CMS Aduhelm proposal sets bad precedent, Gottlieb says
Gottlieb warns that CMS is setting a precedent for denying coverage to drugs that receive accelerated approval
The CMS draft coverage decision on Aduhelm and future Alzheimer’s mAbs could, if finalized, set a precedent for restricting coverage of drugs that have received accelerated approval, former FDA Commissioner Scott Gottlieb told BioCentury.
The popularity of CMS’ proposal to limit coverage to a narrowly defined set of clinical trials should not obscure the broader policy implications of the decision, Gottlieb warned in an interview for BioCentury’s open access video program, The BioCentury Show, which launched this week. “A lot of critics,” Gottlieb said, “applauded Medicare’s muscular response in their coverage decision without really questioning the precedent that was getting set in the context of that decision.” ...