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

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

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.

Target Audience

Pharmacists who practice in managed care settings.

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.
Course summary
Available credit: 
  • 1.25 ACPE
    ACPE The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
  • 1.25 Certificate of Completion
Course opens: 
05/21/2023
Course expires: 
12/31/2023
Cost:
$30.00

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

Financial Relationship Disclosures

Faculty/Reviewer/PlannerReported Relevant Financial Relationships
Leslie Fish
Faculty		Disclosed no relevant financial relationships.
Michelle Rogers
Faculty		Disclosed no relevant financial relationships.
Jonny Clark
Reviewer		Disclosed no relevant financial relationships.
Ruby Singh
Planner		Disclosed no relevant financial relationships.
  • If applicable, relevant financial relationships have been mitigated and documented.
  • Content has undergone a peer review to ensure content validity.

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.

Available Credit

  • 1.25 ACPE
    ACPE The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
  • 1.25 Certificate of Completion

Price

Cost:
$30.00
Please login or register to take this course.

Required Hardware/software

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