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Agency for Care Effectiveness
Drug guidance

Pembrolizumab for treating high-risk early-stage triple-negative breast cancer

5 October 2026

Condition

Breast

Cancer

Published on 02 Jan 2024
Last Updated on 05 Oct 2026

Guidance Recommendations

The Ministry of Health’s Drug Advisory Committee has recommended:

  • Pembrolizumab 100 mg/4 mL solution for infusion for neoadjuvant and adjuvant treatment of previously untreated high-risk, early-stage triple-negative breast cancer.

Funding status

Pembrolizumab 100 mg/4 mL solution for infusion is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication from 1 December 2026.

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

Pembrolizumab for treating high-risk early-stage triple-negative breast cancer (Published 5 Oct 2026) [PDF, 457.24 KB] (opens in new tab)

Plain English Summary

Breast cancer occurs when abnormal cells in the breast grow and divide uncontrollably. When cancer is found only in the breast or nearby lymph nodes and has not spread to other parts of the body, this is known as early breast cancer. Some breast cancer cells have proteins (receptors) on their surface that help them grow. These include oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2). If cancer cells do not have high levels of these three proteins, this is known as triple-negative breast cancer (TNBC), which can grow and spread more quickly than some other types of breast cancer.

Treatment for early breast cancer usually includes surgery. Some patients may have drug treatments such as chemotherapy before surgery to shrink the cancer and make it easier to remove. This is called neoadjuvant treatment. After surgery, patients may need other treatments to destroy any remaining cancer cells and reduce the risk of the cancer coming back. This is known as adjuvant treatment.

Pembrolizumab belongs to a group of medicines called PD-1/PD-L1 checkpoint inhibitors, which are a type of immunotherapy. It helps the body’s immune system find and attack cancer cells. For high-risk early-stage TNBC, pembrolizumab is given as a slow drip into a vein (intravenously) in combination with chemotherapy before surgery. After surgery, pembrolizumab is given on its own.

Pembrolizumab was recommended for government funding because it was considered an acceptable use of healthcare resources. It is included in the Medication Assistance Fund (MAF) (opens in new tab), with its cost subsidised by 40% to 75% for eligible patients. It can also be claimed under MediShield Life. The subsidy class and MediShield Life claim limits are available here (opens in new tab).