Medicare Coverage Analysis Of Alzheimer’s Drugs Begins With Focus On Outcomes, Patient Eligibility
Proposed reimbursement decision to be released 1 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.
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CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.
The company insists it will reconsider the price of Aduhelm if the market turns out to be larger than Biogen anticipates, but big price reductions for branded drugs are rare.
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.