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 ۱,۰۰۰ women a year with HER۲-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.
About one in seven of the ۶۰,۰۰۰ new cases of breast cancer diagnosed every year in the UK are HER۲-positive.
Clinical trials have shown that Enhertu almost doubled median progression-free survival compared with normal chemotherapy, from ۵.۱ months to ۹.۹ months. Median overall survival among people who used it was ۲۳.۴ months, compared with ۱۶.۸ months among those not on it – a ۶.۶-month gain.
“This is 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”, said Claire Rowney, the chief executive of Breast Cancer Now.
The National Institute for Health and Care Excellence (Nice) announced on Thursday that about ۱,۰۰۰ patients a year in England will be eligible to receive the treatment from the NHS after it recommended it for routine use.
Nice, which advises the NHS on whether treatments represent value for money, had previously rejected Enhertu, in July ۲۰۲۴, as too expensive to justify, despite its proven effectiveness.
Rowney hailed “this milestone victory”, which follows two years of determined campaigning by the charity, cancer specialists and women with that form of breast cancer.
The drug has been available since December ۲۰۲۳ in Scotland, which is one of ۲۷ 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.
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The freedom that Nice gained in April to recommend that the NHS can spend up to £۳۵,۰۰۰ a year on a patient’s treatment, up from a previous maximum of £۳۰,۰۰۰, 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.
“This is hugely positive news for women with secondary breast cancer who will now be offered this life-extending treatment on the NHS,” said Dr Anne Rigg, a consultant medical oncologist who is also NHS England’s national speciality adviser for chemotherapy.
Dr Catherine Elliott, Cancer Research UK’s director of research, said: “Enhertu is a targeted treatment that delivers chemotherapy directly to cancer cells.
“Clinical trial results show that, for people with HER۲-low advanced breast cancer whose disease has progressed following treatment, it can help them live longer and delay their cancer from getting worse compared with standard chemotherapy.”
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.”
