NICE Backs Enhertu for HER2-Low Advanced Breast Cancer, Opening NHS Access in England
核心洞察
NICE has recommended Enhertu for routine NHS use in England for adults with HER2 (搜索)-low advanced or metastatic breast cancer (搜索) after prior treatment progression.
The decision follows a UK-US pharmaceutical pricing deal that raised NICE's cost-effectiveness threshold and a new quality-of-life assessment method.
Clinical trials showed Enhertu extended median overall survival to 23.4 months versus 16.8 months with standard chemotherapy, a 6.6-month gain.
The National Institute for Health and Care Excellence (搜索) (NICE) announced on Thursday that it will recommend Enhertu (trastuzumab deruxtecan) for routine use on the National Health Service in England, giving around 1,000 patients a year with HER2 (搜索)-low advanced or metastatic breast cancer (搜索) access to a treatment previously denied to them on cost grounds.
The final draft guidance covers adults whose disease has progressed following prior treatment. Funding will be provided from today under the Cancer Drugs Fund, ahead of a move to routine NHS commissioning within 90 days.
A Reversal After Two Years
NICE had previously rejected Enhertu in July 2024, judging it too expensive to be cost-effective despite its proven effectiveness. The U-turn follows renewed negotiations between NICE, NHS England (搜索) and the drug's two makers, AstraZeneca and Daiichi Sankyo, which produced what NICE called "a commercial solution."
Two methodological changes proved decisive. NICE gained freedom in April to recommend that the NHS spend up to £35,000 a year on a patient's treatment, up from a previous maximum of £30,000 — a change introduced alongside the UK-US trade deal announced last December. NICE also cited a new method for assessing quality of life, the EQ-5D-5L value set, which came into effect in August. In general, treatments that extend how long people live tend to become more cost-effective under the new value set, while those that improve quality of life without extending it tend to become less cost-effective.
It remains unclear whether the drug's two makers reciprocated by reducing the amount they had been seeking.
Survival and Progression Data
Clinical trial evidence showed that Enhertu nearly doubled median progression-free survival compared with standard chemotherapy, from 5.1 months to 9.9 months. Median overall survival among people who used it was 23.4 months, compared with 16.8 months among those not on it — a 6.6-month gain, or roughly seven extra months on average.
Enhertu is an antibody-drug conjugate, described by Cancer Research UK as a targeted treatment that delivers chemotherapy directly to cancer cells. Dr Catherine Elliott, Cancer Research UK's director of research, said trial results show that for people with HER2-low advanced breast cancer (搜索) whose disease has progressed following treatment, it "can help them live longer and delay their cancer from getting worse compared with standard chemotherapy."
Access Across the UK and Europe
Scotland has provided Enhertu for this patient group since December 2023, and it is available in 26 other European countries. Patients with HER2 (搜索)-positive cancers have already been able to receive Enhertu in England. AstraZeneca's UK president, Tom Keith-Roach, said the green light in England brings access to the medicine into line with Scotland and 26 other European countries.
Ministers in Wales and Northern Ireland are likely to implement NICE's recommendation and make the drug available there too, though the guidance does not automatically apply to Northern Ireland.
NICE said it has made 25 other breast-cancer treatments available on the NHS since 2018, but that Enhertu for this group of patients was the only one it had been unable to recommend.
Reaction and Calls for System Reform
Claire Rowney, chief executive of Breast Cancer Now (搜索), called the decision "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." She described it as "this milestone victory" following two years of campaigning by the charity, cancer specialists and women with the disease.
Rowney also pointed to the cost of the delay. "But we can't celebrate this momentous decision without remembering the devastating cost of this delay. Since 2024, when it was first rejected for use, thousands of people have missed out on access to Enhertu and tragically many have died," she said. She called on the government, NICE, NHS England (搜索) and the pharmaceutical industry to work together "to fix this broken system, so that people with incurable metastatic breast cancer (搜索) are not forced to spend precious months and years campaigning for treatments that could give them more time."
Dr Anne Rigg, a consultant medical oncologist and NHS England (搜索)'s national speciality adviser for chemotherapy, said: "This is hugely positive news for women with secondary breast cancer who will now be offered this life-extending treatment on the NHS."
Health secretary Yvette Cooper said Enhertu "can be life-changing" and that the recommendation means NHS patients "will finally be able to benefit from it," crediting campaigners and charities and citing changes to the NICE framework made as part of the UK-US pharmaceutical partnership.
Keith-Roach added that delivering faster, more equitable patient access in future "requires continued strong collaboration across the healthcare system, building on recent changes which improve how the UK values new medicines relative to other countries."
Patient Perspective
Kate Wills, 51, who has HER2 (搜索)-low metastatic breast cancer (搜索) that has spread to her bones and lungs, reacted to the news with tears. "I really can't believe it. I'm so relieved, I'm overjoyed," she said. "It's so hard keeping hope when you have stage four cancer. This gives me enormous hope."
About one in seven of the 60,000 new cases of breast cancer diagnosed every year in the UK are HER2 (搜索)-positive, according to the source materials.