22 October 2022 - In April 2022, the CMS finalised its national coverage determination for aducanumab (Aduhelm) and other monoclonal antibodies for Alzheimer’s disease. 

Aducanumab was approved by the FDA on the basis of a post hoc analysis of one trial, which had been terminated for futility. The analysis suggested a statistically significant — but clinically insignificant — benefit in a surrogate outcome used to measure cognitive decline.

Read New England Journal of Medicine perspective