ENGLAND — The National Institute for Health and Care Excellence (NICE) recommended Enhertu for routine use on the NHS in England on September 17, 2026. Approximately 1,000 women per year in England with HER2-low advanced breast cancer will be eligible to receive Enhertu through the NHS.

Clinical trials showed Enhertu increased median progression-free survival from 5.1 months to 9.9 months compared to standard chemotherapy. The data also indicated that median overall survival for patients using Enhertu was 23.4 months, compared to 16.8 months for those not using it.

Health Secretary Yvette Cooper stated that Enhertu can be life-changing and that the recommendation means NHS patients will finally be able to benefit from it. She added that it is a tribute to the campaigners and charities who never stopped pressing for this. Claire Rowney, chief executive of Breast Cancer Now, stated that they can finally say they did it. Rowney said that this is a momentous day for thousands of people who will now have access to a drug that will give them the opportunity to gain precious time with loved ones. Helen Knight, director of medicines evaluation at NICE, stated she is pleased a commercial solution means the treatment can be made available on the NHS in England. Knight stated she knows the decision "comes too late for many families." Jeannie Ambrose, a campaigner for Enhertu access, died in January 2026.

Patients with HER2-positive breast cancer have been able to access Enhertu in England prior to this decision. Enhertu has been available on the NHS in Scotland since December 2023. The drug is funded in 26 other European countries.

Wales is expected to follow England's guidance on Enhertu shortly. The guidance for Enhertu does not automatically apply to Northern Ireland.

Why It Matters

The approval provides routine NHS funding for a treatment that clinical data shows extends survival for women with HER2-low advanced breast cancer. The reversal of the 2024 rejection follows a change in the cost-effectiveness threshold established by the U.S.-U.K. drug pricing agreement. This policy shift allows NICE to approve treatments with a higher cost per Quality-Adjusted Life Year, directly impacting access to newer therapies within the English health system.

The decision affects approximately 1,000 women annually in England who meet the specific biological criteria for the drug. While the treatment is now available in England, the guidance does not automatically extend to Northern Ireland, though Wales is expected to adopt similar measures. The timeline of events spans from the initial availability in Scotland in 2023 to the final recommendation in 2026, involving clinical evaluation, pricing negotiations, and advocacy efforts.

Timeline

NICE previously rejected Enhertu in July 2024, stating it was not cost-effective. The decision to cover Enhertu follows a U.S.-U.K. drug pricing agreement reached in late 2025.

Under the U.S.-U.K. agreement, NICE raised the cost-effectiveness threshold for NHS treatments from £30,000 to £35,000 per Quality-Adjusted Life Year (QALY). NICE introduced a new method for measuring patient quality of life in August 2026. Claire Rowney stated that they are calling on the government, NICE, NHS England and the pharmaceutical industry to work together to fix the 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.

What's New

Dr Anne Rigg, NHS England's national speciality adviser for chemotherapy, stated that this is hugely positive news for women with secondary breast cancer who will now be offered this life-extending treatment on the NHS. A 2026 parliamentary written answer confirmed that NICE, NHS England, and drug manufacturers resumed discussions to secure a commercial agreement for Enhertu after the April 2026 revision of NICE's cost-effectiveness thresholds. Dr Catherine Elliott stated that clinical trial results show that, for people with HER2-low advanced breast cancer whose disease has progressed following treatment, it can help them live longer and delay their cancer from getting worse compared with standard chemotherapy. Dr Catherine Elliott, Cancer Research UK's director of research, stated that "Enhertu is a targeted treatment that delivers chemotherapy directly to cancer cells."

How Sources Differ

Regarding breast cancer, Dr Anne Rigg, NHS England's national speciality adviser for chemotherapy, stated that this is hugely positive news for women with secondary breast cancer who will now be offered this life-extending treatment on the NHS. Clinical trials found that women with breast cancer who took Enhertu survived for around two years, compared with 17.5 months for those who had chemotherapy. Regarding breast cancer, Approximately 1,000 women per year in England with HER2-low advanced breast cancer will be eligible to receive Enhertu through the NHS. Enhertu is the first licensed targeted treatment for patients with HER2-low breast cancer that cannot be removed surgically or has spread to other parts of the body. Regarding breast cancer, Enhertu is indicated for women with metastatic breast cancer whose tumors have low levels of the protein HER2.