In a first, CMS will test pay­ing less for drugs cleared via ac­cel­er­at­ed ap­proval

The Cen­ters for Medicare and Med­ic­aid Ser­vices said Tues­day af­ter­noon that it will start test­ing a pro­gram to pay drug­mak­ers less for drugs ap­proved via the FDA’s ac­cel­er­at­ed path­way, as a way to in­cen­tivize swifter con­fir­ma­to­ry tri­als.

The move rep­re­sents a big shift in CMS and the fed­er­al gov­ern­ment’s think­ing. Phar­ma com­pa­nies some­times drag their feet on these con­fir­ma­to­ry tri­als, know­ing that pa­tients and pay­ers are still pay­ing full price even with­out the com­plete set of clin­i­cal ev­i­dence the agency typ­i­cal­ly re­quires for a full ap­proval. Con­gress and Pres­i­dent Joe Biden al­so re­cent­ly signed off on new au­thor­i­ty for the FDA to be­gin re­quir­ing these con­fir­ma­to­ry tri­als to be­gin pri­or to the ap­proval.

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