Released Presentations
PLENARY SESSIONS

FIRST PLENARY SESSION:

THE PATIENT AND HEALTH TECHNOLOGY ASSESSMENT: CHALLENGES AND OPPORTUNITIES

Evidence Supporting Reimbursement for a New Cystic Fibrosis Drug

Edward McKone, MSc, MD, FRCPI, FCCP, Consultant Respiratory Physician, National Referral Centre for Adult Cystic Fibrosis, St Vincent's University Hospital and Senior Clinical Lecturer, University College Dublin, Dublin, Ireland

Health Technology Assessment of the New Cystic Fibrosis Drug

Michael Barry, MD, PhD, FRCPI, Clinical Director, National Centre for Pharmacoeconomics, St. James’s Hospital, Dublin, Ireland

The Health Care Decision

James Reilly, JD, Minister for Health, Department of Health, Government of Ireland, Dublin, Ireland (Presented by Michael Barry)

SECOND PLENARY SESSION:

EARLY ENGAGEMENT BETWEEN MANUFACTURERS, HTA ASSESSORS, AND REGULATORS: LEARNING FROM THE PAST TO GUIDE THE FUTURE

Early Engagement between Manufacturers, HTA Assessors and Regulators: Learning from the Past to Guide the Future

John Hutton, BPhil, Professor of Health Economics, Department of Health Sciences, University of York, Heslington, York, UK

Early Engagement between Manufacturers, HTA Assessors and Regulators: EMA Perspective

Sheila Killalea MD, FRCPI, Member of the Scientific Advice Working Party, European Medicines Agency and Senior Clinical Assessor, Irish Medicines Board, Dublin, Ireland

NICE Scientific Advice: An HTA Agency Perspective

Leeza Osipenko, PhD, Senior Scientific Adviser, Scientific Advice Programme, National Institute for Health and Care Excellence (NICE), London, UK

Early Engagement between Manufacturers, HTA Assessors and Regulators: Learning from the Past to Guide the Future: A EUnetHTA Perspective

Mira Pavlovic, MD, Deputy Director for Health Technology Assessment, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France

Scientific Advice from Regulators and HTA: Industry Perspective

Jens Grueger, PhD, Vice President, Global Pricing & Market Access, F. Hoffmann - La Roche AG, Basel, Switzerland

THIRD PLENARY SESSION:

SHOULD MULTI-CRITERIA DECISION ANALYSIS (MCDA) REPLACE COST EFFECTIVENESS ANALYSIS (CEA) FOR EVALUATION OF HEALTH CARE COVERAGE DECISIONS?

Question is not Whether but How to Use MCDA

Rob Baltussen, PhD, Associate Professor, Health Economics, Nijmegen International Center for Health Systems Research and Education (NICHE), Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

Should Multi-Criteria Decisions Analysis (MCDA) Replace Cost Effectiveness Analysis (CEA) for Evaluation of Health Care Coverage Decisions?

Karl Claxton, PhD, Professor of Economics, Centre for Health Economics, University of York, Heslington, York, UK

MCDA in Healthcare Decision Making

Andrew Thomson, PhD, MSc, Head of Epidemiology, VRMM, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK

PODIUM AND POSTER PRESENTATIONS
For contributed research podium and poster abstracts and released slide or poster presentations for the ISPOR 16th Annual European Congress, see: ISPOR Scientific Presentations Database an electronic database of over 23,500 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 Scientific Presentations Database: http://www.ispor.org/research_study_digest/research_index.asp
  • Under Meeting select 16th Annual Europeal Congress – Dublin, Ireland
  • 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.
 WORKSHOP PRESENTATIONS

(Additional presentations will be added as speaker approval is received)

W1: INTRODUCING PATIENT-REPORTED OUTCOMES INTO EMA-MANDATED POST-AUTHORIZATION SAFETY STUDIES AND FDA-MANDATED POST-MARKETING SAFETY COMMITMENTS
Introducing Patient-Reported Outcomes into EMA-mandated Post-Authorization Safety Studies and FDA-Mandated Post-Marketing Safety Commitments

Annette Stemhagen, DrPH, FISPE, Senior Vice President, Epidemiology and Risk Management, United BioSource Corporation, Blue Bell, PA, USA; Janine Collins, MD, Senior Director European Risk Management, United BioSource Corporation, Geneva, PA, USA; Brian David Edwards, MD, MRCP, Principal Consultant, Pharmacovigilance, NDA Regulatory Science Ltd., Leatherhead, UK
W2: USING EARLY ECONOMIC MODELS TO GUIDE CLINICAL AND COMMERCIAL DEVELOPMENT OF NEW THERAPIES
Using Early Economic Models to Guide Clinical and Commercial Development of New Therapies

Francois Lucas, PhD, Principal, Pope Woodhead and Associates, St. Ives, UK; Matthew Taylor, PhD, MSc, Director, York Health Economics Consortium, York, UK; Michael Blankenburg, PhD, MBA, MPH, Manager, Globel HEOR, Global Market Access, and Global Medicine, Bayer HealthCare Pharmaceuticals, Berlin, Germany
Navigating the Waters of Economic Evaluations of Medical Devices

Maarten Ijzerman, PhD, Professor & Chair, Department of Health Technology & Services Research, University of Twente, Enschede, The Netherlands
W3: NAVIGATING THE WATERS OF ECONOMIC EVALUATIONS OF MEDICAL DEVICES
Navigating the Waters of Economic Evaluations of Medical Devices

Ken Redekop, PhD, Associate Professor, Institute for Medical Techonology Assessment (iMTA), Rotterdam, The Netherlands; Maarten Ijzerman, PhD, Professor & Chair, Department of Health Technology & Services Research, University of Twente, Enschede, The Netherlands; Praveen Thokala, PhD, Research Fellow, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
Navigating the Waters of Economic Evaluations of Medical Devices

Maarten Ijzerman, PhD, Professor & Chair, Department of Health Technology & Services Research, University of Twente, Enschede, The Netherlands
W4: VALUE IS IN THE EYE OF THE BEHOLDER: COMPELLING INSIGHTS INTO BIOPHARMA, PAYER, AND PROVIDER PERSPECTIVES
Value is in the Eye of the Beholder: Compelling Insights into Biopharma, Payer and Provider Perspectives

Louise Parmenter, PhD, Senior Strategic Planning Director, Real World & Late Phase Research, Quintiles Outcome, Reading, UK; Marc L. Berger, MD, Vice President, Real World Data and Analytics, Pfizer, New York, NY, USA; Adam Istas, BA, Director, Thought Leadership, Quintiles, Durham, NC, USA; Sarah Garner, PhD, Associate Director, Research and Development, National Institute for Health and Clinical Excellence (NICE), London, UK
W5: QUANTIFYING MEDICATION ADHERENCE: PRACTICAL CHALLENGES AND AN APPROACH TO LINKING ALTERNATIVE MEASURES
Quantifying Medication Adherence: Practical Challenges and an Approach to Linking Alternative Measures

Christine Poulos, PhD, Senior Economist, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA; Jay Patrick Bae, PhD, Principal Research Scientist, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; Sean D. Candrilli, PhD, Head, Health Economics Data Analytics, RTI Health Solutions, Research Triangle Park, NC, USA; A. Brett Hauber, PhD, Vice President, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA
W7: STATISTICAL CHALLENGES IN HTA
Statistical Challenges in HTA – Treatment Switching

Nicholas Latimer, MSc, Research Fellow in Health Economics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
Statistical Challenges in HTA

Marie-Ange Paget, MSc, Project HTA Statistician, EU Statistics, Lilly, France, Neuilly-sur-Seine, France; Claire Watkins, MA, MSc, Statistical Team Leader, Biometrics, AstraZeneca, Macclesfield, England
W8: THE ECONOMIC EVALUTION OF DIAGNOSTICS: CHALLENGES AND METHODS FOR ASSESSING VALUE
Health Economic Evaluations and Diagnostic Technologies: Reflections on Early NICE Experience

Ron L. Akehurst, BSc (Econ), Professor of Health Economics, School of Health and Related Research (ScHARR), University of Sheffield and Member, National Institute for Health and Clinical Excellence (NICE) Diagnostics Committee, Sheffield, UK
A Framework for Assessing the Value of Diagnostics

Eldon Spackman, MA, PhD, Research Fellow, Centre of Health Economics, University of York, Heslington, York, UK; Simon Walker, MSc, Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK
W9: TRANSPARENCY IN SUBMISSION OF DISCRETE EVENT SIMULATION (DES) AND HYBRID DES-MARKOV MODELS
Transparency in Submission of Discrete Event simulation (DES) and hybrid Des-Markov Models

Anuraag R. Kansal, PhD, Research Scientist, Evidera, Bethesda, MD; Roberto Palencia, MA, Global Manager, Health Economics & Outcomes Research, Corporate Market Access, Pricing & Outcomes Research, Boehringer Ingelheim GmbH, Ingelheim, Germany; Sylwia Bujkiewicz, PhD, Lecturer of Population & Public Health Sciences, Department of Health Sciences, Biostatistics Research Group, University of Leicester, Leicester, UK;Sonja Sorensen, MPH, Senior Research Scientist, Evidera, Bethesda, MD, USA
W11: MULTIPLE CHALLENGES IN CAPTURING UTILITIES FOR PAEDIATRIC CONDITIONS
Multiple Challenges in Capturing Utilities for Paediatric Conditions

Cicely Kerr, PhD, Senior Outcomes Researcher, Patient Reported Outcomes, Oxford Outcomes, an ICON plc Company, Oxford, UK; Andrew J Lloyd, DPhil, Vice President (Practice Lead), Patient Reported Outcomes, Oxford Outcomes, an ICON plc Company, Oxford, UK; John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Andrew Walker, PhD, Health Economist & Reviewer, Scottish Medicines Consortium (SMC), University of Glasgow, Glasgow, UK
W12: WHEN COLLECTING PATIENT DATA GETS ELECTRONIC: THE UPSURGE OF E-HEALTH AND THE IMPORTANCE OF BIG DATA TO SHAPE MODERN HEALTH CARE
When Collecting Patient Data Gets Electronic: Promises and Challenges of Deploying an ePRO System in Clinical Trials and Observational Studies

Laure Delbecque, PhD, Patient-Reported Outcomes Consultant, Business & Decision Life Sciences, Brussels, Belgium
When Collecting Patient Data Gets Electronic: Regulatory Perspectives and Experiences on ePRO & eHealth Data

Olivier Chassany, MD, PhD, Professor of Therapeutics, Patient-Reported Outcomes Unit, University Paris 7, Paris, France
When collecting patient data gets electronic: How BIG DATA can improve clinical and health outcome evaluations

Maxime Taquet, MSc, Visiting Research Fellow, Harvard Medical School, Boston, MA, USA
W13: METHODOLOGY TO VALIDATE SURROGATE ENDPOINTS IN CLINICAL TRIALS: WHICH LEVEL OF EVIDENCE IS FIT FOR PURPOSE?
Methodology to Validate Surrogate Endpoints in Clinical Trials: Which Level of Evidence is Fit for Purpose?

Helene Karcher, PhD, Senior Director, LASER Analytica, London, UK; Wilma Erhardt, MSc, Manager, Health Economics, Janssen-Cilag GmbH, Neuss, Germany; Carsten Schwenke, PhD, Owner, SCO:SSiS, Berlin, Germany; Theophile Bigirumurame, MSc, PhD student, Center for Statistics, Hasselt University, Diepenbeek, Belgium
W14: MODELLING APPROACHES WHEN LIMITED BY SINGLE-ARM STUDIES: AN ANALYSIS OF RECENT ONCOLOGY EXAMPLES
Modelling Approaches when Limited by Single-Arm Studies: An Analysis of Recent Oncology Examples

Cyrus A. Chowdhury, MS, Chief Executive Officer, CBPartners, New York City, NY, USA; Rachel Beckerman, PhD, Principal, Value Demonstration, CBPartners, New York, NY, USA; Meghan Gallagher, MSc, Director, Global Evidence Value Development, Sanofi, Cambridge, MA, USA; Mónica Martín de Bustamante, AB, Managing Director, Latin America, CBPartners, Basel, Switzerland
W15: EVIDENCE-BASED DETERMINISTIC SENSITIVITY ANALYSES: CASE STUDIES USING ISPOR-SMDM GUIDELINES FOR UNCERTAINTY ANALYSES
Evidence Based Deterministic Sensitivity Analyses: Case Studies using ISPOR-SMDM Guidelines for Uncertainty Analyses

Anju Parthan, PhD, Associate Director, Life Sciences, OptumInsight, Cambridge, MA, USA; Milton C. Weinstein, PhD, Henry J Kaiser Professor of Health Policy & Management, Harvard School of Public Health, Boston, MA, USA; Kelly Fust, MS, Project Manager, Life Sciences, OptumInsight, Cambridge, MA, USA
W16: THE ROLE OF EVIDENCE SYNTHESIS AND VALUE OF INFORMATION ANALYSIS FOR RESEARCH PRIORITISATION, COMMISSIONING AND CLINICAL TRIAL DESIGN
Considerations

Claire McKenna, PhD, Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK
The Role of Evidence Synthesis and Value of Information Analysis for Research Prioritisation, Commissioning and Clinical Trial Design

Karl Claxton, PhD, Professor of Economics, Centre for Health Economics, University of York, Heslington, York, UK; Claire McKenna, PhD, Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK
Optimal Design of New Research: IVIG for Severe Sepsis

Nicky Welton, PhD, Senior Lecturer, School of Social and Community Medicine, University of Bristol, Bristol, UK
W20: MCDA IN HTA: TRANSLATING THEORY TO PRACTICE THROUGH AN INTERACTIVE WORKSHOP
MCDA In HTA: Translating Theory To Practice Through An Interactive Workshop

Jerome Cheynel, MSc, Health Economist, Medaxial Group, London, UK; Ruth Zeidman, PhD, Senior Consultant, Medaxial Group, London, UK; Shahrul Mt-Isa, PhD, Research Fellow, School of Public Health, Imperial College London, London, UK; Kevin Bowrin, MSc, HEOR Director, Primary Care Business Unit, Pfizer Ltd., Tadworth, Surrey, UK
MCDA: Concepts and Approaches

Shahrul Mt-Isa, PhD, Research Fellow, School of Public Health, Imperial College London, London, UK
W22: TESTING THE MEASUREMENT EQUIVALENCE OF ELECTRONICALLY MIGRATED PATIENT-REPORTED OUTCOME (PRO) INSTRUMENTS: CHALLENGES AND SOLUTIONS
Testing the measurement equivalence of electronically migrated patient-reported outcome (PRO) instruments: Challenges and Solutions

Sonya Eremenco, MA, Director, ePRO New Products, Health Care Analytics, Evidera, Bethesda, MD, USA; Karl McEvoy, BSc, PhD, Health Outcomes, CRF Health, London, UK; Diane Wild, MSc, Vice President, eCOA and Translations, Oxford Outcomes, an ICON plc Company, Oxford, UK; J. Jason Lundy, PhD, Assistant Director, Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA
W23: GARBAGE IN – GARBAGE OUT: DETECTING DATA ERRORS AND MANAGING SUCH ERRORS IN RETROSPECTIVE RESEARCH
Garbage In - Garbage Out: Detecting Data Errors and Managing Such Errors in Retrospective Research

Rolin L. Wade, RPh, MS, Principal, Health Economics and Outcomes Research, Real World Evidence Solutions, IMS Health, Parsippany, NJ, USA; Richard Chapman, MS, PhD, Vice President, Data Analytics, Avalere Health, Washington, DC, USA
W25: NAVIGATING THE PITFALLS AROUND PROGRESSION-FREE SURVIVAL ESTIMATION
Navigating the Pitfalls Around Progression-Free Survival Estimation

Edit Remak, MSc, Research Scientist, Evidera, Budapest, Hungary; Martin Hoyle, MA, MSc, PhD, Senior Research Fellow, Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK
Estimation of Progression-free Survival

John William Stevens, PhD, Statistician, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
W26: INCLUSION OF CLINICAL TRIAL DATA AND OTHER EVIDENCE IN CLINICAL PRACTICE GUIDELINES: AN IMPORTANT OPPORTUNITY FOR INDUSTRY
Inclusion of Clinical Trial Data and Other Evidence in Clinical Practice Guidelines: an Important Opportunity for Industry

Adele R. Weston, PhD, Executive Vice President & Senior Scientist, Health Economics and Outcomes Research, Optum, Sydney, Australia; Deborah Marshall, PhD, MHSA, Canada Research Chair, Health Systems and Services Research and Associate Professor, Department of Community Health Sciences, Faculty of Medicine, University of Calgary, Calgary, AB, Canada
W27: MANAGING UNCERTAINTY: THE NEW WAY FORWARD FOR MARKET ACCESS
Managing uncertainty: the new way forward for market access

Antoni Gilabert, PhD, Managing Director of Pharmaceutical Care, Catalan Autonomous Region Health Service, Barcelona, Spain
Eliciting Formal Patient Preferences for Assessing Benefits and Risks of Medicines

Mondher Toumi, MD, PhD, Professor & Chair of Public Health & Market Access, University Claude Bernard Lyon 1, Lyon, France
W28: ELICITING FORMAL PATIENT PREFERENCES FOR ASSESSING BENEFITS AND RISKS OF MEDICINES
Eliciting Formal Patient Preferences for Assessing Benefits and Risks of Medicines

Shahrul Mt-Isa, PhD, Research Fellow, School of Public Health, Imperial College London, London, UK; Kimberley Hockley, MPH, Research Postgraduate & Team Leader, Patients and Public Involvement Working Group, IMI-PROTECT Work Package Five, School of Public Health, Imperial College London, London, UK; Susan Shepherd, MSc, Senior Manager, Biostatistics (Bone TA - Regional Biostatistics Lead), Amgen (UK) Limited, Uxbridge, UK
W29: ENHANCING THE VALUE OF HEALTH ECONOMIC MODELING THROUGH NOVEL APPLICATION OF REAL WORLD EVIDENCE (RWE)
Real World Data Sources

Christopher M. Blanchette, PhD, MBA, Research Associate Professor, Department of Public Health Sciences, University of North Carolina, Charlotte, NJ, USA
Enhancing the Value of Health Economic Modeling through Novel Application of Real World Evidence (RWE)

Amy O'Sullivan, PhD, Principal, IMS Health, Waltham, MA, USA
W30: SUSTAINABILITY OF OFF-PATENT DRUG POLICIES IN THE QUEST FOR VALUE
Sustainability of Off-Patent Drug Policies in the Quest for Value

Diana Brixner, PhD, RPh, Professor & Executive Director, Department of Pharmacotherapy, University of Utah, Salt Lake City, UT, USA; Nikolaos Maniadakis, MSc, PhD, Professor, Department of Health Services Organization and Management, National School of Public Health, Athens, Greece; Jie Shen, PhD, Head of Market Access, Abbott, Basel, Switzerland
W31: POST-AUTHORISATION STUDIES IN EUROPE: BRIDGING THE GAP BETWEEN REGULATORY AND HEALTH TECHNOLOGY ASSESSMENT (HTA) STAKEHOLDER NEEDS FOR ADDITIONAL EVIDENCE
Post-Authorisation Studies in Europe: Briding the Gape Between Regulatory and Health Technology Assessment (HTA) Stakeholder Needs by Better Design of Studies

Massoud Toussi, MD, PhD, MBA, Medical Director, Health Economics and Outcomes Research, IMS Health, Paris, France
Additional Data Collection for Drugs in Europe HTA Perspective

Francois Meyer, MD, Advisor to the President & Director for International Affairs, Haute Autorité de Santé (HAS), Paris, France
PASS-PAES-HTA Studies

Nicholas Moore, MD, PhD, Head, Department of Pharmacology, University of Bordeaux, Bordeaux, France
W33: THE CORRELATION BETWEEN PATIENT-REPORTED OUTCOMES AND CLINICIAN-REPORTED OUTCOMES
The Correlation between Patient Reported Outcomes and Clinician Reported Outcomes

Eric Gemmen, MA, Senior Director, Biostatistics & Outcomes Research, Scientific Affairs, Quintiles Outcome, Rockville, MD, USA; Katie Zarzar, BA, Associate Patient Reported Outcomes Scientist II, Roche Products Ltd in the UK, Welwyn Garden City, United Kingdom; Shital Kamble, PhD, Outcomes Research Lead, Scientific Affairs, Quintiles Outcome, Rockville, MD, USA; Rebecca Dawsey, BA, Director, Strategic Accounts, Linguistic Validation, TransPerfect, Atlanta, GA, USA
ISSUE PANEL PRESENTATIONS

(Additional presentations will be added as speaker approval is received)

IP3: MEASURING UTILITY FOR ECONOMIC MODELS WITHIN CLINICAL TRIALS: CAN WE DO BETTER?
Measuring Utility for Economic Models within Clinical Trials: Can We Do Better?

Sorrel Wolowacz, PhD, Head, Health Economics Europe, RTI Health Solutions, Manchester, UK; Andrew Briggs, DPhil, MSc, William R. Lindsay President of Health Economics, Department of Health Economics & Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK; Jennifer Petrillo, PhD, Associate Director, Global Health Economics & Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; Lynda Doward, MRes, European Head, Patient-Reported Outcomes, RTI Health Solutions, Manchester, UK
IP4: DOES ASSESSING THE VALUE FOR MONEY OF MEDICAL DEVICES REQUIRE A FLEXIBLE APPROACH?
Value for Money for Medical Devices: A U.S. Perspective

Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, University of Washington School of Pharmacy, Seattle, WA, USA
Ascertaining the Value for Money of Medical Devices: A European Perspective

Mark Campbell, MD, Associate Director, Medical Technologies Evaluation Programme, National Institute for Health and Care Excellence (NICE), Manchester, United Kingdom; Rosanna Tarricone, PhD, Professor, Bocconi University, Milan, Italy
IP5: DEMONSTRATING TREATMENT BENEFIT USING CLINICAL OUTCOME ASSESSMENTS IN GLOBAL CLINICAL TRIALS: HOW RELIABLE ARE THE ASSESSMENTS FROM CROSS-CULTURAL SETTINGS?
Demonstrating Treatment Benefit Using Clinical Outcome Assessments in Global Clinical Trials: How Reliable are the Assessments from Cross-Cultural Settings?

Mira Pavlovic, MD, Deputy Director for Health Technology Assessment, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France
Statistical Perspectives on COA in International Clinical Trials

Paulo Carita, MD, Senior Director, Comparative Effectiveness & Health Outcomes / Global Evidence and Value Development,, Sanofi-Aventis R&D, Chilly-Mazarin, France
IP6: INTEGRATING REIMBURSEMENT NEEDS INTO THE DESIGN OF DRUG DEVELOPMENT PROGRAMS
Integrating Reimbursement Needs into the Design of Drug Development Programs

Christine A. Fletcher, MSc, Executive Director, Biostatistics, Amgen Ltd., Cambridge, UK
Statistics Adding Value in HTA: A Personal View

Timothy R. Auton, MSc, PhD, Director, Biostatistics, Astellas, Leiden, The Netherlands
What Clinical Evidence Do We Need for HTA?

Andrew Walker, PhD, Health Economist & Reviewer, Scottish Medicines Consortium (SMC), University of Glasgow, Glasgow, United Kingdom
IP7: MAKING VALUE-BASED PRICING A REALITY
Making Value-Based Pricing A Reality: Issue Panel

Meindert Boysen, MSc, HPPF, Director, Technology Appraisal Programme, Centre for Health Technology Evaluation, National Institute for Health and Clinical Excellence (NICE), Manchester, United Kingdom; John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, United Kingdom; Roberta Ara, MSc, Senior Research Fellow, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, United Kingdom
Five Observations from an Outsider

Werner Brouwer, PhD, Professor, Institute for Health Policy & Law, Rotterdam, The Netherlands
IP8: HOW ARE THE RESULTS FROM HTA METHODOLOGY RESEARCH IMPLEMENTED IN THE UPDATES OF HTA GUIDELINES?
How are the Results from HTA Methodology Research Implemented in Updates of HTA Guidelines?

Wim Goettsch, PhD, Project Leader of EUnetHTA WP5 on Rapid Assessments and Advisor of International Affairs and Academia, Health Care Insurance Board (CVZ), Diemen, The Netherlands
HTA Methodology Research & HTA Guideline Revision in the Netherlands

Manuela A. Joore, PhD, Associate Professor, Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, CAPHRI, and Maastricht University, Maastricht, The Netherlands
Updating HTA Guidelines Using HTA Methodology Research: Viewpoint from the Healthcare Insurance Board

Saskia Knies, PhD, Advisor of Pharmacoeconomics, Health Care Insurance Board (CVZ), Diemen, The Netherlands
How are the Results from HTA Methodology Research Implemented in Updates of HTA Guidelines?

Allan J. Wailoo, PhD, Professor, University of Sheffield, Sheffield, United Kingdom
IP9: PHARMACY BENEFIT MANAGEMENT IN THE UNITED STATES: NAUGHTY OR NICE? A COMPARISON OF US AND EUROPEAN DRUG EVALUATION AND COVERAGE POLICIES
Guidance on the Use of Medicines in the UK: Nasty or NICE?

Michael Drummond, PhD, Professor of Health Economics, Centre for Health Economics, University of York and Principal Consultant, OptumInsight, Heslington, York, United Kingdom
Pharmacy Benefit Management (PBM) In The United States: Naughty or NICE?

Brian Solow, MD, Chief Medical Officer, OptumRx, Irvine, CA, USA
IP10: REASSEMBLING THE "NICHE AGENT" PUZZLE: HOW SHOULD ORPHAN AND SPECIALTY PRODUCT MANUFACTURERS REFOCUS EVIDENCE DEVELOPMENT IN RESPONSE TO GROWING PRESSURE FOR VALUE DEMONSTRATION?
BioPharma, Regulators and Payers 'Decisions: Different Processes but is there a Convergence in the Approach for Integrating the Patient Perspective?

Eric C. Faulkner, MPH, Director, Global Market Access, Quintiles, Executive Director, Genomics, Biotech, Emerging Medical Technology Institute, National Association of Managed Care Physicians, and Assistant Professor, Institute for Pharmacogenomics and Individualized Therapy, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA; Wills Hughes-Wilson, LLB, Vice President, External Affairs and Chief Patient Access Officer, Sobi Pharmaceuticals, Industry Member, European Union Committee of Experts on Rare Diseases (EUCERD), and Chair, EBE-EuropaBio European Industry Task Force on Orphan Medicinal Products, Brussels, Belgium; Andras Fehervary, MBA, DES, MALD, Head, Government & Public Affairs Europe, Novartis and Industry Member, European Union Committee of Experts on Rare Diseases (EUCERD), Novartis, Basel, Switzerland
IP11: BIOPHARMA, REGULATORS, AND PAYERS DECISIONS: DIFFERENT PROCESSES BUT IS THERE A CONVERGENCE IN THE APPROACH FOR INTEGRATING THE PATIENT PERSPECTIVE?
BioPharma, Regulators and Payers 'Decisions: Different Processes but is there a Convergence in the Approach for Integrating the Patient Perspective?

Patrick Marquis, MD, MBA, President, TwoLegs Consulting LLC, Newton, MA, USA; Laurie B. Burke, RPh, MPH, Director, Study Endpoints and Labeling Development, Office of New Drugs, CDER, U.S. Food and Drug Administration, Silver Spring, MD, USA; Mira Pavlovic, MD, Deputy Director for Health Technology Assessment, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France; Julia A. Gaebler, PhD, Director, Health Economics, Biogen Idec, Weston, MA, USA
IP12: HEALTH ECONOMICS OF PERSONALIZED MEDICINE – DO WE NEED A COMPREHENSIVE RESEARCH PROGRAM?
Health Economics of Personalized Medicine - Do We Need a Comprehensive Research Program?

Uwe Siebert, MD, MPH, MSc, ScD, Professor & Chair, Department of Public Health, Medical Decision Making and Health Technology Assessment, University of Health Sciences, Medical Informatics and Technology, Hall i.T., Austria and Adjunct Professor of Health Policy and Management, Center of Health Decision Science, Harvard School of Public Health, Boston, MA, USA
Health Economics of Personalised Medicine – Do we Need a Comprehensive Research Programme?

Mark J. Sculpher, MSc, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK
Health Economics of Personalised Medicine – Do we Need a Comprehensive Research Programme?

Scott Ramsey, PhD, MD, Member, Fred Hutchinson Cancer Research Center and Professor, Department of Medicine, University of Washington, Seattle, WA, USA
Is There a Need for a Comprehensive Research Program in Health Economics & Personalized Medicine?

Maarten J. IJzerman, PhD, Professor & Chair, Department of Health Technology & Services Research, University of Twente, Enschede, The Netherlands
IP13: SHOULD OFF-LABEL AGENTS BE USED AS COMPARATORS IN HEALTH TECHNOLOGY ASSESSMENTS?
Should Off-Label Agents be Used as Comparators in Health Technology Assessments?

Jeanette Kusel, MSci, Consultant, Costello Medical Consulting Ltd., Cambridge, UK; Eldon Spackman, PhD, Research Fellow, Centre of Health Economics, University of York, York, UK; Andrew Walker, PhD, Health Economist and Reviewer, Scottish Medicines Consortium (SMC), University of Glasgow, Glasgow, UK; Christin Andersson, PhD, Head, Department of Pharmaceutical Review Unit, Dental and Pharmaceutical Benefits Agency, Sweden, Stockholm, Sweden
IP14: POST-LAUNCH DEMANDS: HOW CAN A COMPANY BEST ADDRESS THE CHALLENGES AND OPPORTUNITIES PRESENTED BY THE NEW EU PHARMACOVIGILANCE REQUIREMENTS OF THE REGULATORS, THE ASSESSOR'S NEED FOR REAL WORLD EVALUATION, AND THE PAYERS' NEEDS TO DEMONSTRATE VALUE?
How Can a Company Best Address the Challenges and Opportunities Presented by the New EU Pharmacovigilance Requirements of the Regulators, the Assessor's Need for Real World Evaluation and Other Payers' Needs to Demonstrate Value?

Lisbet Coulton, BA, Director, Tanwood Consulting Ltd, Leatherhead, Surrey, UK
How Can a Company Best Address the Challenges and Opportunities - A Payer/HTA Perspective!

Keith Tolley, MPhil, Director, Tolley Health Economics Ltd., Hardwick House, Buxton, Derbyshire, United Kingdom
Post-Launch Demands: How can a Company Best Address the Challenges and Opportunities presented by the New EU Pharmacovigilance Requirements of the Regulators, the Assessor's Need for Real World Evaluation, and the Payer's Needs to Demonstrate Value?

Thomas Lonngren, PhD, MRPharmS, FRCP, Director, Pharm Executive Consulting, Uppsala, Sweden
IP15: ALIGNING PAYER AND INDUSTRY PERSPECTIVES ON MEASURING VALUE IN HEALTH TECHNOLOGY ASSESSMENT
Aligning Payer and Industry Perspectives on measuring Value in Health Technology Assessment

Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, University of Washington School of Pharmacy, Seattle, WA, USA
Aligning Industry and Payer Perspectives: One Opinion

James F Murray, PhD, Research Fellow, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA
Aligning Payer and Industry Perspectives on Measuring Value in HTA

Ulf Persson, PhD, Research Director, The Swedish Institute for Health Economics, Lund, Sweden
IP16: IS OPEN ACCESS TO CLINICAL TRIAL DATA GOOD FROM THE MARKET ACCESS PERSPECTIVE?
Is Open-access to Clinical Trial Data Good from Market Access Perspective?

Radek Wasiak, MA, MSc, PhD, EU Director, Senior Research Scientist, Evidera, London UK
Disadvantages of Sharing Data

Jerome Dinet, PharmD, Global Evidence Generation Director, IPSEN Pharma, Boulogne-Billancourt, France
Advantages of Sharing Data

Sylvie Gabriel, MD, Senior Vice President, Global Market Access & Pricing, IPSEN Pharma, Boulogne-Billancourt, France
IP17: HOW CAN HEALTH ECONOMIC MODELLERS WIN THE TRUST OF DECISION MAKERS?
How May Health Economic Modellers Win the Trust of Decision-Makers?

Stefano Capri, School of Economics and Management, LIUC University, Castellanza, Italy
How May Health Economic Modellers Win the Trust of Decision-makers?

Samuel Aballea, MSc, Vice President, HEOR, Creativ-Ceutical, Paris, France
IP19: COMPARING THE CHALLENGES OF COMPARATIVE EFFECTIVENESS RESEARCH IN FRANCE, ITALY AND THE NETHERLANDS: CURRENT SITUATION AND PERSPECTIVES
Current Situation and Perspectives

Jeanni van Loon, MSc, Global Managing Director, HEOR & Strategic Market Access, Mapi, Houten, The Netherlands; Francois Meyer, MD, Advisor to the President & Director for International Affairs, Haute Autorité de Santé (HAS), Paris, France; Entela Xoxi, PharmD, Pharmacologist, Research and Clinical Trial Unit, Italian Medicines Agency (AIFA), Rome, Italy; Caroline van der Meijden, PhD, Advisor of Pharmacoeconomics, Health Care Insurance Board (CVZ), Diemen, Netherlands
IP20: PARTNERING WITH PATIENTS: DESIGNING, PARTICIPATING IN, AND REPORTING HEALTH OUTCOMES
Partnering with Patients: Designing, Participating in and Reporting Health Outcomes

Tim Davis, BSc, Chief Executive Officer, Exco InTouch, Sawbridgeworth, United Kingdom
Partnering with Patients: Designing, Participating In And Reporting Health Outcomes

Jan Geissler, MBA, Director, EUPATI, Riemerling, Germany
ISPOR FORUMS
(Additional presentations will be added as speaker approval is received)
PRICING AND REIMBURSEMENT PROCESS FOR MEDICAL DEVICES IN CENTRAL & EASTERN EUROPE

Presented by the ISPOR CEE Network: ISPOR Greece, Hungary, Republic of Macedonia, Russia, and Serbia Regional Chapters
Evidence Base of Pricing and Reimbursement Process for Medical Devices in Hungary

Zoltán Kaló, MD, MSc, PhD, Director, Health Economics Research Centre, Eotvos Lorand University (ELTE) and Syreon Research Institute, Budapest, Hungary
Pricing and Reimbursement Process for Medical Devices in CEE: The Experience of Greece

Mary Geitona, MSc, PhD, President, ISPOR Greece Chapter and Associate Professor, Health Economics and Social Policy, School of Social Policy, University of Peloponnese, Corinth, Greece
PATIENT DATA AND PATIENT REGISTRIES IN CENTRAL & EASTERN EUROPE

Presented by the ISPOR CEE Network: ISPOR Bosnia and Herzegovina, Hungary, Serbia, and Slovakia Regional Chapters
Patient Registries as an Opportunity in Bosnia-Herzegovina for Access to Medicines

Tarik Catic, MScPharm, President, ISPOR Bosnia-Herzegovina Chapter and Health Economics and Pharmacoeconomics Consultant, Sarajevo, Bosnia- Herzegovina
CLINICIAN REPORTED OUTCOMES: GOOD MEASUREMENT PRACTICES

Presented by the ISPOR ClinRO Good Measurement Practices Task Force
Clinician Reported Outcomes: Good Measurement Practices

Laurie B. Burke, RPh, MPH, Director, Study Endpoints and Labeling Development, ONDIO, CDER, Food & Drug Administration (FDA), Silver Spring, MD, USA; Jeremy Hobart, PhD, FRCPJ, Professor of Clinical Neurology and Health Measurement, Peninsula College of Medicine and Dentistry, Plymouth, UK; Patrick Marquis, MD, MBA, President, Twolegs Consulting, Newton, MA, USA; Donald Patrick, PhD, MSPH, Professor, Department of Health Services and Director, Seattle Quality of Life Group & Biobehavioral Cancer Training Program, University of Washington, Seattle, WA, USA
MEET THE EDITORS OF VALUE IN HEALTH

Presented by the Co-Editors-in-Chief of Value in Health
Publishing in Value in Health What makes a Good Paper?

Michael Drummond, MCom, DPhil, Co-Editor-in-Chief, Value in Health and Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK; C. Daniel Mullins, PhD, Co-Editor-in-Chief, Value in Health and Professor, Pharmaceutical Health Services Research Department, University of Maryland, Baltimore, MD, USA
NEW HEALTH CARE REFORMS AND HTA STATUS IN RUSSIA, UKRAINE, BELARUS, KAZAKHSTAN, AND ARMENIA

Presented by ISPOR Russia HTA, Ukraine, Belarus, Armenia, and Kazakhstan Regional Chapters
ECONOMIC EVALUATION OF PHARMACEUTICALS IN PORTUGAL: FROM PIONEERS TO THE LIMITATIONS IMPOSED BY THE ECONOMIC CRISIS

Presented by the ISPOR Portugal Chapter
The Present Role and Perspectives for Development of Economic Evaluation of Pharmaceuticals in Portugal

Eurico Castro Alves, MD, President, INFARMED – National Authority of Medicines and Health Products, Lisbon, Portugal
Fifteen Years of using Economic Evaluation for Medicines Reimbursement Decisions: the Portuguese Experience

Mónica Inés, MSc, Health Technology Assessment/Outcomes Research Manager, Pfizer Portugal, Lisbon, Portugal
Guidelines for the Economic Evaluation of Medicines in Portugal: What to Keep, What to Change, What to Add

Miguel Gouveia, PhD, Associate Professor, Catolica Lisbon School of Business and Economics, Lisbon, Portugal
RISK SHARING ON PHARMACEUTICALS AND DEVICES IN SPAIN: THE REALITIES

Presented by the ISPOR Spain Regional Chapter
RARE DISEASES: TERMS, DEFINITIONS, AND CHALLENGES IN ASSESSING AND APPRAISING DIAGNOSTICS AND TREATMENTS

Presented by the ISPOR Rare Disease Special Interest Group
Rare Diseases: Terms, Definitions, and Challenges in Assessing and Appraiding Diagnostics and Treatments

Chris L. Pashos, PhD, Vice President, United BioSource Corporation, Lexington, MA, USA; Dyfrig Hughes, PhD, MSc, Professor, Centre for Health Economics and Medicines Evaluation, Bangor University, Wales, UK; Mondher Toumi MD, MSc, PhD, Professor & Chair of Decision Sciences, Department of Public Health and Market Access, University Claude Bernard Lyon I, Lyon, France; Zeba M. Khan, RPh, PhD, Vice President, Strategic Market Access & Policy, Celgene, Summit, NJ, USA
THE USE OF RISK-SHARING IN PHARMACEUTICAL PRICING AND REIMBURSEMENT DECISIONS IN CENTRAL & EASTERN EUROPE

Presented by the ISPOR Central & Eastern Europe Network: ISPOR Bulgaria, Croatia, Czech, Romania and Turkish SCP Regional Chapters
Use of Risk-Sharing in Pharmaceutical Pricing and Reimbursment Decisions in Central & Eastern Europe

Jana Skoupa, MD, MBA, Researcher, Medical Data Center, 1st Medical Faculty, Charles University, Prague, Czech Republic
Risk-Sharing Policy in Pharmaceutical Pricing Impelemtned in Croatia

Josip Culig, MD, PhD, Professor, Clinical Pharmacologist, Institute of Public Health Dr.A. Štampar, Zagreb, Croatia
Current Practice for Medicines Reimbursement Agreements in Bulgaria

Alexandra Savova, MPharm, PhD, Associate Professor, Faculty of Pharmacy, Department of Social Pharmacy and Pharmacoeconomics, Medical University of Sofia, Sofia, Bulgaria
VIHRI: RESOURCES AND TIPS FOR WRITING QUALITY AND WELL-SUPPORTED PAPERS

Presented by the VIHRI Editorial Board.
ViHRI: Resources and Tips for Writing Quality and Well-Supported Papers

Dan Greenberg, PhD, Co-Editor-in-Chief, ViHRI (CEEWAA) and Associate Professor & Chairman, Department of Health Systems Management, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Value in Health Regional Issues Focusing on Asia

Kenneth KC Lee, MPhil, PhD, Co-Editor, ViHRI (Asia), Professor of Pharmacy & Head of Pharmacy, Discipline of Pharmacy, Monash University, Sunway campus, Kuala Lumpur, Malaysia, and UK Editor-in-Chief, Journal of Medical Economics, UK
ViHRI: Resources and Tips for Writing Quality and Well-Supported Economic Analysis Papers

J. Jaime Caro, MDCM, FRCPC, FACP, Co-Editor, ViHRI (Latin America ) and Senior Vice President, Research, Evidera, Lexington, MA, USA and Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics, McGill University, Montreal, QC, Canada
THE USE OF PHARMACOECONOMIC PRINCIPLES IN LOCAL DRUG POLICY DECISIONS IN POLAND, RUSSIA, AND UKRAINE

Presented by ISPOR CEE Network: ISPOR Poland, Russia, & Ukraine Regional Chapters
The Use of Pharmacoeconomic Principles in Local Drug Policy Decisions in Poland

Karina Jahnz-Rozyk, MD, PhD, Head of Department of Immunology & Clinical Allergology, Military Institute of Medicine, Warsaw, Poland
The Use of Pharmacoeconomic Principles in Local Drug Policy Decisions in Poland, Russia, and Ukraine

Olha Zaliska, PhD, Dr.Sci (Pharm ), President, ISPOR Ukraine Chapter and Professor & Head of Department of Organization & Economy of Pharmacy, Medicine Technology, Postgraduate Faculty, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine
PHARMACOECONOMICS AND OUTCOMES RESEARCH IN ASIA: WHAT IS NEXT?

Presented by the ISPOR Asia Consortium
Pharmacoeconomics and Outcomes Research in Asia: What is Next?

Isao Kamae, MD, DrPH, Professor of Health Technology Assessment and Public Policy, Graduate School of Public Policy, The University of Tokyo, Tokyo, Japan
Use of Economic Evaluation for Policy Making in Japan

Takashi Fukuda, PhD, Chief Senior Researcher, National Institute of Public Health, Wako, Japan
HTA Trends in China – The Present and Future

Shanlian Hu MD, MSc, Professor of Health Economics, School of Public Health, Fudan University, Director, Center for Health Development Research, Shanghai Bureau of Health, Shanghai, China
EDUCATIONAL SYMPOSIA

(Additional presentations will be added as symposia host approval is received)

BUILDING, EMBEDDING & OPTIMISING MARKET ACCESS CAPABILITIES – FROM STRATEGY TO EXECUTION
(Sponsored by GalbraithWight)
Building, Embedding & Optimizing Market Access Capabilities – From Strategy to Execution

Jackie Briggs, Principal Consultant, GalbraithWight, Polegate, East Sussex, UK; Tanea Neville, Principal Consultant, GalbraithWight, Polegate, East Sussex, UK; Janet Waters, Principal Consultant, GalbraithWight, Polegate, East Sussex, UK; Debbie Thompson, Principal Consultant, GalbraithWight, Polegate, East Sussex, UK; Mark Boyden, Principal Consultant, GalbraithWight, Polegate, East Sussex, UK; Emma Rawlins, Principal Consultant, GalbraithWight, Polegate, East Sussex, UK; Colin Wight, Chief Executive, GalbraithWight, Polegate, East Sussex, UK; Keith Tolley, Economic Assessor, Scottish Medicines Consortium (SMC), Buxton, Derbyshire, UK
PERSONALIZED MEDICINE AND HTA – BRIDGING THE SCIENCE OF PERSONALIZED MEDICINE WITH THE POLICY OF POPULATION DECISION MAKING
(Sponsored by Xcenda)
Personalized Medicine and HTA – Bridging the Science of Personalized Medicine With the Policy of Population Decision Making

Tommy Bramley, PhD, RPh, Senior Vice President, Scientific Consulting, Xcenda, Tampa, FL, USA; Amy L. Grogg, PharmD, President, AmerisourceBergen Consulting Services, Valley Forge, PA, USA

Ken Redekop, MPH, PhD, Associate Professor, Erasmus University, Rotterdam, The Netherlands

Ansgar Hebborn, PhD, Head – Global Market Access Policy, F. Hoffmann-La Roche AG, Global Pricing & Market Access (GPMA), Basel, Switzerland
MEDICINES' ADAPTIVE PATHWAYS TO PATIENTS: THE ROLE OF REAL-WORLD DATA
(Sponsored by EFPIA)
Implementing Adaptive Approaches in Payer Decisions - The Belgian Example
Marc Van de Casteele, MD, PhD, Head of Expert Team, Scientific Support (Assessments), Commission for Reimbursement of Medicines, National Institute for Health and Disability Insurance, Brussels, Belgium
COMPLETING THE PUZZLE TO DELIVER THE BENEFITS OF REAL WORLD DATA IN HEALTH OUTCOMES RESEARCH
(Sponsored by CPRD)
Transforming Clinical Trial Efficiency using Electronic Healthcare Records

Maggie Massam, BSc, Head of Business Development, CPRD, London, UK
Value of Hospital Episodes Statistics (HES) Outpatient data in Outcomes Research

Tarita Murray-Thomas, MSc, Research Scientist, CPRD, London, UK
CPRD GOLD and IMS Hospital Treatment Insights

Arlene Gallagher, MSc, Epidemiologist/Statistician, CPRD, London, UK
Extracting 'Hidden' Information from the Free Text

Rosemary Tate, MSc, DPhil, Senior Research Fellow, School of Informatics, University of Sussex, East Sussex, UK
Incorporating EMIS Data in CPRD

Helen Strongman, MSc, Research Scientist, CPRD, London, UK

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