Does NICE’s “severity modifier” for assessing diseases need to change?

What is Enhertu?Trastuzumab deruxtecan (Enhertu), made by Daiichi Sankyo and AstraZeneca, is a treatment for adult patients with unresectable or metastatic HER2 low breast cancer who have received previous chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. In December 2023 the drug was approved for use on the NHS in Scotland after the Scottish Medicines Consortium used its own method to reach its decision.1 It is also available in 18 other European countries. Around 1000 women in England and Wales would have benefited if it had been approved by the National Institute for Health and Care Excellence (NICE).What has happened?Negotiations between NICE, NHS England, and the manufacturers have been ongoing since July when NICE issued final guidance rejecting Enhertu over concerns about its cost effectiveness.2 Clinical trial evidence shows that Enhertu gives an additional 6.4 months of overall survival (23.9…

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