Key facts
- Approximately 1,000 women a year in England with HER2-low advanced breast cancer will be eligible for Enhertu.
- Enhertu nearly doubled median progression-free survival in clinical trials from 5.1 to 9.9 months.
- Median overall survival with Enhertu was 23.4 months, compared to 16.8 months without it.
- Nice had previously rejected Enhertu in July 2024 due to its cost.
- The UK-US pharmaceutical partnership influenced changes to the Nice framework.
- Enhertu is a targeted treatment that delivers chemotherapy directly to cancer cells.
Thousands of women in England with incurable HER2-low advanced breast cancer will soon have access to the life-extending drug Enhertu on the National Health Service (NHS). The breakthrough comes after successful price negotiations between ministers, NHS England, and the drug's manufacturers, AstraZeneca and Daiichi Sankyo. The National Institute for Health and Care Excellence (Nice), which advises the NHS on treatment value, announced on Thursday that approximately 1,000 patients annually will be eligible for the drug from Thursday.
Nice had previously rejected Enhertu in July 2024, deeming it too expensive despite its proven effectiveness. The drug's availability in England follows two years of campaigning by charities, cancer specialists, and patients. Enhertu has been available in Scotland since December 2023, and is provided in 27 other European countries.
Recent negotiations between Nice, NHS England, and the pharmaceutical firms resulted in a "commercial solution" that allows for Enhertu's routine use. A change in Nice's guidelines in April, allowing up to £35,000 per patient per year for treatment (up from £30,000), proved crucial in reaching this agreement. It remains unclear if the drugmakers reduced their asking price.
Clinical trials indicate that Enhertu significantly improves outcomes for patients with HER2-low advanced breast cancer whose disease has progressed. It nearly doubled median progression-free survival compared to standard chemotherapy, extending it from 5.1 months to 9.9 months. Median overall survival also saw a substantial increase, rising from 16.8 months to 23.4 months.
Health officials and patient advocates have welcomed the decision. Dr. Anne Rigg, a consultant medical oncologist and NHS England's national specialty adviser for chemotherapy, described the news as "hugely positive." Dr. Catherine Elliott, Cancer Research UK's director of research, highlighted Enhertu as a targeted treatment that delivers chemotherapy directly to cancer cells, helping patients live longer and delaying disease progression. Ministers in Wales and Northern Ireland are expected to follow suit. Health Secretary Yvette Cooper stated that the recommendation means NHS patients will finally benefit from the life-changing treatment, crediting campaigners and government changes to the Nice framework.