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After initially rejecting it as "not cost effective" in 2024, NICE has approved Enhertu (trastuzumab deruxtecan) for around 1,000 women with HER2-low advanced breast cancer on the NHS in England. The decision follows a new commercial deal between the drug's makers and the NHS. Patients and advocates are celebrating — though many note the approval came too late for some who died waiting.
Better late than never — but the wait had a cost. The UK's health spending watchdog, NICE, has reversed its 2024 decision and approved Enhertu (trastuzumab deruxtecan, made by Daiichi Sankyo and AstraZeneca) for NHS use in England, effective immediately. The drug is now available to approximately 1,000 women with HER2-low advanced (metastatic) breast cancer — the first licensed targeted therapy for this specific patient group. The reversal came after a new commercial deal was struck, aided by updated NICE cost-effectiveness thresholds and revised quality-of-life assessment methods tied to the UK/US Pharmaceutical Pricing Agreement.
The news has been met with an outpouring of relief from patients and advocates, though Breast Cancer Now noted that "thousands of people have missed out" and many have tragically died since the drug was first rejected. Enhertu has been available in Scotland for over two years and across 26 other European countries.
By the Numbers:
Why it matters: This approval closes a significant access gap for English patients with an aggressive, incurable form of breast cancer. For oncologists and policymakers, it also signals how updated NICE methodologies and commercial negotiations can unlock previously rejected therapies — a precedent that could shape future drug access decisions across the NHS.