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Agency for Care Effectiveness
Drug guidance

Inavolisib in combination with palbociclib and fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer

5 October 2026

Condition

Breast

Cancer

-

Published on 06 Feb 2026
Last Updated on 05 Oct 2026

Guidance Recommendations

The Ministry of Health’s Drug Advisory Committee has not recommended inavolisib, in combination with palbociclib and fulvestrant, for inclusion on the MOH List of Subsidised Drugs for PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine therapy. The decision was based on the unfavourable cost effectiveness compared with palbociclib plus fulvestrant at the proposed price, and the unacceptable price-volume agreement proposed by the company.

Clinical indication, subsidy class and MediShield Life claim limit for inavolisib are provided in the Annex.

Inavolisib in combination with palbociclib and fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer (Updated 05 Oct 2026) [PDF, 341.89 KB] (opens in new tab)

Plain English Summary

Breast cancer develops 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 is a gene that helps control how cells grow and divide. Changes (mutations) in this gene can cause cancer cells to grow and divide uncontrollably.

Inavolisib belongs to a group of targeted medicines called PI3K inhibitors. It blocks and breaks down the mutated PI3K protein in cancer cells, helping to slow or stop cancer growth. It is taken orally, in combination with other breast cancer drugs called palbociclib and fulvestrant.

Inavolisib, in combination with palbociclib and 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 PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer. Your doctor can advise whether inavolisib in combination with palbociclib and fulvestrant, or other treatments may be suitable for you.