FirstWordPharmaFebruary 11, 2022
Tag: Biogen , Alzheimer's , Clinical Trials
Biogen is urging Medicare to broadly reimburse its Alzheimer's drug Aduhelnm, in response to a proposal by the US Centers for Medicaid and Medicare Services (CMS) to sharply limit coverage of new drugs for the disease, as reported in the National Post.
In a preliminary proposal last month, the agency said it would cover Aduhelm, and similar Alzheimer's treatments in development, only for patients enrolled in approved clinical trials.
Biogen chief medical officer Maha Radhakrishnan said the company "is committed to generating data from real-world usage and with coverage, Alzheimer's disease patients will be able seek treatment instead of being restricted to enrolling in randomized controlled trials where they may receive a placebo or be limited by other coverage criteria"
In its letter, Biogen proposed generating such data demonstrating Aduhelm's effectiveness by creating a focused registry to measure outcomes from the treatment, as well as a new clinical data network to allow institutions around the world to share Alzheimer's data and analysis.
It also said it would conduct studies of Medicare claims for Aduhelm to better understand the treatment's use patterns in different regions and demographic groups. The Medicare agency could alter its plan before it is finalized in April.
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