Applications

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

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Assessment
  • Type New application
  • Pre-PASC consultation Closed
  • Pre-MSAC consultation Open
  • Outcome Pending

Application details

Applicant

A. Menarini Australia Pty Limited

Reason for application

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

Service or technology in this application

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

Medical condition this application addresses

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.

Consultation survey and deadlines

The following consultation deadlines apply:

  • Pre-PASC consultation deadline: Closed
  • Pre-MSAC consultation deadline: Friday 14 February 2025 11:59 pm AEDT

For other ways to provide input, see how to have your say.

We welcome input from everyone. We are especially keen to hear from those with lived experience of the health condition, service or technology the applications are addressing.

Find out more about consultation.

Meetings to consider this application

This application will be considered at the following meetings:

  • PASC meeting: 15–16 August 2024
  • ESC meeting: 13–14 February 2025
  • MSAC meeting: 3–4 April 2025

Find out more about our meetings.

Outcome details

The outcome of this application is pending.

More information

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