1766.1 – Genetic testing to detect AKT-pathway alterations in patients with hormone receptor-positive, HER2-negative advanced breast cancer

New Medicare Benefits Schedule item.

Genetic testing, by Next Generation Sequencing (NGS), of tumour tissue from patients with specific types of breast cancer (see below) who have had recurrence or progression of disease on or after a type of treatment called endocrine therapy. The testing is to determine whether there have been alterations to the AKT Pathway in the tumour, which could change how the tumour behaves and could be the reason that the tumour was resistant to endocrine treatment. The results of the test may be used to determine whether the patient will be eligible for treatment with PBS subsidised capivasertib.

Type: Investigative 

The medical service is proposed for patients with breast cancer that has been categorised as Hormone Receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative, and who have recurrent, unresectable, or metastatic breast cancer who have relapsed on endocrine therapy.

One of the reasons tumours might be resistant to endocrine therapy is the activation of the AKT Pathway, a signalling pathway causing tumour growth, and relapse of disease.

The genes involved are PIK3CA, AKT, and PTEN. AKT Pathways activation includes:

• Activating mutations in PIK3CA or AKT1 which can inappropriately activate the pathway.
• Loss of function mutations in PTEN which can lead to unregulated signalling

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The following consultation deadlines apply:

• Pre-PASC consultation deadline: Bypassing PASC
• Pre-MSAC consultation deadline: Friday 12 February 2027 11:59 pm AEDT

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This application will be considered at the following meetings:

• PASC meeting: Bypassing PASC
• ESC meeting: 11 to 12 February 2027
• MSAC meeting: 1 to 2 April 2027

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The outcome of this application is pending.

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