Medicare’s Alzheimer’s Drug Registry: Ease Of Use May Lead To Data Quality Tradeoffs
New details from CMS about the information that providers will be required to submit for Medicare beneficiaries taking anti-amyloid Alzheimer’s drugs indicate the agency could have a hard time getting answers to some of the key questions outlined in its National Coverage Determination.
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Required studies will assess the risks of ARIA and intracerebral hemorrhage, as well as safety in ApoE ε4 homozygotes. For the required registry-based study, the FDA suggests use of the ALZ-NET platform with no mention of CMS’ newly established registry, which may lack the level of detailed information needed to satisfy the drug regulator’s request.
There is no fee to participate, and entries to the registry must be made at baseline and then every six months for up to two years.
BIO Worried CMS’ Alzheimer’s Coverage Is ‘Trial Balloon’ For Lower Accelerated Approval Reimbursement
In a Pink Sheet interview, BIO Chief Advocacy Officer Nick Shipley raised concerns that Medicare’s Alzheimer’s coverage decision is indicative of a broader agency view on accelerated approval that could limit drug reimbursement in both the public and private sector.