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NICE has published final draft guidance that does not recommend Enhertu (also called trastuzumab deruxtecan and made by Daiichi Sankyo) for treating advanced HER2-low breast cancer in adults.

The decision follows the conclusion of negotiations between NHS England and the company that sought to agree a commercial arrangement to make Enhertu available at a cost-effective price for the NHS. 

NICE’s appraisal of Enhertu had been paused since December 2023 while these discussions took place.

This followed NICE’s draft guidance in September that did not recommend Enhertu for people with this type of breast cancer after they’d had chemotherapy. This was because there were uncertainties in the evidence that meant the most likely cost-effectiveness estimates were above the range NICE considers an acceptable use of NHS resources.  

Helen Knight, director of medicines evaluation at NICE, said: “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, and 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.

“Despite accounting for the condition’s severity by applying a severity modifier, and accounting for innovation and uncaptured benefits, the cost the NHS was being asked to pay was too high in relation to the benefits it provides for it to be recommended for routine use in the NHS.

“Without a commercial arrangement that results in a price that represents a cost-effective use of NHS resources, NICE cannot recommend Enhertu.”

It is estimated that around 1,000 people would have been eligible for treatment with trastuzumab deruxtecan if NICE had recommended it.

Registered consultees, including the company and patient carer groups, now have the opportunity to appeal against NICE’s final draft recommendations.