Enhertu drug approved for NHS use in England
About 1,000 women a year in England with incurable HER2-low breast cancer will get the life-extending drug Enhertu on the NHS following a price deal.
Thousands of women in England with incurable breast cancer will now receive a life-extending drug on the NHS. The National Institute for Health and Care Excellence (Nice) announced the approval of Enhertu for routine use after successful negotiations over its cost.
About 1,000 patients a year with HER2-low advanced breast cancer will be eligible for the treatment. This follows a previous rejection by Nice in July 2024, when the drug was deemed too expensive despite its proven effectiveness.
Clinical trial results
Clinical trials have shown significant benefits for patients. Enhertu almost doubled median progression-free survival compared with standard chemotherapy. The data from these trials is shown in the table below.
| Measurement | Enhertu | Standard Chemotherapy |
|---|---|---|
| Median progression-free survival | 9.9 months | 5.1 months |
| Median overall survival | 23.4 months | 16.8 months |
Median overall survival among users was 23.4 months, a gain of 6.6 months compared to the 16.8 months seen with other treatments.
Campaign and approval process
The approval is hailed as a milestone victory by campaigners. Claire Rowney, chief executive of Breast Cancer Now, called it a "momentous day for thousands of people." She said it would give them "the opportunity to gain precious time with loved ones."
The decision follows two years of campaigning by charities, cancer specialists, and patients. Labour ministers, including former health secretary Wes Streeting, worked behind the scenes to broker a deal. Their efforts were initially hampered by the drugmakers' refusal to lower their price.
A key factor was a change to Nice's funding framework in April. The institute gained the freedom to recommend NHS spending of up to £35,000 per patient per year, an increase from a previous £30,000 maximum. Nice agreed to pay more for Enhertu, though it is unclear if the manufacturers, AstraZeneca and Daiichi Sankyo, reduced their asking price.
Medical and political reaction
Dr Anne Rigg, a consultant medical oncologist and NHS England's national speciality adviser for chemotherapy, welcomed the news. She said it was hugely positive news for women with secondary breast cancer.
Dr Catherine Elliott, Cancer Research UK’s director of research, explained the drug's mechanism. Enhertu is a targeted treatment that delivers chemotherapy directly to cancer cells, she said. She noted the trial results show it can help patients live longer and delay disease progression compared to standard chemotherapy.
Health Secretary Yvette Cooper stated the recommendation means NHS patients will finally benefit from the life-changing treatment. She credited campaigners and charities for their relentless pressure. The drug has been available in Scotland since December 2023 and is provided in 27 European countries. Ministers in Wales and Northern Ireland are likely to follow Nice's recommendation.
