Around 1,000 people living with HER2-low advanced breast cancer in England will now be able to access Enhertu on the NHS after the treatment secured a recommendation from the National Institute for Health and Care Excellence (NICE).
The decision marks a significant milestone for patients whose cancer has progressed despite previous treatment, with NHS England making the drug available to eligible individuals immediately.
Enhertu (trastuzumab deruxtecan), developed by Daiichi Sankyo and AstraZeneca, has been recommended for adults with HER2-low advanced or metastatic breast cancer following a review of new commercial arrangements and updated NICE assessment methods.
The approval brings to an end a lengthy period during which Enhertu remained the only breast cancer medicine not recommended by NICE since 2018. During the same period, 25 other breast cancer treatments received positive guidance and became available through the NHS.
NICE's independent appraisal committee had previously concluded that the medicine did not represent sufficient value for money under the pricing proposal originally submitted by the manufacturers.
However, a new commercial agreement has now been reached, supported by changes introduced under the UK-US Pharmaceutical Pricing Agreement.
The changes included higher cost-effectiveness thresholds used by NICE when assessing medicines for NHS adoption, which came into force in April 2026, alongside a new methodology for evaluating quality-of-life benefits published on 27 August 2026.
As a result, NICE was able to revisit the evidence and issue positive draft guidance through its formal review process.
Clinical trial data demonstrated that Enhertu can help people with HER2-low advanced breast cancer live longer compared with standard chemotherapy. The treatment was also shown to delay disease progression, giving patients more time before their cancer worsens.
For clinicians and NHS leaders, the decision highlights the growing role of targeted therapies in treating hard-to-manage forms of breast cancer and reflects an evolving approach to assessing value within the healthcare system.
Helen Knight, Director of Medicines Evaluation at NICE, said:
"I'm pleased that a commercial solution, alongside recent changes to NICE's cost-effectiveness thresholds and the use of new methods for assessing quality-of-life, has meant this treatment can now be provided on the NHS.
“However, we know this decision comes too late for many families, and our thoughts are with them today. Our role is important in ensuring NHS spending on new medicines reflects the benefits they deliver while protecting valuable health resources for other essential patient services.”
The recommendation was issued through NICE's review process, which enables guidance to be reconsidered when new clinical evidence emerges or when revised commercial agreements are put forward.
For patients, clinicians and advocacy groups, the decision represents an important step forward in expanding access to innovative cancer treatments while balancing value for taxpayers and the wider NHS.
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