Survey puts spotlight on US neurologists’ response to CMS Alzheimer drugs decision

In April, the CMS confirmed it would limit medicare coverage for such drugs​​ – the most high profile being Biogen’s Aduhelm - to clinical trials: outlining its decision in the finalized National Coverage Determination.

Shortly after the decision was announced, Spherix surveyed 81 US neurologists and Alzheimer's disease specialists (and interviewed five survey respondents): evaluating their awareness of and opinions on the NCD as well as its potential impact on emerging therapies for Alzheimer's. 

The independent service notes three key takeaways: a lack of consensus on including not-yet-approved therapies in the guidance; a general agreement that current available evidence on anti-amyloid mAbs is insufficient to show they improve health outcomes in Alzheimers; and that the full approval pathway is preferred to accelerated approval.

1) Lack of consensus on the inclusion of not-yet-approved anti-amyloid therapies​

Neurologist generally agree with CMS' overall NCD and with many key elements of the decision.

“A major change between the proposed NCD [in January] and the finalized one is the inclusion of two coverage situations based on the type of FDA approval an anti-amyloid mAb receives,” ​notes Spherix. “However, even with this change, neurologist opinions remain mixed on the finalized decision covering both launched and emerging anti-amyloid mAbs.”​

2) Most neurologists agree that currently available evidence is insufficient to conclude that anti-amyloid mAbs improve health outcomes for Alzheimer's disease patients​

Although the survey was fielded prior to Biogen’s decision to substantially eliminate commercial infrastructure​​ for Aduhelm, neurologists were already reporting 'very low willingness' to prescribe the drug, and most had no patients receiving the mAb.

“The majority are uncomfortable with Aduhelm's cost/benefit profile, and few have confidence that post-marketing data will show Aduhelm provides a clinically significant benefit,” ​notes Spherix.

“Further, physicians were in agreement that current data is insufficient to demonstrate improvement in health outcomes for Alzheimer's patients.”​

3) Neurologists would prefer that developers wait to seek full approval rather than using the accelerated pathway​

Taking into account the CMS' decision, nearly half of surveyed neurologists said they do not believe that late-stage anti-amyloid mAbs should seek approval using the accelerated pathway.

They were much more likely to agree that treatments should instead seek traditional approval, which would require demonstrating a clinically significant effect on cognitive and functional endpoints.