ISPOR 14th Annual European Congress - Released Presentations
 

RELEASED PRESENTATIONS


PLENARY SESSIONS
(Presentations to be added pending speaker approval)
FIRST PLENARY SESSION: Pros and Cons of a Centralized European Pricing & Reimbursement Agency
 
Pros and Cons of a Centralized European Pricing & Reimbursement Agency
Mark J. Sculpher,
MSc, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK
 
Pros and cons of a centralised EU An agency of the European Union Pricing & Reimbursement Agency
Hans-Georg Eichler, MD, MSc, Professor & Senior Medical Officer, European Medicines Agency and CBI Visiting Scholar & Robert E. Wilhelm Fellow, Massachusetts Institute of Technology, London, UK
 
Pros and Cons of a Centralised European Pricing and Reimbursement Agency
Adrian Towse, MA, MPhil, Director, Office of Health Economics, London, UK

SECOND PLENARY SESSION: THE REALITY OF REAL WORLD DATA AND ITS USE IN HEALTH CARE DECISIONS IN EUROPE
 
The reality of real world data and its use in health care decisions in Europe
Xavier Badia, PhD, MD, MPH, Global Leader, Observational COE and Senior Principal, Health Economics and Outcomes Research, IMS Health, Barcelona, Spain
 
The Reality of Real World Data And Its Use In Health Care Decisions
Leslie Levin, MB, MD(Birm), FRCP(Lon), FRCPC, Head of the Medical Advisory Secretariat, Health Quality Ontario, Toronto, ON, Canada
 
The reality of ‘Real World Evidence’ An industry point of view
Patrick Keohane, MB, BS, MRCP(UK), Vice President, Payer Evidence, AstraZeneca, Södertälje, Sweden
 
ATLAS VPM the Healthcare Quality of the Spanish SNS under scrutiny
Enrique Bernal-Delgado, 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

THIRD PLENARY SESSION: HETEROGENEITY IN THE COST-EFFECTIVENESS OF MEDICAL INTERVENTIONS: THE CHALLENGE OF MATCHING PATIENTS TO APPROPRIATE CARE
 
Heterogeneity: matching patients to appropriate care
Karl C. Claxton, MSc, DPhil, Professor & Senior Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK
 
Personalised Healthcare and HTA “Laminar or Turbulent flow”
Greg Rossi, PhD, Vice President, Payer Evidence, AstraZeneca, Macclesfield, Cheshire, UK
 
Heterogeneity — What it is and isn't?
Andreas Gerber,  PhD,  MD, Head, Department of Health Economics, Institute of Quality and Efficiency in Health Care (IQWiG), Cologne, Germany

PODIUM AND POSTER PRESENTATIONS
 

For contributed research podium and poster abstracts and released slide or poster presentations for the ISPOR 14th Annual European Congress, see: ISPOR Outcomes Research Digest an electronic database of over 18,700 research papers presented at ISPOR Annual International Meetings, ISPOR Annual European Congresses, and biennial ISPOR Asia-Pacific & Latin America Conferences from 1998 to date.

  • ISPOR Outcomes Research Digest:  http://www.ispor.org/research_study_digest/research_index.asp
  • Under Meeting select 14th Annual European Congress - Madrid, Spain- 2011
  • Select Search for all research podium and poster abstracts and available slide or poster presentations from the meeting. Alternatively search by disease/disorder, topic or subtopic.

ISSUE PANEL PRESENTATIONS
ISSUE PANELS - SESSION I

IP1: VALUING DIAGNOSTICS: DO WE NEED DIFFERENT METRICS?

Valuing Diagnostics: Do we need Different Metrics?
Peter J. Neumann, ScD, Professor & Director, Center for Evaluation of Value & Risk in Health, Tufts Medical Center, Boston, USA

VALUING DIAGNOSTICS: DO WE NEED DIFFERENT METRICS?
Mark Sculpher, PhD, Professor of Health Economics, University of York, UK

Is the value of a test adequately reflected in the QALY? Some thoughts on tests, desires, needs, and (reimbursement) decisions
Ken Redekop, PhD, Associate Professor, Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands


IP2: VALUE- BASED PRICING: HOW DO APPROACHES VARY BY HEALTHCARE CONTEXT

Value-Based Pricing in the United Kingdom
Michael Drummond, MCom, DPhil
, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK

Value-Based Pricing: How do Approaches Vary by Health Care Context?
J.-Matthias Graf von der Schulenburg, PhD, Professor of Economics & Director, Institute of Risk and Insurance, Gottfried Wilhelm Leibniz Universität Hannover, Hannover, Germany


IP3: GREENPARK COLLABORATIVE PILOT

Greenpark Collaborative: A US Perspective
Marc L. Berger, M.D., Executive VP & Senior Scientist, OptumInsight, New York, NY, USA

Green Park Collaborative Pilot – EMA activities
Hans-Georg Eichler, MD, MSc, Professor & Senior Medical Officer, European Medicines Agency and CBI Visiting Scholar & Robert E. Wilhelm Fellow, Massachusetts Institute of Technology, London, UK

 

IP4: MULTICRITERIA DECISION ANALYSIS (MCDA): A COMMON ROAD MAP FROM DRUG DEVELOPMENT TO REGULATORY AND REIMBURSEMENT DECISIONS?

MCDA at the EMA: the benefit-risk (B/R) assessment
Bruno FLAMION, MD, PhD, 2005-2010 Chair, Scientific Advice Working Party (SAWP) of the CHMP (EMA), Member of the Benefit-Risk Methodology Project Steering Group (EMA), Expert, Federal Agency for Medicines and Health Products (FAMHP), Belgium, Chair, Belgian Committee for Reimbursement of Medicines (CTG-CRM, INAMI-RIZIV) Professor of Physiology & Pharmacology, University of Namur, Belgium

Structured decision making at NICE; is there a role for ‘MCDA’?
Meindert Boysen,
Director, Technology Appraisal Programme, National Institute for Health and Clinical Excellence (NICE), Manchester, UK

An open source MCDA-based framework adaptable to the continuum of healthcare decisionmaking
Mireille M Goetghebeur PhD, BioMedCom Consultants inc, CHU Ste Justine, Canada


IP5: THE IMPACT OF REGULATORY (FDA AND EMA) AND EUNETHTA GUIDELINES ON PATIENT-REPORTED OUTCOMES AND HEALTH-RELATED QUALITY OF LIFE ON MARKET AUTHORISATION AND PRICING

THE IMPACT OF REGULATORY (FDA AND EMA) AND EUNETHTA GUIDELINES ON PATIENT-REPORTED OUTCOMES AND HEALTH-RELATED QUALITY OF LIFE ON MARKET AUTHORISATION AND PRICING
Benoit Arnould, PhD, Director, MAPI Group, MAPI Values, Lyon, France

European network for HTA Joint Action between European Commission and EU Member States
Mira Pavlovic, MD, Deputy Director, DEMESP, French National Authority for Health (HAS), Saint-Denis la Plaine, France

Patient Reported Outcomes: When & Who
Tara Symonds, PhD, Senior Director, Outcomes Research, Pfizer Ltd., Sandwich, Kent, UK


ISSUE PANELS - SESSION II

IP6: OPPORTUNITIES AND CHALLENGES FOR COMPARATIVE EFFECTIVENESS PRAGMATIC CLINICAL TRIALS IN EUROPE

Opportunities and Challenges for Comparative Effectiveness Pragmatic Clinical Trials in Europe
Marc L. Berger, M.D., Executive Vice President & Senior Scientist, Life Sciences, OptumInsight, New York, NY, USA

CHALLENGES FOR PRAGMATIC TRIALS IN EUROPE
Donna Messner, PhD, Senior Project Manager, Center for Medical Technology Policy, Baltimore, MD, USA

Real-Life Pragmatic Trials In Respiratory Disease Perspective based on ELEVATE trial
David Price, MD, Professor & Director, Optimum Patient Care Ltd., Cawston, UK


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?

Personalized Medicine and Companion Diagnostics in Oncology:Challenges and Solutions
Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK


IP8: VALUE BASED PRICING: WHAT WILL IT MEAN IN PRACTICE?

Value-based pricing: what will it mean in practice?
John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK

A framework for Value Based Pricing
Karl Claxton, Professor & Senior Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK

Value Based Pricing: What it will mean in Practice
Jens Grueger, PhD, Vice President & Head, Global Market Access Primary Care, Pfizer Ltd., Tadworth, Surrey, UK


IP9: HTA OF MEDICAL DEVICES IN EUROPE: COOPERATION BETWEEN EVALUATION AGENCIES AND IMPLICATIONS FOR INDUSTRY

HTA of medical devices in the Netherlands: what parts of reimbursement decisions are relevant for other HTA agencies and industry?
Ken Redekop, PhD
, Associate Professor, Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands

HTA OF MEDICAL DEVICES IN SPAIN: COOPERATION BETWEEN HTA AGENCIES AND IMPLICATIONS FOR INDUSTRY
Dr. Antonio Sarría-Santamera, MD, PhD, Director, Department of Social Medicine, Agency for Health Technology Assessment, Madrid, Spain


IP10: HOW WILL INNOVATOR TECHNOLOGIES FARE IN AN INCREASINGLY RESTRICTIVE GLOBAL REIMBURSEMENT ENVIRONMENT: LESSONS FROM COMPARISON OF CELL AND GENE THERAPIES TO CONVENTIONAL BIOPHARMACEUTICALS

Regenerative Cell Therapy Reimbursement: Lessons From a Survey of Global Health Technology Assessments
Daryl S. Spinner, PhD, MBA, Senior Associate, Market Access and Outcomes Strategy, RTI Health Solutions, Research Triangle Park, NC, USA

A View of a 'NICE' Technology Appraiser
Katherine Payne, PhD, Professor, Health Sciences-Economics, University of Manchester, Manchester, UK


ISSUE PANELS - SESSION III

IP11: MULTI-CRITERIA DECISION ANALYSIS: AN APPROPRIATE FRAMEWORK FOR DECISION-MAKING ABOUT NEW MEDICAL TECHNOLOGIES?

International experiences using Multi Criteria Decision Analysis (MCDA) for priority setting
Stuart Peacock, DPhil, Associate Professor, University of British Columbia and Co-Director, Canadian Centre for Applied Research in Cancer Control (ARCC), Vancouver, BC, Canada

MULTI-CRITERIA DECISION ANALYSIS: AN APPROPRIATE FRAMEWORK FOR DECISIONMAKING ABOUT NEW MEDICAL TECHNOLOGIES?
Mark Sculpher, PhD, Professor of Health Economics University of York, UK

Structured decision making at NICE; is there a role for ‘MCDA’?
Meindert Boysen, Director, Technology Appraisal Programme, 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?

Can we alleviate current market failures from international price referencing of pharmaceuticals in middle income countries?
Lou Garrison PhD, Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy Program, Pharmacy, University of Washington, Seattle, USA

CAN WE ALLEVIATE CURRENT MARKET FAILURES FROM INTERNATIONAL PRICE REFERENCING OF PHARMACEUTICALS IN MIDDLE INCOME COUNTRIES?
Jens Grueger, PhD, Vice President & Head, Global Market Access Primary Care, Pfizer Ltd., Tadworth, Surrey, UK

CAN WE ALLEVIATE CURRENT MARKET FAILURES FROM INTERNATIONAL PRICE REFERENCING OF PHARMACEUTICALS IN MIDDLE INCOME COUNTRIES: View of an Academic Expert from a middle income country
Zoltán KalóMD, MSc, PhD, Director, Health Economics Research Centre, Eötvös Loránd University, Budapest, Hungary

CAN WE ALLEVIATE CURRENT MARKET FAILURES FROM INTERNATIONAL PRICE REFERENCING OF PHARMACEUTICALS IN MIDDLE INCOME COUNTRIES?
Iga Lipska, MD, Former Director, HTA Department, Agency for Health Technology Assessment in Poland (AHTAPol), Warsaw, Poland


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?

Scientific Advice with HTAs
Spiros Vamvakas, MD, PhD, Professor & Head of Scientific Advice, Human Medicines Special Areas, European Medicines Agency (EMA), London, UK

Industry experience of multi-stakeholder early advice consultations
James S. Anderson, MA, MBA, European Partnerships Director, Government Affairs, Public Policy and Patient Advocacy, GlaxoSmithKline, Brentford, UK


IP14: VALUE-BASED REIMBURSEMENT FOR PERSONALIZED MEDICINE: WHERE DO WE STAND?

overview US health care value-based purchasing reforms, explore implications for diagnostics and personalized medicines
Michael Longacre, BS, Director, Global Reimbursement Strategy & Payment Policy, Becton Dickenson, Washington, DC, USA

Criteria for Value Assessment of Personalized Medicines and Factors for Achieving Value-based Reimbursement in this Rapidly Advancing Field: Findings from the "HISCREENDIAG" EU project
Lieven Annemans, PhD, MMan, MSc, Professor of Health Economics, I-CHER, Ghent University and Brussels University, Ghent, Belgium

Do Existing Examples of Personalized Medicines Reflect "Ideal" Principles of Value-based Reimbursement?
Anke-Peggy Holtorf, PhD, MBA, Managing Director, Health Outcomes Strategies, GmbH, Basel, Switzerland


IP15: ANALYTIC HIERARCHY PROCESS AND CONJOINT ANALYSIS: TWO APPROACHES TO INCLUDE PATIENTS' PREFERENCES FOR THERAPEUTIC PATHWAYS AND OUTCOMES INTO HEALTH ECONOMIC ANALYSIS

ANALYTIC HIERARCHY PROCESS AND CONJOINT ANALYSIS: TWO APPROACHES TO INCLUDE PATIENTS' PREFERENCES FOR THERAPEUTIC PATHWAYS AND OUTCOMES INTO HEALTH ECONOMIC ANALYSIS
Andreas Gerber, PhD, MD, Head, Department of Health Economics, Institute of Quality and Efficiency in Health Care (IQWiG), Cologne, Germany;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


 WORKSHOP PRESENTATIONS
(Presentations to be added pending speaker approval)
WORKSHOPS - SESSION I

W1: COMPARATIVE EFFECTIVENESS ANALYSES USING SIMULATED TREATMENT COMPARISON (STC)

COMPARATIVE EFFECTIVENESS ANALYSES USING SIMULATED TREATMENT COMPARISON (STC)
Laurent Eckert, PhD, sanofi-aventis R&D, Massy, France

Simulated Treatment Comparison
Jack Ishak, PhD, Director, Biostatistics & Senior Research Scientist, United BioSource Corporation, Dorval, QC, Canada


W4: MOVING TOWARDS VALUE BASED HEALTH CARE IN DIFFERENT CONSTITUENCIES: A PRESENTATION ON BEHALF OF THE ISPOR VALUE BASED HEALTH CARE SPECIAL INTEREST GROUP

Moving towards value based health care (VBHC)
Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA

MOVING TOWARDS VALUE BASED HEALTH CARE IN DIFFERENT CONSTITUENCIES, A PRESENTATION ON BEHALF OF THE ISPOR VALUE BASED HEALTH CARE SPECIAL INTEREST GROUP
Edward Kim, MD, MBA, Executive Director, Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA


W6: MIXING MODES OF PATIENT-REPORTED OUTCOMES DATA COLLECTION IN CLINICAL TRIALS: ISPOR PRO GOOD RESEARCH PRACTICE TASK FORCE REPORT RECOMMENDATIONS

Multiple Modes of Administration and Data Capture: Statistical Issues
Andrew Lloyd, DPhil, Vice President, Oxford Outcomes, Oxford, UK

Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report
Stephen Joel Coons, PhD, Chad J. Gwaltney, PhD, Ron D. Hays, PhD, J. Jason Lundy, MS, Jeff A. Sloan, PhD, Dennis A. Revicki, PhD, William R. Lenderking, PhD, David Cella, PhD, Ethan Basch, MD, MSc on behalf of the ISPOR ePRO Task Force

Mixing Modes of Patient-Reported Outcomes Data Collection in Clinical Trials: Recommendations
Sonya Eremenco, MA, e-PRO Manager, United BioSource Corporation, Bethesda, MD, USA

Multiple Modes of Administration and Data Capture: Practical Considerations
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

"Real-World" Research to Support Evidence-Based Medicine
Mark J Cziraky, PharmD, FAHA, Vice President, Industry Sponsored Research, HealthCore, Inc., Wilmington, DE, USA


W8: WORKING WITH PHYSICIANS, MEDICAL RECORDS, AND PATIENTS TO COLLECT OBSERVATIONAL, REAL-WORLD DATA: THE GOOD, THE BAD, AND THE UGLY

Direct-to-Patient Studies
Elisa Cascade, MBA, Vice President, MediGuard.org, Rockville, MD, USA

Electronic Medical Data
David Ford, MBA, FRSA, Director, Health Informatics Research Labs, Swansea University, Swansea, UK

W9: GENERALIZED EVIDENCE SYNTHESIS IN COMPARATIVE EFFECTIVENESS RESEARCH: COULD THE EVIDENCE BASE BE BROADENED IN MIXED TREATMENT COMPARISONS?

GENERALIZED EVIDENCE SYNTHESIS IN COMPARATIVE EFFECTIVENESS RESEARCH: COULD THE EVIDENCE BASE BE BROADENED IN MIXED TREATMENT COMPARISONS?
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


WORKSHOPS - SESSION II

W10: A REVIEW OF THE TECHNICAL SUPPORT DOCUMENTS FOR THE APPLICATION OF NICE METHODS GUIDANCE ON THE MEASUREMENT AND VALUATION OF HEALTH

Introduction to the NICE reference case, EQ-5D and the alternatives TSDs 8 and 11
John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK

THE USE OF HEALTH STATE UTILITY VALUES IN DECISION ANALYTIC MODELS
Roberta Ara, MSc, Research Fellow, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK

CRITIQUE
Andrew Lloyd, DPhil, Vice President (Practice Lead), Oxford Outcomes, Oxford, UK

USE OF MAPPING TO ESTIMATE HEALTH STATE UTILITY VALUES
Louise Longworth, PhD, Reader in Health Economics, Health Economics Research Group, Brunel University, Uxbridge, UK


W12: BIOSIMILAR ACCESS: THE FUTURE OF VALUE ASSESSMENT

BIOSIMILAR ACCESS: THE FUTURE OF VALUE ASSESSMENT
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


W13: HTA IN GERMANY: EVIDENCE REQUIREMENTS, THE ROLE OF BENEFIT/COST ASSESSMENT, FIRST EXPERIENCES AND CHALLENGES WITH THE GERMAN HEALTH BILL AMNOG

HTA IN GERMANY: EVIDENCE REQUIREMENTS, THE ROLE OF BENEFIT/COST ASSESSMENT, FIRST EXPERIENCES AND CHALLENGES WITH THE GERMAN HEALTH BILL AMNOG
Jens Grueger, PhD, Vice President & Head, Global Market Access Primary Care, Pfizer Ltd., Tadworth, Surrey, UK

HTA IN GERMANY: EVIDENCE REQUIREMENTS, THE ROLE OF BENEFIT/COST ASSESSMENT, FIRST EXPERIENCES AND CHALLENGES WITH THE GERMAN HEALTH BILL AMNOG
Anne Kilburg, MSc, Senior Director, Market Access and Outcomes Strategy - Europe, RTI Health Solutions, Manchester, UK

HTA IN GERMANY: EVIDENCE REQUIREMENTS, THE ROLE OF BENEFIT/COST ASSESSMENT, FIRST EXPERIENCES AND CHALLENGES WITH THE GERMAN HEALTH BILL AMNOG
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

MULTI COUNTRY PILOT STUDY: TTO AND HYBRID
Ben A. Van Hout, PhD, Professor of Health Economics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK

MULTI COUNTRY PILOT STUDY: Introduction and DC
Paul Krabbe, PhD, Associate Professor, Department of Epidemiology, HTA Unit, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

EuroQol Group Valuation Research in perspective
Paul Kind, MSc, MPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK

USING A DISCRETE CHOICE EXPERIMENT INCORPORATING DURATION TO VALUE HEALTH STATES (PRET-AS STUDY)
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)?

Does observational research support the goals of comparative effectiveness research (CER) ?
Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA

Observational data used in Health Technology Assessment by the National Institute of Health and Clinical Excellence
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

Contract Research Organisation Perspective
Jean-Louis Merot MD, Senior Director, Late Phase Project Management, Quintiles, Levallois-Perret, France

GETTING NONINTERVENTIONAL STUDIES OVER START-UP HURDLES IN EUROPE: STAKEHOLDER CHALLENGES & PERSPECTIVES
Louise Parmenter, PhD, Senior Director, Late Phase Strategy and Planning, Quintiles, Inc., Bracknell, Berkshire, UK

Investigator perspective for noninterventional studies
Herman Pieterse, PhD, Professor, Clinical Pharmacology, University of Ghent, Heerhugowaard, The Netherlands


WORKSHOPS - SESSION III

W17: DESIGNING BETTER COMPARATIVE EFFECTIVENESS RESEARCH

Designing Better Comparative Effectiveness Research
Richard Gliklich, MD, President & CEO, Outcome, Cambridge, MA, USA; Newell McElwee, PharmD, MSPH, Exec Director, US Outcomes Research, Merck , North Wales, PA, USA; Donna Messner, PhD, Senior Project Manager, Center for Medical Technology Policy, Baltimore, MD, USA


W19: Rewarding innovation; one step forward, two steps back?

Rewarding innovation; one step forward, two steps back?
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; Elizabeth Jones, MSc, Senior Analyst, OptumInsight, Uxbridge, Middlesex, 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

What can patient preference studies tell us about patient adherence? A novel insight into an old problem
A. Brett Hauber, PhD, Senior Economist and Vice President, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA

WHAT CAN PATIENT PREFERENCE STUDIES TELL US ABOUT PATIENT ADHERENCE? A NOVEL INSIGHT INTO AN OLD PROBLEM
Andrew Lloyd DPhil, Vice President (Practice Lead), Oxford Outcomes, Oxford, UK

What can patient preference studies tell us about patient adherence? A novel insight into an old problem
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?

Linking to THIN Data
Alison Bourke, MSc, MRPharmS, Managing Director, UK, Cegedim Strategic Data Medical Research Ltd., London, UK

LINKING EXISTING DATABASES: POISONED CHALICE OR HOLY GRAIL?
Daniel Huse, MA, Vice President, Thomson Reuters, Cambridge, MA, USA

Linking Existing Databases – Is it Worth the Pain?
Robert J. LoCasale, PhD, MS, Senior Epidemiologist, Epidemiology, Merck, North Wales, PA, USA


WORKSHOPS - SESSION IV

W22: META-ANALYSES AND INDIRECT COMPARISONS FROM RCTS WITH SMALL PATIENT NUMBERS

Meta‐Analysis and Indirect Treatment Comparisons from RCTs with Small Patient Numbers
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

META-ANALYSES AND INDIRECT COMPARISONS FROM RCTS WITH SMALL PATIENT NUMBERS
Heiner C. Bucher, MD, MPH, Director, Institute for Clinical Epidemiology & Biostatistics (CEB), University Clinic Basel, Basel, Switzerland

Meta-Analyses and Indirect Comparisons from RCTs with Small Patient Numbers
Stefan Lange, MD, PhD, Deputy Director, Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany


W23: COHORT, MULTI-COHORT OR POPULATION MODEL? WHY, WHEN AND HOW?

Cohort, Multi-cohort or Population Model? Why, When and How?
Olivier Ethgen MSc, PhD, Associate Professor of Health Economics, Department of Public Health Sciences, University of Liege, Liege, Belgium

Cohort, Multi-Cohort or Population Model? Why, When and How?
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

Is it all about QALY's?
Dominique Dubois, MD, FFPM, FBCPM, Managing Director, Outcomes Research, Patient Value Solutions, Huldenberg, Belgium

THE APPROPRIATENESS OF THE COST PER QALY IN THE DECISION-MAKING PROCESS
Mark Nuijten PhD, MD, MBA, Consultant, Health Economics, Ars Accessus Medica, Amsterdam (Jisp), The Netherlands

THE APPROPRIATENESS OF THE COST PER QALY IN THE DECISION-MAKING PROCESS
Gerry Oster, PhD, Vice President, Policy Analysis Inc. (PAI), Brookline, MA, USA


W25: PRODUCTIVITY COSTS IN MOOD DISORDERS – METHODOLOGICAL CHALLENGES AND POTENTIAL SOLUTIONS

What are the methodological challenges and potential solutions?
Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK


W26: 'MODEL BUSTING': METHODS AND EXPERIENCES IN THE CRITICAL APPRAISAL OF COST-EFFECTIVENESS MODELS SUBMITTED TO REIMBURSEMENT AGENCIES

"Model Busting": The Consultant's Perspective
Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA


W27: HOW MUCH DOES SIZE MATTER? AN EVIDENCE-BASED APPROACH TO SAMPLE-SIZE DECISIONS IN CHOICE-FORMAT CONJOINT STUDIES

How Much Does Size Matter? An Evidence-Based Approach to Sample-Size Decisions in Choice-Format Conjoint Studies
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

Innovative Methods to Identify and Explore Heterogeneity
Donald E. Stull, PhD, Director, Retrospective Data Analysis, RTI Health Solutions, Manchester, UK

Applying LGM and GMM Analyses in Clinical Trials
Katherine Houghton, BSc, Research Health Outcomes Scientist, Retrospective Data Analysis, RTI Health Solutions, Manchester, UK

Heterogeneity in Treatment Response: What is it, why is it important, and how to find it
Károly Kulich, PhD, PRO Expert, Novartis Pharmaceuticals Corporation, Basel, Switzerland


WORKSHOPS - SESSION V

W29: DEVELOPING RISK EQUATIONS TO PROJECT TIME-TO-EVENT DISTRIBUTIONS IN ECONOMIC MODELS

Parametric Survival Analysis Overview
Jack Ishak, PhD, Director, Biostatistics & Senior Research Scientist, United BioSource Corporation, Dorval, QC, Canada

Application to Fit to Risk Equation for Veteran's Dataset
Noemi Kreif, PhD Candidate, Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK

Implications in Economic Analyses
Phil McEwan, PhD, Managing Director, HEOR Consulting, Monmouth, Monmouthshire, UK


W30: NOVEL METHODS FOR CHARACTERIZING UNCERTAINTY IN ECONOMIC ANALYSIS

Using Net Benefits to Report Cost-Effectiveness Results
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

W32: ADAPTING TO EVOLVING GLOBAL EVIDENCE REQUIREMENTS IN MEDICAL DEVICE DEVELOPMENT PROGRAMS

ADAPTING TO EVOLVING GLOBAL EVIDENCE REQUIREMENTS IN MEDICAL DEVICE DEVELOPMENT PROGRAMS
Thomas Goss, PharmD, Vice President, Boston Healthcare Associates, Inc., Boston, MA, USA

ADAPTING TO EVOLVING GLOBAL EVIDENCE REQUIREMENTS IN MEDICAL DEVICE DEVELOPMENT PROGRAMS
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

REGIONAL MARKET ACCESS SEGMENTATION
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

BRIDGING THE GAP IN DATA COLLECTION BETWEEN RESOURCE USE AND PATIENTREPORTED OUTCOMES
Rob Thwaites, MA, Vice President, United BioSource Corporation, London, UK


ISPOR FORUMS

ISPOR Russia and Russia Far-East Regional Chapters
THE ASSESSMENT OF MEDICAL TECHNOLOGIES IN RUSSIA: 15 YEARS OF ROAD MAP DEVELOPMENT

Socially Responsible Pharmacoeconomics Vector
Alexandr Bykov, MD, PhD, Government Relations Manager, Teva, Moscow, Russia

Evidence-Based Medicine in Khabarovsk Health System
Salavat Suleymanov, MD, PhD, President, ISPOR Russia Far-East Regional Chapter and President, Post Graduate Institute for Public Health Workers, Khabarovsk, Russia

Health Technology Assessment: 15 Years Searching for Road Map
Pavel Vorobiev, MD, PhD, MSc, President, ISPOR Russia Regional Chapter, Professor & Head of the Research Department of Health Care Standardization, Sechenov Medical Academy, Moscow, Russia

ISPOR Performance-Based Risk-Sharing Arrangements Good Research Practices Task Force
Developing Good Research Practices for Performance-Based Risk-Sharing Agreements

Developing Good Research Practices for Performance-Based Risk-Sharing Arrangements
Adrian Towse, MA, Director, Office of Health Economics, London, UK

Cross-Cutting and Other Issues
Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy, University of Washington, Seattle, WA, USA

Key Research Questions
Jens Grueger, PhD, Vice President and Head, Global Market Access Primary Care, Pfizer Inc., New York, NY, USA

Desirability of PBRSAs
Gerard de Pouvourville, PhD, Professor, Chair of Health Economics and Management, ESSEC Business School, Cergy Pontoise, France

A Taxonomy of PBRSAS
J.L. (Hans) Severens PhD, Professor, Evaluation in Health Care, Erasmus University Rotterdam, Rotterdam, The Netherlands

ISPOR Hungary, Slovakia, Republic of Macedonia, Turkish SCP and Czech Regional Chapters
ALTERNATIVE IMPLICATIONS OF ECONOMIC CRISIS ON HEALTH CARE IN CENTRAL AND EASTERN EUROPE: AN OPPORTUNITY TO IMPROVE DECISIONS OR STRENGTHEN COST-CONTAINMENT MEASURES?

IMPLICATIONS OF ECONOMIC CRISIS ON HEALTH CARE DECISION‐MAKING
Zoltán Kaló MD, MSc, PhD, Director, Health Economics Research Center, Faculty of Social Sciences, Eötvös Loránd University, Budapest, Hungary; Imre Boncz, MD, MSc, PhD, Associate Professor & Chair, Department of Health-Economics, Policy & Management, University of Pécs, Pécs, Hungary

Implications of Economic Crisis on Health Care and Cost -containment Measures for Pharmaceuticals, Medical Devices and Treatment
Yalçın Kaya, MD, MPH, Manager, Health Policy, Association of Research Based Pharmaceutical Companies, Ankara, Turkey

Impact of the latest drug policies in Slovakia on individual stakeholders
Martin Visnansky, MSc, PharmD, MBA, PhD, President, SLOVAHTA, Bratislava, Slovakia

ISPOR Serbia, Greece, Bosnia-Herzegovina, Israel, Poland Regional Chapters
HTA DEVELOPMENTS IN THE CENTRAL AND EASTERN EUROPEAN REGION: LOCK, STOCK & BARREL IN CHALLENGING TIMES

REPUBLIC OF SERBIA
Vladimir Zah, PhD (c), President, ISPOR Serbia Chapter and Health Economics Consultant, Belgrade, Serbia

HTA in Bosnia and Herzegovina ‐ Situation Overview
Tarik Catic, MSc Pharm, President, ISPOR Bosnia-Herzegovina Chapter, Health Economics and Pharmacoeconomics Consultant, Sarajevo, Bosnia and Herzegovina

Recent Developments in the Process of Updating the National List of Health Services in Israel
Dan Greenberg, PhD, Associate Professor, Department of Health Systems Management, Ben-Gurion University of the Negev, Beer-Sheva, Israel

The experience of GREECE
Mary Geitona, PhD, President, ISPOR Greece Chapter, Professor, Faculty of Social Policy, University of Peloponnese, Korinthos, Greece

THE NEW P&R REGULATIONS AND THEIR IMPACT ON HEALTH CARE SYSTEM IN POLAND
Joanna Lis, MSc, PhD, Director of Public Affairs and Market Access, Sanofi, Warsaw, Poland

Modeling Good Research Practices Task Force
MODELING GOOD RESEARCH PRACTICES

Good MODELING RESEARCH PRACTICES: Controversies
J. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice Presi­dent, Research, United BioSource Corporation, Lexington, MA, USA; Uwe Siebert, MD, MPH, MSc, ScD, Professor of Public Health, UMIT – University of Health Sciences, Medical Informatics & Technology, Hall, i.T., Austria; Andrew Briggs, DPhil, Lindsay Chair, Health Policy & Economic Evaluation, Public Health & Health Policy, University of Glasgow, Glasgow, UK

ISPOR HTA Russia, Ukraine, and Belarus Regional Chapters
HTA AS A DECISION-MAKING INSTRUMENT IN HEALTH CARE: EXPERIENCE IN RUSSIA, UKRAINE, AND BELARUS

HTA ELEMENTS IN RUSSIAN HEALTH CARE
Maria Avksentiyeva, MD, PhD, DSc, Deputy Director, Research Center for Clinical & Economic Evaluation and Pharmacoeconomics, Russian State Medical University, Moscow, Russia

Using HTA Elements on Inpatients in Ukraine
Olena Mandrik, MD, PhD (c), Department of Pharmacy, Danylo Halytsky Lviv National Medical University and Assistant Professor, Kiev-Mohylianska Academy, Kiev, Ukraine

Clinical and Economic Assessment of Medical Technologies as an Instrument of Decision- Making for Forming Limited Drug Lists in Belarus
Vladimir Matveev, MD, PhD, President of ISPOR Belarus Regional Chapter  and Professor, Department of Pediatrics, Vitebsk State Medical University Druzhba Narodov, Vitebsk, Belarus

Dossier System for Developing Reimbursement Lists
Maria Sura, PhD, Head, Research Laboratory, Research Center for Clinical & Economic Evaluation and Pharmacoeconomics, Russian State Medical University, Moscow, Russia

Analysis and Real Data in Medical Provision for “Privileged” People (War Veterans and Persons Affected by the Chernobyl Accident by the Example of Kyiv Region)
Viacheslav Tolubaiev, MD, PhD(c), President, ISPOR Ukraine Student Chapter, Kiev, Ukraine

ISPOR Spain Regional Chapter (CEISPOR)
RECENT CHANGES TO THE SPANISH NATIONAL HEALTH CARE SYSTEM: ANOTHER SIDE OF THE SPANISH REVOLUTION OR A COST-CONSEQUENCE OF ECONOMIC CRISIS?

Nuevo escenario para la industria farmacéutica
Xavier Badia, PhD, MD, MPH, Global Leader, Observational COE & Senior Principal, HEOR, IMS Health, Barcelona, Spain

EL PAPEL DE LA EVALUACION ECONOMICA
Antonio Sarría-Santamera, MD, PhD,
Director, Department of Social Medicine, Agency for Health Technology Assessment, Madrid, Spain


EDUCATIONAL SYMPOSIA

(Presentations to be added pending symposia host approval)

 

VALUE BASED PRICING IN DEVELOPED AND EMERGING MARKETS: PAST, PRESENT AND THE FUTURE
(Sponsored by Double Helix Consulting)

INTEGRATED REGULATORY AND COMMERCIAL PLANNING: INTERNAL APPROACHES AND VALUE TO PAYERS
(Sponsored by PAREXEL International)

BEYOND REAL-WORLD EVIDENCE
(Sponsored by IMS Consulting Group)

THE ECONOMICS OF PERSONALISED MEDICINE
(Sponsored by United BioSource Corporation)

INDUSTRY INVOLVEMENT IN THE HTA PROCESS: VALUE OR BIAS?
(Sponsored by EFPIA)


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