The National Health Service (NHS) in England has approved the use of the breast cancer drug Enhertu for patients with HER2-low advanced breast cancer, making it available from Thursday. The drug, developed by AstraZeneca and Daiichi Sankyo, is estimated to benefit around 1,000 women annually by extending life expectancy by an average of six months.
Enhertu had previously been rejected for NHS funding in 2024 after the National Institute for Health and Care Excellence (NICE) determined it was not cost-effective under the then-current pricing thresholds. At that time, metastatic breast cancer was not classified as severe enough to justify the drug's price, leading to criticism because the treatment was accessible in other parts of the UK, including Scotland, and across Europe. This disparity sparked a broader debate about access to cancer therapies and cost evaluations within the NHS.
A recent shift in the economic landscape has contributed to the reconsideration of Enhertu’s funding. Following a trade agreement reached in April between the UK and the United States, the pricing criteria used by NICE to evaluate cost-effectiveness were adjusted. Previously set between £20,000 and £30,000 per quality-adjusted life year (QALY), the thresholds were raised to between £25,000 and £35,000 in response to a US threat of imposing a 100% tariff on pharmaceutical exports if the UK did not increase its medicine spending. This change, combined with new assessment methods for measuring quality of life, facilitated a commercial agreement between NHS officials and the drug manufacturers.
Helen Knight, NICE’s director of medicines evaluation, expressed relief that a commercial solution had been found, allowing the drug’s approval. She acknowledged that while the decision comes too late for many affected families, the agency must balance granting access to new medicines with maintaining the sustainability of the NHS and ensuring resources are allocated effectively.
Campaigners welcomed the announcement. Claire Rowney, from the charity Breast Cancer Now, described the approval as a "momentous day" in the fight against breast cancer, highlighting the positive impact Enhertu’s availability will have on patients with limited treatment options.
The decision marks a significant development in NHS drug policy, reflecting evolving trade relationships and cost evaluations that have direct consequences on patient access to innovative treatments. Enhertu will now be offered to eligible patients across England as part of the NHS cancer care portfolio.
