Incubate Comment on the Proposed Decision Memo for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Executive Director John Stanford's comment on CMS's Proposed Decision for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease


February 10, 2022

Tamara Syrek Jensen, JD

Director, Coverage and Analysis Group

Centers for Medicare & Medicaid Services

7500 Security Boulevard

Baltimore, MD 21244

Electronically Submitted

RE: Proposed Decision Memo for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Director Jensen:

Incubate appreciates the opportunity to submit a comment to the Centers for Medicare & Medicaid Services’ (CMS’) proposed National Coverage Determination (NCD) to cover anti-amyloid monoclonal antibody treatments (mAbs) for Alzheimer’s disease under a “Coverage with Evidence Development” (CED) framework. On behalf of the early-stage life sciences community, which includes patients, venture capital investors, and biotech companies, we believe that CMS should withdraw this decision and start a new process to determine a better path forward.  As proposed, the NCD sends a dangerous signal to the investors who are supporting the advancement of potential treatments for Alzheimer’s disease—and many other diseases with unmet medical needs, including insufficient treatment options

For decades, Alzheimer’s treatments – and ideally a cure – have remained elusive, frustrating patients, their caretakers, and almost every American impacted by this disease. As our population ages, confronting this malady with science is an imperative we all face—and the venture capital community is leading the way funding biotechs around the country with hopes of new medicines.

Our work can only continue when our successful efforts, however rare, are rewarded to allow our cycle of innovation and investment to continue. The proposal by CMS to only cover anti-amyloid mAbs under randomized control trials fundamentally undermines that opportunity. Even worse, it undermines the Food and Drug Administration’s (FDA) drug review program and inappropriately inserts CMS into both drug safety and efficacy decisions and patient-physician decisions.

As a community, life science investors have consistently failed to recoup our investments into Alzheimer’s disease treatment efforts. It represents the riskiest of already risky ventures – and yet, we continue to fund innovation in the hopes of a breakthrough. CMS’ proposal only makes our calculus harder and, if finalized as proposed, will lead to less investment in a therapeutic area that merits more attention, not less.

Finally, our work is only meaningful when it provides transformational health outcomes to patients. We have heard from a number of our patient advocacy partners that this proposal also jeopardizes outcomes for underserved communities – a future we consider unacceptable. For those reasons, and our own, we ask you withdraw this decision and initiate a more transparent and collaborative process for determining how to ensure patient access to anti-amyloid mAbs.

The United States is currently in a golden age for drug development and discovery, but proposals like this NCD will only serve to undercut the investment needed to bring innovating therapies to patients. I have attached the thoughts of one of Incubate’s Advisory Council members who recently penned an editorial detailing these views further. We would welcome the opportunity to discuss our feedback in greater detail with CMS. 

Thank you again for the opportunity to comment.  


John Stanford 

Executive Director 


Incubate is a 501c(4) organization with the mission to ensure patients continue to reap the benefits of the unrelenting innovation spurred by venture capital investment in the life sciences industry and protected by the American system of intellectual property.