Draft guidance published in September 2023 did not recommend Enhertu for breast cancer patients post-chemotherapy. Credit: ORION PRODUCTION / Shutterstock.com.

The UK National Institute for Health and Care Excellence (Nice) has declined to recommend Daiichi Sankyo‘s Enhertu (trastuzumab deruxtecan) for the treatment of advanced HER2-low breast cancer in adults.

The final draft guidance comes after unsuccessful negotiations between National Health Service (NHS) England and Daiichi Sankyo to reach a cost-effective commercial deal to offer the therapy for NHS use.

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The appraisal of Enhertu by NICE had been on hold since December 2023 while discussions were underway.

Draft guidance published in September had already set a precedent by not recommending Enhertu for patients post-chemotherapy, citing uncertainties in the data and cost-effectiveness that exceeded the institute’s acceptable range for NHS resource use.

Approximately 1000 individuals would have been eligible for treatment with Enhertu if recommended.

Registered consultees, including Daiichi Sankyo and patient carer groups, can appeal against the final draft recommendations.

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NICE maintains its position of not endorsing Enhertu for NHS use without a commercial arrangement that leads to a cost-effective price.

NICE medicines evaluation director Helen Knight stated: “We are extremely disappointed not to be able to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer.

“The backdrop to the commercial discussions was the independent appraisal committee’s belief that, based on the available evidence, Enhertu represents a significant development for people with HER2-low advanced breast cancer who currently have limited chemotherapy options. Most have no targeted treatments available to them.

“However, a key uncertainty in estimating Enhertu’s cost-effectiveness was how much longer people on Enhertu live compared with those receiving standard treatment in the future. The independent committee carefully considered all the evidence and applied its judgement on the most clinically plausible approach on which to base its decision.”

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