Pricing: Free for Members, $30 for Non-Members

Course Description

Pre-approval information exchange (PIE) allows manufacturers to communicate certain information about investigational therapies and new indications with payers and health plans to facilitate timely formulary reviews, coverage, and reimbursement decisions for these products. The information that can be shared in PIE communications includes results from clinical trials, endpoints and populations studied, product pricing information, and the anticipated timeline for Food and Drug Administration (FDA) action. The dissemination of appropriate clinical and economic information is critical to expedite coverage decisions and ultimately provide faster patient access to innovative therapies.

There remains some confusion about PIE despite great interest from manufacturers and payers alike. For instance, while the FDA issued guidance in 2018 that clarified that manufacturers can engage in PIE, there remains confusion about whether PIE communications can be done proactively or only upon receipt of an unsolicited request from a payer or health plan. AMCP’s Policy and Government Relations team will dive into outstanding issues discouraging PIE communications under current sub-regulatory guidance and examine current legislative proposals to promote PIE. Attendees will learn about AMCP’s support for a legislative safe harbor for proactive PIE communications and how they can become involved in advocacy efforts supporting this legislation.