NICE recommends Enhertu for HER2-low advanced breast cancer in England

NICE has recommended Enhertu for adults with HER2-low advanced or metastatic breast cancer whose disease has returned or worsened after chemotherapy, Barts Health NHS Trust reported on September 18, 2026. The recommendation follows a commercial agreement between the companies and the NHS for this patient group, American Pharmaceutical Review reported. MT Newswires, carried by Webull, also framed the decision as dependent on a “commercial solution” plus changes to NICE’s recommendation methods under the U.K.-U.S. Pharmaceutical Pricing Agreement.

A reimbursement reversal that procurement teams can’t ignore

Enhertu (trastuzumab deruxtecan) has stood out in England’s breast cancer coverage decisions. According to American Pharmaceutical Review, NICE said it had not recommended Enhertu before because the price put forward by the companies was not acceptable, and it called Enhertu the only breast-cancer medicine it has been unable to recommend since 2018. Over the same period, NICE issued positive recommendations for 25 other breast-cancer treatments, the report said.

The numbers behind the clinical value case

American Pharmaceutical Review reported that NICE said clinical-trial evidence showed Enhertu can lengthen survival and delay disease progression versus standard chemotherapy in people with HER2-low advanced breast cancer.

Why the 2026 method change matters to pricing and access

According to American Pharmaceutical Review, NICE linked the new recommendation to updates under the U.K.-U.S. Pharmaceutical Pricing Agreement, including cost-effectiveness thresholds that increased in April 2026 and a quality-of-life assessment method published Aug. 27, 2026. MT Newswires also connected the recommendation to those methodological changes.

NICE said the recommendation reflects updates to its methods under the U.K.-U.S. Pharmaceutical Pricing Agreement, including higher cost-effectiveness thresholds that took effect in April 2026 and a new approach to assessing quality of life published Aug. 27, 2026.

Rollout timing and geography: England first, then local obligations

Fierce Pharma reported that NICE said the guidance covers England, and that Wales has issued directions so the NHS there must fund the treatment within 60 days after the final guidance’s publication. The outlet also reported that NICE guidance does not automatically extend to Northern Ireland and that NHS Scotland decisions are handled by a separate group.

What hospital operators will be watching next

Fierce Pharma reported that, before routine NHS coverage, patients could access Enhertu through private care in the U.K., with reported costs as high as £7,500 to £13,000 every three weeks.