Accelerated Approval Of Lilly’s Alzheimer’s Drug Could Last About 15 Months, CEO Says
Lilly expects results from donanemab ongoing confirmatory trial in 2023, while Biogen has nine years to finish its postmarket study. CEO David Ricks discusses impact of aducanumab approval backlash, pricing and national coverage decision at STAT summit.
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Medicare Coverage For Alzheimer’s Treatments Should Have Flexibilities For Labeling Differences, Developers say
Lilly and Genentech express concern that the Centers for Medicare and Medicaid Services will set Medicare coverage parameters for their Alzheimer’s drugs even before all the data is in.
Former CMS chief Mark McClellan discusses what kind of study requirements Medicare might impose if it decides to only cover the new Alzheimer’s drug if in the context of further evidence generation.
Proposed reimbursement decision to be released by 12 January 2022, with a final decision the following April. Biogen's Aduhelm expected to be covered in the interim. Medicare will not consider the cost of treatment in the analysis, but cost may have been a factor in initiating the process.