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Program - Tuesday 11 November 2008 |
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7:00-8:00 |
Educational Symposium (Sponsored by NHS Innovations London) |
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The Do’s and Don’ts with Agencies like NICE or IQWiG – Generating the Right Health Economic Data for Successful Appraisals
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8:00-8:30 |
Exhibits & Poster Presentations Viewing – Session III |
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8:30-9:30 |
ISPOR Forums |
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Health Care Decision MakING around the World : a Global Road Map, Framework of the Decision-Making Process and Application of HTA Methods Principles
Presented by: The ISPOR Health Technology Assessment and Evidence-Based Decisions SIG
The forum will provide clarification of the organizations and processes involved in national health care decision-making through a schematic framework and discuss country specific health care delivery systems and reimbursements processes using The ISPOR Global Health Care Systems Road Map. The forum will conclude with a description of the current application of recently published key principles for HTA methods using data from a global survey of HTA organizations and reimbursement bodies.
Moderator: Kevin Mayo PhD, Co-Chair, ISPOR Global HTA Used in Health Care Reimbursement Working Group and Vice President Market Access Solutions, Bridgehead International Consulting, Denville, NJ, USA
Speakers: Karl Matuszewski MS, PharmD, Co-Chair, ISPOR HTA of Emerging New Technologies Working Group and Senior Director, Clinical Knowledge Service Clinical Practice Advancement Center, University HealthSystem Consortium, Oak Brook, IL, USA; Angeliki Angeli MSc, Institutional Relations and Communication Director, Sanofi Aventis, Athens, Greece; Marcin Czech PhD, MD, MBA, Past President, ISPOR Poland Local Chapter & Adjunct, Dept of Pharmacoeconomics, Faculty of Pharmacy, Medical University of Warsaw, Warsaw, Poland; Bonnie Handke RN, MBA, Co-Chair, ISPOR HTA & Good Research Practices for Reimbursement Decisions Working Group and Director, Health Policy and Planning, Medtronic, Inc, Neuromodulation, Minneapolis, MN, USA
Design And Analysis Of Non-Randomized Studies Of Treatment Effects Using Secondary Databases
Presented by: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force
The Task Force will present major issues of design, analysis, and interpretation of findings from therapeutic effectiveness studies using secondary databases. Methods to handle longitudinal data analysis with time-varying measures including time-dependent confounding will be addressed during this forum.
Speakers: Marc Berger MD, Vice President, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; William Crown PhD, President, i3Innovus, Waltham, MA, USA; Bradley Martin PhD, Associate Professor, College of Pharmacy, University of Arkansas, Little Rock, AK, USA; Uwe Siebert MD, MPH, MSc, ScD, Professor/Chair, Department of Public Health, Medical Decision Making and Health Technology Assessment at the University of Health Sciences, Medical Informatics and Technology, i.T, Austria
Patient Registry Design, Operations, Data & Taxonomy
Presented by: The ISPOR Patient Registry SIG
This session will focus on the practical design and operational considerations in developing registries, the use of patient registry information in evaluating
patient-reported outcomes, and the ISPOR Taxonomy of Patient Registries. Research to date on the classification, characteristics, design, implementation, and
analysis of registries as well as registry reporting & publishing will be presented.
Moderator: Elizabeth Molsen RN, Director, ISPOR Initiatives, ISPOR, Lawrenceville, NJ, USA
Speakers: Chris L. Pashos PhD, Chair, Patient Registry Classification, Strategy & Design Working Group and Vice President and Executive Director, HERQuLES. Abt Associates; Leanne R. Larson MHA, Chair, Patient Registry Design & Operations Working Group and Vice President, Registry Consulting, Ovation Research Group / ICON Clinical Research; Carl Asche PhD, MBA, MS, Associate Professor, University of Utah, Salt Lake City, UT, USA
Patient Reported Outcomes Good Research Practices
Presented by: The ISPOR Patient-Reported Outcomes SIG
Health technology assessors and health care decision-makers use PRO studies to assess product efficacy and effectiveness. Concurrent with the increased
use and significance of PROs in clinical trials is a steady growth in electronic data capture (EDC) and the need to translate and adapt PRO instruments for use
outside the US and Europe. Good research practices in PRO development, modification, mode of administration and translational & linguistic validation are
important for improving the value of this information to decision-makers. This session will present the recommendations of the ISPOR PRO Good Research
Practices Task Forces.
Moderator: Donald Patrick PhD, MSPH, ISPOR PRO Task Force Developer & Member and Professor, University of Washington, Seattle, WA, USA
Speakers: Nancy Kline Leidy PhD, ISPOR PRO Existing Instruments & Their Modifications Task Force Member & Senior Vice President of Scientific Affairs,
United BioSource Corporation, Bethesda, MD, USA; Keith Wenzel BS, ISPOR ePRO Task Force Member & Product Director, ePRO, Perceptive Informatics, Inc.,
Boston, MA, USA; Diane Wild MSc, Chair, ISPOR PRO Translation & Linguistic Validation Task Force and Director, Oxford Outcomes, Oxford, UK
How Do Local Financing Arrangements Impact the Availability of and Access to Medical Devices in Europe? A Multi-Country Perspective
Presented by: The ISPOR Europe Medical Device & Diagnostics Council Forum
National regulatory and financing mechanisms have a significant impact on the development of medical device and diagnostics. A greater understanding of how
different financing systems operate in the context of the medical device sector to develop and support policies that facilitate efficient, high-quality, innovative,
and sustainable health care will be discussed.
Moderator: Michael F. Drummond PhD, Professor of Health Economics, Centre for Health Economics, University of York, York, UK
Speakers: Michael Baeumler MSc, Research Fellow, Department for Health Care Management, Berlin University of Technology, Berlin, Germany; Corinna
Sorenson MPH, MHSA, Research Officer, LSE Health, London School of Economics, London, UK; Giulia Capellaro MSc, Research Fellow, Centre for Research
on Healthcare and Social Management, Bocconi University, Milan, Italy
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9:30-10:00 |
Break, Exhibits & Poster Presentations Viewing – Session III |
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10:00-11:00 |
Issue Panels – Session II |
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PATIENT-REPORTED OUTCOMES RESEARCH ISSUES
IP6: PUBLIC-PRIVATE PARTNERSHIPS IN PRO INSTRUMENT DEVELOPMENT: AN IDEA WHOSE TIME HAS COME?
Moderator: Nancy Kline Leidy PhD, Senior Vice President Scientific Affairs, United BioSource Corporation, Bethesda, MD, USA
Panelist(s): Laurie B. Burke RPh, MPH, Director, FDA/CDER/OND-IO, Silver Spring, MD, USA; Asha Hareendran PhD, Senior Director, Global Outcomes Research, Pfizer, Ltd, UK & Chair, COPD PRO Working Group of the EFPIA Innovative Medicines Initiative (IMI) Respiratory calls, Sandwich, UK; Ingela Wiklund PhD, Director, Global Health Outcomes, GlaxoSmithKline, UK & Co-Chair, COPD PRO Working Group of the EFPIA Innovative Medicines Initiative (IMI) Respiratory calls, Uxbridge, Middlesex, UK
HEALTH POLICY DEVELOPMENT USING OUTCOMES RESEARCH ISSUES
IP7: IS THE PURSUIT OF QALY MAXIMISATION A NOBLE CAUSE? (Speakers at this panel were Invited)
Moderator: Adrian Towse MA, MPhil, Director, Office Health Economics, London, UK
Panelist(s): Mark J. Sculpher PhD, Professor, University of York, York, UK; Erik Nord PhD, Senior Researcher, Norwegian Institute of Public Health, Oslo, Norway; Georg Marckmann MPH, MD Professor, University of Tüebingen, Department of Medical Ethics, Tübingen, Germany
IP8: FAST IS BEST! IS RAPID HEALTH TECHNOLOGY ASSESSMENT TO SUPPORT MARKET ACCESS DECISION-MAKING A GOOD THING?
Moderator: Jeanni Van Loon MSc, Development Director - Europe, Mapi Values, Houten, The Netherlands
Panelist(s): Keith H. Tolley MPhil, Director, Tolley Health Economics Limited, Buxton, Derbyshire, UK; Meindert Boysen MSc, Associate Director Single Technology Appraisals, National Institute for Health and Clinical Excellence (NICE), Manchester, UK; Andrew Walker PhD, Senior Lecturer, University of Glasgow, Glasgow, UK
IP9: MARKET ACCESS OF MEDICAL DEVICES IN EUROPE: HAVE METHODOLOGICAL APPROACHES BECOME A HINDRANCE OR HELP?
Moderator: Stacey J. Ackerman MSE, PhD, Vice President, Covance Market Access Services Inc, San Diego, CA, USA Panelist(s): Uwe Siebert MD, MPH, MSc, ScD, Professor/Chair, Department of Public Health, Medical Decision Making and Health Technology Assessment at the University of Health Sciences, Medical Informatics and Technology, i.T, Austria; Arne Heissel PhD, Director Reimbursment & Health Economics, Spinal & Biologics, Medtronic International, Tolochenaz, Switzerland
IP10: FUTURE SCIENTIFIC AND POLICY CONSEQUENCES OF THE IQWIG APPROACH FOR EUROPE
Moderator: Mark JC Nuijten MD, PhD, MBA, Consultant, Ars Accessus Medica/Erasmus University Rotterdam, Amsterdam, The Netherlands
Panelist(s): Christoph Vauth MSc, Head Health Technology Unit, Leibniz University Hannover, Hannover, Germany; John Hutton PhD, Professor of Health Economics, University of York, York, UK |
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11:00-12:00 |
Poster Author Discussion Hour - Session III |
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11:30-13:00 |
Lunch, Exhibits & Poster Presentations Viewings – Session III |
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11:45-12:45 |
Educational Symposium (Sponsored by i3 Innovus) |
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Personalized Medicine and Targeted Therapy - Who Will Pay for Advances in
Cancer Care?
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12:00-13:00 |
ISPOR Health Technology Assessment And Evidence Based Decisions SIG Informal Meeting |
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Santorini 1-2 |
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13:00-14:20 |
Third Plenary Session |
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Can We Agree on International Guidelines for Economic Evaluation of Health Care Interventions?
Economic (pharmacoeconomic) evaluation is a tool used to assist decision making in the financing and management of health care interventions (drugs, medical devices, and diagnostics) in the health care system or national or private health insurance programs in an individual country. Economic (pharmacoeconomic) guidelines can be used as a standard for preparation of studies to be included in application for reimbursement, a guide for designing and conducting a study, or a template for evaluating the economic study reports. Although there are many similarities between these guidelines from countries and/or technology assessment institutions, methods used to assess technologies may differ. During this session, two methods for economic evaluations used in health care decisions (i.e. incremental cost per QALY and efficiency frontier analysis), as well as the consequences for patient access to innovative health technologies using these methods, will be debated.
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Moderator:
Milton Weinstein PhD
Professor Health Policy and Management, Harvard School of Public Health, Boston, MA, USA |
| IS THE ESTIMATION OF INCREMENTAL COST PER QALY THE ANSWER? |
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Speaker:
Michael Drummond PhD
Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK |
| IS EFFICIENCY FRONTIER APPROACH THE ANSWER? |
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Speaker:
J. Jaime Caro MD,
Senior Vice President of Health Economics, United BioSource Corporation, Concord MA, USA |
| WHY CAN'T WE WORK TOGETHER? |
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Speaker:
Uwe Siebert MPH, MSc
Professor/Chair, Department of Public Health, Medical Decision Making and Health Technology Assessment at the University of Health Sciences, Medical Informatics and Technology, i.T, Austria |
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14:20-14:30 |
ISPOR Research Awards |
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14:30-14:45 |
Break, Exhibits & Poster Presentations Viewing – Session III |
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14:45-15:45 |
Workshops – Session III |
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CLINICAL OUTCOMES RESEARCH
W15: MAXIMISING CLINICAL TRIAL PARTICIPATION – HOW IMPORTANT IS THE SOCIAL CONTEXT?
Discussion Leaders: Matthew D. Reaney MSc, PGDip, Senior Scientist, Health Psychology, AHP Research, Uxbridge, UK; Jane Speight MSc, PhD, Director, AHP Research, Uxbridge, UK; Colin Martin RN, BSc, PhD, YC, Chair in Mental Health, University of the West of Scotland, Ayr, UK
ECONOMIC OUTCOMES RESEARCH
W16: QUANTIFYING AND DISPLAYING UNCERTAINTY AROUND AN EFFICIENCY FRONTIER
Discussion Leaders: Isao Kamae MD, DrPH, Professor, Keio University Graduate School of Health Management, Fujisawa, Kanagawa, Japan; J. Jaime Caro MDCM, FRCPC, FAC, Senior Vice President Health Economics, United BioSource Corporation, Lexington, MA, USA
W17: PRACTICAL ISSUES IN THE EXECUTION OF A BUDGET IMPACT ANALYSIS: A CASE STUDY
Discussion Leaders: Stefan Walzer MA, International Economic Strategy Manager, F. Hoffmann-La Roche Pharmaceuticals AG, PBSE - Economic Value Strategy, Basel, Switzerland; Mark JC Nuijten MD, PhD, MBA, Consultant, Ars Accessus Medica/Erasmus University Rotterdam, Amsterdam, The Netherlands
PATIENT-REPORTED/PREFERENCE-BASED RESEARCH
W18: A CHECKLIST FOR GOOD RESEARCH PRACTICES FOR THE APPLICATION OF CONJOINT ANALYSIS IN HEALTH – FINAL REPORT
Discussion Leaders: John FP Bridges PhD, Assistant Professor, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA; A. Brett Hauber PhD, Senior Economist and Head, RTI Health Solutions, Research Triangle Park, NC, USA; Maarten J. Ijzerman PhD, Professor of Clinical Epidemiology & HTA, University of Twente, Enschede, The The Netherlands
W19: ADDRESSING CROSS-CULTURAL ISSUES WITH PATIENT-REPORTED OUTCOMES ASSESSMENTS TO STRENGTHEN EVIDENCE OBTAINED IN AN INTERNATIONAL CONTEXT
Discussion Leaders: Antoine Regnault PhD, Associate Statistician, Mapi Values France, Lyon, France; Isabelle Mear MA, Managing Director, Mapi Research Institute, Lyon, France; Shalaka Marfatia MS, MPH, Manager Global Outcomes Research, Pfizer Inc, New York, NY, USA; Patrick Mollon MD, ESSEC, MBA, Associate Director, Pfizer Ltd, Sandwich, UK
W26: THE NEW CHILD-FRIENDLY EUROQOL VERSION: EQ-5D-Y
Discussion Leaders: Wolfgang Greiner PhD, Professor for Health Economics and Health Care Management, University of Bielefeld, Faculty of Public Health, Bielefeld, North Rhine-West, Germany; Luciana Scalone PharmD, DSc, Researcher, Centre of Pharmacoeconomics, University of Milan, Milan, Italy; Paul Kind, Professor, University of York, Outcomes Research Group, York, United Kingdom; Frank T. De Charro PhD, Health Economist, Erasmus University Rotterdam, Centre for Health Policy and Law, Rotterdam, The Netherlands.
USE OF REAL WORLD DATA
W20: USE OF REAL WORLD DATA: CHALLENGES IN THE ANALYSIS OF PATIENT REGISTRY DATA
Discussion Leaders: Christopher M. Blanchette PhD, MS, MA, Associate Scientist and Director, Lovelace Respiratory Research Institute, Albuquerque, NM, USA; Shital Kamble BPharm, MMS, MS, Doctoral Student- Research Assistant, The University of North Carolina at Charlotte, Charlotte, NC, USA; Alex Exuzides PhD, Director, ICON Clinical Research, San Francisco, CA, USA; Carl J. Gibbons BsC, (Psych), Research Analyst, Schering-Plough, Welwyn Garden City, UK
HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH
W21: VALUE BASED PRICING IN GERMANY – OLD WINE IN NEW BOTTLES?
Discussion Leaders: Olaf Pirk MD, PhD, Principal, IMS Health, Nuremberg, Germany; Frank-Ulrich Fricke PhD, MSc, Principal, IMS Health, Nuremberg, Germany; Christian Krauth PhD, Head of Working Group Health Economy, Hannover Medical School, Epidemiology, Social Medicine and Health System Research, Hannover, Germany
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15:45-16:00 |
Break, Exhibits & Poster Presentations Viewing – Session III |
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16:00-17:00 |
Workshops – Session IV |
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CLINICAL OUTCOMES RESEARCH
W22: STATISTICAL MEASURES OF TREATMENT EFFECT IN ONCOLOGY: WHAT ARE WE MISSING?
Discussion Leaders: Deirdre Mladsi BA, Global Head, RTI Health Solutions, Research Triangle Park, NC, USA; William D. Irish PhD, Global Head, Biometrics, RTI Health Solutions, Research Triangle Park, NC, USA; Kati Copley-Merriman MBA, MS, Global Head, Regulatory and Health Outcomes Strategy, RTI Health Solutions, Ann Arbor, MI, USA; TBD
ECONOMIC OUTCOMES RESEARCH
W23: COLLABORATIVE MULTI-NATIONAL HEALTH ECONOMIC AND PRO DATA GATHERING: A CASE STUDY HIGHLIGHTING THE ATHENS STROKE REGISTRY
Discussion Leaders: Krista Payne MEd, Director & Research Scientist, United BioSource Corporation, Montreal, QC, Canada; Kostas Vemnos MD, Professor, University of Athens School of Medicine, Alexandra Hospital, Athens, Greece; Liberty Fajutrao MD, MSc, Senior Health Economics and Outcome Research Scientist, AstraZeneca R&D, Sodertalje, Sweden
W24: MODELING OF INFECTIOUS DISEASES AND THEIR TREATMENT FOR HEALTH-ECONOMIC ANALYSIS
Discussion Leaders: Mario Ouwens PhD, Research Consultant, Mapi Values, Houten, Netherlands; Debby Vissers MSc, Senior Research Associate, Mapi Values, Houten, Netherlands; Thierry Van Effelterre dr, Mathematical Modeller, GlaxoSmithKline Biologicals, WW Bio Epidemiology, Rixensart, Belgium
PATIENT-REPORTED/PREFERENCE-BASED RESEARCH
W25: DISCRETE CHOICE MODELING FOR THE QUANTIFICATION OF HEALTH STATES: THE CASE OF THE EQ-5D
Discussion Leaders: Paul Krabbe PhD, Senior Scientist, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands; Luciana Scalone PharmD, DSc, Researcher, Centre of Pharmacoeconomics, Milan, Italy; Mark Oppe MSc, Researcher, Erasmus Medical Center, Rotterdam, The Netherlands; Elly Stolk PhD, Senior Research Associate, Erasmus Medical Center, Rotterdam, The Netherlands
USE OF REAL WORLD DATA
W27: NON-US DATA SOURCES FOR DISEASE AND HEALTH MANAGEMENT: WHAT IS THERE, HOW ARE THEY USED LOCALLY AND HOW TO USE THEM FOR OTHER RESEARCH
Discussion Leaders: Oliver Mast MSc, Head of Global Reimbursement, Roche Diagnostics, Mannheim, Germany; Tomas Sechser MD, PhD, Researcher, The Diabetes Centre, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH
W28: FOOD FOR THOUGHT: SHOULD REIMBURSEMENT CRITERIA FOR PHARMACEUTICALS ALSO BE APPLIED TO NUTRITIONALS?
Discussion Leaders: Eline Kogels MSc, Consultant, Kogels Consultancy Network, Amsterdam, The Netherlands; Mark JC Nuijten MD, PhD, MBA, Consultant, Ars Accessus Medica/Erasmus University Rotterdam, Amsterdam, The Netherlands |
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11th Annual European Congress Main Page
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