NICE Reverses Decision: Enhertu Now Available on NHS England for HER2-Low Metastatic Breast Cancer
核心洞察
NICE has reversed its 2024 rejection of Enhertu, allowing doctors in England to prescribe the drug for HER2-low metastatic breast cancer (搜索) from Thursday.
Enhertu offers patients almost seven extra months of life on average, with some living up to three years longer, affecting about 1,000 women annually.
The reversal follows a UK-US trade deal raising medicine spending by 25% and NICE's QALY threshold increase from £30,000 to £35,000.
Patients in England with HER2-low metastatic breast cancer (搜索) can now access Enhertu on the NHS, two years after the National Institute for Health and Care Excellence (NICE) deemed the drug too expensive. From Thursday, doctors in England are able to prescribe it, with Wales expected to follow shortly, though the guidance does not automatically apply to Northern Ireland.
The decision affects about 1,000 women a year with HER2 (搜索)-low breast cancer. Enhertu can give patients almost seven extra months to live on average, with some living up to three years longer. Women in Scotland have had access to the drug on the NHS since 2023, and it is available in 26 other European countries.
Reversal Driven by Pricing Framework Changes
NICE initially rejected Enhertu in 2024, stating it was not good value for money, prompting charities and patients to campaign for wider availability. The BBC understands that Daiichi Sankyo and AstraZeneca, the drug's developers, have not substantially lowered their prices since that first rejection.
Instead, NICE's reversal is largely attributed to a trade deal with the USA, under which the UK government agreed to spend 25% more on medicines. As part of this, NICE increased the upper threshold per Quality-Adjusted Life Year (QALY) from £30,000 to £35,000. At the end of August, NICE also introduced a different, more nuanced way of measuring a patient's quality of life. According to the BBC, these two changes were enough to tip the balance, and patient campaigns for Enhertu and other drugs are thought to have helped.
Health Secretary Yvette Cooper said: "Enhertu can be life-changing, and this recommendation means NHS patients will finally be able to benefit from it. It is a tribute to the campaigners and charities who never stopped pressing for this."
Mixed Emotions Among Patients and Advocates
Charity Breast Cancer Now (搜索) said campaigners' "persistence paid off," but noted that thousands of people missed out on access to Enhertu and many have died. Chief executive Claire Rowney said: "Today we can finally say we did it," while adding that "we can't celebrate this momentous decision without remembering the devastating cost of this delay."
Kate Wills, 51, who has HER2-low metastatic breast cancer (搜索) that has spread to her bones and lungs, described the news with relief. "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." Wills, whose children are in their teens and early 20s, said she had been aiming to stay alive long enough for her youngest to finish school. "Now I've just dared to dream that I might be around to see them fall in love, to get married."
She also reflected on friends who did not receive the drug in time, including Jeannie Ambrose, who was 53 when she spoke to BBC News two years ago and died in January this year. Wills said her friend would be "thrilled but also angry at how long it's taken and how rejected we've felt."
Industry and Regulator Response
Daiichi Sankyo and AstraZeneca welcomed NICE's decision. AstraZeneca called for "strong collaboration" across the healthcare system to ensure "faster, more equitable patient access in the future."
Helen Knight, director of medicines evaluation at NICE, said she is pleased a "commercial solution" means the treatment can be made available on the NHS in England, but added she knows the decision "comes too late for many families." She said: "Our role is important in ensuring NHS spending on new medicines reflects the benefits they deliver while protecting valuable health resources for other essential patient services."
Rowney called for broader reform: "We are calling 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 are not forced to spend precious months and years campaigning for treatments that could give them more time."