1. DEVELOPING GLOBAL ROAD MAPS FOR REIMBURSEMENT PROCESSES USED IN HEALTH TECHNOLOGY ASSESSMENT: PHARMACEUTICALS, MEDICAL DEVICES, AND DIAGNOSTICS Noreen J. Sullivan 1, Sheryl L. Szeinbach 2, Enrique C. Seoane-Vazquez 2, Karl A. Matuszewski 3, Kevin W. Mayo 4, 5, Stefan Holmstrom 6, Geoffrey Wilson 7, Annie Chicoye 8 1 Resonance Health Analysis Services Pty Ltd, Encinitas, CA, CA, USA, 2 Ohio State University, College of Pharmacy, Columbus, OH, USA, 3 Gold Standard/Elsevier, Tampa, FL, USA, 4 Bridgehead International, New York, New York, USA, 5 University of the Sciences in Philadelphia, PA, USA, 6 Astellas Pharma Europe, HEOR, Leiderdrop, Netherlands, 7 GE Healthcare, Buckinghamshire, UK, 8 IMS Consulting, Puteaux Cedex, France Health technology assessment (HTA) is used to evaluate health care technologies (e.g., pharmaceuticals, medical devices, and diagnostics) with respect to cost and their projected impact on patient outcomes and society. Currently, there is an ongoing initiative by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to develop Road Maps that describe the utilization of HTA in health care. The first part of this project described the decision makers and the decision-making process for HTA in several countries. The second part of this project adds the reimbursement process for products and devices approved through the HTA process. OBJECTIVE: The purpose of this study was to extend the model for HTA decision-making structures to include reimbursement road maps for several countries. BACKGROUND DATA COLLECTION & STRATEGY: Members of the of the ISPOR Special Interest Group (SIG) contacted key individuals in several countries including: Austria, Denmark, France, Hungary, Ireland, Spain, Taiwan, and UK. Pharmaceuticals, medical devices, and diagnostics were used as the framework for our research. The completed decision model template presented in Figure 1 includes the decision maker, the decision-making process, data requirements, and reimbursement processes for each country. The criteria used included: Decision Maker: Payer (person or organization) who makes final decision for coverage and payment of product. Evaluator/Advisor: Person or organization who provides input into the decision-making process via HTA development and/or review but does not make final decision for coverage and payment. Decision-Making Process: HTA evaluation process, as defined in the public domain, for new and emerging technologies. Reimbursement Process: Describes the strategy for coverage and payment of approved pharmaceuticals, medical devices, and diagnostics. VALIDATION: Once models were completed, they were forwarded to a contact affiliated with each Payer organization to confirm their accuracy. METHODS Figure 1. HTA Decision and Reimbursement Process Model Template Table 1. Summary of Reimbursement Processes for HTA in Target Countries RESULTS This study was designed to characterize and present the reimbursement process for HTA in several countries with respect to Key Decision Makers, Evaluators, Advisors and the decision- making process. Although the reimbursement processes for HTA contained features that are common across the countries examined, the coverage and payment mechanisms varied within each country. Future research will focus on the addition of other countries with respect to decision-making and reimbursement processes and how data are used to determine pricing and reimbursement levels for new and emerging technologies. CONCLUSION ACKNOWLEDGEMENT We would like to thank the members of the ISPOR Special Interest Group for Global Health Care Reimbursement Systems and Decision Processes with special thanks to Randa F. Eldessouki, Nadia G. Naaman, and Marilyn Dix- Smith, PhD. For the most part, reimbursement and payment processes for new and emerging technologies parallel the overall HTA process. Key decision makers and Evaluators play an important role in the reimbursement process for HTA and ultimately, influence Key Decision Makers in the acceptance of new and emerging technologies (Table 1). While pathways for reimbursement and coverage varied across countries, we were able to define key characteristics that defined the reimbursement process for the review and approval of new and emerging technologies in countries around the world. For these countries, reimbursement and payment decisions were the responsibility of decision makers who were either closely connected to the Key Decision Maker or who served as a primary decision maker for HTA. Reimbursement and payment levels varied across countries, with levels of reimbursement based on annual income, co-payment, drug categories, or a pre-determined percentage. Other Advisory entities consisted of various committees and agencies that provided economic evaluations as part of their responsibilities to the Key Decision Makers or provided input upon request as an independent or contracted entity. In summary, the process for reimbursement and coverage of new and emerging technologies in the countries examined was fairly centralized and organized within the overall HTA process. Key Decision Maker (Primary & Secondary) Evaluator/Advisor (Person/Organization) *Leading Payer Organization Country Additional Evaluators/Advisors Formulary or Approved Products List Step 2a Step 2 Step 1 Step 3 Approved Not Approved *Leading Payer Organization: The top 3 payer groups covering the majority of the population. Step 4 Reimbursement Step 5