EXTON, Pa., Jan. 27, 2022 /PRNewswire/ -- On January 11th, the Centers for Medicare and Medicaid Services (CMS)' proposed Medicare reimbursement of FDA-approved anti-amyloid monoclonal antibodies (mAbs) be limited to clinical trials under Coverage with Evidence Development (CED). Days later, Spherix surveyed 75 U.S. neurologists and Alzheimer's disease specialists (including five follow-up interviews) to evaluate their awareness of and opinions on this unprecedented event.

The resulting insights are part of a two-wave Special Topix: Impact of CMS Reimbursement Decision on Alzheimer's Disease Therapies service. The second wave will be fielded immediately following the publication of the final determination.

Key takeaways from the first wave of research include:

Indeed, according to an interviewed neurologist, "To pre-judge before the data is submitted on the other three products is unfair. I don't think that that's reasonable because one of them may show a significant clinical improvement."

One neurologist noted, "If Lilly had very strong data on clinical benefit [with donanemab], not just clearing of amyloid, and on the side effect profile, I hope that CMS would change its decision for that particular drug."

Positive cognitive and functional data with acceptable safety from at least one of the ongoing Phase III programs with anti-amyloid mAbs would positively impact neurologists' currently low willingness to participate in such trials.

As mentioned by one interviewed neurologist, "The FDA is very concerning. As you probably are aware, the advisory committee, which were all neurologists and memory disorder neurologists, almost unanimously recommended against it [Aduhelm's approval] and then the FDA went around and said yes, so you lose a lot of confidence right now. My confidence in CMS is much better, much improved. I think they did the right thing. I think this is necessary. Too expensive and too potentially harmful to just willy-nilly start using these medications. We need to know definitively that these are really beneficial."

While CMS' draft NCD decision is specific to anti-amyloid mAbs, the Special Topix report also captures insights on the potential impact that the proposal could have on emerging therapies for Alzheimer's disease with alternative mechanisms of action (i.e., non-amyloid-targeted).

About Special Topix

Special Topix: Impact of CMS Reimbursement Decision on Alzheimer's Disease Therapies (US)includes two waves of research, collecting feedback from U.S. neurologists and Alzheimer's disease specialists about their awareness of and opinions on CMS' draft and final National Coverage Determination (NCD) decision on FDA-approved mAbs targeting amyloid for the treatment of Alzheimer's disease. The waves of research will field immediately following the releases of the draft and final NCD decisions.

Therapies covered include:

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About Spherix Global Insights

Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information, contact:

Virginia Schobel, Neurology Franchise Head

info@spherixglobalinsights.com

http://www.spherixglobalinsights.com

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Neurologists React to CMS' Proposed NCD Decision on Anti-Amyloid Monoclonal Antibodies for Alzheimer's Disease in the Latest from Spherix Global...