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Agency for Care Effectiveness
Drug guidance

Capivasertib in combination with fulvestrant for HR-positive, HER2-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alteration

6 October 2026

Condition

Breast

Cancer

-

Published on 06 Feb 2026
Last Updated on 06 Oct 2026

Guidance Recommendations

The Ministry of Health’s Drug Advisory Committee has not recommended capivasertib in combination with fulvestrant for inclusion on the MOH List of Subsidised Drugs for HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alteration following disease recurrence or progression on or after an endocrine-based regimen with or without a cyclin-dependant kinase 4/6 inhibitor (CDK4/6i). The decision was based on the uncertain extent of clinical benefit compared with fulvestrant monotherapy, unfavourable cost effectiveness compared with alternative treatments, and the unacceptable price-volume agreement proposed by the company.

Clinical indication, subsidy class and MediShield Life claims eligibility for capivasertib are provided in the Annex.

Capivasertib in combination with fulvestrant for HR-positive, HER2-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alteration (Updated 05 Oct 2026) [PDF, 292.76 KB] (opens in new tab)

Plain English Summary

Breast cancer occurs when abnormal cells in the breast grow and divide uncontrollably. If the cancer spreads to nearby areas, this is known as locally advanced breast cancer. If it spreads to other parts of the body, this is known as advanced or metastatic breast cancer.

Breast cancers can be grouped based on certain proteins (receptors) on cancer cells and changes in genes. Some breast cancers have hormone receptors that can help the cancer grow. HR (hormone receptor)-positive breast cancer has receptors for oestrogen or progesterone. HER2 (human epidermal growth factor receptor 2)-negative breast cancer has low levels of the HER2 protein. PIK3CA, AKT1 and PTEN are genes that help control cell growth. Changes (mutations) in these genes can cause cancer cells to grow and divide uncontrollably.

Capivasertib belongs to a group of targeted medicines called AKT inhibitors. It works by blocking AKT proteins on cancer cells, preventing cells from dividing uncontrollably and stopping the cancer from growing. It is taken orally, in combination with a hormone therapy called fulvestrant.

Capivasertib, in combination with fulvestrant, was not recommended for government subsidy because its benefits do not justify its cost. It can be claimed under MediShield Life, and the claim limits are available here (opens in new tab).

There are different types of treatments available for HR-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration. Your doctor can advise whether capivasertib in combination with fulvestrant, or other treatments may be suitable for you.