Stifel now sees BAN2401 Phase 3 data due in the third quarter as “the big 2022 event” for Biogen
Shares of Biogen (BIIB) are under pressure on Wednesday after Medicare said it proposes to only cover the company’s Aduhelm drug for certain recipients who have enrolled in qualifying clinical trials. If finalized, this decision would restrict access to the therapy. Following the news, Piper Sandler analyst Christopher Raymond downgraded the stock to Neutral as he sees the Centers for Medicare and Medicaid Services’ draft decision as “restrictive.” His peer at Oppenheimer also sees the CMS proposal of Coverage with Evidence Development as a potentially “significant setback” for Aduhelm, while Wells Fargo analyst Jim Birchenough called it a “clear negative.”
PROPOSED DRAFT COVERAGE: The Centers for Medicare & Medicaid Services, or CMS, posted on Tuesday night its draft National Coverage Analysis for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. The Centers for Medicare & Medicaid Services proposes to cover Food and Drug Administration approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease under Coverage with Evidence Development in CMS approved randomized controlled trials that satisfy the coverage criteria specified in Section C, and in trials supported by the National Institutes of Health, the document said. All trials must be conducted in a hospital-based outpatient setting, CMS added.
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