Enhertu, a treatment for incurable breast cancer, has now received approval for use on the National Health Service in England after a commercial agreement was reached and the cost-effectiveness framework was revised. The agency’s earlier refusal in 2024 had been based on the medication’s price relative to the spending limits that were in place at that time.
The therapy, created by Daiichi Sankyo, works by targeting the HER2 protein, which is present at high levels in roughly one-fifth of breast-cancer cases. It had already been prescribed in Scotland beginning in December 2023, and the new endorsement applies to adult patients whose disease is HER2-low, metastatic or cannot be removed surgically, and who have already received chemotherapy or whose cancer returned within six months after completing adjuvant treatment.
Results from the key DESTINY-Breast04 trial demonstrated that patients receiving Enhertu lived longer on average than those given standard chemotherapy. In that study, the median overall survival reached 22.9 months, whereas the comparator group experienced 16.8 months. In addition, the medicine slowed the time it took for the disease to progress, offering a meaningful delay for those affected.
The agency’s decision followed a United Kingdom-United States pharmaceutical pricing accord that lifted the NHS’s cost-effectiveness ceiling to a range of £25,000–£35,000 per quality-adjusted life year, up from the previous band of £20,000–£30,000. This higher threshold is intended to enable the recommendation of three to five extra medicines or new indications each year.
Months of campaigning by cancer charities and patient groups helped bring the issue to the fore. Breast Cancer Now described the outcome as a “milestone victory,” while also pointing out that thousands of patients in England had been denied access after the 2024 rejection. The organisation urged that Wales and Northern Ireland receive the drug more quickly and called for systemic reforms to avoid similar delays in the future.
Helen Knight, who leads medicines evaluation at the agency, recognised that the approval arrived later than many families had hoped. She emphasized the need to weigh clinical benefits against the finite resources of the NHS, noting that the timing meant some families would not benefit from the new option.
A commercial agreement between the NHS and Daiichi Sankyo settled the earlier concerns about price. The medicine’s rollout in England now mirrors its availability in Scotland, although differences in access persist across the other UK nations.