1782 – Genetic testing to detect estrogen receptor 1 (ESR1) variants in patients with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, to determine eligibility for treatment with PBS subsidised elacestrant

Page last updated: 16 October 2024

Application Detail

Description of Medical Service

The test is to detect the presence of estrogen receptor 1 gene (ESR1) mutations in tumour tissue using circulating tumour DNA (ctDNA) extracted from blood plasma. This test is for patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer (a/mBC), who have disease progression following at least one line of endocrine therapy, including a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). The test is used to determine eligibility for a potential new PBS subsidised treatment, elacestrant.

Description of Medical Condition

Breast cancer is the abnormal growth of cells lining the breast lobules (milk-producing glands) or breast ducts (passages that drain milk from the lobules towards the nipple), or in the fatty and fibrous tissue of the breast. Advanced breast cancer comprises both locally advanced (inoperable) and metastatic disease (a/mBC). Some patients present with a/mBC disease at diagnosis, and many with early breast cancer eventually progress to a/mBC. ER and HER2 describe the receptor subtype of breast cancer which can provide useful information on the patient’s prognosis and how the cancer cells may respond to treatment.

Reason for Application

New MBS item (MSAC-PBAC co-dependent submission)

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 149 KB)
Application Summary (Word 28 KB)

Application PICO Set (PDF 489 KB)
Application PICO Set (Word 236 KB)

Consultation Survey

Consultation Survey

PASC Consultation
PASC consultation closed Friday 12 July 2024. Any consultation received after this date will automatically be included in the MSAC consultation for this application.

MSAC Consultation
MSAC consultation closes Friday 14 February 2025

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation proves please refer to MSAC Consultation Process

PICO Confirmation

PICO Confirmation (PDF 823 KB)
PICO Confirmation (Word 407 KB)

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

15-16 August 2024

ESC

13-14 February 2025

MSAC

3-4 April 2025