Medicare Draft NCD For Alzheimer's Drugs: When 'Reasonable And Necessary' And 'Safe And Effective' No Longer Align

Proposed decision withholds Medicare coverage from current and future amyloid-directed monoclonal antibody drugs for Alzheimer’s disease unless patients are enrolled in a randomized clinical trial.

Drugs Need More Data On Safety, Effectiveness, Medicare Says • Source: Alamy

The Centers for Medicare and Medicaid Services’ draft decision to condition Medicare coverage for amyloid-directed monoclonal antibody drugs for Alzheimer’s disease on patient participation in qualifying randomized clinical trials signals we may be entering an era where Medicare reimbursement is no longer a given for a drug once it is approved by the US Food and Drug Administration.

The decision if finalized will govern reimbursement by the largest US payer for the Alzheimer’s drugs. It will apply to...

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