Lilly Phase III Alzheimer’s Data Will Set Stage For Unrestricted Medicare Coverage Request
Donanemab results due next year have a good chance of persuading CMS to offer unrestricted coverage, Lilly argues, even though the drug might just have accelerated approval at that point. ‘We believe that having two positive pivotal trials should meet that high level of evidence.’
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Lilly execs caution that even if FDA approves donanemab in 2023, no uptake of any significance is expected until 2024 and beyond. An accelerated approval would essentially preclude Medicare reimbursement, and a CMS policy change or more persuasive trial data could take some time.
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?
Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.