Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Bio­gen’s con­tro­ver­sial Alzheimer’s drug Aduhelm was hit with a na­tion­al de­ci­sion from CMS that re­strict­ed cov­er­age to on­ly ran­dom­ized tri­als, prac­ti­cal­ly guar­an­tee­ing a com­mer­cial flop in the near term, ques­tions sur­faced over why CMS al­so in­clud­ed all amy­loid-tar­get­ed mon­o­clon­al an­ti­bod­ies for Alzheimer’s dis­ease.

With Ei­sai and Bio­gen’s sec­ond Alzheimer’s drug, lecanemab, now show­ing it can slow the rate of cog­ni­tive de­cline ver­sus place­bo, lin­ing up for a like­ly full ap­proval next spring, the ques­tion now turns to whether that da­ta, which is be­ing pre­sent­ed at the Clin­i­cal Tri­als on Alzheimer’s Con­gress in San Fran­cis­co in late No­vem­ber, will be enough for CMS when it asks, “Does the an­ti-amy­loid mAb mean­ing­ful­ly im­prove health out­comes (i.e., slow the de­cline of cog­ni­tion and func­tion) for pa­tients in broad com­mu­ni­ty prac­tice?”

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