G. Caleb Alexander, MD, MS

CMS has proposed a National Coverage Determination decision memorandum specifying “coverage with evidence development” for FDA-approved monoclonal antibodies targeting amyloid for treating Alzheimer’s disease.

The American Academy of Neurology has issued ethical guidance on Aduhelm that outlines important points for neurologists to communicate to patients eligible for the treatment.

The FDA approval of Aduhelm, which was based on beta amyloid as a surrogate endpoint, represented a “regulatory failure,” according to members of an advisory committee convened by the FDA in November 2020.