Pre-Approval Information Exchange for Emerging Therapies

ACPE UAN #:  0233-0000-17-024-H04-P

Release Date: March 29, 2017

Expiration Date:  March 29, 2020

Activity Type:    Knowledge-based

Contact Hours:  1.25

Activity Fee:  Member:  $15        Non-Member: $30

Target Audience: Pharmacists who practice in managed care settings.

Activity Overview

With the growing emphasis on assessing the value of drug treatments and the use of outcomes as a contracting strategy, there is a need for more timely and proactive communication between manufacturers and payers on clinical and pharmacoeconomic data on emerging drug treatments. Currently, federal laws and Food and Drug Administration (FDA) regulations discourage this information exchange prior to FDA approval of a product. What impact would earlier information exchange have on payers? How could this pre-approval information be used for health care decision-making and value-based agreements? 

This session will provide an overview of the current requirements for pre-approval information exchange on emerging therapies, including the impact of recent First Amendment cases. This session will also explore the potential impact to payers and pharmaceutical manufacturers by having access to clinical and economic information about emerging therapies prior to FDA-approval. 

Learning Objectives:  

At the completion of this activity, participants should be able to:

1. Summarize the current regulatory and legislative requirements for pre-approval information exchange between manufacturers and payers for emerging therapies.

2. Identify at least three adverse consequences to the lack of preapproval information exchange for emerging therapies.

3. Discuss possible solutions to address the barriers to pre-approval information exchange for emerging therapies.

4. Describe how expansion of pre-approval information exchange for emerging therapies could impact payers and pharmaceutical manufacturers, including on value-based pricing and contracting.

Schedule of Educational Activity

This activity consists of an audio recording, pre-test assessment questions (not required to pass or continue), post-test questions (required to pass with a score of 70% or higher) and a specific activity evaluation. 

CPE Requirements:   

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 the AMCP Annual Meeting 2017. 

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 web sites.  View the minimum technical and system requirements for continuing education online learning activities.

As an accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of continuing pharmacy education (CPE) activities.  It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias.


An Pham, PharmD, MBA, FAHA | Senior Health Economics and Outcomes Research Liaison, Assistant Professor at University of California San Francisco (UCSF) School of Pharmacy

Mallinckrodt | San Francisco, California

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-17-024-H04-P 1.25 Contact Hours March 29, 2017 - March 29, 2020