NICE Reversed on Enhertu Because the Threshold Moved, Not the Evidence
- NICE final draft guidance published on 17 September 2026 recommends Enhertu (trastuzumab deruxtecan) from Daiichi Sankyo and AstraZeneca for adults with HER2-low advanced or metastatic breast cancer whose disease has progressed after treatment. Around 1,000 people become eligible.
- NICE’s committee had previously been unable to recommend the drug at the price proposed. Enhertu in this population was the only breast cancer treatment NICE had been unable to recommend since 2018, a period in which 25 other breast cancer treatments received positive recommendations.
- NICE attributes the reversal to a commercial solution agreed following changes to its own methods made as part of the UK and US Pharmaceutical Pricing Agreement. Those changes are an increase in the cost-effectiveness thresholds used to judge value for money, effective in April, and a new method for assessing quality of life published on 27 August 2026.
- Clinical trial evidence showed Enhertu helps patients live longer and extends time before disease progression compared with standard chemotherapy. Helen Knight, director of medicines evaluation, said the decision comes too late for many families.
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The clinical evidence did not change. NICE’s threshold did, as a consequence of a bilateral trade agreement, and NICE states the connection in its own announcement rather than leaving it to be inferred.
- A drug rejected on price became acceptable because the price of acceptability rose. NICE names the mechanism: higher cost-effectiveness thresholds from April and a new quality-of-life method published on 27 August, both arising from the UK and US Pharmaceutical Pricing Agreement. Trade policy moved a health technology assessment outcome.
- One rejection against 25 approvals shows how far outside the line this sat. Since 2018 every other breast cancer treatment NICE assessed cleared its bar. Enhertu in HER2-low was the single exception, which means the gap between the offered price and the old threshold was narrow enough for a methods change to close it.
- Every previously rejected appraisal now has grounds to return. NICE confirms its review process permits reconsideration when new evidence or commercial arrangements emerge, and the methods change applies across the portfolio rather than to 1 product. Sponsors holding negative appraisals priced against the old threshold should be modelling resubmission now.