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After previously being rejected on cost grounds, AstraZeneca and Daiichi Sankyo's breast cancer drug Enhertu has been cleared for NHS use in England. NICE approved the drug for HER2-low metastatic breast cancer patients, making it available to roughly 1,000 women a year. The companies now plan to seek similar approvals in Wales and Northern Ireland.
After a prior rejection on cost-effectiveness grounds, AstraZeneca and Daiichi Sankyo's breast cancer drug Enhertu has officially been approved for reimbursement by England's National Health Service. The decision by NICE clears the way for roughly 1,000 women per year with HER2-low metastatic breast cancer to access the treatment — a subtype where cancer cells express lower levels of the HER2 protein that drives tumour growth. The drug had already been available in Scotland since 2023.
The approval follows a notable shift in NICE's cost-effectiveness methodology for late-stage cancer medicines, as well as a US-UK bilateral trade agreement aimed at gradually aligning British drug prices closer to US levels. AstraZeneca had pledged £300 million in UK investments earlier this year, signalling its commitment to its home market. The companies will now pursue access approvals in Wales and Northern Ireland.
By the Numbers:
Why it matters: This approval marks a meaningful win for patients with HER2-low metastatic breast cancer — a group previously with limited targeted options. It also signals a broader policy shift in how the UK values and prices late-stage cancer therapies, with potential implications for future drug access decisions across the NHS.