Women with incurable breast cancer in England can now receive Enhertu on the NHS, following final draft guidance from the National Institute for Health and Care Excellence (NICE). The antibody drug conjugate, also known as trastuzumab deruxtecan, is made by Daiichi Sankyo.
In 2024, NICE declined to approve Enhertu for NHS prescription in England due to financial concerns, though Scotland began offering it to patients as of December 2023.
Commercial Solution Agreed
A new funding arrangement has been established for England’s NHS, following adjustments to NICE’s assessment criteria under the UK/US Pharmaceutical Pricing Agreement. This deal, revealed on December 1, 2025, expanded government funding for medications.
The NHS can now spend £25,000 to £35,000 per quality-adjusted life year (QALY), compared with the previous thresholds of between £20,000 and £30,000. NICE said that increasing the thresholds would allow them to recommend an additional 3-5 new medicines or indications per year.
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Clinical Trial Evidence
Enhertu can be offered to adult patients in England with HER2-low metastatic or unresectable breast cancer, who have had prior chemotherapy for metastatic cancer, or whose cancer recurred during, or within, 6 months of completing adjuvant chemotherapy. The drug targets the HER2 protein, which is found in higher-than-normal levels in about 1 in 5 breast cancers.
Trial results from DESTINY-Breast04 demonstrated that Enhertu extended survival and delayed cancer progression compared to standard chemotherapy. Patients on the drug lived a median of 22.9 months, versus 16.8 months for those receiving alternative treatments.
Helen Knight, NICE’s medicines evaluation director, stated that the new commercial deal and revised cost benchmarks now permit NHS coverage of Enhertu. She noted, however, that the approval arrives too late for many affected families.
The charity Breast Cancer Now welcomed the decision, with chief executive Claire Rowney saying that the wait for Enhertu is finally over for people in England. She called on the government, NICE, NHS England, and the pharmaceutical industry to work together to fix the broken system, so that people with incurable metastatic breast cancer are not forced to spend precious months and years campaigning for treatments that could give them more time.