Any Medicare Study Requirements For Alzheimer’s Drugs Should Be Time Limited, CMS Told
Alliance for Aging Research worries the studies could drag on as long as the nine years Biogen is allowed for collecting Phase IV clinical data on its Aduhelm.
You may also be interested in...
As CMS brings public attention to process with its national coverage analysis for Alzheimer’s drugs, legislation aims to encourage quick recommendations – and strengthen collaboration with FDA.
Former CMS chief Mark McClellan discusses what kind of study requirements Medicare might impose if it decides to only cover the new Alzheimer’s drug if in the context of further evidence generation.
3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals
Pink Sheet and Trialtrove analyses show time given Biogen to complete confirmatory trial exceeds duration of most other late-stage trials of anti-amyloid compounds and is almost double the average time allocated for follow-up studies of novel accelerated approvals since 2016; runway could reflect expectations for a longer follow-up period or potential enrollment challenges.