Enhertu Approved for NHS Use in England After Price Deal
About 1,000 women a year in England with HER2-low advanced breast cancer became eligible to receive trastuzumab deruxtecan (Enhertu) on the NHS from 17 September 2026. The Guardian On that date, the National Institute for Health and Care Excellence (NICE), which advises the NHS in England on which treatments to fund routinely, recommended Enhertu for routine use.
NICE had rejected Enhertu in July 2024. It accepted that the drug worked but judged it too expensive for the NHS. The reversal followed fresh negotiations between NICE, NHS England, and the drug's two makers, the pharmaceutical firms AstraZeneca and Daiichi Sankyo. Those talks produced a "commercial solution," a confidential price arrangement that made the drug available in England for the first time.
The recommendation is set out in NICE technology appraisal TA992. It covers trastuzumab deruxtecan for adult patients with HER2-low breast cancer that is metastatic, meaning it has spread, or unresectable, meaning it cannot be removed by surgery, after chemotherapy. NICE In parliamentary proceedings, Enhertu is described as the first licensed treatment for HER2-low metastatic or unresectable breast cancer. It is approved as a second-line treatment, meaning treatment given after initial chemotherapy has been tried, for HER2-positive and HER2-low breast cancer.
The trial results behind the decision measured two things. Median progression-free survival, the time half the patients lived without their cancer worsening, was 9.9 months with Enhertu compared with 5.1 months with standard chemotherapy. Median overall survival, the time half the patients lived in total, was 23.4 months with Enhertu compared with 16.8 months without it, a gain of 6.6 months. Nearly three years passed between rejection and approval.
Scotland acted earlier. Enhertu has been available there since December 2023, and Scotland is one of 27 European countries where patients can receive it.
In April, NICE was given room to recommend NHS spending of up to £35,000 per patient per year, up from a previous limit of £30,000. On 8 July 2026, AstraZeneca and Daiichi Sankyo were reported to be nearing a pricing agreement with the UK pricing regulator for the treatment. Reuters Each year about 60,000 new cases of breast cancer are diagnosed in the UK, and about one in seven are HER2-positive.
The broader context here is about cost rules, not new medical evidence. The clinical benefit cited in 2026 is the same benefit judged too costly in 2024. A higher spending ceiling plus a confidential commercial deal changed the calculation, without changing the eligible group in TA992. For drug makers and payers, it points to private pricing deals as the path to routine NHS funding for costly cancer drugs. Ministers in Wales and Northern Ireland are likely to adopt NICE's recommendation, which would bring access into line across Great Britain.
