Thousands of women in England with incurable breast cancer will gain access to a life-extending drug on the NHS following successful negotiations over its cost.
Approximately 1,000 women a year with HER2-low advanced breast cancer will be eligible to receive Enhertu starting Thursday, after ministers and the drug’s manufacturers reached a pricing agreement.
About one in seven of the 60,000 new breast cancer cases diagnosed annually in the UK are HER2-positive.
Clinical trials have demonstrated that Enhertu nearly doubles median progression-free survival compared to standard chemotherapy, increasing it from 5.1 months to 9.9 months. Median overall survival for patients on the drug reached 23.4 months, compared to 16.8 months for those not receiving it—a gain of 6.6 months.
“This is a momentous day for thousands of people who will now have access to a drug that gives them the opportunity to gain precious time with loved ones,” said Claire Rowney, chief executive of Breast Cancer Now.
The National Institute for Health and Care Excellence (Nice) announced on Thursday that roughly 1,000 patients a year in England will be eligible for the treatment following its recommendation for routine use.
Nice, which advises the NHS on whether treatments represent value for money, had previously rejected Enhertu in July 2024 as too expensive, despite its proven effectiveness.
Rowney hailed the “milestone victory,” which follows two years of determined campaigning by the charity, cancer specialists, and patients with the disease.
The drug has been available in Scotland since December 2023, which is one of 27 European countries providing it to patients. Labour ministers, including former health secretary Wes Streeting, had been working behind the scenes to add England to that list by brokering a cost deal, though efforts were hampered by the manufacturers’ refusal to lower their price.
Nice’s reversal follows renewed negotiations between the institute, NHS England, and Enhertu’s two makers, AstraZeneca and Daiichi Sankyo. These talks resulted in what Nice termed a “commercial solution,” making the drug available in England for the first time.
The freedom Nice gained in April to recommend NHS spending of up to £35,000 per year on a patient’s treatment—up from a previous £30,000 cap—proved crucial. The institute has agreed to pay more for Enhertu than previously planned, though it remains unclear whether the manufacturers reciprocated by reducing their asking price.
“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 and 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 HER2-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 expected to implement Nice’s recommendation and make the treatment available there as well.
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, 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.”
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