1766 – Genetic testing to detect AKT-pathway alterations in patients with hormone receptor-positive, HER2-negative advanced breast cancer, to determine eligibility for PBS subsidised capivasertib treatment

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

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 will determine whether the patient will be eligible for treatment with PBS subsidised capivasertib.

Type: Investigative technology

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

• PASC consultation: Closed
• MSAC consultation: Closed Friday 11 October 2024

• PASC meeting: 18–19 April 2024
• ESC meeting: 10–11 October 2024
• MSAC meeting: 28–29 November 2024