Medicare CED Update Targets Study ‘Efficiency,’ But May Not Ease Data Collection Burden
It's not clear that the proposed revisions and additions to the Centers for Medicare and Medicaid Services’ existing coverage with evidence development study design requirements would address what some experts view as a program failure – the fact that sponsors of the vast majority of technologies subject to CED have not generated the data CMS is looking for.
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As CMS faces a possible decision on what further study it will require for an Alzheimer’s drug if granted a traditional FDA approval, work on updating Medicare’s underlying CED policies continues. Stakeholders press their case ahead of December meeting.
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.
Payer discomfort with accelerated approvals exploded into the public arena with the Medicare national coverage determination on Aduhelm and similar drugs, and developers worry that the fallout will be far reaching.