Medicare Registry-Based Studies For Alzheimer’s Drugs Still ‘Challenging’ Prospect – Former CMS Official
Executive Summary
Medicare coverage with evidence development requirements for Alzheimer’s drugs that obtain traditional approvals may be more involved than they appear.
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After getting a formal request for Medicare to reconsider coverage for Eisai’s new drug and other mAbs, CMS must decide by mid February whether to undertake the process. The formal timeline for reconsideration runs six to 12 months; past reviews have taken around nine months.
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