From Trial to Treatment: Navigating Formulary Access, Package Insert Constraints, & Payer Expectations in CNS Therapeutics
Time: 2:30 pm
day: Conference Day One
Details:
This workshop explores the complex relationship between clinical trial design, package insert language, and payer formularies, focusing on the real-world implications for CNS access strategy. Drawing from front-line payer insights, attendees will learn how trial inclusion criteria and risk stratification data lock in downstream access barriers or enablers. The session will also cover the evolving role of medical science liaisons (MSLs) in bridging clinical, commercial, and payer priorities, ensuring launch strategies don’t stall in reimbursement bottlenecks.
Key Questions Addressed:
- How do payer formularies interpret and enforce narrow inclusion criteria from clinical trials via package inserts?
- What role do early payer engagements and MSLs play in reshaping access parameters for novel CNS drugs?
- How can access teams anticipate and counteract payer “cost containment” tactics like delayed reimbursement or formulary exclusion?
- How can clinical development teams better design trials to anticipate payer-driven access restrictions post-launch?
- What are the risks and opportunities of post-launch PI revisions in shaping ongoing access and reimbursement outcomes?
