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.
At the completion of this activity, participants should be able to:
Identify which audiences are allowed to receive PIE communications from manufacturers.
Outline two issues with current sub-regulatory guidance that unintentionally discourage PIE communications.
Identify the guidance that motivated the development the PIE guidance.
This knowledge-based activity has been designed to meet the educational needs of pharmacists in managed care settings.
Adam Colborn, JD
Director, Government Relations
Jennifer L. Mathieu, MA
Vice President, Policy & Government Relations
Kristie Yadro, PharmD
Director, Medical Value and Access Strategy
Astellas Pharma US, Inc.
The Academy of Managed Care Pharmacy (AMCP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
ACPE UAN:0233-0000-22-024-H03-P • Activity Type: Knowledge-Based
Contact Hours: 1
Release Date: May 10, 2022 • Expiration Date: December 31, 2023
Activity Fee: Free for Members and $50 for Non-Members
Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live activity presented at eLearning Days 2022. CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor. Please allow 72 hours for processing and posting in your NABP account.
To receive credit for an online activity you must:
- Review the full content of the activity.
- Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
- Complete a specific activity evaluation.
System Technical Requirements/Viewing Requirements:
System Requirements Courses and learning activities are delivered via your Web browser and Acrobat PDF. For all activities, you should have a basic comfort level using a computer and navigating websites. View the minimum technical and system requirements for continuing education online learning activities
|Activity Number||Credit Amount||Accreditation Period|
|ACPE UAN #0233-0000-22-024-H03-P||1 Contact Hour||May 10, 2022 - December 31, 2023|