Why FDA is meeting with payers about Aduhelm, other Alzheimer’s mAbs
Duke-Margolis discussion draft stresses the role of stakeholder collaboration to develop evidence about efficacy, safety of AD mAbs
Answering critical scientific and medical questions about Aduhelm and other potential Alzheimer’s treatments will require cooperation among payers, FDA, drug companies and physicians, according to a discussion guide the Duke-Margolis Center for Health Policy distributed to participants ahead of a private roundtable meeting Wednesday.
The meeting, and a future public meeting on the same topic, are being funded as part of a $2.5 million grant FDA awarded Duke-Margolis to support regulatory research related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act. Prior to her appointment in April as Director of the FTC’s Bureau of Economics, Marta Wosinska was principal investigator for the grant...