Short Statement on Alzheimer’s HTA

The Beneluxa group is following with attention the therapies relative to Alzheimer’s disease coming to the market. Recently the FDA in the US approved an anti-amyloid antibody amid some controversy; a decision from EMA is not yet available.
Beneluxa wishes to emphasize that clinical endpoints such as changes in cognitive scores or dementia scales are considered as the endpoints relevant for HTA agencies in Alzheimer’s clinical trials. Biomarker data are not considered sufficient for demonstration of benefit for HTA agencies.

Last update: 29 June 2021