Aduhelm Messaging
Aduhelm (generically known as aducanumab) is a monoclonal antibody that aims to remove amyloid from the brain. Amyloid is one of the substances that accumulates in excessive quantities in the brains of individuals with Alzheimer’s disease. Anti-amyloid drugs are being developed based on the hope that removing amyloid will result in symptomatic relief or slow progression of disease.
Rigorous clinical trials with Aduhelm showed that the drug did remove amyloid but without credible evidence of clinically meaningful benefit. The FDA nevertheless approved Aduhelm on June 7, 2021 for use in early stages of Alzheimer’s disease.
Latest News
Centers for Medicare & Medicaid Services Decision on Aduhelm - April 2022
On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) finalized its decision to limit its coverage of Aduhelm only to those individuals enrolled in randomized clinical trials conducted in a hospital-based outpatient setting. This decision was part of a broader national policy for coverage of any future FDA-approved monoclonal antibody directed against amyloid for use in Alzheimer’s disease.