England approves breast cancer drug Enhertu after UK-US pharma deal

England's medicines regulator, NICE, has approved the life-extending breast cancer drug Enhertu for NHS use, reversing a 2024 rejection. The decision will benefit around 1,000 women annually with HER2-low metastatic breast cancer. The policy shift stems from a UK-US pharmaceutical deal with the Trump administration, under which the UK agreed to spend 25% more on medicines, raising NICE's cost-effectiveness thresholds. While campaigners celebrate the breakthrough, critics warn the trade deal will cost the NHS billions.

Enhertu NHS approval England

• ▪The National Institute for Health and Care Excellence approved the breast cancer drug Enhertu for NHS use in England on September 17, 2026
• ▪The NHS approval of Enhertu in England is expected to benefit approximately 1,000 women per year who have HER2-low metastatic breast cancer
• ▪The drug companies Daiichi Sankyo and AstraZeneca did not substantially lower their prices for Enhertu since Enhertu was first rejected by NICE in 2024

UK-US pharmaceutical trade deal

• ▪The UK-US pharmaceutical deal with the Trump administration is projected to cost the NHS £1 billion over the next three years and potentially billions of pounds annually in the longer term
• ▪The UK government agreed to spend 25% more on medicines as part of a pharmaceutical trade deal with the Trump administration
• ▪Six UK select committee chairs, including Dame Chi Onwurah, Liam Byrne, and Layla Moran, requested the National Audit Office to investigate the financial implications of the UK-US pharmaceutical deal with the Trump administration

NICE cost-effectiveness threshold changes

• ▪NICE introduced a new, more nuanced method for measuring a patient's quality of life at the end of August 2026
• ▪NICE increased its cost-effectiveness threshold from £20,000-£30,000 to £25,000-£35,000 per Quality-Adjusted Life Year as part of the UK-US pharmaceutical agreement

Patient campaigner stories

• ▪Breast Cancer Now chief executive Claire Rowney stated that thousands of people missed out on Enhertu and many died during the two-year delay between NICE's 2024 rejection and its 2026 approval of Enhertu for NHS England use
• ▪Patient campaigner Jeannie Ambrose, who advocated for NHS access to Enhertu, died in January 2026 at the age of 53

HER2-low breast cancer treatment

• ▪Enhertu has been available to breast cancer patients on the NHS in Scotland since 2023 and is available in 26 other European countries
• ▪Enhertu is a life-extending drug that can give patients with HER2-low metastatic breast cancer an average of almost seven extra months to live

Debatable claims

• ▪AstraZeneca and Daiichi Sankyo should have lowered Enhertu's price for NHS England
• ▪NICE's drug evaluation system requires fundamental reform to prevent patient delays
• ▪The UK-US pharmaceutical deal imposes an unacceptable financial burden on the NHS