Medicare Aduhelm Coverage Policy Overrules FDA: Can Two Wrongs Make A Right?
Plenty of people believe the US FDA should never have approved Biogen/Eisai’s Alzheimer’s therapy. But does that really mean it is okay for the Medicare agency to decide as a matter of policy that the drug has not been proven safe and effective?
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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.
Two House committees have launched investigations into the US FDA approval of Biogen/Eisai’s Aduhelm for Alzheimer’s, assuring that headlines questioning the effectiveness of the therapy will continue. It didn’t have to be this way.
Use of expedited pathway for Biogen's Alzheimer's drug was discussed at a center director briefing in late April, where it garnered backing from several senior CDER officials, as well as CBER director Peter Marks and OCE director Richard Pazdur.