London – The National Institute for Health and Care Excellence (NICE) announced on Thursday that it has approved the use of AstraZeneca and Daiichi Sankyo’s breast‑cancer drug Enhertu for patients in England with HER2‑low metastatic disease. The decision removes a major barrier that had previously prevented the drug’s reimbursement on cost‑effectiveness grounds.
What the approval means for patients
Enhertu, priced at £1,455 per 100 mg vial in the United Kingdom, delivers chemotherapy directly to tumours that express the HER2 protein while sparing healthy tissue. NICE’s recommendation will allow the drug to be reimbursed for roughly 1,000 women each year who meet the HER2‑low criteria, expanding treatment options beyond the limited availability in Scotland since 2023.
Clinical evidence behind the decision
The agency based its endorsement on data from a 2022 clinical trial that showed Enhertu could extend overall survival by about six months for a subset of patients with late‑stage disease. The trial results, combined with recent changes to Britain’s cost‑effectiveness methodology, convinced NICE that the therapy now offers sufficient value for the NHS.
Industry response
Laura McMullin, UK general manager for Daiichi Sankyo, welcomed the ruling, stating, “NICE’s decision to revisit the way it values late‑stage cancer medicines is a positive initial step which enabled this outcome.” The companies said they will now seek similar approvals from health authorities in Wales and Northern Ireland.
Broader context
The approval follows a broader shift in the UK’s approach to pricing high‑cost oncology drugs, including a recent U.S.–U.K. agreement aimed at gradually aligning British drug prices with those in the United States. While the list price remains high, the NHS’s ability to reimburse the drug should improve access for eligible patients across England.
What’s next
Healthcare providers will begin integrating Enhertu into treatment pathways for HER2‑low metastatic breast cancer, and patients are expected to receive the medication through standard NHS channels. The move also signals a potential pathway for other innovative, targeted therapies to gain NHS coverage as cost‑effectiveness frameworks evolve.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
