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Drug Development with Reimbursement in Mind: Obtaining the Input of Payers to Inform Clinical Trial Design

Track:
Comparative Effectiveness Research/Global Health Outcomes and Economics

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
245

Room Number:
9

Level:
Intermediate

Type:
Forum

Title:
Drug Development with Reimbursement in Mind: Obtaining the Input of Payers to Inform Clinical Trial Design

Chair(s):
Charles A. Stevens, JD, MBA
Vice President and General Manager
PAREXEL Consulting, United States

Description:
Regulatory approval does not lead to commercial success unless sponsors understand the evidence requirements of payers. Sponsors can minimize the risks of reimbursement denial by incorporating payer input into preregistration studies. This session will explore practical ways in which sponsors can seek and obtain actionable payer input during drug development.

Learning Objective(s):
Discuss what clinical evidence payers require in order to grant reimbursement for newly approved drugs; Explore ways to interact with payers during drug development to inform the design of clinical studies; Describe the pros and cons of joint meetings with regulators and payers during drug development in order to agree on clinical studies that will satisfy the needs of both.

Presentation(s) & Speaker(s):
Panelist
Andrew Bate, PhD, MA
Senior Director, Analytics Team Lead, WSR Epidemiology
Pfizer Inc, United Kingdom

Panelist
Brandon T. Suehs, PharmD, PhD
Principal Researcher
Comprehensive Health Insights, a Humana Company, United States