Eric Faulkner, Senior Director of US Market Access and Reimbursement, will chair a session entitled
Clinical Utility or Impossibility? Meeting Evolving Value Requirements for Devices and Diagnostics at The Advanced Medical Technology Association Conference to be held September 21-24 in Washington, DC. AdvaMed is a leading medical technology industry association, whose members produce over 90% of the health technology purchased in the United States and approximately 50% of worldwide health technology available worldwide.
The abstract for the session and other key speakers are as follows:
As health decision makers request more complex and costly evidence of product value, manufacturers are pressed to generate an expanding variety of evidence to support product reimbursement, adoption and diffusion. Preferences for historical evidence hierarchy-based approaches, where the randomized controlled trial (RCT) is considered ideal, have complicated evolution of HTA practices that take into account the unique factors inherent to devices and diagnostics. For such rapidly evolving technologies, one-size-fits-all approaches challenge innovation and access. As the “rules of the road” continue to change for devices and diagnostics, how do manufacturers maximize commercialization potential, minimize avoidable risks, and distinguish “got to have” versus “nice to know” evidence requirements? This panel will explore current practice and policy issues in an environment increasingly focused on value-based and personalized health care, where stakeholders often seek direct evidence of clinical utility to characterize product value. How we can meet evolving evidence requirements for devices and diagnostics in a manner that balances our need for evidence with the practical realities required for obtaining such information? How should the requirements for value-based decision making for devices develop and are evolving requirements reasonable?
Distinguished speakers include the following:
- Rich Toselli, VP, Evidence-based Medicine, Johnson & Johnson
- Randel Richner, President, NeoCure BioEconomic Strategies
- Marcel Salive, Director, Division of Medical and Surgical Services, Coverage Analysis Group, Centers for Medicare and Medicaid Services
- Patrick Terry, Co-founder and (former) Director, Director of Consumer Advocacy & Governmental Affairs, Genomic Health
Mr. Faulkner’s responsibilities at RTI Health Solutions involve evaluation of US and international pricing and reimbursement issues, health technology assessment practices, product reimbursement and commercialization strategies and changing health policy. He has recently served as an expert advisor to the Personalized Medicine Subcommittee of the President’s Council of Advisors on Science and Technology and the Personalized Healthcare Initiative of the US Department of Health and Human Services. In addition, Eric serves on the Leadership Committee of the Health Technology Assessment for Emerging Technologies Working Group of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) and is a key editor for an upcoming book entitled Medical Device and Diagnostics Outcomes Research: Issues and Good Research Practices supported by the US Medical Device and Diagnostics Council of ISPOR.
In addition to his role at RTI Health Solutions, Mr. Faulkner also serves as Director of the Genomic Biotech Institute (GBI) of the National Association of Managed Care Physicians (NAMCP) and is Editor-in-Chief of the GBI special section of the Journal of Managed Care Medicine, Genomics and Biotechnology. Eric also serves as an adjunct Assistant Professor for the Institute for Pharmacogenomics and Individualized Therapy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill.
Additional information about the conference is available
Please contact Eric directly if you plan to attend the conference and would like to pre-arrange a meeting time with him.