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NHS to Offer Enhertu for HER2-low Advanced Breast Cancer in England

By Drooid · · How we work

Core Approval and Access

The National Institute for Health and Care Excellence (NICE) has recommended that the NHS provide the targeted therapy Enhertu to roughly 1,000 women a year with HER2-low advanced breast cancer. The decision follows a commercial agreement that lowered the drug’s price enough for routine use. Starting later this week, eligible patients in England will receive the treatment, joining Scotland—where Enhertu has been available since December 2023—and the other 26 European nations already offering it.

Background and Clinical Evidence

HER2-low disease accounts for about one-in-seven of the 60,000 new breast-cancer cases diagnosed annually in the UK. Clinical trials demonstrated that Enhertu nearly doubled median progression-free survival, extending it from 5.1 months with standard chemotherapy to 9.9 months. Median overall survival improved by 6.6 months, from 16.8 months to 23.4 months for patients receiving the drug. NICE had previously rejected Enhertu in July 2024, deeming it too costly despite the efficacy data.

Official Statements & Responses

Claire Rowney, chief executive of Breast Cancer Now, hailed the decision as a “milestone victory” after two years of campaigning by charities, specialists, and patients. Dr Anne Rigg, a consultant medical oncologist and NHS England’s national speciality adviser for chemotherapy, called the move “hugely positive news” for women with secondary breast cancer. Cancer Research UK’s director of research, Dr Catherine Elliott, emphasized that Enhertu delivers chemotherapy directly to cancer cells, allowing patients to live longer and delay disease progression. Health Secretary Yvette Cooper described the recommendation as “life-changing” and credited recent changes to the NICE framework under the UK-US pharmaceutical partnership.

Data and Expected Impact

  • Eligibility: ~1,000 English patients per year with HER2-low advanced breast cancer.
  • Survival Benefit: Median overall survival gain of 6.6 months versus standard chemotherapy.
  • Cost Threshold: NICE’s April policy shift raised the permissible spend per patient from £30,000 to £35,000 annually, enabling the higher-priced drug to be funded.

Verbatim Quotes

  • “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” — Claire Rowney, the chief executive of Breast Cancer Now
  • “This is hugely positive news for women with secondary breast cancer who will now be offered this life-extending treatment on the NHS,” — Dr Anne Rigg, a consultant medical oncologist

The approval expands access to a therapy that has already improved outcomes in Scotland and across Europe, offering thousands of English women additional time with their families while the NHS navigates the financial implications of high-cost oncology treatments.