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.