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Managed Care Research in Action

(R5) Accelerated Approvals, Where Are We Now? A Follow Up on The Advantages and Pitfalls

Wednesday, April 2, 2025
2:30 PM – 3:45 PM CST
ACPE UAN: | Contact Hours: 1.25 | Activity Type: Knowledge-based
Disclosure(s):
Timothy O'Shea, MS, PharmD: No financial relationships to disclose
Sneha Sharma, PharmD: No financial relationships to disclose
Soumya Vishwanath, PharmD: No financial relationships to disclose
The FDA established the Accelerated Approval Program in 1992 to combat the HIV epidemic and bring valuable treatments to patients quicker than traditional drug approval pathways. While gold-standard clinical trials can take up to two decades, the Accelerated Approval Program ensures crucial treatments are approved based on surrogate endpoints to increase access. The catch: drug manufacturers are expected to conduct confirmatory trials to prove the primary endpoint. These trials should be underway as the drug is approved, but this is not the case in practice.

This session will focus on the successes and pitfalls of the Accelerated Approval Pathway, including an analysis of the status of the drugs, patient/caregiver perspectives on receiving these drugs, and present trends of management strategies from national payers. Lastly, the session will describe innovative payment models and one health plan’s perspective including impact to self-funded groups and management strategies of accelerated approval drugs.

Learning Objectives:

At the completion of this activity, participants should be able to:
  1. Identify key aspects of the Accelerated Approval Program including successes, challenges, and impact on unmet diseases.
  2. Discuss payer perspectives and management strategies of drugs approved through the Accelerated Approval Program.
  3. Describe one health plan’s overall perspective, including impact to self-funded groups, on management strategies of accelerated approval drugs.