB)
1507 Ratified PASC Outcome (Word 85 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 864 KB)
Public Summary Document (Word 301 KB)

Meetings for this Application

PASC

Bypassing PASC

ESC

Bypassing ESC

MSAC

1-2 August 2024