international society for pharmacoeconomics and outcomes research
ISPOR 14th Annual European Congress 5-8 November 2011 Hotel Auditórium Madrid
Madrid, Spain Rational Health Care Decision Making in Challenging Economic Times
PROGRAM
OVER 1500 PRESENTATION S
22% Increase abstracts in submitted!
Early Registration Deadline: 20 September 2011
KEY INFORMATION CONGRESS PROGRAM COMMITTEE
RESEARCH POSTER PRESENTATIONS
PROGRAM COMMITTEE CHAIR Xavier Badia, PhD, MD, MPH, Global Leader, Observational COE & Senior Principal, HEOR, IMS Health, Barcelona, Spain
POSTER SESSION I: SUNDAY, 6 NOVEMBER Set-Up: 11:30-12:00 Poster Display Hours: 12:00-20:00 Poster Author Discussion Hour: 18:15-19:15 Dismantle: 20:00-20:30
RESEARCH REVIEW COMMITTEE CO-CHAIRS Jan J.V. Busschbach, PhD, Interim Director, Department of Medical Psychology & Psychotherapy, Erasmus MC, Rotterdam, The Netherlands Dominik Golicki, MD, PhD, MA, Partner, HealthQuest sp z o.o., Warsaw, Poland Michael Schlander, PhD, MD, MBA, Chairman & Scientific Director, Institute for Innovation & Valuation in Health Care (InnoVal), Wiesbaden, Germany Erkki Soini, MSc, RN, Chief Executive Officer, ESiOR Ltd., Kuopio, Finland WORKSHOP REVIEW COMMITTEE CO-CHAIRS Fernando Antoñanzas, MA, PhD, Economist, Department of Economics, University of La Rioja, Logrono, Spain Nancy J. Devlin, PhD, Director of Research, Office of Health Economics, London, UK ISSUE PANEL REVIEW COMMITTEE CO-CHAIRS Peter Hertzman, PhD, Executive Director, HEOR, BMS Europe, Rueil Malmaison, France Jacco Keja, PhD, Regional Leader, EMEA, HEOR, IMS Health, London, UK and Lecturer in Life Sciences Pricing and Management, Institute for Health Policy and Management, Erasmus University, Rotterdam, The Netherlands DECISION-MAKER CASE STUDY REVIEW COMMITTEE CHAIR Antoni Gilabert Perramon, PhD, Managing Director of Pharmaceutical Care and Complementary Benefits, Catalan Health Service, Department of Health and Social Security, Government of Catalonia, Barcelona, Spain CONGRESS PROMOTIONAL OPPORTUNTIES
EXHIBIT: Register now! Over 2900 attendees in 2010! ADVERTISE: Advertise in the Program and Schedule of Events! SPONSOR: Give your company increased visibility and prominence! ADVERTISING DEADLINE: 16 September 2011
POSTER SESSION II: MONDAY, 7 NOVEMBER Set-Up: 7:30-8:00 Poster Display Hours: 8:00-19:30 Poster Author Discussion Hour: 17:30-18:30 Dismantle: 19:30-20:00 POSTER SESSION III: TUESDAY, 8 NOVEMBER Set-Up: 7:30-8:00 Poster Display Hours: 8:00-16:00 Poster Author Discussion Hour: 11:00-12:00 Dismantle: 16:00-16:30 CONGRESS VENUE INFORMATION/ HOTEL RESERVATIONS
Hotel Auditórium Madrid Avenida de Aragón, 400, 28022 Madrid The hotel is conveniently situated near the Madrid International Airport Barajas and is approximately 16 km (10 miles) from central Madrid. ISPOR Rates: The discounted room rate for ISPOR congress attendees is r113 for single occupancy and r128 for double occupancy. These rates include applicable taxes and daily complimentary buffet breakfast. Delegate rates are available until the deadline of 6 November 2011 (subject to availability) Reservations: Must be made using the Hotel Auditórium online reservation system available at www.ispor.org (Event name: ISPORNOV). Cancellations or changes to reservations without penalty must be made 30 days prior to arrival.
for more info: www.ispor.org
ISPOR 14th Annual European Congress 5-8 November 2011 n Madrid, Spain SATURDAY, 5 NOVEMBER All Day Course (9:00-18:00) Introduction to Pharmacoeconomics
Lieven Annemans, PhD, MMan, MSc, Ghent University – Brussels University, Belgium This course incorporates pharmacoeconomics into study design and data analysis. Participants collect and calculate costs of different alternatives, determine the economic impact of clinical outcomes, and identify, track and assign costs to different types of health care resources used.
Saturday, 5 November
MORNING COURSES (9:00-13:00) NEW! Introduction to Design & Analysis of Retrospective Database Studies
Michael Johnson, PhD, College of Pharmacy, University of Houston, USA This course will provide an overview of analytic techniques and specific best practices to improve causal inference in retrospective database studies, including an introductory level discussion of causal graphs, stratification analysis, propensity scoring, instrumental variable and structural modeling techniques.
Introduction to Patient-Reported Outcomes Assessment: Instrument Development & Evaluation
Andrew Lloyd, DPhil; Annabel Nixon, PhD; & Sarah Acaster, MSc, Oxford Outcomes, UK Instrument development and evaluation includes psychometric analyses such as the use of factor analysis and other techniques. This course will cover the recent draft guidance from the FDA as well as existing guidance from the EMEA regarding instrument development.
Introduction to Modeling
Uwe Siebert, MD, MPH, MSc, ScD, University of Health Sciences, Medical Informatics and Technology, Austria, & Harvard Medical School, Boston, MA, USA This course presents an introductory discussion of pharmacoeconomic modeling techniques such as Monte Carlo analysis, Markov modeling, and probabilistic sensitivity analysis.
Discrete Event Simulation for Economic Analyses – Concepts
J. Jaime Caro, MDCM, FCRPC, FACP, McGill University & United BioSource Corporation, USA; Jörgen Möller, MSc Mech Eng, United BioSource Corporation, Sweden Topics to be covered are: How does it work, what are the components of a DES, where is it used, for which problems is DES well suited, what are the advantages and disadvantages of DES, PSA as a simple task.
Bayesian Methods in Economic Evaluations – Introduction
Christopher S. Hollenbeak, PhD, Penn State College of Medicine, USA This course provides an overview of the Bayesian approach and its applications to health economics and outcomes research. It covers basic elements of Bayesian statistics, contrasting briefly with classical (frequentist) statistics and introduces available statistical packages.
Statistical Methods for Pharmacoeconomics & Outcomes Research
Andrew Briggs, PhD, University of Glasgow, UK; Neil Hawkins, PhD, MSc, University of York, UK An introduction to statistical methods with an emphasis on the use of techniques commonly employed in pharmacoeconomics and outcomes research is given. Key considerations for planning and analyzing studies and interpreting results will be reviewed. Differences between a classical (frequentist) approach to statistics and a Bayesian view of probability are discussed.
Cost-Effectiveness Analysis alongside Clinical Trials
Scott Ramsey, MD, PhD, Fred Hutchinson Cancer Research Center, USA; Sean Sullivan, PhD, MSc, University of Washington, USA; Richard Willke, PhD, Pfizer, Inc, USA This course will present the design, conduct, and reporting of cost-effectiveness analyses alongside clinical trials. Trial design, selecting data elements, database design and management, analysis, and reporting of results will be presented.
Full Short Course descriptions at www.ispor.org
Elements of Pharmaceutical/Biotech Pricing I – Introduction
Jack M. Mycka, Global MME LLC, USA; Renato Dellamano, PhD, MME Europe & ValueVector, Italy This course gives participants a basic understanding of the key terminology and issues involved in pricing decisions. It covers the tools to build and document product value, the role of pharmacoeconomics and the differences in payment systems that help to shape pricing decisions.
Saturday, 5 November
AFTERNOON COURSES (14:00-18:00) Meta-Analysis & Systematic Literature Review
Neil Hawkins, PhD, MSc, University of York, UK; Olivia Wu, PhD, MSc, University of Glasgow, UK This course highlights and expounds upon four key areas: 1) impetus for meta-analysis and systematic reviews; 2) basic steps to perform a quantitative systematic review; 3) statistical methods of combining data; and 4) appraisal and use of meta-analytic reports.
Applications in Using Large European Databases
John Parkinson, PhD, GPRD, UK; Ron Herings, PhD, PharmD, Pharmo, The Netherlands; Rob Thwaites, MA, MCom, United BioSource Corporation, UK This course evaluates European health care databases, discussing each in-depth with directions on how to access information and how researchers utilize this information. The ISPOR International Digest of Databases - a tool that identifies databases around the world for research purposes - will be discussed.
Patient Registries
Leanne Larson, MHA, Outcome, USA; Michelle Bulliard, RN, BScN, MICR, Outcome, Switzerland; Elizabeth Hernberg-Stahl, MSc, Late Phase Solutions Europe AB, Sweden This course reviews patient registries and their applications in identifying “real world” clinical, safety, and patient-perspective issues. The pros and cons of registry data and how it can support health economics/outcomes research initiatives and decision making are addressed. Registry strategy, design, operations and measures of program success are discussed.
Advanced Retrospective Database Analysis
William H. Crown, PhD, Optum Insights, USA This course discusses the ISPOR Checklist for Retrospective Database Studies and selected topics related to estimators and sampling distributions, properties of sampling distributions, and ordinary least squares (OLS) regression.
Utility Measurements (Preference-Based Techniques)
Jan Busschbach, PhD, Erasmus Medical Center & Viersprong Institute for Studies on Personality Disorders, The Netherlands Methods for measuring preference-based outcomes and important issues are reviewed, such as: potential insensitivity of generic instruments for disease-specific problems, and to what extent adaptation of generic or disease-specific quality of life instruments may offer a solution.
Pharmacoeconomic Modeling – Applications
Mark S. Roberts, MD, MPP, University of Pittsburgh Graduate School of Public Health, USA Students will have hands-on experience in constructing a decision analysis tree including Markov models, Monte Carlo simulations, sensitivity analysis, determination of probability values and transition probabilities. This course is a follow-up to “Introduction to Modeling”.
Discrete Event Simulation for Economic Analyses – Applications
J. Jaime Caro, MDCM, FCRPC, FACP, McGill University & United BioSource Corporation, USA; Jörgen Möller, MSc Mech Eng, United BioSource Corporation, Sweden Topics to be covered are: Components of a DES; How do you build a model? Modeling of processes and resource use; Modeling of variables and decisions. Simple animation will be demonstrated using ARENA software.
Introduction to Health Technology Assessment (HTA)
Uwe Siebert, MD, MPH, MSc, ScD, University of Health Sciences, Medical Informatics and Technology, Austria, & Harvard Medical School, USA This course introduces key elements, methods and language of health technology assessment (HTA) and provides an overview of basic HTA disciplines. Using real world examples, the course –2–
reviews the practical steps involved in developing and using HTA reports in different countries and health care systems.
Sunday, 6 November
MORNING COURSES (8:00-12:00) Bayesian Methods in Economic Evaluations – Advanced Keith R. Abrams, PhD, University of Leicester, UK This course covers the differences between Bayesian and classical approaches, and the application of Bayesian analysis to clinical trials and cost-effectiveness analyses.
Reimbursement Systems in Europe
James Furniss; Sasha Richardson, MBA; & Timothy Fitzgerald, Bridgehead International, UK This course reviews procedures employed by European health authorities to regulate market access. Faculty describe reimbursement legislation, processes and organizations of various countries and describe the role of the pharmaceutical and/or medical device manufacturer.
Risk-Sharing/Performance-Based Arrangements
Adrian Towse, MA, MPhil, Office of Health Economics, UK; Lou Garrison, PhD; & Josh Carlson, PhD, University of Washington, USA Theory and practice, including incentives and barriers, of these arrangements are analyzed using examples of performance-based schemes from Europe, the United States, and Australia.
Case Studies in Pharmaceutical/Biotech Pricing II – Advanced
Jack M. Mycka, MME LLC, USA; Renato Dellamano, PhD, MME Europe & ValueVector, Italy Case studies analyze new product pricing, focusing on the need to thoroughly evaluate the business environment and the need to integrate pricing, reimbursement and pharmacoeconomics strategies with clinical development and marketing strategies.
Transferability of Cost-Effectiveness Data between Countries
JL (Hans) Severens, PhD; SMAA Evers, PhD LL.M; & MA Joore, PhD, Maastricht University, The Netherlands This course discusses factors that make economic data more difficult to transfer from one country to another than clinical data, and the evidence on the variability of cost-effectiveness results across countries. We will review the methods that offer a solution and their pros and cons. Finally, we will discuss emerging international guidance for dealing with issues of transferability.
Cost Estimation and Assessing Financial (Budget) Impact of New Health Care Technologies
Josephine Mauskopf, PhD, RTI Health Solutions, USA; C. Daniel Mullins, PhD, University of Maryland, USA Learn methods to determine the cost-of-illness of a health condition using a “top-down” or “bottom-up” approach. Learn how to estimate the impact of new health care technologies.
NEW! Establishing the Content Validity of PatientReported Outcome (PRO) Instruments
Donald L. Patrick, PhD, MSPH, University of Washington; Mona L. Martin, RN, MPA, Health Research Associates, Inc.; Chad Gwaltney, PhD, Brown University, USA Requirements for establishing content validity of PRO instruments, definitions of evidence requirements, issues necessitating clarity, and logistical needs for gathering acceptable evidence are covered. Practical exercises are used to establish evidence of content validity for PRO instruments.
NEW! Conjoint Analysis – Theory & Methods
A. Brett Hauber, PhD, RTI Health Solutions, USA; John F. P. Bridges, PhD, Johns Hopkins Bloomberg School of Public Health, USA Discuss the conceptual basis for quantifying decision maker preferences for medical interventions and practical design and analytical issues that must be addressed to obtain valid empirical preference estimates.
NEW! Network Meta-Analysis in Relative Effectiveness Research Jeroen P. Jansen, PhD, Mapi Values, USA The fundamentals and concepts of network meta-analysis will be presented and proposed. Case studies are implemented with the WinBUGS package. This course requires basic knowledge of metaanalysis and statistics.
ISPOR 14th Annual European Congress 5-8 November 2011 n Madrid, Spain IP4: MULTICRITERIA DECISION ANALYSIS (MCDA): A COMMON ROAD MAP FROM DRUG DEVELOPMENT TO REGULATORY AND REIMBURSEMENT DECISIONS? Moderator: Ron Goeree, MA, Director, Programs for Assessment of Technology in Health Research Institute, McMaster University, Hamilton, ON, Canada Panelists: Bruno Flamion, MD, PhD, Pharmacological and Medical Expert, Federal Agency for Medicines and Health Products, Brussels, Belgium; Carole Longson, PhD, Director, Centre for Health Technology Evaluation, National Institute for Health and Clinical Excellence (NICE), Manchester, UK; Mireille Goetghebeur, PhD, Vice President, Operations, BioMedCom Consultants Inc., Dorval, QC, Canada IP5: THE IMPACT OF REGULATORY (FDA AND EMA) AND EUNETHTA GUIDELINES ON PATIENTREPORTED OUTCOMES AND HEALTH-RELATED QUALITY OF LIFE ON MARKET AUTHORISATION AND PRICING Moderator: Benoit Arnould, PhD, Director, MAPI Group, MAPI Values, Lyon, France Panelists: Mira Pavlovic, MD, Deputy Director, DEMESP, French National Authority for Health (HAS), Saint-Denis la Plaine, France; Tara Symonds, PhD, Senior Director, Outcomes Research, Pfizer Ltd., Sandwich, Kent, UK; Paul Trueman, MA, EU Development Director, Mapi Values, Bollington, Cheshire, UK
PROGRAM SATURDAY, 5 NOVEMBER 9:00-18:00
PRE-CONGRESS SHORT COURSES
18:15-19:15 EDUCATIONAL SYMPOSIUM VALUING INNOVATION: SHOULD INNOVATION BE CONSIDERED IN PRICING AND REIMBURSEMENT OF HEALTH CARE TECHNOLOGIES? This symposium will discuss ways of defining and measuring innovation and the use of value-based pricing to reflect the value of innovation in pricing and reimbursement decisions. A case study illustrating the estimation of the full life-cycle value of an innovative technology will be presented. (Sponsored by OptumInsight) 19:30-20:30 EDUCATIONAL SYMPOSIUM VALUE BASED PRICING – PAST, PRESENT AND THE FUTURE An overview of VBP using examples of health care systems in which it has been implemented will be presented. An explanation of how value assessments have been conducted within the VBP agenda in key markets and the challenges of introducing VBP into a health care system, using the example of the UK, will be provided. This symposium will provide insight into the challenges and identify the differences in the relative importance of VBP elements for different market and therapy areas. (Sponsored by Double Helix)
16:00-17:00 WORKSHOPS – SESSION I W1: COMPARATIVE EFFECTIVENESS ANALYSES USING SIMULATED TREATMENT COMPARISON (STC) Discussion Leaders: K. Jack Ishak, PhD, Director, Biostatistics & Senior Research Scientist, United BioSource Corporation, Dorval, QC, Canada; Laurent Eckert, PhD, sanofi-aventis R&D, Massy, France; J. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice President of Health Economics, United BioSource Corporation, Lexington, MA, USA W2: MODELING EARLY PRICING AND STRATEGIC ASSESSMENTS OF ONCOLOGY AGENTS Discussion Leaders: Adam Lloyd, MPhil, Senior Principal, IMS Health, London, UK; Julie Munakata, MS, Principal, HEOR, IMS Consulting Group, Redwood City, CA, USA; Thomas Tencer, PhD, Global Market Access and Health Economics, Eisai, Inc., Woodcliff Lake, NJ, USA W3: DEALING WITH EXTERNALITIES WITHIN THE CONTEXT OF HEALTH TECHNOLOGY ASSESSMENTS Discussion Leaders: Aline Gauthier, MSc, Director, Health Economics and Outcomes Research, Amaris Consulting UK, London, UK; Lieven Annemans, PhD, Professor, Centre for Health Economics Research and Health Economist, I-CHER, University of Ghent, Ghent, Belgium W4: MOVING TOWARDS VALUE BASED HEALTH CARE IN DIFFERENT CONSTITUENCIES: A PRESENTATION ON BEHALF OF THE ISPOR VALUE BASED HEALTH CARE SPECIAL INTEREST GROUP Discussion Leaders: Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA; Edward Kim, MD, MBA, Executive Director, Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; Eldon Spackman, PhD, Research Fellow, Center for Health Economics, University of York, Heslington, York, UK; Huseyin Naci, MHS, PhD Candidate, London School of Economics, London, UK W5: MULTIPLE CRITERIA DECISION ANALYSIS FOR HEALTH TECHNOLOGY ASSESSMENT Discussion Leaders: Praveen Thokala, PhD, Research Associate, University of Sheffield, Sheffield, UK; Alejandra Dueñas, PhD, Associate Professor of Operations Management, Management Department, IÉSEG School of Management - Lille-Paris, Paris, France; Nancy J. Devlin, PhD, Director of Research, Office of Health Economics, London, UK W6: MIXING MODES OF PATIENT-REPORTED OUTCOMES DATA COLLECTION IN CLINICAL TRIALS: ISPOR PRO GOOD RESEARCH PRACTICE TASK FORCE REPORT RECOMMENDATIONS Discussion Leaders: Stephen Joel Coons, PhD, Executive Director, Patient-Reported Outcome (PRO) Consortium, Critical Path Institute, Tucson, AZ, USA; Damian McEntegart, MSc, Senior Director, Statistics & Product Support Services, Perceptive Informatics, Nottingham, UK; Sonya Eremenco, MA, e-PRO Manager, United BioSource Corporation, Bethesda, MD, USA; Jean Paty, PhD, Founder & Senior Vice President, Scientific, Quality & Regulatory Affairs, Invivodata, Inc., Pittsburgh, PA, USA W7: PROSPECTIVE OBSERVATIONAL STUDIES FOR NEWLY LAUNCHED DRUGS TO ASSESS RELATIVE EFFECTIVENESS Discussion Leaders: Adrian Towse, MA, Director, Office of Health Economics, London, UK; Sebastian Schneeweiss, MD, ScD, Director of Drug Evaluation and Outcomes Research, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA; Mark Cziraky, PharmD, Vice President, Research Development and Operations, HealthCore, Inc., Wilmington, DE, USA; Wim Goettsch, PhD, Deputy Secretary of the Medicinal Products Reimbursement Committee and European network for Health Technology Assessment (EUnetHTA) Partner, Health Care Insurance Board (CVZ), Diemen, The Netherlands W8: WORKING WITH PHYSICIANS, MEDICAL RECORDS, AND PATIENTS TO COLLECT OBSERVATIONAL, REAL-WORLD DATA: THE GOOD, THE BAD, AND THE UGLY Discussion Leaders: Elisa Cascade, MBA, Vice President, MediGuard.org, Rockville, MD, USA; David Ford, MBA, FRSA, Director, Health Informatics Research Labs, Swansea University, Swansea, UK; Melanie Blackwood, MSc, EU Head of Late Phase Project Management, Quintiles, Bracknell, Berkshire, UK
SUNDAY, 6 NOVEMBER 8:00-12:00
PRE-CONGRESS SHORT COURSES
12:00-12:30
EXHIBITS & POSTER PRESENTATIONS – SESSION I
12:30-14:15 WELCOME & FIRST PLENARY SESSION WELCOME & PRESENTATION OF ISPOR SERVICE AWARDS & VALUE IN HEALTH AWARD Mark J. Sculpher, MSc, PhD, 2011-2012 ISPOR President and Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK CONGRESS PROGRAM OVERVIEW Xavier Badia, PhD, MD, MPH, Program Committee Chair First Plenary Session: PROS AND CONS OF A CENTRALIZED EUROPEAN PRICING & REIMBURSEMENT AGENCY One of the goals of the European Union (EU), established in 1993, is the integration of processes which are common to all member countries. For example, the European Medicines Agency (EMA) is responsible for the evaluation of medicine applications for European marketing authorization. Under this centralised procedure companies submit a single marketing authorisation application to the Agency. Once granted, marketing authorisation is valid in all 27 EU member countries. Many of the processes for evaluating a new drug, device, or diagnostic for pricing and reimbursement decisions are common to all EU member countries. Should an agency similar in structure to EMA be established with a centralized procedure for pricing and reimbursement? Should this be a decision making agency or only undertake health technology assessment? If the latter, what forms of evaluation should be undertaken? The pros and cons of such an agency will be debated. Moderator: Mark J. Sculpher, MSc, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK Speakers: Hans-Georg Eichler, MD, MSc, Profesor & Senior Medical Officer, European Medicines Agency and CBI Visiting Scholar & Robert E. Wilhelm Fellow, Massachusetts Institute of Technology, London, UK; Adrian Towse, MA, Director, Office of Health Economics, London, UK 14:45-15:45 ISSUE PANELS – SESSION I IP1: VALUING DIAGNOSTICS: DO WE NEED DIFFERENT METRICS? Moderator: Peter J. Neumann, ScD, Professor & Director, The Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA Panelists: Mark J. Sculpher, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK; Ken Redekop, PhD, Associate Professor, Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands; Manuel GarcíaGoñi, PhD, Assistant Professor, Applied Economics, University of Madrid, Madrid, Spain IP2: VALUE-BASED PRICING: HOW DO APPROACHES VARY BY HEALTH CARE CONTEXT? Moderator: Bengt Jonsson, PhD, Professor of Economics, Stockholm School of Economics, Stockholm, Sweden Panelists: Isao Kamae, MD, DrPH, Professor, Department of Pharmacoeconomics, Keio University Graduate School of Health Management, Fujisawa, Japan; J-Matthias Graf von der Schulenburg, PhD, Professor of Economics & Director, Institute of Risk and Insurance, Gottfried Wilhelm Leibniz Universität Hannover, Hannover, Germany; Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK IP3: GREENPARK COLLABORATIVE PILOT Moderator: Sean Tunis, MD, MSc, Founder & Director, Center for Medical Technology Policy, Baltimore, MD, USA Panelists: Marc Berger, MD, Executive Vice President & Senior Scientist, Life Sciences, OptumInsight, New York, NY, USA; Hans-Georg Eichler, MD, MSc, Profesor & Senior Medical Officer, European Medicines Agency and CBI Visiting Scholar & Robert E. Wilhelm Fellow, Massachusetts Institute of Technology, London, UK; Finn Børlum Kristensen, MD, PhD, Director of Coordinating Secretariat, European network for Health Technology Assessment (EUnetHTA) and Chairman of the EUnetHTA Executive Committee, Copenhagen, Denmark
17:15-18:15 WORKSHOPS – SESSION II W9: GENERALIZED EVIDENCE SYNTHESIS IN COMPARATIVE EFFECTIVENESS RESEARCH: COULD THE EVIDENCE BASE BE BROADENED IN MIXED TREATMENT COMPARISONS? Discussion Leaders: David Vanness, PhD, Assistant Professor, Department of Population Health Sciences, University of Wisconsin, Madison, WI, USA; Agnes Benedict, MSc, MA, Research Scientist, United BioSource Corporation, Budapest, Hungary W10: A REVIEW OF THE TECHNICAL SUPPORT DOCUMENTS FOR THE APPLICATION OF NICE METHODS GUIDANCE ON THE MEASUREMENT AND VALUATION OF HEALTH Discussion Leaders: John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Louise Longworth, PhD, Reader in Health Economics, Health Economics Research Group, Brunel University, Uxbridge, UK; Roberta Ara, MSc, Research Fellow, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Andrew J. Lloyd, DPhil, Director, Oxford Outcomes, Oxford, UK –3–
ISPOR 14th Annual European Congress 5-8 November 2011 n Madrid, Spain PROGRAM CONTINUED... W11: PROBLEMATIC SENSITIVITY ANALYSIS: DRAWBACKS AND A WAY FORWARD Discussion Leaders: Julie Roiz, MSc, Senior Specialist, Health Economics, GlaxoSmithKline Biologicals, Wavre, Belgium; Gerhart Knerer, MA, MSc, PhD Student, Department of Operational Research, University of Southampton, Southampton, UK W12: BIOSIMILAR ACCESS: THE FUTURE OF VALUE ASSESSMENT Discussion Leaders: Cyrus A. Chowdhury, MSc, Vice President, Global Market Access, Insight Strategy Advisors, New York, NY, USA; Monica Martin de Bustamante, Fellow, Global Market Access, Insight Strategy Advisors, New York, NY, USA; Corinna Sorenson, MPH, MHSA, Research Fellow, European Health Policy, Health & Social Care, London School of Economics and European Health Technology Institute for Socio-Economic Research, London, UK W13: HTA IN GERMANY: EVIDENCE REQUIREMENTS, THE ROLE OF BENEFIT/COST ASSESSMENT, FIRST EXPERIENCES AND CHALLENGES WITH THE GERMAN HEALTH BILL AMNOG Discussion Leaders: Anne Kilburg, MSc, Senior Director, Market Access and Outcomes Strategy Europe, RTI Health Solutions, Manchester, UK; Peter Kolominsky-Rabas, PhD, MBA, Director, Centre for Health Technology Assessment (HTA) and Public Health (IZPH), University of Erlangen-Nurnberg, Erlangen, Germany; Jens Grueger, PhD, Vice President & Head, Global Market Access Primary Care, Pfizer Ltd., Tadworth, Surrey, UK; Anne Heyes, MBA, Head, Market Access and Outcomes Strategy Europe, RTI Health Solutions, Manchester, UK W14: VALUING HEALTH IN ECONOMIC EVALUATIONS; INNOVATIVE RESPONSES TO METHODOLOGICAL CHALLENGES Discussion Leaders: Ben A. Van Hout, PhD, Professor of Health Economics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Paul F.M. Krabbe, PhD, Associate Professor, Department of Epidemiology, HTA Unit, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Paul Kind, MSc, MPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK; Brendan Mulhern, Msc, Researcher, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK W15: DOES OBSERVATIONAL RESEARCH SUPPORT THE GOALS OF COMPARATIVE EFFECTIVENESS RESEARCH (CER)? Discussion Leaders: Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA; Alex Exuzides, PhD, Director, Late Phase & Outcomes Research, ICON, San Francisco, CA, USA; Hannah Patrick, MRCP, MFPHM, Consultant Clinical Advisor to the IP Programme, National Institute of Clinical Excellence (NICE), London, UK W16: GETTING NON-INTERVENTIONAL STUDIES OVER START-UP HURDLES IN EUROPE: STAKEHOLDER CHALLENGES & PERSPECTIVES Discussion Leaders: Louise Parmenter, PhD, Senior Director, Late Phase Strategy and Planning, Quintiles, Inc., Bracknell, Berkshire, UK; Herman Pieterse, PhD, Professor, Clinical Pharmacology, University of Ghent, Heerhugowaard, The Netherlands; Jean-Louis Merot, MD, Senior Director, Late Phase Project Management, Quintiles, Levallois-Perret, France 18:15-19:15
POSTER AUTHOR DISCUSSION HOUR – SESSION I
18:15-20:00 EXHIBITORS’ RECEPTION & POSTER PRESENTATIONS – SESSION I
9:45-10:15 BREAK, EXHIBITS & POSTER PRESENTATIONS – SESSION II 10:15-11:15 ISSUE PANELS – SESSION II IP6: OPPORTUNITIES AND CHALLENGES FOR COMPARATIVE EFFECTIVENESS PRAGMATIC CLINICAL TRIALS IN EUROPE Moderator: Marc L. Berger, MD, Executive Vice President & Senior Scientist, Life Sciences, OptumInsight, New York, NY, USA Panelists: Sean Tunis, MD, MSc, Founder & Director, Center for Medical Technology Policy, Baltimore, MD, USA; David Price, MD, Professor & Director, Optimum Patient Care Ltd., Cawston, UK; Finn Børlum Kristensen, MD, PhD, Director of Coordinating Secretariat, European network for Health Technology Assessment (EUnetHTA) and Chairman of the EUnetHTA Executive Committee, Copenhagen, Denmark IP7: PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS IN ONCOLOGY: HOW DO THESE NEW INNOVATIVE TECHNOLOGIES INFLUENCE HEALTH POLICY AND DERIVE VALUE WITHOUT SPECIFIC DESIGNS FOR COMPARATIVE EFFECTIVENESS? Moderator: Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK Panelists: Sean D. Sullivan, PhD, RPh, MS, Professor & Director, Pharmaceutical Outcomes Research and Policy Program, University of Washington School of Pharmacy, Seattle, WA, USA; Steve Clark, BA, Vice President, Market Access & Reimbursement, i3 Innovus, Eden Prairie, MN, USA; Josephine Sollano, PhD, Head of Oncology, Outcomes, Pfizer, New York, NY, USA IP8: VALUE-BASED PRICING: WHAT WILL IT MEAN IN PRACTICE? Moderator: John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK Panelists: Karl Claxton, PhD, Professor & Senior Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK; Jens Grueger, PhD, Vice President & Head, Global Market Access Primary Care, Pfizer Ltd., Tadworth, Surrey, UK; Adrian Towse, MA, Director, Office of Health Economics, London, UK IP9: HTA OF MEDICAL DEVICES IN EUROPE: COOPERATION BETWEEN EVALUATION AGENCIES AND IMPLICATIONS FOR INDUSTRY Moderator: Geoffrey Wilson, DPhil, MSc, Head of Health Economics & Reimbursement, EMEA, GE Healthcare, Chalfont-St-Giles, Bucks, UK Panelists: Ken Redekop, PhD, Associate Professor, Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands; Antonio Sarría-Santamera, MD, PhD, Director, Department of Social Medicine, Agency for Health Technology Assessment, Madrid, Spain; Francois Meyer, MD, Director HTA Division, Department of Medical, Economic and Public Health, French National Authority for Health (HAS), Paris, France IP10: HOW WILL INNOVATOR TECHNOLOGIES FARE IN AN INCREASINGLY RESTRICTIVE GLOBAL REIMBURSEMENT ENVIRONMENT: LESSONS FROM COMPARISON OF CELL AND GENE THERAPIES TO CONVENTIONAL BIOPHARMACEUTICALS Moderator: Eric C. Faulkner, MPH, Senior Director, Market Access and Outcomes Strategy, RTI Health Solutions, Research Triangle Park, NC, USA Panelists: Daryl S. Spinner, PhD, MBA, Senior Associate, Market Access and Outcomes Strategy, RTI Health Solutions, Research Triangle Park, NC, USA; Koenraad Blot, MD, Managing Director, Xintera Consulting, Leuven, Belgium; Katherine Payne, PhD, Professor, Health Sciences-Economics, University of Manchester, Manchester, UK 11:30-12:30
MONDAY, 7 NOVEMBER 7:00-8:00 EDUCATIONAL SYMPOSIUM THE ROLE OF HEALTH ECONOMICS PROFESSIONALS AS CATALYSTS OF CHANGE: DRIVING CHANGE IN PRODUCT DEVELOPMENT TO SATISFY PAYER REQUIREMENTS This symposium will address the need for change in product development to satisfy payer stakeholders and the role of health outcomes and health economics departments in leading this change. (Sponsored by PAREXEL International) 8:00-8:30 EXHIBITS & POSTER PRESENTATIONS – SESSION II 8:30-9:45 WELCOME & SECOND PLENARY SESSION WELCOME & PRESENTATION OF ISPOR RESEARCH EXCELLENCE AWARD Mark J. Sculpher, MSc, PhD, 2011-2012 ISPOR President and Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK SECOND Plenary Session: THE REALITY OF REAL WORLD DATA AND ITS USE IN HEALTH CARE DECISIONS IN EUROPE Initial decisions on reimbursement of a new technology usually include the extent to which it does more good than harm under ideal circumstances [efficacy]. However, the goal is to determine the extent to which a technology does more good than harm under usual circumstances of health care practices [effectiveness]. How is this information on ‘usual circumstance of health care practices’ being collected, analyzed, and reported? Who is responsible for collecting, analyzing and reporting the information? Manufacturers? Government? During this session, the issues of collecting and analyzing real world data in Europe, such as patient registry data, reimbursement data, prospective observational studies, or other health care practice-based information will be presented. The question of who is responsible and the real use of this information in healthcare decision-making will be debated. Moderator: Xavier Badia, PhD, MD, MPH, Global Leader, Observational COE & Senior Principal, Health Economics and Outcomes Research, IMS Health, Barcelona, Spain Speakers: Patrick Keohane, Global Outcomes, AstraZeneca, Södertälje, Sweden; Enrique BernalDelgado, MD PhD, Head, Health Services Research and Health Policy Unit (ARiHS), Health Research Institute of Aragón (IIS), Co-Chair, Atlas of Variations in Medical Practice in Spain and Scientific Coordinator, ECHO Project, Zaragoza, Spain; Leslie Levin, MD, FRCP (Lon), FRCPC, Head & Senior Medical Advisor, Ontario Ministry of Health and Long-Term Care, Toronto, ON, Canada
RESEARCH PODIUM PRESENTATIONS – SESSION I
ASSESSING EFFECT OF MEDICATION ADHERENCE AND PERSISTENCE ON COST-EFFECTIVENESS AD1: COMPLIANCE MEASUREMENT USING ADMINISTRATIVE DATA FROM GERMAN SICKNESS FUNDS Frey S, Stargardt T, University of Hamburg, Hamburg, Germany AD2: COST-CONSEQUENCE ANALYSIS OF SWITCHING FROM AN ORAL ANTIPSYCHOTIC TO LONG ACTING INJECTABLE RISPERIDONE AMONG PATIENTS WITH SCHIZOPHRENIA Degli Esposti L, Sangiorgi D, Buda S, CliCon Srl, Ravenna, Italy AD3: ASSESSING THE COMPLIANCE AND PERSISTENCE OF ALLERGEN IMMUNOTHERAPY IN ALLERGIC RHINITIS USING A RETROSPECTIVE PHARMACY DATABASE FROM THE NETHERLANDS Kiel MA1, Gerth van Wijk R2, Röder E2, Al MJ1, Hop WC2, Rutten-van Mölken MP1, 1Erasmus University, Rotterdam, The Netherlands, 2Erasmus Medical Center, Rotterdam, The Netherlands AD4: PREDICTORS AND OUTCOMES OF PATIENTS WITH ACUTE CORONARY SYNDROME WHO RECEIVE OPTIMAL THERAPY: RESULTS FROM THE ANTIPLATELET TREATMENT OBSERVATIONAL REGISTRIES (APTOR I AND II) Zeymer U1, Berkenboom G2, Coufal Z3, Belger M4, Tomlin ME5, Sartral M6, Norrbacka K7, Fakhouri W4, Bakhai A8, 1Herzzentrum Ludwigshafen, Ludwigshafen, Germany, 2ULB Erasme University Hospital, Brussels, Belgium, 3Bata’s Regional Hospital, Zlin, Czech Republic, 4Eli Lilly and Company, Windlesham, Surrey, UK, 5Eli Lilly and Company, Indianapolis, IN, USA, 6Eli Lilly and Company, Suresnes, France, 7Eli Lilly and Company, Vantaa, Finland, 8Barnet General Hospital, Barnet, UK ALTERNATIVE VIEWS IN CANCER OUTCOMES RESEARCH CN1: MEAN VERSUS MEDIAN OVERALL SURVIVAL (OS) FOR DESCRIBING VALUE OF NEW CANCER THERAPIES: A CASE STUDY Davies A1, Briggs A1, Wagner S2, Kotapati S3, Schneider J4, Ebeid O4, Levy AR5, 1Oxford Outcomes Ltd., Oxford, UK, 2Bristol-Myers Squibb Company, Washington Crossing, PA, USA, 3Bristol-Myers Squibb Pharmaceuticals, Wallingford, CT, USA, 4Oxford Outcomes Ltd., Morristown, NJ, USA, 5Oxford Outcomes Ltd., Vancouver, BC, Canada CN2: MEASURING PUBLIC PREFERENCES FOR COLORECTAL CANCER SCREENING USING NEW GENOME-BASED NANOTECHNOLOGIES Fermont JM, Groothuis-Oudshoorn K, IJzerman MJ, University of Twente, Enschede, The Netherlands CN3: VALIDATION STUDY OF THE BASELINE QUALITY OF LIFE AS A PROGNOSTIC INDICATOR OF SURVIVAL: A POOLED ANALYSIS OF INDIVIDUAL PATIENT DATA FROM NCIC CLINICAL TRIALS Ediebah DE1, Quinten C2, Coens C1, Zikos E1, Ringash J3, Gotay C4, Flechtner HH5, Osoba D6, King – 4 – M7, Cleeland C8, Greimel E9, Reeve BB10, Taphoorn M11, Schmucker-Von Koch J12, Weis J13, Bottomley
PROGRAM CONTINUED... St Prex, Switzerland; Olivier Ethgen, MSc, PhD, Associate Professor of Health Economics, Department of Public Health Sciences, University of Liege, Liege, Belgium W19: REWARDING INNOVATION: ONE STEP FORWARD, TWO STEPS BACK? Discussion Leaders: Alistair Mcguire, PhD, Head of Social Policy, LSE Health and Social Care, London, UK; Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK; Benedikte Lensberg, MSc, Project Leader, OptumInsight, Uxbridge, UK; Monique Martin, Msc, MBA, Vice President, UK & French HEOR Operations, OptumInsight, Uxbridge, UK W20: WHAT CAN PATIENT PREFERENCE STUDIES TELL US ABOUT PATIENT ADHERENCE? A NOVEL INSIGHT INTO AN OLD PROBLEM Discussion Leaders: Andrew J. Lloyd, DPhil, Director, Oxford Outcomes, Oxford, UK; A. Brett Hauber, PhD, Senior Economist and Vice President, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA; John F.P. Bridges, PhD, Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA W21: LINKING EXISTING DATABASES – POISONED CHALICE OR HOLY GRAIL? Discussion Leaders: Alison Bourke, MSc, MRPharmS, Managing Director, UK, Cegedim Strategic Data Medical Research Ltd., London, UK; Ron M.C. Herings, PhD, Director, PHARMO Institute, Utrecht, The Netherlands; Daniel Huse, MA, Vice President, Thomson Reuters, Cambridge, MA, USA; Robert J. LoCasale, PhD, MS, Senior Epidemiologist, Epidemiology, Merck, North Wales, PA, USA
A1, 1European Organisation for Research and Treatment of Cancer Head Quarters, Bruxelles, Belgium, 2European Center for Disease Prevention and Control, Surveillance and Response Support Epidemiological Methods Unit, Stockholm, Sweden, 3The Princess Margaret Hospital, Toronto, QC, Canada, 4University of British Columbia, Vancouver, BC, Canada, 5Otto-von-Guericke University Magdeburg, Magdeburg, Germany, 6Quality of Life Consulting, West Vancouver, BC, Canada, 7University of Sydney, Sydney, Australia, 8University of Texas, M.D. Anderson Cancer Center, Houston, TX, USA, 9 Medical University of Graz, Graz, Austria, 10University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 11VU University Medical Center, Department of Neurology, The Hague, The Netherlands, 12University of Regensburg, Regensburg, Germany, 13University of Freiburg, Freiburg, Germany CN4: HETEROGENEITY IN PREDICTING THE FUTURE IMPACT OF TECHNOLOGIES TO CONTROL HEPATOCELLULAR CARCINOMA (HCC): A COMPARISON OF STAKEHOLDER VIEWS FROM EUROPE AND ASIA Bridges JF1, Gallego G1, Joy SM1, Blauvelt BM2, 1Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 2University of Massachusetts, Hadley, MA, USA NEW APPROACHES FOR EFFECTIVE USE OF DATA DA1: ARTIFICIAL NEURAL NETWORK META-MODELS IN COST-EFFECTIVENESS ANALYSIS OF INTENSIVE BLOOD-GLUCOSE CONTROL: A CASE STUDY APPLIED TO THE UK PROSPECTIVE DIABETES STUDY (UKPDS) INDIVIDUAL PATIENT OUTCOME SIMULATION MODEL Alam M1, Briggs A2, 1University of Glamorgan, Pontypridd, UK, 2Glasgow University, Glasgow, UK DA2: A CHOICE THAT MATTERS: COMPARING METHODS OF DATA SYNTHESIS IN COSTEFFECTIVENESS MODELLING Vemer P, Al M, Oppe M, Rutten-Van Mölken M, iMTA, Erasmus University, Rotterdam, The Netherlands DA3: THE POWER OF ASSUMPTIONS Van Hout BA, Stevens JW, University of Sheffield, Sheffield, UK DA4: FINDING TREATMENT EFFECTS WITHIN SUBGROUPS WHEN USING THE PROPENSITY SCORE TO CONTROL FOR SELECTION BIAS: A MONTE CARLO SIMULATION STUDY van Eeren H1, Spreeuwenberg MD2, van Manen JG3, de Rooij M4, Stijnen T5, Busschbach J1, 1Erasmus University Medical Center, Rotterdam, The Netherlands, 2Maastricht University, Maastricht, The Netherlands, 3Viersprong Institute for Studies on Personality Disorders, Halsteren, The Netherlands, 4 Methodology and Statistics Unit, FSW, Leiden University, Leiden, The Netherlands, 5Department of Medical Statistics & Bioinformatics, Leiden University Medical Center, Leiden, The Netherlands ESTIMATION OF PRODUCTIVITY COST PC1: PRODUCTIVITY COSTS IN MOOD DISORDERS – DO THE METHODOLOGICAL CHALLENGES JUSTIFY THE PRECLUSION OF PRODUCTIVITY COSTS FROM ECONOMIC EVALUATIONS? Lensberg B1, Drummond M2, Danchenko N3, Despiégel N4, François C3, 1OptumInsight, Uxbridge, UK, 2 University of York, Heslington, York, UK, 3Lundbeck SAS, Issy-les-Moulineaux , France, 4OptumInsight, Nanterre, France PC2: ESTIMATION OF PRODUCTIVITY COSTS USING THE FRICTION COST METHOD: NEW EVIDENCE USING NATIONAL DATA erdogan-Ciftci E, Koopmanschap MA, Erasmus University Rotterdam, Rotterdam, The Netherlands PC3: BREAST AND PROSTATE CANCER PRODUCTIVITY COSTS: A COMPARISON OF THE HUMAN CAPITAL APPROACH AND FRICTION COST APPROACH Hanly P, Timmons A, Walsh P, Sharp L, National Cancer Registry Ireland, Cork, Ireland PC4: HEALTH SERVICES UTILIZATION, WORK ABSENTEEISM AND COSTS OF PANDEMIC INFLUENZA A (H1N1) Garin O1, Galante M1, Sicuri E1, Cots F2, Garcia-Altés A3, Ferrer M4, Nebot M1, Dominguez À1, Alonso J4, 1 CIBERESP, Barcelona, Spain, 2Parc de Salut Mar, Barcelona, Spain, 3Catalan Agency for Health Information, Assessment and Quality (CAHIAQ), Barcelona, Spain, 4IMIM-Hospital del Mar, Barcelona, Spain DIFFERENCES AND OPPORTUNITIES IN PRICING AND MARKET ACCESS PR1: KEY MARKET ACCESS DRIVERS FOR A SUCCESSFUL HEALTH TECHNOLOGY APPRAISAL OUTCOME – THE CASE OF RHEUMATOID ARTHRITIS Ackermann J1, Urbinati D2, Strandberg-Larsen M3, Toumi M4, 1Creativ-Ceutical, Paris, France, 2CreativCeutical, Luxembourg, Luxembourg, 3Novo Nordisk A/S, Søborg, Denmark, 4University Claude Bernard Lyon 1, Lyon, France PR2: VALUE-BASED PRICING IN THE UK: DEVELOPING AN EVALUATION FRAMEWORK FOR BURDEN OF ILLNESS Easley C1, Tang J2, 1Pope Woodhead & Associates, St Ives, UK, 2Cambridge University, Cambridge, UK PR3: INDUSTRY PREPAREDNESS AGAINST GERMAN REFORMS Devienne E1, White R2, Mukku S2, 1University of Cambridge, Cambridge, UK, 2Double Helix Consulting Group, London, UK PR4: ANALYSIS OF PRICE LEVELS OF PRESCRIPTION DRUGS AND DETERMINANTS OF INTERNATIONAL PRICE DIFFERENCES BETWEEN THE UNITED STATES AND SELECTED EUROPEAN COUNTRIES Kanavos P, Vandoros S, Ferrario A, London School of Economics and Political Science, London, UK
15:00-15:15
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS – SESSION II
15:15-16:15
RESEARCH PODIUM PRESENTATIONS – SESSION II
HEALTH CARE DECISION-MAKER’S CASE STUDIES CASE1: THERAPEUTIC EQUIVALENCE AS A MEANS OF IMPROVING THE EFFICIENCY IN THE USE OF BIOLOGICAL AGENTS IN RHEUMATOID ARTHRITIS Bautista J1, Garcia Lopez A1, Flores S2, 1Hospital Virgen del Rocio, Sevilla, Spain, 2Agencia de Evaluacion de Tecnologias Sanitarias de Andalucia, Sevilla, Spain CASE2: MAIN CONCERNS ABOUT BIAS SUBMITTED BY STAKEHOLDERS SUPPORTING THE INTRODUCTION OF NEW DRUGS INTO THE FORMULARY OF THE VENETO REGION Visentin E1, Alberti C1, Maran PR1, Aiello A2, Magrì MR1, Miggiano C1, Scroccaro G1, 1Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy, 2PBE Consulting, Verona, Italy CASE3: ESTABLISHING A NATIONAL PROGRAM FOR PUBLIC INITIATION AND FINANCING OF RESEARCH – THE CASE OF NORWAY Ringard Å, Wang H, Høymork SC, Norwegian Knowledge Centre for the Health Services, Oslo, Norway CASE4: IMPLEMENTATION OF AN ONLINE DRUG MONITORING AND SAFETY REGISTRY FOR CHILDREN PRESCRIBED ANTIPSYCHOTICS Wegner SE1, Trygstad T2, Wegner LM3, McKee J2, Sheitman B3, 1AccessCare, Morrisville, NC, USA, 2North Carolina Community Care Networks, Inc., Raleigh, NC, USA, 3University of North Carolina at Chapel Hill, Chapel Hill, NC, USA MIXED TREATMENT COMPARISONS MATURE MT1: IMPACT OF THE CHOICE OF PRIOR DISTRIBUTION ON RELATIVE EFFECT SIZES USING BAYESIAN NETWORK META-ANALYSIS Goring S1, Ghement I2, Kalsekar A3, L’Italien G4, Levy A5, 1Oxford Outcomes, Vancouver, BC, Canada, 2 Ghement Statistical Consulting, Richmond, BC, Canada, 3Bristol-Myers Squibb, Princeton, NJ, USA, 4 Bristol-Myers Squibb and Yale University School of Medicine, Wallingford, CT, USA, 5Dalhousie University, Halifax, NS, Canada MT2: THE USE OF CONTINUOUS DATA VERSUS CATEGORICAL DATA IN MTC: THE CASE OF HAQ MULTIPLIER IN RHEUMATOID ARTHRITIS Schmitz S1, Adams RC2, Walsh C1, Barry M2, 1Trinity College Dublin, Dublin, Ireland, 2National Centre for Pharmacoeconomics, Dublin, Ireland MT3: A BAYESIAN APPROACH TO MODEL SELECTION PROCEDURES WITHIN MIXED TREATMENT COMPARISON FRAMEWORK Osiewalski K, Szmurlo D, HTA Consulting, Krakow, Poland MT4: MIXED TREATMENT COMPARISONS USING AGGREGATE AND INDIVIDUAL-PARTICIPANT LEVEL DATA: AN EFFICIENT USE OF EVIDENCE FOR COST-EFFECTIVENESS MODELLING Saramago P1, Sutton AJ2, Cooper NJ2, Manca A1, 1University of York, Heslington, York, UK, 2University of Leicester, Leicester, Leicestshire, UK DECISIONS AND THE IMPACT OF NICE IN THE UK NI1: THE UK NICE SINGLE TECHNOLOGY APPRAISAL PROCESS: A QUALITATIVE STUDY BASED ON MANUFACTURERS’ SUBMISSIONS Kaltenthaler E, University of Sheffield, Sheffield, UK NI2: THE IMPACT OF NICE GUIDANCE ON THE DIFFUSION OF MEDICAL DEVICES Cabo R1, Sorenson C2, Lynch P3, Eggington S3, 1GE Healthcare, Bucks, UK, 2London School of Economics and European Health Technology Institute for Socio-Economic Research, London, UK, 3Medtronic, Tolochenaz, Switzerland NI3: ECONOMIC EVALUATION IN NICHE MARKETS: THE ROLE OF THE UK’S ADVISORY GROUP FOR NATIONAL SPECIALISED SERVICES FOR RARE DISEASES AND DISORDERS Khan N1, Kiss N1, Pang F2, 1Oxford Outcomes Ltd., Morristown, NJ, USA, 2Shire Human Genetic Therapies, Inc, Basingstoke, UK NI4: THE ASSOCIATION BETWEEN FINANCIAL IMPACT AND THE LIKELIHOOD OF RECOMMENDATION OF MEDICINES FOR USE IN ENGLAND AND WALES Mauskopf JA1, Chirila C1, Birt J2, Boye KS2, Bowman L2, Grainger D2, 1RTI Health Solutions, Research Triangle Park, NC, USA, 2Eli Lilly and Company, Indianapolis, IN, USA MERGING PRO AND UTILITY ASSESSMENT UT1: COMBINING DCE AND TTO INTO A SINGLE VALUE FUNCTION Van Hout BA1, Oppe M2, 1University of Sheffield, Sheffield, UK, 2iMTA, Rotterdam, The Netherlands UT2: UPDATE OF THE PATIENT-REPORTED OUTCOME AND QUALITY OF LIFE INSTRUMENTS DATABASE (PROQOLID) USING THE FDA GUIDANCE ON PRO MEASURES Caron M, Perrier LL, Vaissier V, Savre I, Acquadro C, MAPI Research Trust, Lyon, France UT3: THE VALIDITY OF THE EQ-5D, SF-6D, SF-36 AND SF-12 IN MENTAL HEALTH CONDITIONS. A SYSTEMATIC REVIEW Papaioannou D, Peasgood T, Brazier J, Parry G, University of Sheffield, Sheffield, UK
12:30-14:00 LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS – SESSION II 12:45-13:45 EDUCATIONAL SYMPOSIUM BEYOND REAL-WORLD EVIDENCE The current focus of many pharmaceutical organizations is the use of real-world evidence (RWE) in product research and development decisions. However, the field of RWE is by no means clear. Many methodological and perhaps even more fundamental philosophical questions will need to be answered. This symposium will explore the methodological and fundamental philosophical questions relating to the use of RWE and identify future directions beyond RWE. (Sponsored by IMS Consulting Group) 14:00-15:00 WORKSHOPS – SESSION III W17: DESIGNING BETTER COMPARATIVE EFFECTIVENESS RESEARCH Discussion Leaders: Penny Mohr, MA, Vice President, Program Development, Center for Medical Technology Policy, Baltimore, MD, USA; Richard Gliklich, MD, President & CEO, Outcome, Cambridge, MA, USA; Robert W. Dubois, MD, PhD, Chief Science Officer, National Pharmaceutical Council, Washington, DC, USA W18: PRODUCTIVITY GAINS - UNDERVALUED AND OF INCREASING IMPORTANCE IN AN ERA OF SHRINKING NUMBERS OF WORKING-AGED ADULTS? Discussion Leaders: M.J. Postma, PhD, Professor, Department of Pharmacy, University of Groningen, Groningen, The Netherlands; Mark Connolly, PhD, Managing Director, Global Market Access Solutions, –5–
PROGRAM CONTINUED... UT4: COMPARISON OF THE PERFORMANCE OF EQ-5D AND SF-6D IN PATIENTS WITH CHRONIC PAIN –RESULTS FROM 3 RANDOMIZED CONTROLLED TRIALS Obradovic M, Lal A, Liedgens H, Grünenthal GmbH, Aachen, Germany Added value of value of information VI1: DETERMINING THE IMPACT OF MODELING ADDITIONAL SOURCES OF UNCERTAINTY IN VALUE OF INFORMATION ANALYSIS Corro Ramos I, Rutten-van Mölken MP, Al MJ, Erasmus University Rotterdam, Rotterdam, The Netherlands VI2: A NOVEL APPROACH TO ANALYSING VALUE DRIVER IMPORTANCE ACROSS MULTIPLE TARGET PRODUCT PROFILES Wild L, Mukku SR, Double Helix Consulting Group, London, UK VI3: SEQUENTIAL TREATMENT OF FOLLICULAR NON-HODGKIN LYMPHOMA: COST-EFFECTIVENESS AND VALUE OF INFORMATION Soini EJ1, Martikainen JA1, Vihervaara V2, Mustonen K2, Nousiainen T3, 1ESiOR Ltd, Kuopio, Finland, 2 Roche Oy, Espoo, Finland, 3Department of Medicine, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland VI4: THE VALUE OF INFORMATION OF A MULTICENTRE RANDOMISED CONTROLLED TRIAL OF INTRAVENOUS IMMUNOGLOBULIN FOR SEPSIS (SEVERE SEPSIS AND SEPTIC SHOCK) Soares MO, University of York, Heslington, York, UK 16:30-17:30
Netherlands, 2Erasmus University Rotterdam, Rotterdam, The Netherlands, 3RUG, Groningen, The Netherlands RISK SHARING AND PATIENT ACCESS RS1: LITERATURE REVIEW ON PATIENT ACCESS SCHEMES, FLEXIBLE PRICING SCHEMES AND RISK SHARING AGREEMENTS FOR MEDICINES Puig-Peiró R, Mestre-Ferrandiz J, Sussex J, Towse A, Office of Health Economics, London, UK RS2: COST-EFFECTIVENESS OF END-OF-LIFE, LIFE-EXTENDING INTERVENTIONS: NICE’S COSTEFFECTIVENESS THRESHOLD EXPLORED Hamerslag L, Haynes S, Kusel J, Costello S, Costello Medical Consulting Ltd., Cambridge, UK RS3: EVIDENCE, PROCESS OR CONTEXT? EXAMINING THE FACTORS THAT DRIVE COVERAGE DECISIONS OF PHARMACEUTICALS BY HEALTH TECHNOLOGY ASSESSMENT BODIES IN EUROPE Cerri K, Fernández JL, Knapp M, London School of Economics and Political Science, London, UK RS4: THE INTERIM CANCER DRUGS FUND: HOW TO NOT SPEND ≤50 MILLION Timm B, Brooks-Rooney C, Hamerslag L, Costello S, Costello Medical Consulting, Cambridge, UK 17:30-18:30
POSTER AUTHOR DISCUSSION HOUR – SESSION II
17:30-18:30 ISPOR FORUM THE ASSESSMENT OF MEDICAL TECHNOLOGIES IN RUSSIA: 15 YEARS OF ROAD MAP DEVELOPMENT This forum will focus on the development of decision making in Russia’s health care system during the last 15 years. The impact of the application of outcomes research, health care expenditure and the recent federal reforms implemented in the Russian Federation health care system will be discussed. Presented by the ISPOR Russia and Russia Far-East Regional Chapters
RESEARCH PODIUM PRESENTATIONS – SESSION III
TAKING HETEROGENEITY INTO ACCOUNT HG1: APPLYING FRAILTY MODEL IN LONGITUDINAL SURVIVALS OF CHRONIC DISEASES Li Y, Holtzer-Goor K, Uyl-de Groot C, Al M, iMTA, Erasmus University Rotterdam, Rotterdam, The Netherlands HG2: CHARACTERIZING THE INDIVIDUAL COURSE OF HEALTH-RELATED QUALITY OF LIFE AFTER SUBARACHNOID HEMORRHAGE Winter Y1, Klotsche J2, Ringel F3, Spottke A4, Gharevi N4, Klockgether T4, Schramm J4, Urbach H4, Wittchen HU2, Rehm J2, Meyer B3, Dodel R1, 1Philipps-University, Marburg, Germany, 2Technical University Dresden, Dresden, Germany, 3Klinikum Rechts der Isar, Technical University, Munich, Germany, 4University of Bonn, Bonn, Germany HG3: COST COMPARISONS AND METHODOLOGICAL HETEROGENEITY IN COST-OF-ILLNESS STUDIES: THE EXAMPLE OF COLORECTAL CANCER Hanly P1, O’Ceilleachair A1, Skally M1, O’Neill C2, Sharp L1, 1National Cancer Registry, Cork, Ireland, 2 National University of Ireland Galway, Galway, Ireland HG4: THE VALUE OF HETEROGENEITY FOR COST-EFFECTIVENESS SUBGROUP ANALYSIS: THEORETICAL FRAMEWORK AND APPLICATION Espinoza M1, Manca A2, Claxton K3, Sculpher MJ4, 1University of York, Heslington, York, UK REIMBURSEMENT DECISIONS BASED ON HTA ARGUMENTS HT1: EFFECTIVENESS, EFFICIENCY AND BUDGET IMPACT AFFECT THE BELGIAN DRUG REIMBURSEMENT DECISION (DRD) Bormans V, Van Wilder P, SMART&BI, Zaventem, Belgium HT2: VALUE-BASED PRICING: ONE THRESHOLD TOO FAR FOR THE UK Roberts G, Double Helix Consulting Group, London, UK HT3: UNDERSTANDING THE COMPLEXITY OF HTA NETWORKS Andreykiv M1, Van Engen A1, Wiebinga C1, Zorzi O1, Mark R2, 1Quintiles, Hoofddorp, The Netherlands, 2 Ni3 AG, Zürich, Switzerland HT4: WHAT DETERMINES THE RECOMMENDATIONS ISSUED BY POLISH HEALTH TECHNOLOGY AGENCY (AHTAPOL)? Niewada M, Polkowska MA, Jakubczyk M, Golicki D, HealthQuest, Warsaw, Poland CROSSWALKS BETWEEN QALY INSTRUMENTS AND PROS MA1: MAPPING THE EQ-5D INDEX FROM I-QOL IN IDIOPATHIC AND NEUROGENIC OAB PATIENTS: RESULTS FROM A CROSS-SECTIONAL STUDY IN THE UNITED STATES AND FOUR EUROPEAN COUNTRIES Kay S1, Tolley K2, Globe D3, Piercy J4, Anderson P4, 1Adelphi Real World, Bollington, Cheshire, UK, 2Tolley Health Economics, Buxton, UK, 3Allergan, LLC, Irvine, CA, USA, 4Adelphi Real World, Macclesfield, Cheshire, UK MA2: MAPPING FACT-P TO COUNTRY SPECIFIC PATIENT HEALTH STATUS MEASURED BY EQ-5D IN METASTATIC CASTRATE RESISTANT PROSTATE CANCER PATIENTS Spencer M1, Diels J2, 1Janssen-Cilag UK Limited, High Wycombe, UK, 2Janssen Pharmaceutica, Beerse, Belgium MA3: MAPPING THE DIABETES HEALTH PROFILE (DHP-18) ONTO THE EQ-5D AND SF-6D GENERIC PREFERENCE BASED MEASURES OF HEALTH Meadows K1, Mulhern B2, Rowen D2, Brazier J2, 1DHP Research & Consultancy Ltd., London, UK, 2 University of Sheffield, Sheffield, UK MA4: MODELLING EQ-5D HEALTH STATE VALUES: DEVELOPING A LIMITED DEPENDENT VARIABLE, MIXTURE MODELING APPROACH Wailoo AJ, Hernández M, Ara R, University of Sheffield, Sheffield, UK LOOKING BEYOND EXISTING HORIZONS MO1: METHODS FOR EXTRAPOLATING SURVIVAL DATA USED IN NICE TECHNOLOGY APPRAISALS: INCONSISTENCIES AND LIMITATIONS Latimer N, University of Sheffield, Sheffield, UK MO2: EXTRAPOLATION IN ONCOLOGY MODELLING: NOVEL METHODS FOR NOVEL COMPOUNDS Annemans L1, Asukai Y2, Barzey V2, Kotapati S3, Lees M4, Van Baardewijk M5, Wang Q4, Batty AJ6, Fisher D6, 1Ghent University, Ghent, Belgium, 2IMS Health, London, UK, 3Bristol-Myers Squibb Pharmaceuticals, Wallingford, CT, USA, 4Bristol-Myers Squibb, Uxbridge, Middlesex, UK, 5Bristol-Myers Squibb, Braine L’Alleud, Belgium, 6BresMed Health Solutions, Sheffield, South Yorkshire, UK MO3: A METHODOLOGICAL FRAMEWORK FOR DEVELOPING MODELS OF WHOLE DISEASE AREAS TO INFORM RESOURCE ALLOCATION DECISIONS Tappenden P, Brennan A, Chilcott J, Squires H, University of Sheffield, Sheffield, UK MO4: OUTCOMES BEYOND HEALTH Joore MA1, Dellaert B2, Spijkers L1, Severens JL2, Krabbe P3, Dirksen C1, 1MUMC, Maastricht, The
17:30-19:30 EXHIBITORS’ WINE & CHEESE RECEPTION & POSTER PRESENTATIONS – SESSION II 20:00-23:00 SOCIAL EVENT An Elegant Dinner at the Casino de Madrid. Please see ISPOR website for details and registration.
TUESDAY, 8 NOVEMBER 7:00-8:00 EDUCATIONAL SYMPOSIUM THE ECONOMICS OF PERSONALISED MEDICINE The promise of personalised medicine is to improve the quality of health care through the use of genetic information. As a new health care technology, genetic testing is demonstrating its potential to ensure that new and existing medical interventions are used more effectively and more safely. In challenging economic times, however, it is particularly important to quantify the impact of genetic testing on clinical and economic outcomes. The development of personalised medicine will further highlight the need for payers and assessment agencies to make trade-offs that are acceptable to the populations they serve. (Sponsored by UBC) 8:00-8:30 EXHIBITS & POSTER PRESENTATIONS – SESSION III 8:30-9:30 ISPOR FORUMS DEVELOPING GOOD RESEARCH PRACTICES FOR PERFORMANCE-BASED RISK-SHARING AGREEMENTS: DESIGN, IMPLEMENTATION, AND EVALUATION In “pay-for-performance” or “risk-sharing” schemes the product’s performance is tracked in a defined patient population over a specified period of time, and the level of reimbursement is tied by formula to the outcomes achieved. The Good Research Practices Task Force will discuss best research practices to assure a product’s performance in a defined patient population over a specified period of time. Presented by the ISPOR Performance-Based Risk-Sharing Arrangements Good Research Practices Task Force ALTERNATIVE IMPLICATIONS OF ECONOMIC CRISIS ON HEALTH CARE IN CENTRAL AND EASTERN EUROPE: AN OPPORTUNITY TO IMPROVE DECISIONS OR STRENGTHEN COST-CONTAINMENT MEASURES? In challenging economic times governments tend to implement cost-containment measures and improve the efficiency of public spending. The question for policy-makers is whether the goal is really to improve rational health care decision-making or just to reduce public health care spending. Examples of the implications of economic crisis on health care systems in the Central and Eastern European countries will be provided. Presented by the ISPOR Hungary, Slovakia, Republic of Macedonia, Turkish SCP and Czech Regional Chapters HTA DEVELOPMENTS IN THE CENTRAL AND EASTERN EUROPEAN (CEE) REGION: LOCK, STOCK & BARREL IN CHALLENGING TIMES During the last six years, health technology assessment/health economics has been increasingly adopted with rapid gains in its perceived value and importance. This forum will present up-to-date HTA requirements and assess the impact of past, current and future HTA implementation on health care decisions in various countries of the CEE region. Presented by the ISPOR Serbia, Greece, BosniaHerzegovina, Israel, Poland Regional Chapters GOOD RESEARCH PRACTICES FOR MODELING ISPOR and SMDM developed a series of reports on good research practices (preferred practices) for conducting modeling studies. These recommendations for preferred practices in modeling and the contentious issues debated in their development will be presented. Presented by the ISPOR Modeling Good Research Practices Task Force HTA AS A DECISION-MAKING INSTRUMENT IN HEALTH CARE: EXPERIENCE OF RUSSIA, UKRAINE, AND BELARUS This forum will discuss developments and results of introducing HTA methods in Russia, Ukraine and Belarus, none of which have a formal HTA agency. IT and web-based tools and programs for optimizing drug consumption and assessing costs will be presented. Presented by ISPOR HTA Russia, Ukraine, and Belarus Regional Chapters 9:30-10:00 BREAK, EXHIBITS & POSTER PRESENTATIONS – SESSION III
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Biostatistics (CEB), University Clinic Basel, Basel, Switzerland; Stefan Lange, MD, Deputy Director, Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany; Uwe Siebert, MD, MPH, MSc, ScD, Professor and Chair, Department of Public Health, Medical Decision Making and Health Technology Assessment, UMIT - University of Health Sciences, Medical Informatics and Technology and Oncotyrol Center for Personalized Cancer Medicine, Hall/Innsbruck, Austria W23: COHORT, MULTI-COHORT OR POPULATION MODEL? WHY, WHEN AND HOW? Discussion Leaders: Olivier Ethgen, MSc, PhD, Associate Professor of Health Economics, Department of Public Health Sciences, University of Liege, Liege, Belgium; James O’Mahony, MA, PhD Candidate, Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands W24: THE APPROPRIATENESS OF THE COST PER QALY IN THE DECISION-MAKING PROCESS Discussion Leaders: Mark Nuijten, PhD, MD, MBA, Consultant, Health Economics, Ars Accessus Medica, Amsterdam (Jisp), The Netherlands; Dominique Dubois, MD, Managing Director, Outcomes Research, Patient Value Solutions, Huldenberg, Belgium; Gerry Oster, PhD, Vice President, Policy Analysis Inc. (PAI), Brookline, MA, USA W25: PRODUCTIVITY COSTS IN MOOD DISORDERS – METHODOLOGICAL CHALLENGES AND POTENTIAL SOLUTIONS Discussion Leaders: Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK; Nicolas Despiégel, MSc, Project Leader, Life Sciences, OptumInsight, Nanterre, France; Leona Hakkaart, PhD, Associate Professor, Erasmus University Rotterdam, Rotterdam, The Netherlands W26: ‘MODEL BUSTING’: METHODS AND EXPERIENCES IN THE CRITICAL APPRAISAL OF COSTEFFECTIVENESS MODELS SUBMITTED TO REIMBURSEMENT AGENCIES Discussion Leaders: Eldon Spackman, PhD, Research Fellow, Center for Health Economics, University of York, Heslington, York, UK; Susan Griffin, PhD, Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK; Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA; Edward Kim, MD, MBA, Executive Director, Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA W27: HOW MUCH DOES SIZE MATTER? AN EVIDENCE-BASED APPROACH TO SAMPLE-SIZE DECISIONS IN CHOICE-FORMAT CONJOINT STUDIES Discussion Leaders: F. Reed Johnson, PhD, Distinguished Fellow and Principal Economist, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA; A. Brett Hauber, PhD, Senior Economist and Vice President, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA; Deborah Marshall, MHSA, PhD, Associate Professor, Canada Research Chair, Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada W28: INNOVATIVE METHODS FOR DEMONSTRATING VALUE FOR PHARMACEUTICAL PRODUCTS: RETHINKING DATA ANALYSIS WITH IMPLICATIONS FOR STUDY DESIGN AND PERSONALIZED MEDICINE Discussion Leaders: Donald E. Stull, PhD, Director, Retrospective Data Analysis, RTI Health Solutions, Manchester, UK; Katherine Houghton, BSc, Research Health Outcomes Scientist, Retrospective Data Analysis, RTI Health Solutions, Manchester, UK; Ari Gnanasakthy, MBA, PRO Expert, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
10:00-11:00 ISSUE PANELS - SESSION III IP11: MULTI-CRITERIA DECISION ANALYSIS: AN APPROPRIATE FRAMEWORK FOR DECISIONMAKING ABOUT NEW MEDICAL TECHNOLOGIES? Moderator: Nancy J. Devlin, PhD, BA, Director of Research, Office of Health Economics, London, UK Panelists: Mark J. Sculpher, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK; Stuart Peacock, DPhil, Associate Professor, University of British Columbia and Co-Director, Canadian Centre for Applied Research in Cancer Control (ARCC), Vancouver, BC, Canada; Carole Longson, PhD, Director, Centre for Health Technology Evaluation, National Institute for Health and Clinical Excellence (NICE), Manchester, UK IP12: CAN WE ALLEVIATE CURRENT MARKET FAILURES FROM INTERNATIONAL PRICE REFERENCING OF PHARMACEUTICALS IN MIDDLE INCOME COUNTRIES? Moderator: Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research and Policy Program, University of Washington School of Pharmacy, Seattle, WA, USA Panelists: Zoltan Kalo, MD, MSc, PhD, Director, Health Economics Research Centre, Eötvös Loránd University, Budapest, Hungary; Iga Lipska, MD, Former Director, HTA Department, Agency for Health Technology Assessment in Poland (AHTAPol), Warsaw, Poland; Jens Grueger, PhD, Vice President & Head, Global Market Access Primary Care, Pfizer Ltd., Tadworth, Surrey, UK IP13: IT IS ALWAYS TOO EARLY UNTIL IT IS TOO LATE: WHAT CAN WE LEARN FROM THE PILOTS OF MULTI-STAKEHOLDER CONSULTATIONS IN EARLY-STAGE DRUG DEVELOPMENT? Moderator: Peter L. Kolominsky-Rabas, MD, PhD, MBA, Director, Centre for Health Technology Assessment (HTA) and Public Health (IZPH), University of Erlangen-Nuremberg, Erlangen, Germany Panelists: Ron Akehurst, BSc, Professor of Health Economics & Dean of School of Health & Related Research (ScHARR), University of Sheffield, Sheffield, UK; Spiros Vamvakas, MD, PhD, Professor & Head of Scientific Advice, Human Medicines Special Areas, European Medicines Agency (EMA), London, UK; James S. Anderson, PhD, European Partnerships Director, Government Affairs, Public Policy and Patient Advocacy, GlaxoSmithKline, Brentford, UK IP14: VALUE-BASED REIMBURSEMENT FOR PERSONALIZED MEDICINE: WHERE DO WE STAND? Moderator: Eric C. Faulkner, MPH, Senior Director, Market Access and Outcomes Strategy, RTI Health Solutions, Research Triangle Park, NC, USA Panelists: Anke-Peggy Holtorf, PhD, MBA, Managing Director, Health Outcomes Strategies, GmbH, Basel, Switzerland; Michael Longacre, BS, Director, Global Reimbursement Strategy & Payment Policy, Becton Dickenson, Washington, DC, USA; Lieven Annemans, PhD, Professor, Centre for Health Economics Research and Health Economist, I-CHER, University of Ghent, Ghent, Belgium IP15: ANALYTIC HIERARCHY PROCESS AND CONJOINT ANALYSIS: TWO APPROACHES TO INCLUDE PATIENTS’ PREFERENCES FOR THERAPEUTIC PATHWAYS AND OUTCOMES INTO HEALTH ECONOMIC ANALYSIS Moderator: Andreas Gerber, PhD, MD, Head, Department of Health Economics, Institute of Quality and Efficiency in Health Care (IQWiG), Cologne, Germany Panelists: Axel Mühlbacher, PhD, Professor for Health Economics, IGM Institute Health Economics and Health Care Management, Hochschule Neubrandenburg, Neubrandenburg, Germany; Maarten Ijzerman, PhD, Professor, Department of Health Technology and Services Research, University of Twente, Enschede, The Netherlands 11:00-12:00
POSTER AUTHOR DISCUSSION HOUR – SESSION III
11:30-13:00
LUNCH, EXHIBITS & POSTER PRESENTATIONS – SESSION III
16:00-17:00 WORKSHOPS - SESSION V W29: DEVELOPING RISK EQUATIONS TO PROJECT TIME-TO-EVENT DISTRIBUTIONS IN ECONOMIC MODELS Discussion Leaders: K. Jack Ishak, PhD, Director, Biostatistics & Senior Research Scientist, United BioSource Corporation, Dorval, QC, Canada; Phil McEwan, PhD, Managing Director, HEOR Consulting, Monmouth, Monmouthshire, UK; Noemi Kreif, PhD Candidate, Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK W30: NOVEL METHODS FOR CHARACTERIZING UNCERTAINTY IN ECONOMIC ANALYSIS Discussion Leaders: Ken O’Day, PhD, Director, Xcenda, LLC, Palm Harbor, FL, USA; Denise Globe, PhD, Senior Director, Global Health Outcomes Strategy and Research, Allergan, LLC, Irvine, CA, USA; Stephen K. Gruschkus, PhD, MPH, Assistant Director, Xcenda, LLC, Palm Harbor, FL, USA; Katherine B. Winfree, PhD, MPH, Research Scientist, Global Health Outcomes, Oncology, Eli Lilly and Company, Indianapolis, IN, USA W31: HANDLING UNCERTAINTY IN A BUDGET IMPACT ANALYSIS Discussion Leaders: Mark Nuijten, PhD, MD, MBA, Consultant, Health Economics, Ars Accessus Medica, Amsterdam (Jisp), The Netherlands; Ken Redekop, PhD, Associate Professor, Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands; Stefan Walzer, PhD, MA, Global Health Economics, F. Hoffmann-La Roche Pharmaceuticals AG, Basel, Switzerland W32: ADAPTING TO EVOLVING GLOBAL EVIDENCE REQUIREMENTS IN MEDICAL DEVICE DEVELOPMENT PROGRAMS Discussion Leaders: Thomas Goss, PharmD, Vice President, Boston Healthcare Associates, Inc., Boston, MA, USA; Sheri Dodd, MSc, Vice President, Reimbursement, Economics and Health Policy, Medtronic Cardiac Rhythm Disease Management, Mounds View, MN, USA; Bernd Brueggenjuergen, MD, MPH, Managing Director, Alpha Care, GmbH, Celle, Germany W33: OVERCOMING THE COMPLEXITY OF AN INCREASINGLY FRAGMENTED REGIONAL AND LOCAL MARKET ACCESS REQUIREMENT Discussion Leaders: Mondher Toumi, MD, PhD, Professor, Market Acess, University Claude Bernard Lyon 1, Lyon, France; Claudio Jommi, Associate Professor, Università del Piemonte Orientale and Pharmaceutical Observatory, Cergas, University of Bocconi, Milano, Italy; Antoni Gilabert Perramon, PhD, Managing Director of Pharmaceutical Care and Complementary Benefits, Catalan Health Service, Department of Health and Social Security, Government of Catalonia, Barcelona, Spain W34: BRIDGING THE GAP IN DATA COLLECTION BETWEEN RESOURCE USE AND PATIENT-REPORTED OUTCOMES Discussion Leaders: Radek Wasiak, PhD, EU Director and Research Scientist, Economic Analysis & Solutions, United BioSource Corporation, London, UK; Betina T. Blak, PhD, MSc, Health Economist, UK, Cegedim Strategic Data Medical Research Ltd., London, UK; Tara Symonds, PhD, Senior Director, Outcomes Research, Pfizer Ltd., Sandwich, Kent, UK; Rob Thwaites, MA, Vice President, United BioSource Corporation, London, UK W35: DESIGNING AND IMPLEMENTING EFFECTIVE RARE DISEASE REGISTRIES Discussion Leaders: Leanne Larson, MHA, Vice President, Outcome, Cambridge, MA, USA; Michelle Bulliard, RN, Director Clinical Operations, Outcome, St-Prex, Switzerland
11:45-12:45 EDUCATIONAL SYMPOSIUM INDUSTRY INVOLVEMENT IN THE HTA PROCESS: VALUE OR BIAS? HTA agencies and HTA stakeholders seem to agree that there is value in stakeholder involvement in the HTA process. However there is disagreement on the degree of stakeholder involvement, particularly the degree of industry involvement. Industry develops the technologies that are being assessed and are in possession of key information and data but does their involvement compromise the independence and therefore the effectiveness of HTA agencies? How should industry involvement be managed to bring greatest value to the HTA process? This symposium will present a discussion on the appropriate degree of industry involvement in the HTA process. (Sponsored by EFPIA) 13:00-14:15 THIRD PLENARY SESSION HETEROGENEITY IN THE COST-EFFECTIVENESS OF MEDICAL INTERVENTIONS: THE CHALLENGE OF MATCHING PATIENTS TO APPROPRIATE CARE Inevitable variation between patients in the effects of disease and responses to treatment gives rise to heterogeneity in the benefits and costs of interventions. This heterogeneity challenges payers in selecting the most appropriate intervention given patients’ observed characteristics such as medical history and disease characteristics. The need to understand heterogeneity in the costs and benefits of interventions raises important methodological issues: how to make the best use of existing routinely available information to estimate costs and benefits in sub-groups of patients? how to establish the optimal number of patient sub-groups? the appropriate assessment of the additional information offered by diagnostic tests; and the implications of offering choice to patients and physicians to reveal information on the costeffectiveness of therapies. During this session, these issues will be presented from the perspective of the researcher, the payer, and a manufacturer of companion diagnostic and drug combinations. Moderator: Uwe Siebert, MD, MPH, MSc, ScD, Professor & Chair, Department of Public Health, Medical Decision Making and Health Technology Assessment, UMIT - University of Health Sciences, Medical Informatics and Technology and Oncotyrol Center for Personalized Cancer Medicine, Hall/Innsbruck, Austria Speakers: Karl C. Claxton, MSc, DPhil, Professor & Senior Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK; Andreas Gerber, PhD, MD, Head, Department of Health Economics, Institute of Quality and Efficiency in Health Care (IQWiG), Cologne, Germany; Greg Rossi, PhD, Vice President, Global Health Economics and Pricing, Genentech Inc, San Francisco, CA, USA 14:15-14:30
ISPOR RESEARCH PRESENTATION AWARDS
14:30-14:45
BREAK, EXHIBITS & POSTER PRESENTATIONS – SESSION III
14:45-15:45 WORKSHOPS - SESSION IV W22: META-ANALYSES AND INDIRECT COMPARISONS FROM RCTS WITH SMALL PATIENT NUMBERS Discussion Leaders: Heiner C. Bucher, MD, MPH, Director, Institute for Clinical Epidemiology & –7–
ISPOR 14th Annual European Congress 5-8 November 2011 n Madrid, Spain Name Degrees position
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ISPOR Congress REGISTRATION
ISPOR SHORT COURSE REGISTRATION SATURDAY, 5 NOVEMBER 2011 (All Day Course) 9:00-18:00 q Introduction to Pharmacoeconomics
SATURDAY, 5 NOVEMBER 2011 (Morning Courses) 9:00-13:00 qN EW! Introduction to Design & Analysis of Retrospective Database Studies q Introduction to Patient-Reported Outcomes Assessment: Instrument Development & Evaluation q Introduction to Modeling q Discrete Event Simulation for Economic Analyses – Concepts q Bayesian Methods in Economic Evaluations – Introduction q Statistical Methods for Pharmacoeconomics & Outcomes Research q Cost-Effectiveness Analysis alongside Clinical Trials q Elements of Pharmaceutical/Biotech Pricing I – Introduction
SATURDAY, 5 NOVEMBER 2011 (Afternoon Courses) 14:00-18:00 q Meta-Analysis & Systematic Literature Review q Applications in Using Large European Databases q Patient Registries q Advanced Retrospective Database Analysis q Utility Measurements (Preference-Based Techniques) q Pharmacoeconomic Modeling – Applications q Discrete Event Simulation for Economic Analyses – Applications q Introduction to Health Technology Assessment (HTA)
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SUNDAY, 6 NOVEMBER 2011 (Morning Courses) 8:00-12:00 q Bayesian Methods in Economic Evaluations – Advanced q Reimbursement Systems in Europe q Risk-Sharing/Performance-Based Arrangements for Drugs and Other Medical Products q Case Studies in Pharmaceutical/Biotech Pricing II – Advanced q Transferability of Cost-Effectiveness Data between Countries q Cost Estimation and Assessing Financial (Budget) Impact of New Health Care Technologies q NEW! Establishing the Content Validity of Patient-Reported Outcome (PRO) Instruments q NEW! Conjoint Analysis – Theory & Methods q NEW! Network Meta-Analysis in Relative Effectiveness Research HALF DAY SHORT COURSE FEES
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ship ($140/$35 Students) , which includes a one year online subscription to Value in Health – The Journal of the International Society for Pharmacoeconomics and Outcomes Research. * The Non-Member rate includes an annual ISPOR membership ($140/$35 Students). ** One Day Registration Details: One day registration does not include ISPOR membership benefits and cannot be combined. Cancellation Details: Cancellation fee before 20 September 2011 is US $145. No refunds given after 20 September 2011.
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