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FDA, CMS Working To Smooth ‘Baton Handoff’ From New Drug Approval To Reimbursement

 
• By Sue Sutter

FDA commissioner Robert Califf wants to develop a postapproval evidence generation system through ongoing collaboration with CMS. Public health experts say efforts by FDA and CMS to work more closely could result in greater clarity on trial designs early in development programs.

Passing the baton
The handoff from drug approval to reimbursement should be smoother, FDA's Califf says. • Source: Shutterstock

The US Food and Drug Administration and Centers for Medicare and Medicaid Services are working together to try to smooth what FDA commissioner Robert Califf calls the “baton handoff” from new drug approval to reimbursement.

Although few specifics about the collaborative effort have been publicly disclosed, the initiative appears aimed at avoiding a repeat of the type of situation that occurred with Biogen, Inc.’s Alzheimer’s drug Aduhelm (aducanumab-avwa)

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