Thousands of women in England with incurable breast cancer will get access to a life-extending drug on the NHS after negotiations over its cost proved successful. About 1,000 women a year with HER2-low advanced breast cancer will be able to obtain Enhertu from Thursday after ministers and the drug’s makers struck a deal on its price. Clinical trials have shown that Enhertu almost doubled median progression-free survival compared with normal 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.

The National Institute for Health and Care Excellence (Nice) announced on Thursday that about 1,000 patients a year in England will be eligible to receive the treatment from the NHS after it recommended it for routine use. Nice had previously rejected Enhertu in July 2024 as too expensive to justify, despite its proven effectiveness. The drug has been available since December 2023 in Scotland, which is one of 27 European countries that provide it to patients. Labour ministers, including ex-health secretary Wes Streeting, have been working behind the scenes for some time to add England to that list by brokering a deal on cost. Their efforts were hampered by the drugmakers’ refusal to lower their price.

Nice’s U-turn follows recent renewed negotiations between it, NHS England and Enhertu’s two makers, the pharmaceutical firms AstraZeneca and Daiichi Sankyo. They resulted in what Nice called “a commercial solution” that means the drug is now available in England for the first time. The freedom that Nice gained in April to recommend that the NHS can spend up to £35,000 a year on a patient’s treatment, up from a previous maximum of £30,000, proved crucial. It has agreed to pay more for Enhertu than it was previously prepared to do. But it is unclear if the drug’s two makers reciprocated by reducing the amount they had been seeking.

Ministers in Wales and Northern Ireland are likely to implement Nice’s recommendation and make it available there too. Yvette Cooper, the health secretary, 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, and it follows the changes this government has made to the Nice framework as part of the UK-US pharmaceutical partnership so more people can benefit from cutting-edge treatments.”

The BBC understands that the drug companies Daiichi Sankyo and AstraZeneca have not substantially lowered their prices since the drug was first rejected. The reason NICE has reversed its decision is largely because of a trade deal with the USA, where the UK government agreed to spend 25% more on medicines. As part of this, NICE has increased how much the NHS will pay for every extra year of good quality life a medication can give. This is known as a QALY (Quality-Adjusted Life Year) – and the upper threshold per QALY has gone 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. These two changes were enough to tip the balance.

It is thought that patient campaigns for Enhertu – and other drugs – have helped too. Daiichi Sankyo and AstraZeneca welcome NICE’s decision, but the latter is calling for “strong collaboration” across the healthcare system to ensure “faster, more equitable patient access in the future.” Breast Cancer Now’s Claire Rowney says: “We are calling on the government, NICE, NHS England 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.”

Helen Knight, director of medicines evaluation at NICE, says she is pleased a “commercial solution” means the treatment can be made available on the NHS in England but adds she knows the decision “comes too late for many families.” “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,” she says.