Biogen’s Plea To Medicare: Just Cover The Aduhelm Clinical Trial Population
Company discusses its strategy for negotiating a change in the recently-proposed Medicare coverage decision for Alzheimer’s drugs during a presentation to analysts.
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Proposed Medicare national coverage policy would delay access to Alzheimer’s drugs for too long and the government should instead cover the drugs under specific conditions until research already underway comes in, Global Alzheimer’s Platform Foundation president John Dwyer argues.
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.
‘Embarrassing About-Face’: FDA’s Aduhelm Labeling Change Does Little To Improve Frustration Over Alzheimer’s Approval
US FDA’s update to Biogen’s Aduhelm label was the right move, drug policy experts say, but that doesn’t mean the agency should expect a round of applause. Instead, they expect it will only heighten the controversy and tension over the unexpected June accelerated approval of the pricey new Alzheimer’s disease drug and could further erode trust in the agency. The updated indication, which emphasizes initiating treatment in patients with mild disease, still gives plenty of wiggle room for wider prescribing.