In June 2021, the Food and Drug Administration (FDA) approved the first therapy to treat Alzheimer’s disease in nearly two decades. But the approval, once seen as a significant step for a disease that effects millions and has seen little progress in treatment or prevention, has been largely overshadowed by controversies around safety, effectiveness and cost. What tools can the FDA and Centers for Medicare and Medicaid Services (CMS) employ to incentivize innovation of breakthrough therapies for Alzheimer’s disease? What should be the standard for approval? And, how should approved therapies be reimbursed to reward innovation and ensure access?
On June 6, join the Schaeffer Center for a discussion about the regulatory challenges of approving and reimbursing therapies for Alzheimer’s disease. Schaeffer Center Director of Research Darius Lakdawalla will moderate a discussion between Rachel Sachs, Treiman Professor of Law at Washington University in St. Louis School of Law, and Joe Grogan, former Director of the Domestic Policy Council and Associate Director for Health Programs at the Office of Management and Budget.