CMS kicks off 9-month process on whether to lim­it cov­er­age to Bio­gen's new Alzheimer's drug

The Cen­ters for Medicare & Med­ic­aid Ser­vices late Mon­day opened a for­mal process, rarely done for new ther­a­peu­tics, to care­ful­ly re­view whether it will lim­it cov­er­age na­tion­wide for mon­o­clon­al an­ti­bod­ies tar­get­ing amy­loid for the treat­ment of Alzheimer’s dis­ease, in­clud­ing Bio­gen’s new­ly ap­proved Aduhelm.

While it re­mains un­like­ly that CMS won’t end up pay­ing for Aduhelm (Medicare of­fi­cial­ly draws the line at care that is “not rea­son­able and nec­es­sary,” but CMS de­nies on­ly about 3% of claims sub­mit­ted by hos­pi­tals and physi­cians), the stakes are high as Bio­gen ex­pects that about 80% of pa­tients el­i­gi­ble for Aduhelm are cov­ered by Medicare, and pri­vate in­sur­ers are like­ly to fol­low the fed­er­al gov­ern­ment’s lead.

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