(EDU-R7) The Accelerated Approval Pathway: Current Challenges and the Managed Care Impact

In 1992, the U.S. Food and Drug Administration (FDA) established the Accelerated Approval pathway to provide early access to medications for patients with serious and life-threatening conditions that fill an unmet need. The drug approval process for Accelerated Approval is expedited compared to the traditional drug approval pathway by using surrogate endpoints or intermediate clinical endpoints for approval that may reasonably predict the clinical benefit of the drug. The risk of using surrogate endpoints is that they may not represent a clinical endpoint of true importance which can then challenge payers who are managing very high-cost therapies that may have uncertain clinical effectiveness.

This session will describe the role of the Accelerated Approval pathway and what benefits and limitations there are to this expedited approval pathway. In addition, the session will review payer management trends and strategies for medications approved by this pathway and lastly, will discuss proposed recommendations for reform with regards to expedited drug approvals.