Program

Program - Saturday, 2 November 2013
9:00-18:00
PRE-CONGRESS SHORT COURSES
 
Program - Sunday, 3 November 2013
8:00-17:00
PRE-CONGRESS SHORT COURSES
17:30-18:30
EDUCATIONAL SYMPOSIUM (Sponsored by Double Helix Consulting)
EXPERIENCES FROM THE UK NHS REFORMS: THE PAYER, PROVIDER, AND PHARMA PERSPECTIVES FOR EFFECTIVE STAKEHOLDER PARTNERSHIPS

Symposium Description

18:45-19:45
EDUCATIONAL SYMPOSIUM (Sponsored by LASER ANALYTICA)
BRIDGING TO REAL LIFE: HOW PREDICTIVE MODELING AND CAREFUL STUDY DESIGN SUPPORT THE EVALUATION AND GENERATION OF REAL-WORLD EVIDENCE

Symposium Description

Program - Monday, 4 November 2013
7:30-8:30
EDUCATIONAL SYMPOSIUM (Sponsored by GalbraithWight)
BUILDING, EMBEDDING & OPTIMIZING MARKET ACCESS CAPABILITIES – FROM STRATEGY TO EXECUTION

Symposium Description

8:45-14:15
RESEARCH POSTER PRESENTATIONS VIEWING – SESSION I
 
8:45-10:45
WELCOME & FIRST PLENARY SESSION
8:45-9:00
WELCOME
William H. Crown, PhD William H. Crown, PhD
2013-2014 ISPOR President and Chief Scientific Officer Optum Labs, Cambridge, MA, USA
9:00-9:15
CONGRESS PROGRAM OVERVIEW
Michael Barry, MD, PhD Michael Barry, MD, PhD, FRCPI
Clinical Director, National Centre for Pharmacoeconomics
St. James’s Hospital, Dublin, Ireland
John Hutton, BPhil John Hutton, BPhil
Professor of Health Economics, Department of Health Sciences
University of YorK, Heslington, York, UK
9:15-10:45
FIRST PLENARY SESSION: THE PATIENT AND HEALTH TECHNOLOGY ASSESSMENT: CHALLENGES AND OPPORTUNITIES

It is increasingly argued that patients, or patient organizations, should play a more active role in HTA. However, given that reimbursement decisions in most European public health care systems are made from a community, or population, perspective, what is the role of the individual patient viewpoint? During this session, as a case study, the unmet clinical need for the cystic fibrosis (CF) patient, especially in Ireland and the UK due to the prevalence of “the Celtic Gene”, and clinical studies demonstrating the efficacy of a new high cost drug will be presented. A discussion on the HTA pharmacoeconomic evaluation of this high cost drug will be followed by an explanation of the negative HTA decision i.e. why “No”. We will then hear what it is like to live with CF and the hope that this new drug provides. The recognised tension between patients demanding this drug and the payer struggling to afford it will be discussed. The patient’s view of economic evaluation, highlighting that there are differences in what HTA assessors & patient’s value, will be addressed. The Minister of Health will then provide the final decision.

9:15 - 9:20 Michael Barry, MD, PhD Moderator:  Michael Barry, MD, PhD, FRCPI, Clinical Director, National Centre for Pharmacoeconomics, St. James’s Hospital, Dublin, Ireland
9:20 - 9:35 Edward McKone MSc, MD Evidence Supporting Reimbursement for a New Cystic Fibrosis Drug
Speaker: 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
9:35 - 9:50 Michael Barry, MD, PhD Health Technology Assessment of the New Cystic Fibrosis Drug
Speaker:  Michael Barry, MD, PhD, FRCPI, Clinical Director, National Centre for Pharmacoeconomics, St. James’s Hospital, Dublin, Ireland
9:50 - 10:05 Katie Murphy A Patient's Perspective on the New Cystic Fibrosis Drug
Speaker:  Katie Murphy, TLC4CF Regional Officer, Cystic Fibrosis Association of Ireland, Dublin, Ireland
10:05 - 10:15 James Reilly, JD The Health Care Decision
Speaker: James Reilly, JD, Minister for Health, Department of Health, Government of Ireland, Dublin, Ireland
10:15 - 10:45   DISCUSSION
10:45-11:00
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION I
11:00-12:00
ISSUE PANELS – SESSION I
11:00-12:00 Clinical Outcomes Research Issues
IP1: GUIDELINES FOR NETWORK META-ANALYSIS – ISPOR/AMCP/NPC VERSUS PRISMA
Moderator:

Kristian Thorlund, PhD, MStat, Visiting Associate Professor, Department of Preventive Medicine, Stanford University, Palo Alto, CA, USA

Panelists:

Edward J. Mills, PhD, MSc, Visiting Associate Professor, Department. Preventive Medicine, Stanford University, Palo Alto, CA, USA; Jeroen P. Jansen, PhD, MSc, Founding Partner & Director, Redwood Outcomes (formerly at Mapi) and Adjunct Assistant Professor of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA; Christopher O'Regan, MSc, Head of HTA & Outcomes Research, Merck Sharp Dohme Ltd., Hoddesdon, UK

11:00-12:00 ECONOMIC OUTCOMES RESEARCH ISSUES
IP2: EMPIRICAL ESTIMATION OF COST-EFFECTIVENESS THRESHOLDS - THE CASE OF NICE
Moderator: Mark J. Sculpher, MSc, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK
Panelists: Martin Buxton, BA, Professor, Health Economics Research Group, Brunel University, Uxbridge, UK; Karl Claxton, PhD, Professor of Economics, Centre for Health Economics, University of York, Heslington, York, UK; Adrian Towse, MA, MPhil, Director, Office of Health Economics, London, UK
11:00-12:00
IP3: MEASURING UTILITY FOR ECONOMIC MODELS WITHIN CLINICAL TRIALS: CAN WE DO BETTER?
Moderator:

Sorrel Wolowacz, PhD, Head, Health Economics Europe, RTI Health Solutions, Manchester, UK

Panelists:

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

11:00-12:00 HEALTH POLICY DEVELOPMENT USING OUTCOMES RESEARCH ISSUES
IP4: DOES ASSESSING THE VALUE FOR MONEY OF MEDICAL DEVICES REQUIRE A FLEXIBLE APPROACH?
Moderator: Cynthia P. Iglesias, PhD, Senior Research Fellow, Department of Health Sciences, Centre for Health Economics, Hull York Medical School, University of York, Heslington, York, United Kingdom
Panelists:

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; Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, University of Washington School of Pharmacy, Seattle, WA, USA

11:00-12:00 PATIENT-REPORTED OUTCOMES & PATIENT PREFERENCE RESEARCH ISSUES
IP5: DEMONSTRATING TREATMENT BENEFIT USING CLINICAL OUTCOME ASSESSMENTS IN GLOBAL CLINICAL TRIALS: HOW RELIABLE ARE THE ASSESSMENTS FROM CROSS-CULTURAL SETTINGS?
Moderator: Antoine Regnault, PhD, Research Director, HEOR & Strategic Market Access, Mapi, Lyon, France
Panelists:

Donald L. Patrick, PhD, MSPH, Professor, University of Washington, Seattle Quality of Life Group, and Center for Disability Policy and Research, Seattle, WA, USA; Paulo Carita, MD, Senior Director, Comparative Effectiveness & Health Outcomes / Global Evidence and Value Development,, Sanofi-Aventis R&D, Chilly-Mazarin, France; Mira Pavlovic, MD, Deputy Director for Health Technology Assessment, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France

12:00-14:15
LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION I
 
12:15-13:15
EDUCATIONAL SYMPOSIUM (Sponsored by IMS Health)
THE INTERSECTION OF HEALTH ECONOMICS AND REAL-WORLD EVIDENCE – VALIDATING HEALTH CARE DECISION MAKING

Symposium Description

13:15-14:15
POSTER AUTHOR DISCUSSION HOUR – SESSION I
 
14:15-15:15
RESEARCH PODIUM PRESENTATIONS – SESSION I
 

HEALTH CARE EXPENDITURE OR REIMBURSEMENT STUDIES - BIOLOGICS

14:15-14:30
BI1 ADHERENCE AND RESOURCE USE AMONG PATIENTS TREATED WITH BIOLOGICS. FINDINGS FROM THE BEETLE STUDY (BIOLOGICAL DRUGS: EVALUATION OF ECONOMICS, TREATMENTS, AND LABELING IN REAL-WORLD SETTING)
Degli Esposti L
, Sangiorgi D, Buda S
CliCon Srl, Ravenna, Italy
14:30-14:45
BI2 WHAT ARE THE KEY DRIVERS OF REIMBURSEMENT FOR BIOSIMILARS? AN EXAMINATION OF REIMBURSEMENT PROCESSES AND RECOMMENDATIONS ACROSS NINE COUNTRIES
    de Silva SU, Smith TA, Bending MW
Mapi, London, UK
14:45-15:00
BI3 DIFFERENCES IN APPROACH TO BIOSIMILARS: NICE VERSUS SMC RECOMMENDATIONS
Izmirlieva M
, Ando G
IHS, London, UK
15:00-15:15
BI4 IMPACT OF EXCLUSIVE HOSPITAL DISTRIBUTION OF BIOSIMILAR ON DRUG HEALTH CARE BUDGET
Rémuzat C1, Vataire AL1, Cetinsoy L1, Aballea S1, Toumi M2
1Creativ-Ceutical, Paris, France, 2University Claude Bernard Lyon 1, Lyon, France
 

CANCER OUTCOMES RESEARCH STUDIES

14:15-14:30
CA1 RESPONSIVENESS OF THE EQ-5D IN ONCOLOGY: A META-ANALYSIS
Smith AB1, Cocks K1, Taylor M2, Parry D3
1University of York, York, UK, 2York Health Economics Consortium, York, UK, 3AstraZeneca UK, Macclesfield, UK
14:30-14:45
CA2 THE BURDEN OF CAREGIVING IN CANCER: THE STATUS OF CLINICAL RESEARCH
Foster RE, Bardos JI, Wilson TJ, Hamerslag L, Kusel J
Costello Medical Consulting Ltd., Cambridge, UK
14:45-15:00
CA3 EMA APPROVAL OF DRUGS ON THE BASIS OF PIVOTAL NON-COMPARATIVE PHASE II TRIAL DATAMacaulay R
HERON Health, London, UK
15:00-15:15
CA4 MEASURING THE COST OF LOST PRODUCTIVITY DUE TO PREMATURE CANCER-RELATED MORTALITY: A EUROPEAN OVERVIEW
Hanly P1, Soerjomataram I2, Sharp L3
1National College of Ireland, Dublin, Ireland, 2International Agency for Research on Cancer, Lyon, Ireland, 3National Cancer Registry Ireland, Cork, Ireland
 

CONCEPTUAL PAPERS

14:15-14:30
CP1 INCREMENTAL COST PER QUALITY-ADJUSTED LIFE YEAR GAINED? THE NEED FOR ALTERNATIVE METHODS TO EVALUATE MEDICAL INTERVENTIONS FOR ULTRA-RARE DISORDERS
Schlander M1, Garattini S2, Kolominsky-Rabas P3, Nord E4, Persson U5, Postma M6, Richardson J7, Simoens S8, Sola Morales O9, Tolley K10, Toumi M11
1University of Heidelberg, Wiesbaden, Germany, 2Mario Negri Institute for Pharmacological Research, Milano, Italy, 3University of Erlangen-Nuremberg, Erlangen, Germany, 4Norwegian Institute of Public Health, Oslo, Norway, 5The Swedish Institute for Health Economics, Lund, Sweden, 6Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), Department of Pharmacy, University of Groningen, Groningen, The Netherlands, 7Monash University, Melbourne, Australia, 8KU Leuven, Leuven, Belgium, 9HITT, Barcelona, Spain, 10Tolley Health Economics, Buxton, UK, 11University Claude Bernard Lyon 1, Lyon, France
14:30-14:45
CP2 THE MULTIMODEL ENSEMBLE APPROACH TO REDUCING STRUCTURAL UNCERTAINTY IN DECISION ANALYTICAL MODELLING
Parham PE1, Hughes DA2
1Bangor University, Gwynedd, UK, 2Bangor University, Bangor, UK
14:45-15:00
CP3 THE GROWING ROLE OF QUALITATIVE INTERVIEWS IN HEALTH OUTCOMES RESEARCH
Guillemot J1, Gauthier A1, Hass B2, Basso F3, Cognet M1
1Amaris, London, UK, 2Boehringer Ingelheim GmbH, Ingelheim, Germany, 3Boehringer Ingelheim GmbH, Vienna, Austria
15:00-15:15
CP4 CONCEPTUAL AND PRACTICAL CONSIDERATIONS WHEN DEALING WITH MISSING UTILITY DATA IN LONGITUDINAL TRIALS AND SUBSEQUENT USE IN COST-EFFECTIVENESS ANALYSES
Weston AR1, Brnabic A1, Standfield LB2
1Optum, Sydney, Australia, 2Griffith University, Queensland, Australia
 

RESEARCH ON METHODS - MODELING STUDIES

14:15-14:30
MO1 A GUIDE TO ADJUSTING SURVIVAL TIME ESTIMATES TO ACCOUNT FOR TREATMENT SWITCHING IN RANDOMISED CONTROLLED TRIALS
Latimer NR*1, Abrams KR2, Lambert PC2, Crowther MJ2, Wailoo AJ1, Morden JP3, Akehurst RL1, Campbell MJ1
1University of Sheffield, Sheffield, UK, 2University of Leicester, Leicester, UK, 3The Institute of Cancer Research, Sutton, UK
14:30-14:45
MO2 USE OF REAL-WORLD EVIDENCE (RWE) TO VALIDATE A TRIAL-BASED HEALTH ECONOMIC MODEL
Munakata J*1, Li H2, Luo R3, Guo Y3, O'Sullivan A4, Duran A5, Nelson M6
1IMS Health, San Francisco, CA, USA, 2IMS Health, Alexandria, CA, USA, 3IMS Health, Plymouth Meeting, PA, USA, 4IMS Health, Waltham, MA, USA, 5IMS Health, London, UK, 6IMS Health, Alexandria, VA, USA
14:45-15:00
MO3 MULTI-STATE STATISTICAL MODELLING TO QUANTIFY AN INDIVIDUAL-BASED MICRO SIMULATION MODEL FOR RADIOTHERAPY TREATMENT IN LUNG CANCER PATIENTS
Bongers ML*1, De Ruysscher D2, Oberije C3, Lambin P3, Uyl-de Groot CA4, Coupe VMH1
1VU University Medical Center, Amsterdam, The Netherlands, 2University Hospitals Leuven/KU Leuven, Leuven, Belgium, 3MAASTRO Clinic, Maastricht, The Netherlands, 4Erasmus University Rotterdam, Rotterdam, The Netherlands
15:00-15:15
MO4 BAYESIAN CALIBRATION METHOD TO ESTIMATE TRANSITION PROBABILITIES FOR A MARKOV MODEL BASED ON A CONTINUOUS OUTCOME MEASURE: APPLICATION IN PARKINSON'S DISEASE
Neine M, Briquet B, Mokdad CE, Vataire AL, Aballea S
Creativ-Ceutical, Paris, France
 

PATIENT PREFERENCE STUDIES

14:15-14:30
PP1 A METHODOLOGY FOR PREDICTING THE IMPACT OF COPAYMENTS ON THE UTILIZATION OF HEALTH TECHNOLOGIES
Sabatelli L
GLOB MOD, Barcelona, Spain
14:30-14:45
PP2 MULTINATIONAL CONSISTENCY OF A DISCRETE CHOICE MODEL IN QUANTIFYING HEALTH STATES FOR THE EXTENDED 5-LEVEL EQ-5D
Krabbe PFM1, Devlin NJ2, Stolk EA3, Shah KK4, Oppe M3, van Hout B4, Quik EH1, Pickard AS5, Xie F6
1University of Groningen, University Medical Center Groningen, Groningen, The Netherlands, 2Office of Health Economics, London, UK, 3Erasmus University Rotterdam, Rotterdam, The Netherlands, 4University of Sheffield, Sheffield, UK, 5University of Illinois at Chicago, Chicago, IL, USA, 6McMaster University, Hamilton, ON, Canada
14:45-15:00
PP3 CAN THE USE OF SOCIAL MEDIA AND MOBILE APPS IMPROVE PATIENT KNOWLEDGE OF DISEASE AND HEALTH OUTCOMES? A SYSTEMATIC REVIEW
Abogunrin S, Martin A
Evidera, London, UK
15:00-15:15
PP4 THE IMPORTANCE OF PATIENT-REPORTED OUTCOMES IN REIMBURSEMENT OF ORPHAN PRODUCTS IN EUROPE
Lyons EJ1, McGeagh J1, Es-Skali IJ2, Parmenter L1, Nijhuis T3, Boucher G1
1Quintiles Outcome, Reading, UK, 2Quintiles Consulting, Hoofddorp, The Netherlands, 3Quintiles, Hoofddorp, The Netherlands
   
15:15-15:30
BREAK & EXHIBITS VIEWING
 
15:30-19:30
RESEARCH POSTER PRESENTATIONS VIEWING – SESSION II
 
15:30-16:30
RESEARCH PODIUM PRESENTATIONS – SESSION II
 

RESEARCH ON METHODS - CLINICAL STUDIES

15:30-15:45 CL1 A COMPARISON OF METHODOLOGIES FOR ESTIMATING SURVIVAL IN PATIENTS TREATED WITH SECOND-GENERATION TYROSINE-KINASE INHIBITORS (TKIS) FOR CHRONIC MYELOID LEUKAEMIA (CML)
    Pennington B1, Batty AJ1, Clifton-Brown E2
1BresMed, Sheffield, UK, 2Pfizer Ltd, Tadworth, UK
15:45-16:00 CL2 ADDRESSING HETEROGENEITY IN BASELINE RISK OF COPD EXACERBATIONS USING META-REGRESSION
Cope S1, Buckley F2, Baldwin M3, Kraemer M4, Jansen J2
1Mapi, Toronto, ON, Canada, 2Mapi, Boston, MA, USA, 3Novartis Pharmaceuticals UK Limited, Horsham, West Sussex, UK, 4Novartis Pharma AG, Basel, Switzerland
16:00-16:15 CL3 VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID TUMOURS: SYSTEMATIC REVIEW OF STATISTICAL METHODS, RESULTS, AND IMPLICATIONS FOR POLICY MAKERS
    Ciani O1, Davis S2, Tappenden P2, Garside R3, Stein K1, Cantrell A2, Saad E4, Buyse M5, Taylor R1
1University of Exeter, Exeter, UK, 2University of Sheffield, Sheffield, UK, 3University of Exeter, Truro, UK, 4Dendrix, Sao Paulo, Brazil, 5IDDI, Louvain-la-Neuve, Belgium
16:15-16:30 CL4 FRAMEWORK FOR EVIDENCE ASSESSMENT BASED ON GRADE AND APPLICATION TO HPV VACCINATION IN MALES IN THE EUROPEAN HEALTH CARE CONTEXT
    Siebert U1, Sroczynski G2, Baker P3, Borget I4, Castellsagué X5, Chapman R5, von Knebel-Doeberitz M7, Mortensen GL8, La Torre G9
1UMIT – University for Health Sciences, Medical Informatics and Technology / ONCOTYROL / Harvard University, Hall i. T./ Innsbruck / Boston, Austria, 2UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria, 3Men's Health Consultant, Brighton, UK, 4Institut Gustave Roussy, Villejuif, France, 5L'Hospitalet de Llobregat, Barcelona, Spain, 6Evidera, London, UK, 7University of Heidelberg, German Cancer Research Center, Heidelberg, Germany, 8AnthroConsult, Aarhus C, Denmark, 9Sapienza University of Rome, Rome, Italy
 

CARDIOVASCULAR DISEASE OUTCOMES RESEARCH STUDIES

15:30-15:45 CV1 CHALLENGES IN MODELLING THE COST EFFECTIVENESS OF INTERVENTIONS IN CARDIOVASCULAR DISEASE
Burgers LT, Redekop WK, Severens JL
Erasmus University Rotterdam, Rotterdam, The Netherlands
15:45-16:00 CV2 APPLICATION OF BEHAVIOURAL ECONOMICS TO THE UNDERSTANDING OF ADHERENCE: DOES AN INDIVIDUAL'S TIME PREFERENCE INFLUENCE ADHERENCE TO MEDICATIONS?
    Fargher EA, Morrison V, Plumpton CO, Hughes DA
Bangor University, Bangor, UK
16:00-16:15 CV3 PATTERNS OF GENERIC AND PROPRIETARY PRESCRIBING OF STATINS OVER TIME IN ENGLAND
Leonard SA, Wilson TJ, Hamerslag L
Costello Medical Consulting Ltd., Cambridge, UK
16:15-16:30 CV4 IMPACT OF SHORT PERIODS WITH IMPROVED OR WORSENED INR CONTROL ON LIFE EXPECTANCY AND QALYS IN PATIENTS WITH ATRIAL FIBRILLATION
    Lesén E1, Björholt I1, Björstad Å1, Fahlén M2, Odén A3
1Nordic Health Economics, Gothenburg, Sweden, 2Department of Medicine, Kungälv Hospital, Kungälv, Sweden, 3Department of Mathematical Sciences, Chalmers University of Technology, Gothenburg, Sweden
 

MEDICAL DEVICE & DIAGNOSTIC RESEARCH

15:30-15:45 MD1 COMPARING VIRTUAL COLONOGRAPHY WITH CONVENTIONAL COLONOSCOPY FOR COLORECTAL CANCER SCREENING: WHAT ARE THE DRIVERS OF COST-EFFECTIVENESS?
    Kriza C1, Emmert M2, Wahlster P1, Niederländer C1, Schaller SU1, Kolominsky-Rabas PL1
1Centre for Health Technology Assessment (HTA) and Public Health (IZPH), University of Erlangen-Nuremberg, Erlangen, Germany, 2School of Business and Economics, Institute of Management, University of Erlangen-Nuremberg, Nuremberg, Germany
15:45-16:00 MD2 MARKET ACCESS OF IMPLANTABLE MEDICAL DEVICES: EVIDENTIARY REQUIREMENTS ACROSS GLOBAL MARKETS
    Chawla AS1, Spinner DS1, Ransom JF2, Doyle J2, Faulkner EC1
1Quintiles Consulting, Durham, NC, USA, 2Quintiles Global Consulting, Hawthorne, NY, USA
16:00-16:15 MD3 DECISON MAKING UNDER UNCERTAINTY: COVERAGE WITH EVIDENCE DEVELOPMENT IN THE CONTEXT OF MEDICAL DEVICES
    Sorenson C1, Drummond M2
1London School of Economics and European Health Technology Institute for Socio-Economic Research, London, UK, 2University of York, Heslington, UK
16:15-16:30 MD4 QUALITY CRITERIA FOR THE DEVELOPMENT OF IMPLANT REGISTRIES
Niederländer CS, Wahlster P, Kriza C, Schaller SU, Kolominsky-Rabas PL
Centre for Health Technology Assessment (HTA) and Public Health (IZPH), University of Erlangen-Nuremberg, Erlangen, Germany
 

PRICING STUDIES

15:30-15:45 PR1 PRICE DIFFERENCES TRIGGERED BY THE AVAILABILITY OF BIOSIMILARS IN DEVELOPED COUNTRIES
Reinaud F1, Ando G2
1IHS, Paris, France, 2IHS, London, UK
15:45-16:00 PR2 PHARMACEUTICAL POLICIES, REGULATION AND EFFICIENCY
Maniadakis N1, Kourlaba G2, Shen J3, Holtorf AP4, Kalo Z5
1National School of Public Health, Athens, Greece, 2National and Kapodistrian University of Athens School of Medicine, Athens, Greece, 3Abbott, Basel, Switzerland, 4Health Outcomes Strategies LLC, Basel, Switzerland, 5Syreon Research Institute, Budapest, Hungary
16:00-16:15 PR3 VARIABILITY IN HYBRID DRUG AVAILABILITY AND PRICING IN EUROPE
Flostrand SJA1, Lor S1, Hughes ALH2
1IMS Consulting Group, La Défense, France, 2IMS Consulting Group, London, UK
16:15-16:30 PR4 OVERVIEW OF COVERAGE WITH EVIDENCE DEVELOPMENT IN SWEDEN
Schroeder M1, Kornfeld A2, Ben Abdallah I2, Rémuzat C2, Toumi M3
1Creativ-Ceutical, Copenhagen, Denmark, 2Creativ-Ceutical, Paris, France, 3University Claude Bernard Lyon 1, Lyon, France
 

RESEARCH ON METHODS - PRO/QOL STUDIES

15:30-15:45 QL1 MAPPING THE CCQ ONTO EQ-5D SCORES (IM)POSSIBLE?
Boland MRS1, van Boven JF2, Rutten-van Mölken MPMH1
1Erasmus University Rotterdam, Rotterdam, The Netherlands, 2University of Groningen, Groningen, The Netherlands
15:45-16:00 QL2 MEASURING PATIENT-RELEVANT TREATMENT BENEFIT IN DERMATOLOGY – DEVELOPMENT AND VALIDATION OF THE SHORT QUESTIONNAIRE "PATIENT BENEFIT INDEX 2.0"
    Blome C1, von Usslar K1, Augustin M2
1University Medical Center Hamburg, Hamburg, Germany, 2University Medical Center Hamburg-Eppendorf, Hamburg, Germany
16:00-16:15 QL3 THE MEASUREMENT OF HEALTH-RELATED QUALITY OF LIFE: GERMAN FINDINGS FROM THE MULTI-INSTRUMENT COMPARISON (MIC) STUDY
    Schlander M1, Khan MA2, Iezzi A2, Maxwell A2, Richardson J2
1University of Heidelberg, Wiesbaden, Germany, 2Monash University, Melbourne, Australia
16:15-16:30 QL4 PSYCHOMETRIC VALIDATION OF PERCEIVED DEFICITS QUESTIONNAIRE – DEPRESSION (PDQ-D) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER (MDD)
   

Lam RW1, Saragoussi D2, Danchenko N3, Rive B4, Lamy FX5, Brevig T6
1University of British Columbia, Vancouver, BC, Canada, 2Lundbeck SAS, ISSY LES MOULINEAUX CEDEX, France, 3Lundbeck SAS, Issy-les-Moulineaux, France, 4Lundbeck S.A.S., Issy-Les Moulineaux, France, 5Lundbeck S.A.S., Issy-les-Moulineaux, France, 6H. Lundbeck A/S, Valby, Denmark

16:45-17:45
WORKSHOPS – SESSION I
16:45-17:45 CLINICAL OUTCOMES RESEARCH
W1: INTRODUCING PATIENT-REPORTED OUTCOMES INTO EMA-MANDATED POST-AUTHORIZATION SAFETY STUDIES AND FDA-MANDATED POST-MARKETING SAFETY COMMITMENTS
Discussion Leaders: 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
16:45-17:45 ECONOMIC OUTCOMES RESEARCH
W2: USING EARLY ECONOMIC MODELS TO GUIDE CLINICAL AND COMMERCIAL DEVELOPMENT OF NEW THERAPIES
Discussion Leaders: 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
16:45-17:45
W3: NAVIGATING THE WATERS OF ECONOMIC EVALUATIONS OF MEDICAL DEVICES
Discussion Leaders:

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

16:45-17:45 HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH
W4: VALUE IS IN THE EYE OF THE BEHOLDER: COMPELLING INSIGHTS INTO BIOPHARMA, PAYER, AND PROVIDER PERSPECTIVES
Discussion Leaders:

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

16:45-17:45 PATIENT-REPORTED OUTCOMES & PATIENT PREFERENCE RESEARCH
W5: QUANTIFYING MEDICATION ADHERENCE: PRACTICAL CHALLENGES AND AN APPROACH TO LINKING ALTERNATIVE MEASURES
Discussion Leaders:

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

16:45-17:45 USE OF REAL WORLD DATA
W6: DOES IT MAKE SENSE TO EXPAND AN EVIDENCE SYNTHESIS OF RANDOMIZED TRIALS WITH OBSERVATIONAL REAL WORLD DATA?
Discussion Leaders: Kristian Thorlund, PhD, MStat, Associate Professor, Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada; Jeroen P. Jansen, PhD, MSc, Founding Partner & Director, Redwood Outcomes (formerly at Mapi) and Adjunct Assistant Professor of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA; Edward J. Mills, PhD, MSc, Visiting Associate Professor, Department. Preventive Medicine, Stanford University, Palo Alto, CA, USA
17:45-19:30
EXHIBITORS’ OPEN HOUSE RECEPTION & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION II
 
18:00-19:00
ISPOR FORUMS – SESSION I
18:00-19:00 PRICING AND REIMBURSEMENT PROCESS FOR MEDICAL DEVICES IN CENTRAL & EASTERN EUROPE

The scientific evidence-base for medical devices is limited compared to pharmaceuticals, partly because long-term randomized clinical studies are not required for marketing authorization. In consequence it is difficult to establish objective and verifiable criteria for the pricing and reimbursement decisions of medical devices. There is a growing need for transparent evidence-based health policy decisions, especially in countries with severe economic constraints. This forum will explore options for improving evidence-based pricing and reimbursement for medical devices in the Central & Eastern European countries with limited resources for HTA implementation. Presented by the ISPOR CEE Network: ISPOR Greece, Hungary, Republic of Macedonia, Russia, and Serbia Regional Chapters

Moderator/Speaker: Vlad Zah, BSc, Health Economics Consultant, Belgrade, Serbia

Speakers: 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; Zoltán Kaló, MD, MSc, PhD, Director, Health Economics Research Centre, Eotvos Lorand University (ELTE) and Syreon Research Institute, Budapest, Hungary: Ljubica Suturkova, PhD, President, ISPOR Republic of Macedonia Chapter and Professor, Faculty of Pharmacy, University St. Cyril and Methodius, Skopje, Republic of Macedonia: Lubov Krasnova, MD, PhD, Assistant Professor, Department of Hematology & Geriatrics, Faculty for Postgraduate Medical Education, FirstSechenov State Medical University, Moscow, Russia

18:00-19:00 PATIENT DATA AND PATIENT REGISTRIES IN CENTRAL & EASTERN EUROPE

The role of patients in reimbursement processes is increasingly influencing access to drugs and other technologies. The manufacturer has to minimize cost impact and maximize patients access since the budget impact of new products is a concern for payers, which could lead to delayed or reduced access to treatment. That is where real life data and HTA are needed to provide arguments. This forum will discuss the importance of patient data and patient registries and their impact on reimbursement process, including HTA. Cross-border registries collaboration, which has become a hot topic in the region, will be examined. Examples from Slovakia (socioeconomic and QOL survey in patients with multiple sclerosis); Bosnia-Herzegovina (patient registries as an opportunity to improve access to medicines); Hungary (the role of public and private data sources in market access); and Serbia (unexplored opportunities) will be discussed. Presented by the ISPOR CEE Network: ISPOR Bosnia and Herzegovina, Hungary, Serbia, and Slovakia Regional Chapters

Moderator/Speaker: Dominik Tomek, PharmD, MPH, PhD, President, ISPOR Slovakia Chapter and Faculty of Pharmacy, Comenius University and Faculty of Medicine, Slovak Medical University, Bratislava, Slovakia

Speakers: Tarik Catic, MScPharm, President, ISPOR Bosnia-Herzegovina Chapter and Health Economics and Pharmacoeconomics Consultant, Sarajevo, Bosnia- Herzegovina; Imre Boncz, MD, MSc, PhD, Habil, Professor & Director, Institute for Health Insurance, Faculty of Health Sciences, University of Pecs, Pecs, Hungary; Dragana Atanasijevic, MD, MSc, Assistant Director, Sector for Health Care, Republic Institute for Health Insurance, Ministry of Health, Belgrade, Serbia

18:00-19:00 CLINICIAN REPORTED OUTCOMES: GOOD MEASUREMENT PRACTICES

ISPOR Clinician Reported Outcomes Good Measurement Practices Task Force members will present the US and EMA regulatory perspectives, define which outcome assessments should be considered ClinROs and recommend ClinRO measures to document treatment benefit in clinical trials. Identification of the concept of measurement and context of use, evaluation of the measure’s measurement properties, and rules for implementation will be included. Presented by the ISPOR ClinRO Good Measurement Practices Task Force

Moderator: Laurie B. Burke, RPh, MPH, Director, Study Endpoints and Labeling Development, ONDIO, CDER, Food & Drug Administration (FDA), Silver Spring, MD, USA

Speakers: 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

18:00-19:00 MEET THE EDITORS OF VALUE IN HEALTH

This forum will provide attendees with the opportunity to meet with the editors of Value in Health. Session topics include: What makes a great paper? How will my paper be reviewed? How can I volunteer to be a reviewer for Value in Health? The editors will also be on hand to answer any other questions you may have about publishing in Value in Health. Presented by the Co-Editors-in-Chief of Value in Health

Moderators/Speakers: 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

Speakers: Several Co-Editors of Value in Health will also participate in the discussion.
18:00-19:00 NEW HEALTH CARE REFORMS AND HTA STATUS IN RUSSIA, UKRAINE, BELARUS, KAZAKHSTAN, AND ARMENIA

This forum will discuss the main directions of the health care reforms in the CIS countries and how to achieve greater efficiency by implementing health technology assessment. The forum will encourage HTA development and regional and international cooperation in the HTA field to support rational decision making in health care. Presented by ISPOR Russia HTA, Ukraine, Belarus, Armenia, and Kazakhstan Regional Chapters

Moderator: Vitaly V. Omelianovskiy, MD, PhD, President, ISPOR Russia HTA Chapter and Professor & Director of Center for HTA, Russian Presidential Academy of National Economy & Public Administration, Moscow, Russia

Speakers: Ludmila Maksimova, PhD, Head of International Cooperation and Strategic Development, National Center for HTA, Moscow, Russia; Maria Avxentyeva, MD, PhD, Deputy Director of Center for HTA, Russian Presidential Academy of National Economy & Public Administration, Moscow, Russia; Konstantin Kosyachenko, MD, PhD, President of the Ukrainian HTA Agency & Head, Department for Technologies and Pharmacoeconomics, Kiev Medical University, Kiev, Ukraine; Olha Zaliska, PhD, PharmD, Professor & Head, Department of Management and Economics of Pharmacy and Medical Technologies, Danylo Halytsky National Medical University, Lviv, Ukraine;
Alexander Kostyuk, MD, PhD, Professor, Department of Clinical Pharmacology & Pharmacotherapy & Head of Department for International Collaboration, Astana Medical University, Astana, Kazakhstan; Talgat Nurgozhin, MD, DSc, Professor, Nazarbayev N. A. University, Almaty, Kazakhstan

18:00-19:00 ECONOMIC EVALUATION OF PHARMACEUTICALS IN PORTUGAL: FROM PIONEERS TO THE LIMITATIONS IMPOSED BY THE ECONOMIC CRISIS

This forum will provide a general overview of the evolution of economic evaluation of pharmaceuticals in Portugal. In addition, Portuguese health economic guidelines and the need for reform will be discussed as well as the present economic crisis and its impact. Presented by the ISPOR Portugal Chapter

Moderator: Carlos Gouveia Pinto, PhD, President, ISPOR Portugal Chapter and Associate Professor, Institute for Advanced Studies in Economics and Management, University of Lisbon, Lisbon, Portugal

Speakers: Mónica Inés, MSc, Health Technology Assessment/Outcomes Research Manager, Pfizer Portugal, Lisbon, Portugal; Miguel Gouveia, PhD, Associate Professor, Catolica Lisbon School of Business and Economics, Lisbon, Portugal; Eurico Castro Alves, MD, President, INFARMED – National Authority of Medicines and Health Products, Lisbon, Portugal

18:30-19:30
POSTER AUTHOR DISCUSSION HOUR – SESSION II
19:00-20:00 STUDENT WELCOME RECEPTION
 

All students and faculty are welcome to attend!

Program - Tuesday, 5 November 2013
7:30-8:30
EDUCATIONAL SYMPOSIUM (Sponsored by Xcenda)
PERSONALIZED MEDICINE AND HTA – BRIDGING THE SCIENCE OF PERSONALIZED MEDICINE WITH THE POLICY OF POPULATION DECISION MAKING

Symposium Description

8:45-13:45
RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III
 
8:45-9:45
WORKSHOPS - SESSION II
8:45-9:45 CLINICAL OUTCOMES RESEARCH
W7: STATISTICAL CHALLENGES IN HTA
Discussion Leaders: Marie-Ange Paget, MSc, Project HTA Statistician, EU Statistics, Lilly, France, Neuilly-sur-Seine, France; Keith R Abrams, PhD, Professor of Medical Statistics, Department of Health Sciences, University of Leicester, Leicester, United Kingdom; Nicholas Latimer, MSc, Research Fellow in Health Economics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Claire Watkins, MA, MSc, Statistical Team Leader, Biometrics, AstraZeneca, Macclesfield, England
8:45-9:45 ECONOMIC OUTCOMES RESEARCH
W8: THE ECONOMIC EVALUTION OF DIAGNOSTICS: CHALLENGES AND METHODS FOR ASSESSING VALUE
Discussion Leaders: 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; Josh J. Carlson, MPH, PhD, Research Assistant Professor, Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, WA, USA; 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
8:45-9:45
W9: TRANSPARENCY IN SUBMISSION OF DISCRETE EVENT SIMULATION (DES) AND HYBRID DES-MARKOV MODELS
Discussion Leaders: Anuraag R. Kansal, PhD, Research Scientist, Evidera, Bethesda, MD, USA; 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
8:45-9:45 HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH
W10: OVERCOMING INCOMPLETE EVIDENCE NETWORK AND HETEROGENEITY ISSUES WITH SIMULATED TREATMENT COMPARISONS
Discussion Leaders: K. Jack Ishak, PhD, MSc, Senior Director, Biostatistics and Senior Research Scientist, Health Economics, Evidera, St-Laurent, QC, Canada; Irina Proskorovsky, MSc, Senior Biostatistician, Evidera, St-Laurent, QC, Canada; Agnes Benedict, MSc, Research Scientist, Evidera, Budapest, Hungary; Connie Chen, PharmD, Senior Director, Global Health Economics and Outcomes Research, Pfizer Global Pharmaceuticals, New York, NY, USA
8:45-9:45 PATIENT-REPORTED OUTCOMES & PATIENT PREFERENCE RESEARCH
W11: MULTIPLE CHALLENGES IN CAPTURING UTILITIES FOR PAEDIATRIC CONDITIONS
Discussion Leaders: 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
8:45-9:45 USE OF REAL WORLD DATA
W12: WHEN COLLECTING PATIENT DATA GETS ELECTRONIC: THE UPSURGE OF E-HEALTH AND THE IMPORTANCE OF BIG DATA TO SHAPE MODERN HEALTH CARE
Discussion Leaders: Laure Delbecque, PhD, Patient-Reported Outcomes Consultant, Business & Decision Life Sciences, Brussels, Belgium; Maxime Taquet, MSc, Visiting Research Fellow, Harvard Medical School, Boston, MA, USA; Olivier Ethgen, PhD, MSc, Adjunct Professor, Health Economics, University of Liege, Liege, Belgium; Olivier Chassany, MD, PhD, Professor of Therapeutics, Patient-Reported Outcomes Unit, University Paris 7, Paris, France
9:45-10:15
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III
10:15-11:30
WELCOME & SECOND PLENARY SESSION
WELCOME
William H. Crown, PhD William H. Crown, PhD
2013-2014 ISPOR President and Chief Scientific Officer Optum Labs, Cambridge, MA, USA
SECOND PLENARY SESSION: EARLY ENGAGEMENT BETWEEN MANUFACTURERS, HTA ASSESSORS, AND REGULATORS: LEARNING FROM THE PAST TO GUIDE THE FUTURE

We now have almost four years of experience of early engagement, both bilateral between manufacturers and HTA assessors and trilateral involving manufacturers jointly with HTA assessors and regulators.  The process is time-consuming for all parties.  What have we learned from the various initiatives?  Do manufacturers receive useful advice about their clinical and pharmacoeconomic research plans?  What are the most contentious elements (e.g. choice of therapeutic alternatives, clinical endpoints, length of studies)?  Is there any evidence that, by following the advice, market access is more easily obtained?  In the future will such discussions lead to greater harmonization of evidence requirements across Europe, or not?

10:15 – 10:25

John Hutton, BPhil

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

10:25 – 10:35

Sheila Killalea MD

A Regulator’s Perspective
Speaker:  Sheila Killalea MD, FRCPI, Member of the Scientific Advice Working Party, European Medicines Agency and Senior Clinical Assessor, Irish Medicines Board, Dublin, Ireland

10:35 – 10:45

Leeza Osipenko, PhD

An HTA Agency Perspective
Speaker: Leeza Osipenko, PhD, Senior Scientific Adviser, Scientific Advice Programme, National Institute for Health and Care Excellence (NICE), London, UK

10:45 – 10:55

Mira Pavlovic, MD

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

10:55 – 11:05

Jens Grueger, PhD

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

11:05 – 11:30

DISCUSSION

11:30-13:45
LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III
 
11:45-12:45
EDUCATIONAL SYMPOSIUM (Sponsored by EFPIA)
MEDICINES' ADAPTIVE PATHWAYS TO PATIENTS: THE ROLE OF REAL-WORLD DATA

Symposium Description

12:45-13:45
POSTER AUTHOR DISCUSSION HOUR – SESSION III
 
13:45-14:45
ISSUE PANELS – SESSION II
13:45-14:45 CLINICAL OUTCOMES RESEARCH ISSUES
IP6: INTEGRATING REIMBURSEMENT NEEDS INTO THE DESIGN OF DRUG DEVELOPMENT PROGRAMS
Moderator: Christine A. Fletcher, MSc, Executive Director, Biostatistics, Amgen Ltd., Cambridge, UK
Panelists: Andrea Manca, PhD, Senior Research Fellow, Centre for Health Economics, University of York, Heslington, York, United Kingdom; Andrew Walker, PhD, Health Economist & Reviewer, Scottish Medicines Consortium (SMC), University of Glasgow, Glasgow, United Kingdom; Timothy R. Auton, MSc, PhD, Director, Biostatistics, Astellas, Leiden, The Netherlands
13:45-14:45 ECONOMIC OUTCOMES RESEARCH ISSUES
IP7: MAKING VALUE-BASED PRICING A REALITY
Moderator: Meindert Boysen, MSc, HPPF, Director, Technology Appraisal Programme, Centre for Health Technology Evaluation, National Institute for Health and Clinical Excellence (NICE), Manchester, United Kingdom
Panelists: John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, United Kingdom; Werner Brouwer, PhD, Professor, Institute for Health Policy & Law, Rotterdam, The Netherlands; Roberta Ara, MSc, Senior Research Fellow, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, United Kingdom
13:45-14:45 HEALTH POLICY DEVELOPMENT USING OUTCOMES RESEARCH ISSUES
IP8: HOW ARE THE RESULTS FROM HTA METHODOLOGY RESEARCH IMPLEMENTED IN THE UPDATES OF HTA GUIDELINES?
Moderator: 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
Panelists: Manuela A. Joore, PhD, Associate Professor, Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, CAPHRI, and Maastricht University, Maastricht, The Netherlands; Saskia Knies, PhD, Advisor of Pharmacoeconomics, Health Care Insurance Board (CVZ), Diemen, The Netherlands; Allan J. Wailoo, PhD, Professor, University of Sheffield, Sheffield, United Kingdom
13:45-14:45
IP9: PHARMACY BENEFIT MANAGEMENT IN THE UNITED STATES: NAUGHTY OR NICE? A COMPARISON OF US AND EUROPEAN DRUG EVALUATION AND COVERAGE POLICIES
Moderator: Scott Ramsey, PhD, MD, Member, Fred Hutchinson Cancer Research Center and Professor, Department of Medicine, University of Washington, Seattle, WA, USA
Panelists: Michael Drummond, PhD, Professor of Health Economics, Centre for Health Economics, University of York and Principal Consultant, OptumInsight, Heslington, York, United Kingdom; Gérard de Pouvourville, PhD, Professor, Department of Health Care Management and Chair, Health Economics Institute, ESSEC Business School, Cergy-Pontoise, France; Brian Solow, MD, Chief Medical Officer, OptumRx, Irvine, CA, USA
13:45-14:45
IP10: REASSEMBLING THE "NICHE AGENT" PUZZLE: HOW SHOULD ORPHAN AND SPECIALTY PRODUCT MANUFACTURERS REFOCUS EVIDENCE DEVELOPMENT IN RESPONSE TO GROWING PRESSURE FOR VALUE DEMONSTRATION?
Moderator: 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
Panelists: 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; Steven Simoens, PhD, MSc, MA, Professor of Pharmacoeconomics, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
14:45-15:00
BREAK & EXHIBITS VIEWING
 
15:00-19:00
RESEARCH POSTER PRESENTATIONS VIEWING – SESSION IV
 
15:00-16:00
ISSUE PANELS - SESSION III
15:00-16:00 CLINICAL OUTCOMES RESEARCH ISSUES
IP11: BIOPHARMA, REGULATORS, AND PAYERS DECISIONS: DIFFERENT PROCESSES BUT IS THERE A CONVERGENCE IN THE APPROACH FOR INTEGRATING THE PATIENT PERSPECTIVE?
Moderator: Patrick Marquis, MD, MBA, President, TwoLegs Consulting LLC, Newton, MA, USA
Panelists: 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
15:00-16:00 ECONOMIC OUTCOMES RESEARCH ISSUES
IP12: HEALTH ECONOMICS OF PERSONALIZED MEDICINE – DO WE NEED A COMPREHENSIVE RESEARCH PROGRAM?
Moderator: Scott Ramsey, PhD, MD, Member, Fred Hutchinson Cancer Research Center and Professor, Department of Medicine, University of Washington, Seattle, WA, USA
Panelists: Maarten J. IJzerman, PhD, Professor & Chair, Department of Health Technology & Services Research, University of Twente, Enschede, The Netherlands; 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; Mark J. Sculpher, MSc, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK
15:00-16:00
IP13: SHOULD OFF-LABEL AGENTS BE USED AS COMPARATORS IN HEALTH TECHNOLOGY ASSESSMENTS?
Moderator: Jeanette Kusel, MSci, Consultant, Costello Medical Consulting Ltd., Cambridge, UK
Panelists: 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
15:00-16:00 HEALTH POLICY DEVELOPMENT USING OUTCOMES RESEARCH ISSUES
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?
Moderator: Lisbet Coulton, BA, Director, Tanwood Consulting Ltd, Leatherhead, Surrey, UK
Panelists: Panelists: Shelley Gandhi, MSc, Director, NDA Regulatory Science Ltd, Leatherhead, UK; Thomas Lonngren, PhD, MRPharmS, FRCP, Director, Pharm Executive Consulting, Uppsala, Sweden; Keith Tolley, MPhil, Director, Tolley Health Economics Ltd., Hardwick House, Buxton, Derbyshire, United Kingdom
15:00-16:00
IP15: ALIGNING PAYER AND INDUSTRY PERSPECTIVES ON MEASURING VALUE IN HEALTH TECHNOLOGY ASSESSMENT
Moderator: Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, University of Washington School of Pharmacy, Seattle, WA, USA
Panelists: James F Murray, PhD, Research Fellow, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; Helen Knight, PhD, Associate Director, Appraisals, National Institute for Health and Care Excellence (NICE), London, UK; Ulf Persson, PhD, Research Director, The Swedish Institute for Health Economics, Lund, Sweden
16:15-17:15
WORKSHOPS – SESSION III
16:15-17:15 CLINICAL OUTCOMES RESEARCH          
W13: METHODOLOGY TO VALIDATE SURROGATE ENDPOINTS IN CLINICAL TRIALS: WHICH LEVEL OF EVIDENCE IS FIT FOR PURPOSE?
Discussion Leaders: 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
16:15-17:15 ECONOMIC OUTCOMES RESEARCH
W14: MODELLING APPROACHES WHEN LIMITED BY SINGLE-ARM STUDIES: AN ANALYSIS OF RECENT ONCOLOGY EXAMPLES
Discussion Leaders: 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
16:15-17:15
W15: EVIDENCE-BASED DETERMINISTIC SENSITIVITY ANALYSES: CASE STUDIES USING ISPOR-SMDM GUIDELINES FOR UNCERTAINTY ANALYSES
Discussion Leaders: 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
16:15-17:15 HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH
W16: THE ROLE OF EVIDENCE SYNTHESIS AND VALUE OF INFORMATION ANALYSIS FOR RESEARCH PRIORITISATION, COMMISSIONING AND CLINICAL TRIAL DESIGN
Discussion Leaders: Karl Claxton, PhD, Professor of Economics, Centre for Health Economics, University of York, Heslington, York, UK; Nicky Welton, PhD, Senior Lecturer, School of Social and Community Medicine, University of Bristol, Bristol, UK; Claire McKenna, PhD, Research Fellow, Centre for Health Economics, University of York, Heslington, York, UK; Hendrik Koffijberg, PhD, Assistant Professor, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
16:15-17:15 PATIENT-REPORTED OUTCOMES & PATIENT PREFERENCE RESEARCH
W17: DO YOU WANT TO HEAR THE BAD NEWS? PATIENT PREFERENCES AND THE DEBATE ON THERAPEUTICALLY UNINFORMATIVE DIAGNOSTIC-TEST INFORMATION
Discussion Leaders: F. Reed Johnson, PhD, Distinguished Fellow & Principal Economist, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA; 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; Axel C. Mühlbacher, PhD, Professor for Health Economics and Health Care Management, IGM Institute, Neubrandenburg, Germany
16:15-17:15 USE OF REAL WORLD DATA
W18: APPLICATION OF OBSERVATIONAL METHODS TO VACCINE UTILIZATION STUDIES
Discussion Leaders: H. Keri Yang, PhD, MPH, MS, Director, Merck & Co., Inc., West Point, PA, USA Josephine A. Mauskopf, PhD, Vice President, Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA; Shuvayu Sen, PhD, Executive Director, Global Health Outcomes, Merck & Co., Inc., Whitehouse Station, NJ, USA
17:15-19:00
EXHIBITORS’ WINE & CHEESE RECEPTION & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION IV
 
17:30-18:30
ISPOR FORUMS – SESSION II
17:30-18:30 RISK SHARING ON PHARMACEUTICALS AND DEVICES IN SPAIN: THE REALITIES

Experiences on shared risk in Spain both in pharmaceuticals and health devices will be the main focus of this forum. Additionally, barriers to the implementation of these types of risk-sharing agreements will be discussed. Presented by the ISPOR Spain Regional Chapter

Moderator/Speaker: Olga Espallardo, MBA, MSc, Director Health Economics, Hospital Services & Health Policy, Johnson & Johnson, Madrid, Spain

Speakers: Carme Piñol, MD, MSc, Principal PMA & HE, IMS Health, Barcelona, Spain; Antoni Gilabert, MD, MBA, PhD, Director, Pharmaceutical Care and Complimentary Benefits, Catsalut, Madrid, Spain; Ana Clopés, MD, Pharmacy Director, Catalan Institute of Oncology, Barcelona, Spain

17:30-18:30 RARE DISEASES: TERMS, DEFINITIONS, AND CHALLENGES IN ASSESSING AND APPRAISING DIAGNOSTICS AND TREATMENTS

There are many concepts and terms that describe rare diseases, their treatments and related health technologies. These differ according to context (e.g. among jurisdictions) and application. Terms and definitions used in outcomes research and the numerous research- and HTA-related challenges to the evaluation of diagnostics and treatments for rare diseases will be discussed. Presented by the ISPOR Rare Disease Special Interest Group

Moderator/Speaker: Chris L. Pashos, PhD, Vice President, United BioSource Corporation, Lexington, MA, USA

Speakers: 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

17:30-18:30 THE USE OF RISK-SHARING IN PHARMACEUTICAL PRICING AND REIMBURSEMENT DECISIONS IN CENTRAL & EASTERN EUROPE

Central and Eastern European (CEE) countries are using different approaches to address financing of high-cost medicines, where the access to these medicines remains uncertain. In order to reduce this uncertainty, there is a need for new arrangements between payors and manufacturers. This will enable optimal market access of innovative medicine while limiting the risk to payors. This Forum will discuss the legal background of risk-sharing schemes, implementation, and the impact on patient´s access to highcost medicines. The most frequently used schemes in Central & Eastern countries will be described. Furthermore, speakers will explain the advantages and disadvantages of risk-sharing arrangements amongst the key stakeholders in CEE.  Presented by the ISPOR Central & Eastern Europe Network: ISPOR Bulgaria, Croatia, Czech, Romania and Turkish SCP Regional Chapters

Moderator/Speaker: Jana Skoupa, MD, MBA, Researcher, Medical Data Center, 1st Medical Faculty, Charles University, Prague, Czech Republic

Speakers: Alexandra Savova, MPharm, PhD, Associate Professor, Faculty of Pharmacy, Department of Social Pharmacy and Pharmacoeconomics, Medical University of Sofia, Sofia, Bulgaria; Josip Culig, MD, PhD, Professor, Clinical Pharmacologist, Institute of Public Health Dr.A. Štampar, Zagreb, Croatia; Sorin Paveliu, MD, PhD, Associate Professor, Faculty of Pharmacy, Department of Pharmacology, Titu Maiorescu University, Bucharest, Romania; Mete Saylan, MD, Senior Market Access Manager, Novartis Pharma Turkey, Istanbul, Turkey

17:30-18:30 VIHRI: RESOURCES AND TIPS FOR WRITING QUALITY AND WELL-SUPPORTED PAPERS

ISPOR Value in Health Regional Issues (ViHRI) is a new scientific journal of the Society to encourage and enhance the science of pharmacoeconomic/health economic and health outcomes research and its use in health care decisions in Asia, Latin America, Central & Eastern Europe, Western Asia, and Africa. Writing papers for scientific journals can be challenging. The purpose of this forum is to provide feedback directly from the ViHRI Editorial Board on how to write a good scientific paper by avoiding mistakes, common pitfalls, and technical difficulties. The emphasis of this forum is to equip prospective ViHRI submitters with strong writing skills and resources to improve the quality of articles. Examples of properly and well-supported manuscripts will be provided. Presented by the VIHRI Editorial Board.

Moderator: 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

Speakers: Imre Boncz, MD, MSc, PhD, Habil, Co-Editor, ViHRI (CEEWAA) and Professor & Director, Institute for Health Insurance, Faculty of Health Sciences, University of Pecs, Pecs, Hungary; 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; 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

17:30-18:30 THE USE OF PHARMACOECONOMIC PRINCIPLES IN LOCAL DRUG POLICY DECISIONS IN POLAND, RUSSIA, AND UKRAINE
(Presented in Russian and English)

This forum will discuss changes in drug policy decisions in Poland, Russia, and Ukraine with particular focus on the use of pharmacoeconomic principles in local drug policy decisions. Speakers will describe how these principles have been applied for effective formulary management, individual patient treatment, drug policy determination, and resource allocation. Presented by ISPOR CEE Network: ISPOR Poland, Russia, & Ukraine Regional Chapters

Moderator/Speaker: Joanna Lis, MSc, PhD, President, ISPOR Poland Chapter and Adjunct Professor, Pharmacoeconomics Department, Medical University of Warsaw and Director, Public Affairs and Market Access, Sanofi Poland, Warsaw, Poland

Speakers: Karina Jahnz-Rozyk, MD, PhD, Head of Department of Immunology & Clinical Allergology, Military Institute of Medicine, Warsaw, Poland; Pavel Vorobiev, MD, PhD President, ISPOR Russia Chapter and Professor & Head, Department of Hematology & Geriatrics, Faculty for Postgraduate Medical Education, First Sechenov Moscow State Medical University, Moscow, Russia; 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

17:30-18:30 PHARMACOECONOMICS AND OUTCOMES RESEARCH IN ASIA: WHAT IS NEXT?

Following the global trend, the concepts of pharmacoeconomics (PE) and outcomes research (OR) have been introduced in Asia in the last decade to mitigate the scarcity of resources for health care. New therapeutic technologies have also been developed to address unmet medical needs; but budgetary pressures are forcing countries to make difficult choices. Although still evolving, PE as an assessment technique is valuable to aid decision making relating to proper health care resource allocations. This forum will introduce the current status of PE/OR in countries in Asia and explore the future development of the discipline in the region. Presented by the ISPOR Asia Consortium

Moderator: Isao Kamae, MD, DrPH, Professor of Health Technology Assessment and Public Policy, Graduate School of Public Policy, The University of Tokyo, Tokyo, Japan

Speakers: Seungjin Bae, ScD, Assistant Professor, College of Pharmacy, Ewha Woman’s University, Seoul, South Korea; Takashi Fukuda, PhD, Chief Senior Researcher, National Institute of Public Health, Wako, Japan; 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; Donald D. Yin, PhD, Associate Vice President & Head, Global Health Outcomes, Merk & Co., Inc., Whitehouse Station, NJ, USA

   
18:00-19:00
POSTER AUTHOR DISCUSSION HOUR – SESSION IV
 
19:30-23:30
Program - Wednesday, 6 November 2013
7:30-8:30
EDUCATIONAL SYMPOSIUM (Sponsored by CPRD)
COMPLETING THE PUZZLE TO DELIVER THE BENEFITS OF REAL WORLD DATA IN HEALTH OUTCOMES RESEARCH

Symposium Description

8:45-14:45
 
8:45-9:45
WORKSHOPS – SESSION IV
8:45-9:45 CLINICAL OUTCOMES RESEARCH
W19: CAN WE USE COMPARATIVE EFFECTIVENESS APPROACHES TO ASSESS HARMS ACROSS TREATMENTS?
Discussion Leaders: Edward J. Mills, PhD, MSc, Visiting Associate Professor, Department. Preventive Medicine, Stanford University, Palo Alto, CA, USA; Kristian Thorlund, PhD, MStat, Associate Professor, Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada; Christopher O'Regan, MSc, Head of HTA & Outcomes Research, Merck Sharp Dohme Ltd., Hoddesdon, UK
8:45-9:45 ECONOMIC OUTCOMES RESEARCH
W20: MCDA IN HTA: TRANSLATING THEORY TO PRACTICE THROUGH AN INTERACTIVE WORKSHOP
Discussion Leaders: 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
8:45-9:45 HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH
W21: CHOOSING THE FIRST TIER CONTINENT FOR MEDICAL DEVICES- 510(K)/PMA VERSUS CE-MARK
Discussion Leaders: Manfred Scheppach, MSc, Consultant, AiM GmbH, Lörrach, Germany; Michael Weißer, MSc, Consultant, AiM GmbH, Lörrach, Germany; Judy Rosenbloom, FASE, President and Founder, JR Associates, Reseda, CA, USA; Jo Ellen Slurzberg, BA, Vice President, Global Health Policy, JR Associates, Reseda, CA, USA
8:45-9:45 PATIENT-REPORTED OUTCOMES & PATIENT PREFERENCE RESEARCH
W22: TESTING THE MEASUREMENT EQUIVALENCE OF ELECTRONICALLY MIGRATED PATIENT-REPORTED OUTCOME (PRO) INSTRUMENTS: CHALLENGES AND SOLUTIONS
Discussion Leaders: 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
8:45-9:45 USE OF REAL WORLD DATA
W23: GARBAGE IN – GARBAGE OUT: DETECTING DATA ERRORS AND MANAGING SUCH ERRORS IN RETROSPECTIVE RESEARCH
Discussion Leaders: 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
9:45-10:00
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION V
 
10:00-11:00
ISSUE PANELS – SESSION IV
10:00-11:00 CLINICAL OUTCOMES RESEARCH ISSUES
IP16: IS OPEN ACCESS TO CLINICAL TRIAL DATA GOOD FROM THE MARKET ACCESS PERSPECTIVE?
Moderator: Radek Wasiak, MA, MSc, PhD, EU Director, Senior Research Scientist, Evidera, London UK
Panelists: Sylvie Gabriel, MD, Senior Vice President, Global Market Access & Pricing, IPSEN Pharma, Boulogne-Billancourt, France; Jerome Dinet, PharmD, Global Evidence Generation Director, IPSEN Pharma, Boulogne-Billancourt, France; Bina Rawal, -, Medical, Innovation & Research Director, Association of the British Pharmaceutical Industry, London, United Kingdom
10:00-11:00 ECONOMIC OUTCOMES RESEARCH ISSUES
IP17: HOW CAN HEALTH ECONOMIC MODELLERS WIN THE TRUST OF DECISION MAKERS?
Moderator: Samuel Aballea, MSc, Vice President, HEOR, Creativ-Ceutical, Paris, France
Panelists: The development of new drugs is often accompanied by several models, developed by different stakeholders (manufacturers, researchers commissioned by HTA authorities or independent researchers), for various countries. Comparisons between models generally show substantial discrepancies, and many decision-makers give little credit to model results. The panel will discuss ways to make models more trustworthy for decision-makers, and the issue whether unified disease models are desirable. G. Meier will represent the modeller’s perspective, relating to her experience in developing and presenting economic models for vaccines. P. Tappenden will represent a decision-maker’s perspective from the UK, where NICE has long experience in using models. S. Capri will represent a perspective of an Italian HTA authority, which has more limited resources for reviewing models.
10:00-11:00 HEALTH POLICY DEVELOPMENT USING OUTCOMES RESEARCH ISSUES
IP18: HOW MULTIDISCIPLINARY DOES EDUCATION FOR FUTURE HEALTH CARE DECISION MAKERS NEED TO BE?
Moderator: Siegfried Walch, PhD, Head of Department, Nonprofit, Social and Healthcare Management, Management Center Innsbruck (MCI), Innsbruck, Austria
Panelists: Michael Urban, PhD, Scientific Publication Specialist, VIBRANT MED-EL, Innsbruck, Austria; JL (Hans) Severens, PhD, Professor of Evaluation in Health Care, Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, Netherlands; Ivan Spehar,  Lecturer, Department of Health Management and Health Economics, Univeristy of Oslo, Oslo, Norway
10:00-11:00
IP19: COMPARING THE CHALLENGES OF COMPARATIVE EFFECTIVENESS RESEARCH IN FRANCE, ITALY AND THE NETHERLANDS: CURRENT SITUATION AND PERSPECTIVES
Moderator: Jeanni van Loon, MSc, Global Managing Director, HEOR & Strategic Market Access, Mapi, Houten, The Netherlands
Panelists: 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
10:00-11:00 PATIENT-REPORTED OUTCOMES & PATIENT PREFERENCE RESEARCH ISSUES
IP20: PARTNERING WITH PATIENTS: DESIGNING, PARTICIPATING IN, AND REPORTING HEALTH OUTCOMES.
Moderator: Tim Davis, BSc, Chief Executive Officer, Exco InTouch, Sawbridgeworth, United Kingdom
Panelists: Zach Hallinan, BS, Director of Research and Translation Services, CISCRP, Boston, MA, USA; Jim Kremidas, BS, Independent Consultant, Member of CISCRP Advisory Board, Durham, NC, USA; Jan Geissler, MBA, Director, EUPATI, Riemerling, Germany
11:15-12:30
WELCOME & THIRD PLENARY SESSION
WELCOME
William H. Crown, PhD William H. Crown, PhD

2013-2014 ISPOR President and Chief Scientific Officer Optum Labs, Cambridge, MA, USA
THIRD PLENARY SESSION: SHOULD MULTI-CRITERIA DECISION ANALYSIS (MCDA) REPLACE COST EFFECTIVENESS ANALYSIS (CEA) FOR EVALUATION OF HEALTH CARE COVERAGE DECISIONS?

Although economic evaluation is now well-established as part of the reimbursement process for new technologies in many European countries, concerns are sometimes raised that the measures of economic benefit commonly used (such as the QALY) are too narrow, or that the findings from economic evaluation should be considered alongside other factors in a deliberative decision-making process. Multi-Criteria Decision Analysis (MCDA) is a formal method for considering several factors, or domains, when reaching a decision. During this plenary session, the use of MCDA versus cost-effectiveness analysis (CEA) in health care coverage decisions will be debated. Each speaker will present a position on the use of MCDA in health care coverage decisions. Then the speakers will respond to each other’s position in a debate format followed by audience participation.

11:15 – 11:25

Jaime Caro, MDCM

Moderator:  J. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice President, Research, Evidera, Lexington, MA, USA and Adjunct Professor of Medicine, Epidemiology, and Biostatistics, McGill University, Montreal, QC, Canada

11:25 – 11:35

Rob  Baltussen, PhD

MCDA for HTA: The Question Is Not Whether But Merely How To Do It

Speaker:  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

11:35 – 11:45

Karl  Claxton, PhD

Why MCDA Should Not be Used: No Estimation of Opportunity Costs

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

11:45 – 11:55

Andrew Thomson, PhD

A Regulator’s Perspective on MCDA vs. CEA for Health Care Decisions

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

11:55 – 12:30

Speaker & Audience Debate

 

12:30-12:45
ISPOR 16th ANNUAL EUROPEAN CONGRESS RESEARCH PRESENTATION AWARDS

Moderator: William Crown, PhD, 2013-2014 ISPOR President and Chief Scientific Officer, Optum Labs, Cambridge, MA USA

ISPOR BEST PODIUM PRESENTATIONS

Presented by: Axel Mühlbacher, PhD, Professor, Health Economics and Health Care Management, Hochschule Neubrandenburg, Neubrandenburg, Germany

ISPOR BEST POSTER PRESENTATIONS

Presented by: Imre Boncz, MD, MSc, PhD, Co-Editor, VIHRI (CEEWAA) and Professor, Faculty of Health Sciences, University of Pécs, Pécs, Hungary
12:45-13:45
LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION V
 
12:45-13:45
POSTER AUTHOR DISCUSSION HOUR – SESSION V
 
13:45-14:45
WORKSHOPS – SESSION V
13:45-14:45 CLINICAL OUTCOMES RESEARCH
W24: METHODS FOR DEALING WITH TREATMENT SWITCHING IN CLINICAL TRIALS
Discussion Leaders: Keith R. Abrams, PhD, Professor of Medical Statistics, Department of Health Sciences, University of Leicester, Leicester, UK; Michael J. Crowther, MSc, Research Associate & NIHR Doctoral Research Fellow, Department of Health Sciences, University of Leicester, Leicester, UK; Nicholas R Latimer, PhD, Research Fellow in Health Economics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Joshua Ray, MSc, Health Economist, GPMA, F. Hoffmann-La Roche Ltd., Basel, Switzerland
13:45-14:45 ECONOMIC OUTCOMES RESEARCH
W25: NAVIGATING THE PITFALLS AROUND PROGRESSION-FREE SURVIVAL ESTIMATION
Discussion Leaders: Edit Remak, MSc, Research Scientist, Evidera, Budapest, Hungary; John William Stevens, PhD, Statistician, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Martin Hoyle, MA, MSc, PhD, Senior Research Fellow, Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK;Noemi Muszbek, MSc, Senior Research Scientist, Evidera, London, UK
13:45-14:45 HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH
W26: INCLUSION OF CLINICAL TRIAL DATA AND OTHER EVIDENCE IN CLINICAL PRACTICE GUIDELINES: AN IMPORTANT OPPORTUNITY FOR INDUSTRY
Discussion Leaders: 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
13:45-14:45
W27: MANAGING UNCERTAINTY: THE NEW WAY FORWARD FOR MARKET ACCESS
Discussion Leaders: Antoni Gilabert, PhD, Managing Director of Pharmaceutical Care, Catalan Autonomous Region Health Service, Barcelona, Spain; Thomas Mueller, MD, Head, Pharmaceuticals Department, Federal Joint Committee (G-BA), Berlin, Germany; Meriem Bouslouk, DMD, MSc, Desk Officer, Pharmaceuticals Department, Federal Joint Committee (G-BA), Berlin, Germany; Mondher Toumi, MD, PhD, Professor & Chair of Public Health & Market Access, University Claude Bernard Lyon 1, Lyon, France
13:45-14:45 PATIENT-REPORTED OUTCOMES & PATIENT PREFERENCE RESEARCH
W28: ELICITING FORMAL PATIENT PREFERENCES FOR ASSESSING BENEFITS AND RISKS OF MEDICINES
Discussion Leaders: 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
14:45-15:00
BREAK & EXHIBITS VIEWING
 
15:00-16:00
WORKSHOPS – SESSION VI
15:00-16:00 ECONOMIC OUTCOMES RESEARCH
W29: ENHANCING THE VALUE OF HEALTH ECONOMIC MODELING THROUGH NOVEL APPLICATION OF REAL WORLD EVIDENCE (RWE)
Discussion Leaders: Amy O'Sullivan, PhD, Principal, IMS Health, Waltham, MA, USA; Christopher M. Blanchette, PhD, MBA, Research Associate Professor, Department of Public Health Sciences, University of North Carolina, Charlotte, NJ, USA; Julie Munakata, MS, Principal, HEOR, IMS Health, San Francisco, CA, USA
15:00-16:00 HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH
W30: SUSTAINABILITY OF OFF-PATENT DRUG POLICIES IN THE QUEST FOR VALUE
Discussion Leaders: 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; Zoltan Kalo, MD, MSc, PhD, Executive, Syreon Research Institute, Budapest, Hungary
15:00-16:00
W31: POST-AUTHORISATION STUDIES IN EUROPE: BRIDGING THE GAP BETWEEN REGULATORY AND HEALTH TECHNOLOGY ASSESSMENT (HTA) STAKEHOLDER NEEDS FOR ADDITIONAL EVIDENCE
Discussion Leaders: Luis Prieto, PhD, Scientific Administrator, Pharmacovigilance and Risk Management, European Medicines Agency, London, UK; Francois Meyer, MD, Advisor to the President & Director for International Affairs, Haute Autorité de Santé (HAS), Paris, France; Nicholas Moore, MD, PhD, Head, Department of Pharmacology, University of Bordeaux, Bordeaux, France; Massoud Toussi, MD, PhD, MBA, Medical Director, Health Economics and Outcomes Research, IMS Health, Paris, France
15:00-16:00
W32: COMBINATION PRODUCTS – NEW CHALLENGES FROM BOTH A REGULATORY AS WELL AS A REIMBURSEMENT STANDPOINT
Discussion Leaders: Manfred Scheppach, MSc, Consultant, AiM GmbH, Lörrach, Germany; Michael Weißer, MSc, Consultant, AiM GmbH, Lörrach, Germany; Judy Rosenbloom, FASE, President and Founder, JR Associates, Reseda, CA, USA; Jo Ellen Slurzberg, BA, Vice President, Global Health Policy, JR Associates, Reseda, CA, USA
15:00-16:00 PATIENT-REPORTED OUTCOMES & PATIENT PREFERENCE RESEARCH
W33: THE CORRELATION BETWEEN PATIENT-REPORTED OUTCOMES AND CLINICIAN-REPORTED OUTCOMES
Discussion Leaders: 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

Contact ISPOR @ info@ispor.org | View Legal Disclaimer
© 2018 International Society for Pharmacoeconomics and Outcomes Research.
All rights reserved under International and Pan-American Copyright Conventions.