Aduhelm on the condition that patients are in clinical trials and have early-stage symptoms.
A final decision is expected in April following an additional 30-day comment period in which members of the public can weigh in on the proposed coverage policy. Of the two studies, only one showed patients taking Aduhelm had a slowing in cognitive decline compared with patients receiving placebos. The conflicting results led to ongoing debate over whether the drug really works. As part of the FDA approval, Biogen and its partnerAduhelm has faced widespread criticism since its approval in June, in part because concerns that its priceif millions of patients start taking it.
Still, the policy could mean that it won’t be easy for many patients to receive treatment if they live in an area where there isn’t an eligible clinical trial, he added.— Ronald C. Petersen of the Mayo Clinic Alzheimer’s Disease Research Center
Source: Law Daily Report (lawdailyreport.net)
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