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.
With this timely and forward-looking decision, CMS will support the FDA by covering the drug and any related services (including, in some cases, PET scans if required by trial protocol) for people with Medicare who are participating in these trials. The decision is specific to individuals who have a clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s Disease (AD) or mild dementia with a confirmed presence of plaque on the brain.
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. This was a controversial decision since it entailed prescribing a very expensive medication that requires monthly intravenous infusions and that may have serious side effects without proof of clinical usefulness.
The CMS decision remedies this situation. We will explain to our patients that enrollment in rigorously controlled clinical trials where all costs are paid by CMS is much more sensible than taking a costly medication of unproven benefit that is potentially harmful. Hopefully, the new data obtained through CMS-funded research will show that Aduhelm is effective and worth the cost and the risk.
This is only a temporary setback. The pipeline is full of drugs in various phases of development. The Clinical Trials Program at the Mesulam Center is enrolling participants into such studies. As we wait for therapeutic breakthroughs, there are safe drugs such as donepezil, rivastigmine, galantamine and memantine, which have proven though modest clinical efficacy and that are FDA-approved for use in MCI and AD.
— Marsel Mesulam, MD
Director of the Mesulam Center for Cognitive Neurology and Alzheimer's Disease
Chief of Behavioral Neurology in the Department of Neurology, Ruth Dunbar Davee Professor of Neuroscience
04/12/2022