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

On April 7, 2022 CMS issued an NCD that covers FDA approved monoclonal antibodies directed against amyloid for the treatment of AD under Coverage with Evidence Development (CED), when furnished in accordance with the coverage criteria specified in the NCD for patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia. The complete NCD decision memorandum is available on our website (see link below).

https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305

Below is a list of studies that have been determined to meet the requirements for coverage under CED.

Study Title:  Alzheimer's National Registry for Treatment and Diagnostics
Sponsor:  Alzheimer's Disease and Related Disorders Association, Inc
Clinicaltrials.gov number:  NCT06170268 
CMS Approval Date: 1/29/2024

Study Title:  Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry
Sponsor:  Emory University
Clinicaltrials.gov number:  NCT05999084
CMS Approval Date: 11/14/2023

Study Title:  A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Sponsor:  Beth Israel Deaconess Medical Center
Clinicaltrials.gov number:   NCT05925621
CMS Approval Date: 07/11/23

Study Title: Prospective Study on Anti-Amyloid-β Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Coverage of Evidence Development (The Anti-Aβ mAb CED Study)
Clinicaltrials.gov number:   NCT06058234
Temporary Clinical Trial # “99999999”
Study Description/Summary (PDF)
CMS Approval Date: 07/06/2023

Prescribing clinicians or their staff shall submit at first baseline treatment via the dedicated CMS CED data submission portal and every six months for up to 24 months (five total assessments). Below are links to the The Anti-Aβ mAb CED Study summary, CMS Alzheimer’s Disease data submission Landing Page, CMS National Patient Registry data submission portal, example data submission form, training video, provider and patient fact sheets.

• The Anti-Aβ mAb CED Study Summary and Description (PDF)
• CMS National Patient Registry (Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease CED Study Registry). The Landing page includes:
  • Link to National Patient Registry portal
  • Example data submission form
  • Data Submission Training video
  • Data Dictionary
• CMS National Patient Registry data collection portal direct link
• Provider Fact Sheet
• Patient Fact Sheet