The National Institute for Health and Care Excellence (NICE) has approved the breast cancer drug Enhertu for use by the NHS in England, reversing its rejection of the treatment in July 2024 on cost-effectiveness grounds. NICE gave the green light yesterday evening, and the drug will be available to eligible patients from Thursday.
Enhertu, also known as trastuzumab deruxtecan, can be offered to adult patients in England with HER2-low metastatic or unresectable breast cancer. They must have previously received chemotherapy for metastatic cancer, or have had their cancer return during, or within, 6 months of finishing adjuvant chemotherapy.
Around a thousand women living with incurable metastatic breast cancer are expected to benefit each year. HER2-low breast cancer accounts for roughly half of all breast cancer cases. The treatment is a targeted cancer therapy given as an infusion.
NICE said in a press release on 17 September 2026 that a commercial solution had been agreed for NHS use in England. The NHS has secured a significant discount on Enhertu, which costs more than £100,000 per year. The precise terms of the agreement and the size of the discount have not been made public.
The drug is manufactured by AstraZeneca and Daiichi Sankyo. Its UK list price is £1,455 per 100 mg vial, while its cost in the US is about £10,000 per month.
The decision follows revisions to NICE’s methods for judging cost effectiveness. NICE’s thresholds rose in April from £20,000-£30,000 per healthy year of life to £25,000-£35,000. The changes formed part of the UK/US Pharmaceutical Pricing Agreement struck with President Trump’s administration in April.
NICE had previously concluded that metastatic breast cancer was insufficiently “severe” under its criteria to justify the cost of Enhertu. Its committee also found in 2024 that the manufacturers had not offered a sufficiently low price. The revised framework and the commercial agreement have now resolved the pricing barrier to an England-wide recommendation.
Clinical evidence considered by NICE showed that Enhertu helps people with HER2-low advanced breast cancer live longer. NICE said the treatment can also extend the period before the cancer worsens when compared with standard chemotherapy.
Results from the DESTINY-Breast04 trial found that people receiving trastuzumab deruxtecan had slower disease progression and better overall survival than those receiving “treatment of physician choice”. Findings from the trial were presented at the American Society of Clinical Oncology conference in Chicago.
Enhertu has been available in Scotland since December 2023 and is already accessible in 26 other European nations. The approval closes the gap between England and Scotland for the eligible group, though it remains unknown whether the treatment will also be approved for use in Wales and Northern Ireland.
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