ISSUE: Prior authorization (PA) is an increasingly common gatekeeping strategy used by U.S. payers to manage specialty drug utilization. At the same time, burdensome PA requirements may create barriers to access for patients in need. For example, recent analyses of a new class of cholesterol-lowering medications called proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) report that PA requirements for PCSK9is were substantially more extensive than those for other cardiometabolic drugs and more than half of PCSK9i prescriptions were rejected even among clinically appropriate patients. As more and more expensive specialty drugs become available to treat chronic conditions, the challenge of ensuring appropriate access within real world budget constraints has come into sharp focus. There is an urgent need to explore this issue from the perspectives of all relevant stakeholders.

OVERVIEW: This panel will debate the pros and cons of PA requirements and explore approaches to handling the competing priorities of balancing costs and access, using PCSK9is as a case study. Jalpa Doshi will moderate the panel and provide an overview of the current landscape of PA requirements as well as pose key questions for the panelists to debate: What are best practices for ensuring appropriate use among patients? What types of PA requirements are blunt tools for cost containment versus necessary for ensuring prescribing in patients for whom the drugs offer high value? Should high budget impact drugs be handled differently? Steven Miller will discuss PA efforts to balance costs and access from a PBM/payer perspective. Cat Davis Ahmed will represent the patient perspective, offering insights on patient experiences and the human consequences of restrictive PA policies. Seth Baum will represent clinical societies calling for PA reform and offer a provider perspective on the burden of administrative requirements and their impact on patient care as well as a physician’s practice.