Centers for Medicare & Medicaid Services Decision on Aduhelm

On January 11, 2022, the Centers for Medicare & Medicaid Services (CMS) decided to limit its coverage of Aduhelm only to those individuals enrolled in randomized clinical trials conducted in a hospital-based outpatient setting.

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 is helpful. It will motivate and enable the company marketing Aduhelm to complete the additional clinical trial mandated by the FDA more rapidly. Hopefully, the new data will show that Aduhelm is effective and worth the cost and the risk. Until that happens, we will encourage patients to enroll in relevant clinical trials rather than seek to have this prescribed to them

This is only a temporary setback. The pipeline is full of drugs in various phases of development, including alternative approaches to remove amyloid. In the meantime, there are FDA approved drugs such as donepezil, rivastigmine, galantamine and memantine, which have proven clinical efficacy. These drugs are safe but offer very modest benefits. This is why we are all so engaged in research aiming to discover additional and more effective treatments.

 — 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

01/12/2022