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US Medicare Starts Coverage Policy Review For Biogen's Aduhelm

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  • The U.S. government started a review process for national Medicare coverage of Biogen Inc's (NASDAQ: BIIB) Alzheimer's drug, Aduhelm.

  • The Centers for Medicare & Medicaid Services expects to give a proposed decision within six months and a final decision within nine months.

  • Aduhelm is priced at $56,000 per year, which could represent significant spending for the government's Medicare program for people aged 65 and older.

  • The review will include an analysis of published clinical studies and medical society guidelines, as well as two public hearings later this month to assess the therapy's benefits.

  • Last week, the FDA revised its prescribing recommendations for Aduhelm amid criticism that its initial approval applied to all Alzheimer's patients rather than a narrower group in which the Company conducted trials.

  • Also, FDA Acting Commissioner Janet Woodcock asked for a federal investigation into meetings between agency staff and Biogen executives before the approval decision.

  • Price Action: BIIB shares are up 1.6% at $354.76 during the market session on the last check Tuesday.

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