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Daiichi Sankyo and partner company AstraZeneca have been unwilling to offer a price that would enable NICE to recommend Enhertu as cost effective for the NHS in final guidance published yesterday.

Helen Knight, director of medicines evaluation at NICE yesterday said:

“We are deeply disappointed that we are unable to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer

“As we’ve always made clear, the fastest and only guaranteed way to get medicines like Enhertu to the patients who need them is for companies to offer a fair price.

“NICE and NHS England offered as much flexibility as possible, but the companies did not put forward a new price, so we have no choice but to publish our final decision which is not to recommend the medicine in this group of patients.

“I would like to thank the breast cancer community for their hard work on this issue and I am sorry we do not have better news.”

Enhertu is the first breast cancer treatment NICE has been unable to recommend for 6 years and breaks a line of 21 positive breast cancer recommendations. This includes the positive recommendation in February for Talazoparib (Talzenna) for treating HER2 negative locally advanced or metastatic breast cancer.

Talzenna was approved using the same process as the evaluation of Enhertu for advanced HER2-low breast cancer.

If Daiichi Sankyo and AstraZeneca decide they are willing to drop their price to a level that makes Enhertu good value for money for the taxpayer, NICE will consider it under its rapid review process, with a decision potentially within weeks. 

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

Our methods and processes

NICE updated the methods and processes it uses to evaluate medicines in 2022 to allow greater weight to be given to medicines that address severe diseases.

22 appraisals (either final or at final draft guidance) have involved the use of the updated severity weighting. 17 (77%) have resulted in a positive recommendation, including 15 for cancer treatments. Of these, 2 treatments are for advanced breast cancer alongside treatments for brain tumours in children and advanced blood, bowel, endometrial, gastric and lung cancers.

This change in methods recently allowed greater weighting to be applied to medicines for cystic fibrosis, allowing patients to receive important drugs and reflecting the seriousness and lifelong nature of the condition. This had not been possible under previous methods.

Overall, 79% of the appraisals for cancer medicines carried out under the updated methods have been recommended. The approval rate for all cancer appraisals carried out since 2009, under previous methods was 78%.

The updated severity modifier was introduced following public consultation to allow extra weight to be given to a wider range of treatments than the end-of-life modifier it replaced. The severity modifier is being monitored and an evaluation of its use is ongoing.

Associated guidance and resources

Trastuzumab deruxtecan for treating HER2-low metastatic or unresectable breast cancer after chemotherapy