Enhertu approved for NHS use in England for breast cancer patients

AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo announced that their breast cancer treatment Enhertu has received approval for use in England's National Health Service, following a recommendation by the National Institute for Health and Care Excellence (NICE).

The drug will be available for NHS patients with HER2-low metastatic breast cancer, a condition where tumors express lower levels of the HER2 protein that contributes to tumor growth. Approximately 1,000 women per year are expected to be eligible for the treatment. Enhertu's list price in the UK is £1,455 ($1,950) per 100 mg vial, though the companies did not disclose the terms of the agreement with NICE.

Enhertu had previously been rejected for NHS funding in England on cost-effectiveness grounds. The drug has been available in Scotland since 2023. The two companies said they will now seek approval from health bodies in Wales and Northern Ireland.

NICE's recommendation was based on 2022 trial data showing the drug extended survival in some patients by approximately six months. The decision also follows changes to Britain's cost-effectiveness methodology and a US-UK agreement aimed at gradually aligning British drug prices closer to US levels.

Enhertu delivers chemotherapy directly to tumors identified by the HER2 marker while limiting effects on healthy cells. It has been approved in several countries for certain breast, gastric, and lung cancers.

"NICE's decision to revisit the way it values late-stage cancer medicines is a positive initial step which enabled this outcome," said Laura McMullin, UK general manager at Daiichi Sankyo.

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