Available Until 12/31/2023

The Accelerated Approval Pathway: Current Challenges and the Managed Care Impact

Course Description:

In 1992, the U.S. Food and Drug Administration (FDA) established the Accelerated Approval pathway to provide early access to medications for patients with serious and life-threatening conditions that fill an unmet need. The drug approval process for Accelerated Approval is expedited compared to the traditional drug approval pathway by using surrogate endpoints or intermediate clinical endpoints for approval that may reasonably predict the clinical benefit of the drug. The risk of using surrogate endpoints is that they may not represent a clinical endpoint of true importance which can then challenge payers who are managing very high-cost therapies that may have uncertain clinical effectiveness.

This session will describe the role of the Accelerated Approval pathway and what benefits and limitations there are to this expedited approval pathway. In addition, the session will review payer management trends and strategies for medications approved by this pathway and lastly, will discuss proposed recommendations for reform with regards to expedited drug approvals.

Learning Objectives:

At the completion of this activity, participants should be able to:
  1. Define the U.S. Food and Drug Administration’s (FDA) Accelerated Approval Pathway.
  2. Explain how the FDA’s Accelerated Approval Pathway is different from the traditional drug approval pathway.
  3. Summarize the type of data used in accelerated approvals and the potential advantages and disadvantages in using this data.
  4. Discuss specific payer challenges with managing medications approved via the Accelerated Approval Pathway and potential strategies to manage these medications.
  5. Identify at least two possible recommendations to reform the Accelerated Approval Pathway.


Faculty:

Leslie Fish, RPh, PharmD

VP of Pharmacy

IPD Analytics, LLC

Worcester, MA



Michelle Rogers, PharmD, BCPS

Director, Clinical Pharmacy

IPD Analytics, LLC

Aventura, FL

Moderator:

Rachel DiPietro

Vice President

The Kinetix Group

New York, NY


Accreditation:

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:0233-0000-22-048-H04-P  • Activity Type: Knowledge-Based
Contact Hours: 1.25
Release Date: October 14, 2022 •  Expiration Date: December 31, 2023
Activity Fee: Free for Members and $30 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 Nexus 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.



Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-22-048-H04-P 1.25 Contact Hours October 14, 2022 - December 31, 2023