The Accelerated Approval Program: Balancing Crucial Patient Access with Timely Evidentiary Needs

Pricing: Free for Members and Non-Members

Course Description

The FDA’s Accelerated Approval Program (AAP) has long served as a critical mechanism to expedite patient access to promising therapies for serious or life-threatening conditions. Now, its balance between timely access and evidentiary rigor is under renewed attention. In recent years, payers have increasingly adopted a more cautious stance toward therapies approved under the AA program, particularly in non-oncology medicines, reflecting payers’ concerns around the uncertainty of clinical benefits.

This session will investigate trends in the AA program over time, including an examination of the current landscape, expected future volume of therapies applying for and being approved under the AA program, and trends related to oncology and non-oncology therapeutic areas. The session will also discuss policy updates aimed at reforming the AAP and highlight the perspectives of manufacturers, payers, and patients, both where there is consensus and where there is disagreement about the future of the program.

Target Audience

Pharmacists who practice in managed care settings.

Learning Objectives

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

  1. Describe the current landscape of the FDA Accelerated Approval Program, including recent trends and key differences between oncology and non-oncology approvals.
  2. Examine research findings on clinical benefits and life years gained within oncology approvals through the Accelerated Approval Program compared to standard of care therapies
  3. Discuss multi-stakeholder perspectives on managing accelerated approval drugs, including evidence generation, coverage decisions, and patient access strategies.

 

Course summary
Available credit: 
  • 1.25 ACPE
    The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Course opens: 
04/20/2026
Course expires: 
12/31/2027
Cost:
$30.00

Bridget Doherty, MPH, MS
Director, Access and Policy Research
Johnson & Johnson Innovative Medicine

Timothy O'Shea, MS, PharmD
Director, Specialty Pharmacy
Horizon BCBS

Tyler Wagner, PharmD, PhD
Director of Research 
National Pharmaceutical Council

Disclosures

Bridget Dohery
Faculty		Employee: Johnson & Johnson
Timothy O'Shea
Faculty		Disclosed no relevant financial relationships
Tyler Wagner
Faculty		Employee: National Pharmaceutical Council
Soumya Vishwanath
Peer Reviewer		Employee: Prime Therapeutics (Clinical Pharmacist)
Brooke Whittington
Planner		Disclosed no relevant financial relationships

 

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: 0233-0000-26-011-H04-P • Activity Type: Knowledge-Based
Contact Hours: 1.00
Release Date: April 20, 2026 •  Expiration Date: December 31, 2027
Activity Fee: Free for Members and 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 2026. 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
    The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Price

Cost:
$30.00
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