Alzheimer’s Disease Policy Task Force

The Alzheimer’s Disease Policy Task Force is an ad hoc coalition of patient, family caregiver, and professional organizations, working collectively to organize and educate the Alzheimer’s disease community and decisionmakers on:

1. The Food & Drug Administration’s (FDA) Accelerated Approval pathway, and
2. The Centers for Medicare & Medicaid Services’ (CMS) coverage determination processes for amyloid-targeted monoclonal antibody therapies for the treatment of Alzheimer’s disease.

Task Force Background

On July 12, 2021, CMS announced the opening of a national coverage determination (NCD) analysis for “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG00460N),” a process that allows the agency to review existing clinical evidence and determine a Medicare coverage policy for monoclonal antibody therapies (mAB therapies) targeting amyloid for the treatment of Alzheimer’s disease. This NCD analysis, and expected draft and final decision, will apply to those currently approved by the FDA as well as future monoclonal antibodies that target amyloid. CMS has initiated its coverage decision for the mAB drug class, which encompasses several drugs in clinical development and includes molecules that have been designated with breakthrough therapy status by the FDA and could be available soon.

CMS’s coverage decision will have tremendous implications for the entire class of therapeutics under development for the treatment of Alzheimer’s disease. Similarly, the accelerated approval pathway — which has been widely used for many years to the enormous benefit of people fighting cancer and other serious diseases—is under threat just as its use by FDA is poised to benefit people fighting Alzheimer’s disease and other forms of dementia.

To learn more about the Task Force and to join, contact Michael Ward at [email protected].

Partners

Financial support for the Alzheimer’s Disease Policy Task Force has been provided by:

• Alliance for Aging Research
• Biogen Inc.
• Biotechnology Innovation Organization
• Eisai Pharmaceuticals
• Genentech, Inc.
• Global Alzheimer’s Platform Foundation
• Global CEO Initiative on Alzheimer’s Disease (CEOi)
• Leaders Engaged on Alzheimer’s Disease (LEAD Coalition)
• Pharmaceutical Researchers and Manufacturers of America
• UsAgainstAlzheimer’s

Task Force Guidelines for Non-Industry/Industry Members

Task Force member activities will include regular calls to help guide messaging and strategy for agency meetings, public comments, grassroots, and media messaging. Only non-industry Task Force member groups will be asked to participate in policy position and strategy calls, meetings with federal agencies and offices, and to sign on to comments and letters. While the Task Force may seek technical review from industry experts, Task Force member groups will maintain full editorial control and therefore have the final word on all content. Sponsorship of the Task Force does not imply endorsement of Task Force policy positions.

Webinar: CMS’s Coverage Decision: It’s Not Just About Alzheimer’s Disease

Alzheimer’s Disease Policy Task Force Submits Comments on Draft Medicare Coverage Decision for Monoclonal Antibodies Targeting Amyloid

On Thursday, February 10^th the Alzheimer’s Disease Policy Task Force (ADPTF) submitted feedback to the Centers for Medicare and Medicaid Services (CMS) on their draft Medicare coverage determination for the use of monoclonal antibodies (mABs) targeting amyloid for the treatment of Alzheimer’s disease (AD).

The Task Force’s letter can be found here.