Spherix Global Insights

January 27, 2022

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

Insights capture the potential impact of the proposed NCD decision on Biogen/Eisai’s Aduhelm, Eli Lilly’s donanemab, Eisai/Biogen’s lecanemab, and Roche/Genentech’s gantenerumab

EXTON, Pa., January 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:

  1. Lack of consensus on the inclusion of not-yet-approved anti-amyloid mAbs in the proposed NCD decision

Neurologists generally agree with CMS’ overall National Coverage Determination (NCD) draft and many key elements of the proposal – such as trials being limited to MCI and mild Alzheimer’s disease patients and only among those with demonstrated amyloid positivity. However, respondents show lack of consensus on whether the NCD should include not-yet-approved anti-amyloid mAbs (i.e., Eli Lilly’s donanemab, Eisai/Biogen’s lecanemab, and Roche/Genentech’s gantenerumab).

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.”

  1. Desired flexibility for CMS to revise its reimbursement decision if positive clinical data from ongoing Phase III programs of anti-amyloid mAbs

Given neurologists’ mixed opinions, it is perhaps not surprising that they believe that positive Phase III data on cognitive and functional outcomes with acceptable safety from ongoing trials with late-phase agents would likely motivate CMS to loosen coverage in a revised reimbursement decision.

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.”

  1. Neurologist interest in enrolling patients or participating in CMS-approved/NIH-supported trials to accessing DMTs

While Aduhelm has a low current prescriber base, the majority of neurologists are at least somewhat likely to enroll their Medicare-covered Alzheimer’s disease patients in a CMS-approved randomized controlled trial or an NIH-supported trial as part of the NCD to potentially access the drug. However, neurologists will first need to overcome perceptions that it will be burdensome to enroll patients and difficult to identify hospital-based clinical sites to refer them to.

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.

  1. Neurologists’ confidence in the FDA vs. CMS

Given Aduhelm’s FDA approval against the advice of the agency’s advisory committee and Aduhelm’s label subsequently being revised to narrow its approved indication, neurologists’ confidence in the agency has been eroded in the past year. Conversely, their confidence in CMS has remained on par (or has improved) over the past year.

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:

  • Biogen/Eisai’s Aduhelm
  • Eli Lilly’s donanemab
  • Eisai/Biogen’s lecanemab
  • Roche/Genentech’s gantenerumab
  • Cortexyme’s atuzaginstat
  • Athira Pharma’s ATH-1017
  • Cassava Sciences’ simufilam
  • Anavex Life Sciences’ blarcamesine
  • Annovis’ ANVS401
  • Synaptogenix’s bryostatin

Learn more about our services here.

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.

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