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Real-World Evidence Conference

Translating Insights into Real-World Value.

Session 6: RWE in Payer and HTA Decision Making and Considerations for R&D Organizations

Session Chair(s)

James  Harnett, PharmD, MS

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


Oriol  Solà-Morales, MD, PhD, MS


Oriol Solà-Morales, MD, PhD, MS

  • Cheif Executive Officer
  • Fundacio HITT, Spain
Jon  Campbell, PhD


Jon Campbell, PhD

  • Senior Vice President for Health Economics
  • Institute for Clinical and Economic Review (ICER) , United States
Pall  Jonsson, PhD, MS


Pall Jonsson, PhD, MS

  • Programme Director - Data
  • National Institute for Health and Care Excellence (NICE), United Kingdom
Daniel A. Ollendorf, PhD, MPH


Daniel A. Ollendorf, PhD, MPH

  • Director, Value Measurement & Global Health Initiatives
  • Center for the Evaluation of Value and Risk in Health, United States