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Session 6: RWE in Payer and HTA Decision Making and Considerations for R&D Organizations
Session Chair(s)
James Harnett, PharmD, MS
Executive Director, Health Economics and Outcomes Research
Regeneron Pharmaceuticals, Inc. , United States
RWE is playing an increasing role in informing decisions across stakeholders with significant attention focused on regulator acceptance. Payers and HTA bodies can also leverage RWE to address gaps in evidence around subpopulations, longer-term outcomes and comparative effectiveness. Further, there is an increasing intersection of evidence requirements between regulators and payers. This session will focus on case studies, best practices and how to prepare R&D organizations for addressing future regulatory and reimbursement evidence requirements.
Learning Objective : At the conclusion of this session, participants should be able to:
- Assess the expanding role of RWE for informing decisions by payers and HTA bodies
- Identify guidance and best practices for generating fit-for-purpose RWE for payers and HTA bodies
- Evaluate implications of growing intersection of regulatory and payer/HTA requirements for biopharmaceutical R&D organizations
Speaker(s)
Speaker
Oriol Solà-Morales, MD, PhD, MS
Fundacio HITT, Spain
Cheif Executive Officer
Speaker
Jon Campbell, PhD
Institute for Clinical and Economic Review (ICER) , United States
Senior Vice President for Health Economics
Speaker
Pall Jonsson, PhD, MS
National Institute for Health and Care Excellence (NICE), United Kingdom
Programme Director - Data and RWE
Speaker
Daniel A. Ollendorf, PhD, MPH
Center for the Evaluation of Value and Risk in Health, United States
Director, Value Measurement & Global Health Initiatives