From Trial to Treatment: Navigating Formulary Access, Package Insert Constraints, & Payer Expectations in CNS Therapeutics
Time: 1:45 pm
day: Conference Day One
Details:
This workshop examines the gap between regulatory approval and market success in CNS therapeutics. Through psychiatry and neurology case studies, participants will explore how trial design, labeling, and payer expectations impact adoption. Attendees will share best practices and strategies to overcome access hurdles in mental health, where generics, weak algorithms, and patient heterogeneity challenge competitiveness.
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?
