The FDA Expedited Approval Pathways: Considerations for Real-World Effectiveness and Health Plan Design

Session Description:

This session provides a high-level discussion of the four FDA regulatory pathways that grant expedited approval of drugs indicated for conditions with high, unmet need. The expedited approval pathway brings drugs that often treat serious or life-threatening conditions to the market faster than the standard FDA approval process, allowing patients access to therapies sooner. However, there are many uncertainties in the process, including the implications for health plans in determining coverage and formulary decisions when drugs approved through an expedited pathway demonstrate uncertainty in clinical benefit or undetermined real-world effectiveness.This session is designed for attendees to consider the risk-benefit ratio of the FDA expedited approval process and explore alternative and transitional financing models for coverage of drugs approved through an expedited pathway.

Learning Objectives:

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

  • Describe the four FDA expedited approval pathways.
  • Identify the drug classes that plans are required to cover under Medicare Part D.
  • Understand the alternative financing and coverage policies that can be deployed to address drugs approved through an expedited pathway.


Erin A. Ferries, PhD, MPH

Pharmacy Policy Lead

Humana Healthcare Research

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.


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: 0233-0000-21-028-H04-P  • Activity Type: Knowledge-Based
Contact Hours: 1
Release Date: July 6, 2021 •  Expiration Date: December 31, 2022
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 AMCP 2021 Virtual.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.

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-21-028-H04-P 1 Contact Hour June 15, 2021 - December 31, 2022