England’s National Institute for Health and Care Excellence has recommended Enhertu for routine National Health Service use in adults with HER2-low advanced or metastatic breast cancer whose disease has progressed following treatment.
NICE said about 1,000 people could be eligible for treatment. Enhertu, or trastuzumab deruxtecan, is made by Daiichi Sankyo and AstraZeneca.
The recommendation appears in NICE’s final draft guidance. The decision followed a commercial agreement between the companies and the NHS on use of the treatment for this patient group.
NICE previously had not recommended Enhertu at the price proposed by the companies. The agency said Enhertu was the only breast-cancer medicine it had been unable to recommend since 2018. During that period, NICE said it made positive recommendations for 25 other breast-cancer treatments that became available through the NHS.
The new recommendation follows changes to NICE’s methods under the U.K.-U.S. Pharmaceutical Pricing Agreement. The changes include higher cost-effectiveness thresholds that took effect in April and a new method for assessing quality of life published Aug. 27, 2026.
NICE said clinical-trial evidence showed that Enhertu can extend survival and increase the time before disease progression compared with standard chemotherapy in people with HER2-low advanced breast cancer.
The recommendation was made through NICE’s review process, which permits guidance to be reconsidered when new evidence or commercial arrangements become available.
Helen Knight, NICE’s director of medicines evaluation, said the commercial agreement and revisions to cost-effectiveness methods enabled the recommendation.
Anne Rigg, a consultant medical oncologist and NHS England’s national specialty adviser for chemotherapy, said eligible patients can access Enhertu from the date of the announcement.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!