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.
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FDA-CMS communications are expected to evolve as both agencies look to improve their relationship.
Biogen caught a lucky break in getting the first FDA approval for a potentially disease-modifying Alzheimer’s therapy, but doubt over clinical benefit and commercial missteps have left Biogen in a precarious position a year later.