National Coverage Analysis (NCA) Tracking Sheet

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

CAG-00460N

Issue

Alzheimer’s disease is a progressive, currently irreversible brain disorder that slowly degrades memory, cognitive function, and ability to carry out tasks of daily living. It is the most common cause of dementia among older adults. In Alzheimer’s disease, brain cell functioning is disrupted resulting in failure of brain cells to communicate with one another, leading eventually to cell death. Although many molecular and cellular changes are associated with the onset and progression of Alzheimer’s disease, aggregates of beta amyloid are thought to play an important role in its pathophysiology.

On June 7, 2021, the Food and Drug Administration (FDA) approved, using accelerated approval, aducanumab (brand name Aduhelm™) with an indication for the treatment of Alzheimer’s disease. Aducanumab is a monoclonal antibody directed against amyloid beta to reduce amyloid accumulations.

CMS is initiating a national coverage determination (NCD) analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. When making NCDs under section 1862(a)(1)(A) of the Social Security Act, Medicare does not consider the cost of the treatment in the analysis.

CMS is soliciting public comment relevant to the analysis. We are particularly interested in comments that include scientific evidence and that address the following questions regarding the treatment of individuals with Alzheimer’s disease with monoclonal antibodies directed against brain amyloid:

  1. Which health outcomes are important, and what degree of improvement in them is meaningful for patients receiving treatment?
  2. What characteristics of patients with Alzheimer’s disease are important to optimizing the likelihood of positive health outcomes from treatment?
  3. What issues of equity and inclusion must be accounted for in the diagnosis and treatment of Alzheimer’s disease?
  4. What health care providers should be included as part of the patient’s treatment team? Should medical specialists be included in the care team of patients receiving treatment? If so, which specialists should be included in the care?
  5. In what setting(s) should treatment and care be given?

CMS is following a long-standing statutory process that includes multiple opportunities for the public to participate and submit comments about the proposed topic on the CMS Coverage website. During the two public comment periods, you can submit comments using the orange “Comment” button at the top of the page. The initial 30-day public comment period begins with the posting date of this tracking sheet. The posting of the proposed NCD initiates another 30-day public comment period.

For this NCD, we are pleased to also announce that two National Stakeholder Calls are scheduled for July 22 from 9:00 to 11:00 AM (EDT) and July 27 from 2:00 to 4:00 PM (EDT). Click on the dates to register for the calls.

Meetings Held By CMS on Treatment for Alzheimer’s Disease
CMS is committed to transparency and wants everyone to understand how decisions regarding Medicare coverage are made. Listed below are the names of all organizations the agency has met with regarding monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. This list will be updated throughout the analysis process.

Alzheimer’s Association
American Academy of Neurology
American Geriatrics Society
America’s Health Insurance Plans
Biogen
BlueCross BlueShield Association
C2N Diagnostics
Duke University, Margolis Center for Health Policy
Eli Lilly
Eisai Inc.
Genentech
Johns Hopkins University
Memory Advocate Peers
Rubix Health, LLC
Society of Nuclear Medicine & Molecular Imaging
UsAgainstAlzeimers
Voices of Alzheimer’s
Paul Aisen, MD, Professor of Neurology, Director, Alzheimer's Therapeutic Research Institute,
     Keck School of Medicine of USC
Jeffrey Cummings, MD, ScD, Research Professor, Department of Brain Health, UNLV School of
     Integrated Health Sciences; Director, Chambers-Grundy Center for Transformative Neuroscience at UNLV
Howard Fillit, MD, Cofounder and Chief Science Officer, The Alzheimer's Drug Discovery Foundation,
     Clinical Professor of Geriatric Medicine and Palliative Care, Medicine and Neuroscience, The Icahn School of Medicine at Mount Sinai
Marwan Noel Sabbagh MD, FAAN, Professor of Neurology, Alzheimer's and Memory Disorders Division,
     Barrow Neurological Institute, Clinical Professor of Neurology, Creighton University
Dennis J. Selkoe, MD, Vincent and Stella Coates Professor of Neurologic Diseases, Harvard Medical
     School; Co-Director, Center for Neurologic Diseases, Department of Neurology, Brigham and Women’s Hospital

Benefit Category

Drugs and Biologicals

Requestor Information

Requestor NameRequestor Letter
Internal N/A

Important Dates

Formal Request Accepted and Review Initiated
07/12/2021
Expected NCA Completion Date
04/11/2022
Public Comment Period
07/12/2021 - 08/11/2021
Proposed Decision Memo Released
01/11/2022
Proposed Decision Memo Public Comment Period
01/11/2022 - 02/10/2022
Decision Memo Released
04/07/2022
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
David Dolan
David.Dolan@cms.hhs.gov
410-786-3365
Lead Medical Officers
Joseph Hutter, M.D.

Actions Taken

July 12, 2021

CMS initiates this NCD analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.

CMS announces that two National Stakeholder Calls are scheduled for July 22 from 9:00 to 11:00 AM (EDT) and July 27 from 2:00 to 4:00 PM (EDT). Click on the dates to register for the calls.

August 18, 2021

The transcript from the July 22 Stakeholder's call has been posted.
The transcript from the July 27 Stakeholder's call has been posted.

January 11, 2022

April 7, 2022