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Women with incurable breast cancer can now receive Enhertu (trastuzumab deruxtecan, Daiichi Sankyo) on the NHS in England, under final draft guidance from the National Institute for Health and Care Excellence (NICE).
The antibody drug conjugate was initially rejected for NHS use in England in 2024, with NICE saying at the time that “the most likely cost-effectiveness estimate are above the upper end of the range NICE considers an acceptable use of NHS resources”. Enhertu has been available in Scotland since December 2023.
In a press release issued on 17 September 2026, NICE said a commercial solution has been agreed for NHS use in England, following changes made to NICE evaluation methods as part of the UK/US Pharmaceutical Pricing Agreement.
This agreement, announced on 1 December 2025, led to increased government investment in medicines and means the NHS can spend £25,000 to £35,000 per quality-adjusted life year (QALY), compared with the previous thresholds of between £20,000 and £30,000. In a statement issued the same day, NICE said that increasing the thresholds would “allow us to recommend an additional 3-5 new medicines or indications per year”.
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 (human epidermal growth factor receptor 2) protein, which is found in higher-than-normal levels in about 1 in 5 breast cancers.
Announcing the approval on 17 September 2026, NICE said: “Clinical trial evidence showed that Enhertu helps people with HER2-low advanced breast cancer live longer, and can also increase the time before their cancer gets worse compared with standard chemotherapy.”
Evidence from the DESTINY-Breast04 trial showed that people taking trastuzumab deruxtecan had delayed disease progression and improved overall survival, compared with ‘treatment of physician choice’ (TPC). Median survival overall was 22.9 months for people taking the drug, compared with 16.8 months for TPC.
Helen Knight, director of medicines evaluation at NICE, said: “I’m pleased that a commercial solution, alongside recent changes to NICE’s cost-effectiveness thresholds and the use of new methods for assessing quality-of-life, has meant this treatment can now be provided on the NHS.
“However, we know this decision comes too late for many families and our thoughts are with them today. Our role is important in ensuring NHS spending on new medicines reflects the benefits they deliver while protecting valuable health resources for other essential patient services.”
Claire Rowney, chief executive of the charity Breast Cancer Now, said: “This milestone victory belongs to every person who refused to accept that access to a life-extending treatment was out of reach. For people in England, the wait for Enhertu is finally over. We must now also see Wales and Northern Ireland make Enhertu available for use on the NHS for those who need more time to live.”
Rowney added: “Since 2024 when it was first rejected for use, thousands of people have missed out on access to Enhertu and tragically many have died”.
She said: “We are calling on the government, NICE, NHS England and the pharmaceutical industry to work together to fix this 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.”
