NHS Approves Breast Cancer Drug Rejected Two Years Ago After Trump Deal Raises NICE Spending Limit

The NHS in England is set to offer the breast cancer drug Enhertu to about 1,000 women a year after the National Institute for Health and Care Excellence (NICE) reversed a 2024 decision not to recommend the treatment on cost-effectiveness grounds.

Enhertu, made by AstraZeneca and Daiichi Sankyo, will be available to eligible patients with HER2-low metastatic breast cancer following a new commercial agreement involving the manufacturers, NICE and NHS England. The drug had previously been unavailable through routine NHS funding in England, although it has been available in Scotland since 2023.

The reversal follows changes to NICE's medicines assessment framework introduced under the UK-US pharmaceutical agreement with the Trump administration. The deal raised the amount NICE considers acceptable to spend on new medicines, while changes to its assessment methods also contributed to the latest decision.

Enhertu Was Rejected in 2024

NICE rejected Enhertu in July 2024 for adults with HER2-low metastatic or unresectable breast cancer after chemotherapy. Its committee concluded that the treatment was not cost-effective, with the most likely estimates remaining above the range it considered an acceptable use of NHS resources.

NICE said at the time that AstraZeneca and Daiichi Sankyo had not offered a price that would allow the drug to be recommended as cost-effective. Government figures later estimated that around 1,000 to 1,500 people could have been eligible for Enhertu in England.

The drug is used to treat HER2-low metastatic breast cancer, a form of the disease that has spread or cannot be removed through surgery. BBC reporting said Enhertu can extend patients' lives by almost seven months on average compared with chemotherapy.

The treatment has been available through the NHS in Scotland since 2023, leaving eligible patients in England without routine access while the drug was not recommended by NICE.

UK-US Deal Changes NICE Rules

Under the UK-US pharmaceutical pricing arrangement, NICE's standard cost-effectiveness threshold increased from between £20,000 and £30,000 to between £25,000 and £35,000 for each quality-adjusted life year gained. The government also agreed to increase NHS spending on new medicines as part of the arrangement.

The revised thresholds took effect in April. NICE said the changes were intended to improve access to new medicines while supporting investment in the life sciences sector.

The framework also changed how patient quality of life is assessed. Helen Knight, NICE's director of medicines evaluation, said the revised thresholds, changes to quality-of-life assessment and a commercial agreement with the manufacturers meant Enhertu could now be provided through the NHS.

Health Secretary Yvette Cooper described the treatment as 'life-changing' and said the decision followed changes to the NICE framework under the UK-US pharmaceutical partnership.

MPs Question Long-Term Costs

The wider changes have prompted scrutiny over their impact on NHS spending. The Financial Times reported that MPs estimate the pharmaceutical arrangement could cost the health service £1 billion over three years, with spending potentially rising further as more medicines are approved under the revised rules.

Six House of Commons select committee chairs have asked the National Audit Office to examine the agreement and assess its financial implications and value for money.

The government has said the pharmaceutical arrangement is intended to improve access to innovative medicines, support investment in the UK's life sciences sector and increase NHS spending on new treatments.