1782.1 – 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

New Medicare Benefits Schedule item (MSAC–PBAC co-dependent submission)

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.

Type: Investigative technology

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.

The following consultation deadlines apply:

• Pre-PASC consultation deadline: Bypassing PASC
• Pre-MSAC consultation deadline: Friday 12 June 2026 11:59 pm AEST

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This application will be considered at the following meetings:

• PASC meeting: Bypassing PASC
• ESC meeting: 11 to 12 June 2026
• MSAC meeting: 30 to 31 July 2026 

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The outcome of this application is pending.

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