ISPOR 16th Annual European Congress 2-6 November 2013 The Convention Centre Dublin Dublin, Ireland

Finding the Right Pieces for the Health Care Decision-Making Puzzle

PROGRAM

Early Registration Deadline:

17 September 2013 Over 2,000 abstracts submitted, an 11% increase!

FOR MORE INFO: WWW.ISPOR.ORG

key information CONGRESS PROGRAM COMMITTEE PROGRAM COMMITTEE CO-CHAIRS Michael Barry, MD, PhD, FRCPI, Clinical Director, National Centre for Pharmacoeconomics, St. James’s Hospital, Dublin, Ireland John Hutton, BPhil, Professor of Health Economics, Department of Health Sciences, University of York, Heslington, York, UK RESEARCH REVIEW COMMITTEE CO-CHAIRS Imre Boncz, MD, MSc, PhD, Habil, Professor & Vice Dean, Institute for Health Insurance, Faculty of Health Sciences, University of Pécs, Pécs, Hungary Luciana Scalone, PhD, PharmD, ScD, Researcher, Research Centre on Public Health, University of Milan-Bicocca, Monza, Italy

Mondher Toumi, MD, MSc, PhD, Professor & Chair of Public Health & Market Access, and Professor, UFR d’Odontologie, University Claude Bernard Lyon 1, Lyon, France Carin A. Uyl-de Groot, PhD, Professor of Health Technology Assessment, Head of Health Economics & Director, Institute for Medical Technology Assessment (iMTA), Erasmus University Rotterdam, Rotterdam, The Netherlands WORKSHOP REVIEW COMMITTEE CO-CHAIRS Keith Abrams, MSc, PhD, Professor of Medical Statistics, Department of Health Sciences, University of Leicester, Leicester, UK

Mira Pavlovic, MD, Deputy Director for Health Technology Assessment, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France ISSUE PANEL REVIEW COMMITTEE CO-CHAIRS Wim Goettsch, PhD, Project Leader, EUnetHTA WP5 on Rapid Assessments and Advisor of International Affairs and Academia, Health Care Insurance Board (CVZ), Diemen, The Netherlands Diego F. Ossa, MD, MSc, Global Director, Market Access, Novartis Pharma AG, Basel, Switzerland

VENUE INFORMATION/HOTEL RESERVATIONS THE CONVENTION CENTRE DUBLIN The Convention Centre Dublin is situated overlooking the River Liffey at Spencer Dock. By taxi, the Convention Centre Dublin is approximately 20 minutes from the Dublin Airport (~10km/6 miles), and approximately 5 minutes from Dublin city center. The Luas Red Line tram runs directly behind The CCD, providing a convenient link to downtown Dublin.

HOTEL RESERVATIONS ISPOR Rates: ISPOR has partnered with the Irish Hotels Federation to offer discounted room rates and a hotel booking service for congress attendees. Discounted ISPOR attendee room rates are available at multiple hotels in Dublin, with options to meet different budget, location, and hotel standard preferences. Attendee rates are limited and available on a first-come, first-serve basis.

Reservations: Use the Irish Hotels Federation online reservation system available at www.ispor.org >> 16th Annual European Congress >> Hotel and Venue Information Cancellations or changes to reservations without penalty must be made no later than 30 days prior to date of arrival, please see individual hotel terms & conditions.

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ISPOR 16th Annual European Congress 2-6 November 2013 • The Convention Centre Dublin, Dublin, Ireland

I S POR S H O RT CO U R S E S SATURDAY, 2 NOVEMBER All Day Course 9:00-18:00 INTRODUCTION TO HEALTH ECONOMIC / PHARMACOECONOMIC EVALUATIONS Lorne Basskin, PharmD, Pharmacoeconomic Consultant, USA Discuss how to incorporate pharmacoeconomics into study design and data analysis, collect and calculate costs of different alternatives, determine the economic impact of clinical outcomes, and identify, track, and assign costs to different types of health care resources. MORNING COURSES 9:00-13:00 INTRODUCTION TO DATABASE ANALYSIS OF OBSERVATIONAL STUDIES OF TREATMENT EFFECTS Bradley C. Martin, PhD, PharmD, RPh, University of Arkansas for Medical Science College of Pharmacy, USA; Linus Jönsson, PhD, MD, MSc, OptumInsight, Sweden Review analytic techniques and specific best practices to improve causal inference in database analysis, including the use of stratification analysis before multivariable modeling, multivariable regression, propensity scoring, instrumental variable, and structural modeling techniques. INTRODUCTION TO PATIENT-REPORTED OUTCOMES ASSESSMENT: INSTRUMENT DEVELOPMENT & EVALUATION Andrew Lloyd, DPhil, Oxford Outcomes, UK; Kellee Howard, MSc, Oxford Outcomes, USA This course familiarizes participants with the range and scope of what PROs are used for, how they are developed and evaluated, what they measure, and how PRO data can be used to support licensing and reimbursement applications. INTRODUCTION TO MODELING Uwe Siebert, MD, MPH, MSc, ScD, University of Health Sciences, Medical Informatics and Technology, Austria Review pharmacoeconomic modeling techniques such as Monte Carlo analysis, Markov modeling, and probabilistic sensitivity analysis. STATISTICAL METHODS FOR PHARMACOECONOMICS & OUTCOMES RESEARCH Andrew Briggs, DPhil, MSc, University of Glasgow, UK; Neil Hawkins, PhD, CStat, University of York, UK Discuss the foundations upon which major statistical tests are based, the application of these tests to pharmacoeconomic problems, and the importance of correlation between variables and the use of regression techniques. COST-EFFECTIVENESS ANALYSIS ALONGSIDE CLINICAL TRIALS Scott D. Ramsey, MD, PhD, Fred Hutchinson Cancer Research Center, USA; Richard J. Willke, PhD, Pfizer Inc., USA Review design, conduct, and reporting of cost-effectiveness analyses alongside clinical trials. Analyses guided by an analysis plan and hypotheses, an incremental analysis using an intention to treat approach, characterization of uncertainty, and standards for reporting results are presented. ELEMENTS OF PHARMACEUTICAL / BIOTECH PRICING Jack M. Mycka, MME LLC, USA; Renato Dellamano, PhD, ValueVector, Italy Discuss key terminology and issues in pricing decisions, tools to build and document product value, the role of pharmacoeconomics, and the differences in payment systems that help shape pricing decisions. AFTERNOON COURSES 14:00-18:00 INTRODUCTION TO HEALTH TECHNOLOGY ASSESSMENT (HTA) Uwe Siebert, MD, MPH, MSc, ScD, University of Health Sciences, Medical Informatics and Technology, Austria Evaluate key elements, methods, and language of health technology assessment and its basic disciplines. Using real world examples, review the practical steps involved in developing and using HTA reports. META-ANALYSIS & SYSTEMATIC LITERATURE REVIEW Neil Hawkins, PhD, CStat, University of York, UK; Olivia Wu, PhD, MSc, University of Glasgow, UK Analyze four key areas: impetus for network meta-analysis and systematic reviews; basic steps to perform a quantitative systematic review; statistical methods of combining data; and appraisal and use of meta-analytic reports.

USE OF PROPENSITY SCORES IN OBSERVATIONAL STUDIES OF TREATMENT EFFECTS John Seeger, PharmD, DrPH, Harvard Medical School/Brigham and Women’s Hospital, USA Evaluate concerns about bias and the methods for causal inference in observational studies; assess how propensity scores can reduce bias; review risk adjustment models, confounding, standard adjustment, and propensity scoring methodology. INTRODUCTION TO PATIENT PREFERENCE METHODS USED FOR QALYS Jan Busschbach, PhD, Erasmus MC, The Netherlands Learn methods for measuring preference-based outcomes, review issues such as potential insensitivity of generic instruments for disease-specific problems, and review the extent to which adaptation of generic or disease-specific quality of life instruments may offer a solution. PHARMACOECONOMIC MODELING – APPLICATIONS Mark S. Roberts, MD, MPP, University of Pittsburgh, USA; Shelby L. Corman, PharmD, MS, BCPS, Pharmerit International, USA Gain hands-on experience in constructing a decision analysis tree including, Markov models, Monte Carlo simulations, sensitivity analysis, determination of probability values, and transition probabilities.

SUNDAY, 3 NOVEMBER MORNING COURSES 8:00-12:00 BAYESIAN METHODS IN ECONOMIC EVALUATIONS – INTRODUCTION Christopher S. Hollenbeak, PhD, Penn State College of Medicine, USA Review the basics of Bayesian statistics, the differences between Bayesian and classical approaches, and how to apply the Bayesian approach to clinical trials and cost-effectiveness analyses. DISCRETE EVENT SIMULATION FOR ECONOMIC ANALYSES – CONCEPTS J. Jaime Caro, MDCM, FRCPC, FACP, McGill University, Canada; Jörgen Möller, MSc Mech Eng, Lund University, Sweden; Denis Getsios, United BioSource Corporation, USA Gain a basic understanding of key concepts of discrete event simulation with focus on the use of these simulation models to address health economic (and device-related) problems. PATIENT REGISTRIES Leanne Larson, MHA, PAREXEL International, USA Patient registries and their applications in identifying “real world” clinical, safety, and patient-perspective issues, regulatory trends and requirements, operational components, management issues, and measures of program success are discussed. USE OF INSTRUMENTAL VARIABLES IN OBSERVATIONAL STUDIES OF TREATMENT EFFECTS Benjamin M. Craig, PhD, Moffitt Cancer Center, USA; Bradley C. Martin, PhD, PharmD, University of Arkansas for Medical Sciences College of Pharmacy, USA Sample selection models provide a test and correction for the presence of selection bias, enabling an investigator to obtain unbiased estimates of treatment effects. Faculty will discuss the various models and their applications. REIMBURSEMENT SYSTEMS IN EUROPE James Furniss, GfK Bridgehead, UK Using the ISPOR Global Health Care Systems Roadmap, discuss health technology decision-making processes for coverage and reimbursement decisions in various reimbursement systems across Western, Central, and Eastern Europe. TRANSFERABILITY OF COST-EFFECTIVENESS DATA BETWEEN COUNTRIES JL (Hans) Severens, PhD, Maastricht University, The Netherlands; Silvia Evers, PhD, LLM, Maastricht University, The Netherlands; Manuela Joore, PhD, Maastricht University, The Netherlands Review factors making economic data more difficult to transfer among countries than clinical data. Discuss methods to assess transferability of foreign cost, effects and cost-effectiveness estimates, and transferability of health state valuation based on the

EQ-5D instrument. CONJOINT ANALYSIS – THEORY & METHODS A. Brett Hauber, PhD, RTI Health Solutions, USA; John F. P. Bridges, PhD, Johns Hopkins Bloomberg School of Public Health, USA Learn the conceptual and empirical basis for using conjoint analysis to elicit preferences in outcomes research. Conceptual basis for quantifying decision-maker preferences and practical design and analytical issues are presented. AFTERNOON COURSES 13:00-17:00 BAYESIAN METHODS IN ECONOMIC EVALUATIONS – APPLICATIONS Keith R. Abrams, PhD, University of Leicester, UK Introduces the use of Bayesian methods in evidence synthesis and allows participants to gain hands-on experience using such modeling techniques within WinBUGS. DISCRETE EVENT SIMULATION FOR ECONOMIC ANALYSES – APPLICATIONS J. Jaime Caro, MDCM, FRCPC, FACP, McGill University, Canada; Jörgen Möller, MSc Mech Eng, Lund University, Sweden; Denis Getsios, United BioSource Corporation, USA Gain experience using practical hands-on discrete event simulation exercises. Topics include: components of a DES; how to build a model; modeling of processes and resource use; and modeling of variables and decisions. ADVANCED ECONOMETRIC METHODS FOR ESTIMATING TREATMENT EFFECTS IN OBSERVATIONAL STUDIES William Crown, PhD, Optum Labs, USA Review analytic techniques for estimation of treatment effects and statistical properties of estimators, ordinary least squares regression (OLS), and maximum likelihood estimation. Applying Mixed Methods to Establish Content Validity of PRO, CLINRO, and OBSRO Assessment Instruments Donald L. Patrick, PhD, MSPH, University of Washington, USA; Jeremy Hobart, PhD, FRCP, Plymouth University Peninsula Schools of Medicine and Dentistry, UK; Stefan Cano, PhD, Plymouth University Peninsula Schools of Medicine and Dentistry, UK; Laurie Burke, RPh, MPH, U.S. Food and Drug Administration, USA Review requirements for establishing the content validity of patientreported, clinician-reported, and care-giver-reported instruments. Learn definitions of evidence requirements and logistical needs for gathering evidence. NETWORK META-ANALYSIS IN RELATIVE EFFECTIVENESS RESEARCH Jeroen P. Jansen, PhD, Mapi, USA; Alexandra Ellis, MSc, Brown University, USA Learn the fundamentals and concepts of network meta-analysis. The material in this course is motivated by instructive and real examples. Case studies are implemented with the WinBUGS package. RISK-SHARING / PERFORMANCE-BASED ARRANGEMENTS FOR DRUGS AND OTHER MEDICAL PRODUCTS Lou Garrison, PhD, University of Washington, USA; Adrian Towse, MA, MPhil, Office of Health Economics, UK; Josh Carlson, PhD, University of Washington, USA Relevant theory and practice of “pay-for-performance” or “risksharing” arrangements are analyzed here, using examples from Europe, the US, and Australia. COST ESTIMATION AND ASSESSING FINANCIAL (BUDGET) IMPACT OF NEW HEALTH CARE TECHNOLOGIES Josephine Mauskopf, PhD, RTI Health Solutions, USA; C. Daniel Mullins, PhD, University of Maryland, USA; Stephanie Earnshaw, PhD, MS, RTI Health Solutions, USA Review methods to determine costs associated with a health condition and the budget impact of new technologies, incidenceand prevalence-based costing strategies, treatment algorithms, event-based approaches, as well as static and dynamic methods for estimating the budget impact of a new drug.

Complete Short Course descriptions available at www.ispor.org

ISPOR 16th Annual European Congress 2-6 November 2013 • The Convention Centre Dublin, Dublin, Ireland

C ONG R E S S P R O G RA M SATURDAY, 2 NOVEMBER 9:00-18:00

IP4: DOES ASSESSING THE VALUE FOR MONEY OF MEDICAL DEVICES REQUIRE A FLEXIBLE APPROACH? Moderator: Cynthia P. Iglesias, PhD, University of York, York, UK Panelists: Mark Campbell, MD, National Institute for Health and Care Excellence (NICE), Manchester, UK; Rosanna Tarricone, PhD, Bocconi University, Milan, Italy; Lou Garrison, PhD, University of Washington School of Pharmacy, Seattle, WA, USA IP5: PARTNERING WITH PATIENTS: DESIGNING, PARTICIPATING IN, AND REPORTING HEALTH OUTCOMES Moderator: Tim Davis, BSc, Exco InTouch, Sawbridgeworth, UK Panelists: Zach Hallinan, BS, CISCRP, Boston, MA, USA; Jim Kremidas, BS, Quintiles, Durham, NC, USA; Jan Geissler, MBA, EUPATI, Riemerling, Germany

PRE-CONGRESS SHORT COURSES

SUNDAY, 3 NOVEMBER 8:00-17:00

PRE-CONGRESS SHORT COURSES

17:30-18:30 EDUCATIONAL SYMPOSIUM THE POLICY–PRACTICE GAP This symposium will focus on how the on-going changes in health care policy in markets across the world are redefining value in the market place and leading both to changes in existing partnerships and the potential of new partnerships in product commercialization. (Sponsored by Double Helix Consulting)

12:00-14:15

18:45-19:45 EDUCATIONAL SYMPOSIUM BRIDGING TO REAL LIFE: HOW PREDICTIVE MODELING CAN SUPPORT THE EVALUATION AND GENERATION OF REAL-WORLD EVIDENCE Bridging studies combine advanced predictive and integrative modeling with the optimal use of all relevant clinical and real-life data available, offering a powerful alternative to inform strategic decisions for drug evaluation and evidence generation. A panel of users and decision makers will introduce key concepts and examples of bridging studies in context, discussing their relevance, strengths, and limitations. (Sponsored by LASER ANALYTICA)

MONDAY, 4 NOVEMBER

13:15-14:15

7:30-8:30 EDUCATIONAL SYMPOSIUM BUILDING, EMBEDDING & OPTIMIZING MARKET ACCESS CAPABILITIES – FROM STRATEGY TO EXECUTION From strategy to execution, this symposium will discuss building, embedding, and optimizing market access capabilities. (Sponsored by GalbraithWight) 8:45-14:15

POSTERS - I

BREAK, EXHIBITS & POSTERS - I

11:00-12:00 ISSUE PANELS - I IP1: GUIDELINES FOR NETWORK META-ANALYSIS – ISPOR/AMCP/NPC VERSUS PRISMA Moderator: Kristian Thorlund, PhD, MStat, Stanford University, Palo Alto, CA, USA Panelists: Edward Mills, PhD, MSc, Stanford University, Palo Alto, CA, USA; Jeroen P. Jansen, PhD, Mapi and Tufts University School of Medicine, Boston, MA, USA; Christopher O’Regan, MSc, MSD Ltd., Hoddesdon, UK IP2: EMPIRICAL ESTIMATION OF COST-EFFECTIVENESS THRESHOLDS – THE CASE OF NICE Moderator: Mark J. Sculpher, MSc, PhD, University of York, York, UK Panelists: Martin Buxton, BA, Brunel University, Uxbridge, UK; Karl Claxton, PhD, University of York, York, UK; Adrian Towse, MA, MPhil, Office of Health Economics, London, UK IP3: MEASURING UTILITY FOR ECONOMIC MODELS WITHIN CLINICAL TRIALS: CAN WE DO BETTER? Moderator: Sorrel Wolowacz, PhD, RTI Health Solutions, Manchester, UK Panelists: Andrew Briggs, DPhil, MSc, University of Glasgow, Glasgow, UK; Jennifer Petrillo, PhD, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; Lynda Doward, MRes, RTI Health Solutions, Manchester, UK

POSTER AUTHOR DISCUSSION HOUR - I

14:15-15:15 RESEARCH PODIUMS - I HEALTH CARE EXPENDITURE OR REIMBURSEMENT STUDIES - BIOLOGICS 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 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 BI3: DIFFERENCES IN APPROACH TO BIOSIMILARS: NICE VERSUS SMC RECOMMENDATIONS Izmirlieva M, Ando G, IHS, London, UK 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 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 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 CA3: EMA APPROVAL OF DRUGS ON THE BASIS OF PIVOTAL NON-COMPARATIVE PHASE II TRIAL DATA Macaulay R, HERON Health, London, UK 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 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, 2 Mario 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 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

8:45-10:45 WELCOME & 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. Moderator/Speaker: Michael Barry, MD, PhD, FRCPI, Clinical Director, National Centre for Pharmacoeconomics, St. James’s Hospital, Dublin, Ireland Speakers: Edward McKone, MSc, MD, FRCPI, MB, MRCPI, Senior Clinical Lecturer, School of Medicine & Medical Science, St. Vincent’s Hospital and Fellow, UCD Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Dublin, Ireland; Orla Tinsley, BA, Campaigner for Cystic Fibrosis, Ambassador, The Women’s Fund, and Freelance Columnist, The Irish Times, Dublin, Ireland; James Reilly, JD, Minister for Health, Department of Health, Government of Ireland, Dublin, Ireland 10:45-11:00

LUNCH, EXHIBITS & POSTERS - I

12:15-13:15 EDUCATIONAL SYMPOSIUM THE INTERSECTION OF HEALTH ECONOMICS AND REAL-WORLD EVIDENCE – VALIDATING HEALTH CARE DECISION MAKING The data revolution in health care, including the availability of real-time, patient-level, integrated information, provides huge opportunities for exponentially faster decision making but also challenges for health economics. Definitions of quality of care and methodological approaches need to be agreed to fully maximize the potential of real-world data use. Practical applications and the pragmatic synergies between the fields of RWE and health economics will be explored. (Sponsored by IMS Health)

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ISPOR 16th Annual European Congress 2-6 November 2013 • The Convention Centre Dublin, Dublin, Ireland

C ONG R ESS P R O G RA M CO N T I N U E D 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 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 MO1: A GUIDE TO ADJUSTING SURVIVAL TIME ESTIMATES TO ACCOUNT FOR TREATMENT SWITCHING IN RANDOMISED CONTROLLED TRIALS Latimer NR1, 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 MO2: USE OF REAL-WORLD EVIDENCE (RWE) TO VALIDATE A TRIAL-BASED HEALTH ECONOMIC MODEL Munakata J1, 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 MO3: MULTI-STATE STATISTICAL MODELLING TO QUANTIFY AN INDIVIDUAL-BASED MICRO SIMULATION MODEL FOR RADIOTHERAPY TREATMENT IN LUNG CANCER PATIENTS Bongers ML1, 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 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 PP1: A METHODOLOGY FOR PREDICTING THE IMPACT OF COPAYMENTS ON THE UTILIZATION OF HEALTH TECHNOLOGIES Sabatelli L, GLOB MOD, Barcelona, Spain 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, 1 University of Groningen, University Medical Center Groningen, Groningen, The Netherlands, 2Office of Health Economics, London, UK, 3Erasmus University Rotterdam, Rotterdam, The Netherlands, 4 University of Sheffield, Sheffield, UK, 5University of Illinois at Chicago, Chicago, IL, USA, 6McMaster University, Hamilton, ON, Canada 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, United BioSource Corporation, London, UK 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

POSTERS - II

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, 6 United BioSource Corporation, 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 CV1: CHALLENGES IN MODELLING THE COST EFFECTIVENESS OF INTERVENTIONS IN CARDIOVASCULAR DISEASE Burgers LT, Redekop WK, Severens JL, Erasmus University Rotterdam, Rotterdam, The Netherlands 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 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 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, 2 Department of Medicine, Kungälv Hospital, Kungälv, Sweden, 3Department of Mathematical Sciences, Chalmers University of Technology, Gothenburg, Sweden MEDICAL DEVICE & DIAGNOSTIC RESEARCH 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 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, 2 Quintiles Global Consulting, Hawthorne, NY, USA 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 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 PR1: PRICE DIFFERENCES TRIGGERED BY THE AVAILABILITY OF BIOSIMILARS IN DEVELOPED COUNTRIES Reinaud F1, Ando G2,1IHS, Paris, France, 2IHS, London, UK 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 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 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 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 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, 2 University Medical Center Hamburg-Eppendorf, Hamburg, Germany 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

15:30-16:30 RESEARCH PODIUMS - II RESEARCH ON METHODS - CLINICAL STUDIES 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 CL2: ADDRESSING HETEROGENEITY IN BASELINE RISK OF COPD EXACERBATIONS USING METAREGRESSION 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 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, 1 University of Exeter, Exeter, UK, 2University of Sheffield, Sheffield, UK, 3University of Exeter, Truro, UK, 4 Dendrix, Sao Paulo, Brazil, 5IDDI, Louvain-la-Neuve, Belgium 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 R6, von Knebel-Doeberitz M7,

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CON GRESS PROG RAM C ONT I NUE D TUESDAY, 5 NOVEMBER

QL4: PSYCHOMETRIC VALIDATION OF PERCEIVED DEFICITS QUESTIONNAIRE – DEPRESSION (PDQ-D) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER (MDD) Lam RW1, Saragoussi D2, Danchenko N2, Rive B2, Lamy FX2, Brevig T4, 1University of British Columbia, Vancouver, BC, Canada, 2Lundbeck SAS, Issy-les-Moulineaux, France, 4H. Lundbeck A/S, Valby, Denmark 16:45-17:45 WORKSHOPS - I 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, United BioSource Corporation, Blue Bell, PA, USA; Janine Collins, MD, United BioSource Corporation, Geneva, PA, USA; Andrew Bottomley, PhD, European Organisation for Research and Treatment of Cancer Head Quarters, Brussels, Belgium; Brian David Edwards, MD, MRCP, NDA Regulatory Science Ltd., Leatherhead, UK W2: USING EARLY ECONOMIC MODELS TO GUIDE CLINICAL AND COMMERCIAL DEVELOPMENT OF NEW THERAPIES Discussion Leaders: Francois Lucas, PhD, Pope Woodhead and Associates, St. Ives, UK; Matthew Taylor, PhD, MSc, York Health Economics Consortium, York, UK; Michael Blankenburg, PhD, MBA, MPH, Bayer HealthCare Pharmaceuticals, Berlin, Germany W3: NAVIGATING THE WATERS OF ECONOMIC EVALUATIONS OF MEDICAL DEVICES Discussion Leaders: Ken Redekop, PhD, Institute for Medical Techonology Assessment (iMTA), Rotterdam, The Netherlands; Maarten Ijzerman, PhD, University of Twente, Enschede, The Netherlands; Praveen Thokala, PhD, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK W4: VALUE IS IN THE EYE OF THE BEHOLDER: COMPELLING INSIGHTS INTO BIOPHARMA, PAYER, AND PROVIDER PERSPECTIVES Discussion Leaders: Louise Parmenter, PhD, Quintiles Outcome, Reading, UK; Simon Holt, Novartis, Basel, UK; Adam Istas, BA, Quintiles, Durham, NC, USA; Sarah Garner, PhD, National Institute for Health and Clinical Excellence (NICE), London, UK W5: QUANTIFYING MEDICATION ADHERENCE: PRACTICAL CHALLENGES AND AN APPROACH TO LINKING ALTERNATIVE MEASURES Discussion Leaders: Christine Poulos, PhD, RTI Health Solutions, Research Triangle Park, NC, USA; Jay Patrick Bae, PhD, Eli Lilly and Company, Indianapolis, IN, USA; Sean D. Candrilli, PhD, RTI Health Solutions, Research Triangle Park, NC, USA; A. Brett Hauber, PhD, RTI Health Solutions, Research Triangle Park, NC, USA W6: DOES IT MAKE SENSE TO EXPAND AN EVIDENCE SYNTHESIS OF RANDOMIZED TRIALS WITH OBSERVATIONAL REAL WORLD DATA? Discussion Leaders: Kristian Thorlund, PhD, MStat, McMaster University, Hamilton, ON, Canada; Jeroen P. Jansen, PhD, Mapi and Tufts University School of Medicine, Boston, MA, USA; Edward Mills, PhD, MSc, Stanford University, Palo Alto, CA, USA 17:45-19:30

EXHIBITORS’ RECEPTION & POSTERS - II

18:00-19:00 ISPOR FORUMS - I CLINICIAN REPORTED OUTCOMES (ClinROs): GOOD MEASUREMENT PRACTICES Task Force members representing the European Medicines Agency, the US Food & Drug Administration, industry, and research will define which outcome assessments should be considered ClinROs and make recommendations on the evaluation of ClinRO instruments to document treatment benefit in clinical trials. Presented by the ISPOR ClinRO Good Measurement Practices Task Force MEET THE EDITORS OF VALUE IN HEALTH The editors of Value in Health will provide insights into the manuscript review process and give advice on what makes a successful paper. Presented by the Co-Editors-in-Chief of Value in Health PRICING AND REIMBURSEMENT PROCESS FOR MEDICAL DEVICES IN CENTRAL & EASTERN EUROPE This forum will explore options for improving evidence-based pricing and reimbursement for medical devices in the CEE countries with economic constraints. Presented by the ISPOR CEE Network: ISPOR Greece, Hungary, Republic of Macedonia, Russia, and Serbia Regional Chapters PATIENT DATA AND PATIENT REGISTRIES IN CENTRAL & EASTERN EUROPE This forum will discuss the importance of patient data and patient registries and their impact on reimbursement process, including HTA. Examples from Hungary, Serbia, and Slovakia will be provided. Presented by the ISPOR CEE Network: ISPOR Bosnia and Herzegovina, Hungary, Serbia, and Slovakia Regional Chapters NEW HEALTH CARE REFORMS AND HTA STATUS IN RUSSIA, UKRAINE, BELARUS, KAZAKHSTAN, AND ARMENIA This forum will discuss main directions of the health care reforms in the CIS countries and the ways to make them efficient through implementing HTA, clinical, and economic assessment approaches, as well as encouraging 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 ECONOMIC EVALUATION OF PHARMACEUTICALS IN PORTUGAL: FROM methodological PIONEERS in europe TO THE LIMITATIONS IMPOSED BY THE ECONOMIC CRISIS This forum will provide an overview of evolution of economic evaluation of pharmaceuticals in Portugal. Health economic guidelines, the need for reform, and the impact posed by the economic crisis will be described. Presented by the ISPOR Portugal Chapter 18:30-19:30

POSTER AUTHOR DISCUSSION HOUR - II

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7:30-8:30 EDUCATIONAL SYMPOSIUM PERSONALIZED MEDICINE AND HTA – BRIDGING THE SCIENCE OF PERSONALIZED MEDICINE WITH THE POLICY OF POPULATION DECISION MAKING Despite the allure and potential of personalized medicine, the individualization of therapy presents unique challenges for HTA bodies who have traditionally made population-based decisions. Recent HTA decisions, evolving evidence requirements, and approaches to reimbursement/pricing for personalized medicine modalities will be reviewed. In addition, insights will be shared on the future application of HTA principles and reimbursement and pricing practices as they apply to personalized therapies. (Sponsored by Xcenda) 8:45-9:45 WORKSHOPS - II W7: STATISTICAL CHALLENGES IN HTA Discussion Leaders: Marie-Ange Paget, MSc, Lilly, France, Neuilly-sur-Seine, France; Keith R. Abrams, PhD, The Institute of Cancer Research, Sutton, UK; Nicholas Latimer, MSc, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Claire Watkins, MA, MSc, AstraZeneca, Macclesfield, UK W8: THE ECONOMIC EVALUTION OF DIAGNOSTICS: CHALLENGES AND METHODS FOR ASSESSING VALUE Discussion Leaders: Eldon Spackman, MA, PhD, University of York, York, UK; Simon Walker, MSc, University of York, York, UK; Josh J. Carlson, MPH, PhD, University of Washington, Seattle, WA, USA; Ron L. Akehurst, BSc (Econ), School of Health and Related Research (ScHARR), University of Sheffield and National Institute for Health and Clinical Excellence (NICE) Diagnostics Committee, Sheffield, UK W9: TRANSPARENCY IN SUBMISSION OF DISCRETE EVENT SIMULATION (DES) AND HYBRID DESMARKOV MODELS Discussion Leaders: Anuraag R Kansal, PhD, United BioSource Corporation, Bethesda, MD, USA; Roberto Palencia, MA, Boehringer Ingelheim GmbH, Ingelheim, Germany; Sylwia Bujkiewicz, PhD, University of Leicester, Leicester, UK; Sonja Sorensen, MPH, United BioSource Corporation, Bethesda, MD, USA W10: OVERCOMING INCOMPLETE EVIDENCE NETWORK AND HETEROGENEITY ISSUES WITH SIMULATED TREATMENT COMPARISONS Discussion Leaders: K. Jack Ishak, PhD, MSc, United BioSource Corporation, Dorval, QC, Canada; Irina Proskorovsky, MSc, United BioSource Corporation, Dorval, QC, Canada; Agnes Benedict, MSc, United BioSource Corporation, Budapest, Hungary; Connie Chen, PharmD, Pfizer Global Pharmaceuticals, New York, NY, USA W11: MULTIPLE CHALLENGES IN CAPTURING UTILITIES FOR PAEDIATRIC CONDITIONS Discussion Leaders: Cicely Kerr, PhD, Oxford Outcomes, an ICON plc Company, Oxford, UK; Andrew J Lloyd, DPhil, Oxford Outcomes, an ICON plc Company, Oxford, UK; John Brazier, PhD, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, South Yorkshire, UK; Andrew Walker, PhD, 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 Discussion Leaders: Laure Delbecque, PhD, Business & Decision Life Sciences, Brussels, Belgium; Maxime Taquet, MSc, Harvard Medical School, Boston, MA, USA; Olivier Ethgen, PhD, MSc, University of Liege, Liege, Belgium; Olivier Chassany, MD, PhD, University Paris 7, Paris, France 8:45-13:45

POSTERS - III

9:45-10:15

BREAK, EXHIBITS & POSTERS - III

10:15-11:30 WELCOME & 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? Moderator: John Hutton, BPhil, Professor of Health Economics, Department of Health Sciences, University of York, Heslington, York, UK Speakers: Leeza Osipenko, PhD, Senior Scientific Adviser, Scientific Advice Programme, National Institute for Health and Care Excellence (NICE), London, UK; Jens Grueger, PhD, Vice President, Global Pricing & Market Access, F. Hoffmann - La Roche AG, Basel, Switzerland; Spiros Vamvakas, MD, PhD, Head of Scientific Advice & Professor for Pharmacology, European Medicines Agency, London, UK (invited); Mira Pavlovic, MD, Deputy Director for Health Technology Assessment, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France 11:30-13:45

LUNCH, EXHIBITS & POSTERS - III

11:45-12:45 EDUCATIONAL SYMPOSIUM MEDICINES’ ADAPTIVE PATHWAYS TO PATIENTS: THE ROLE OF REAL-WORLD DATA The pharmaceutical industry’s business model is changing from a dichotomous model of one-off licensing with subsequent market entry, to a progressive and flexible model of adaptive pathways to patients, with adaptive licensing and adaptive market entry. This session will explore how real-world data

CON GRESS PROGRAM C ONT I NUE D IP15: ALIGNING PAYER AND INDUSTRY PERSPECTIVES ON MEASURING VALUE IN HEALTH TECHNOLOGY ASSESSMENT Moderator: Lou Garrison, PhD, University of Washington School of Pharmacy, Seattle, WA, USA Panelists: James F. Murray, PhD, Eli Lilly and Company, Indianapolis, IN, USA; Helen Knight, PhD, National Institute for Health and Care Excellence (NICE), London, UK; Ulf Persson, PhD, The Swedish Institute for Health Economics, Lund, Sweden

can support the new paradigm which will enable product launches, starting with a limited indication in a limited patient population on the basis of limited clinical trial data and expanding as more clinical results become available from actual clinical practice. (Sponsored by EFPIA) 12:45-13:45

POSTER AUTHOR DISCUSSION HOUR - III

13:45-14:45 ISSUE PANELS - II IP6: INTEGRATING REIMBURSEMENT NEEDS INTO THE DESIGN OF DRUG DEVELOPMENT PROGRAMS Moderator: Christine A. Fletcher, MSc, Amgen Ltd, Cambridge, England Panelists: Andrea Manca, PhD, University of York, Heslington, York, UK; Andrew Walker, PhD, Scottish Medicines Consortium (SMC), University of Glasgow, Glasgow, UK; Timothy R. Auton, MSc, PhD, Astellas, Leiden, The Netherlands IP7: MAKING VALUE-BASED PRICING A REALITY Moderator: Meindert Boysen, MSc, HPPF, National Institute for Health and Clinical Excellence (NICE), Manchester, UK Panelists: John Brazier, PhD, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, South Yorkshire, UK; Werner Brouwer, PhD, Institute for Health Policy & Law, Rotterdam, The Netherlands; Roberta Ara, MSc, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK IP8: HOW ARE THE RESULTS FROM HTA METHODOLOGY RESEARCH IMPLEMENTED IN THE UPDATES OF HTA GUIDELINES? Moderator: Wim Goettsch, PhD, EUnetHTA and Health Care Insurance Board (CVZ), Diemen, The Netherlands Panelists: Manuela A. Joore, PhD, Maastricht University, Maastricht, The Netherlands; Saskia Knies, PhD, Health Care Insurance Board (CVZ), Diemen, The Netherlands; Allan J Wailoo, PhD, University of Sheffield, Sheffield, UK 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, Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA Panelists: Michael Drummond, PhD, OptumInsight and University of York, Heslington, UK; Gerard de Pouvourville, PhD, ESSEC Business School, Cergy Pontoise, France; Brian Solow, MD, 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? Moderator: Eric C. Faulkner, MPH, Quintiles, National Association of Managed Care Physicians & University of North Carolina, Chapel Hill, NC, USA Panelists: Wills Hughes-Wilson, LLB, European Union Committee of Experts on Rare Diseases (EUCERD) and Sobi Pharmaceuticals, Brussels, Belgium; Andras Fehervary, MBA, DES, MALD, Novartis and European Union Committee of Experts on Rare Diseases (EUCERD), Basel, Switzerland; Steven Simoens, PhD, MSc, MA, KU Leuven, Leuven, Belgium 14:45-15:00

BREAK & EXHIBITS VIEWING

15:00-19:00

POSTERS - IV

16:15-17:15 WORKSHOPS - III W13: METHODOLOGY TO VALIDATE SURROGATE ENDPOINTS IN CLINICAL TRIALS: WHICH LEVEL OF EVIDENCE IS FIT FOR PURPOSE? Discussion Leaders: Helene Karcher, PhD, LASER Analytica, London, UK; Wilma Erhardt, MSc, Janssen-Cilag GmbH, Neuss, Germany; Carsten Schwenke, PhD, SCO:SSiS, Berlin, Germany; Theophile Bigirumurame, MSc, Hasselt University, Diepenbeek, Belgium W14: MODELLING APPROACHES WHEN LIMITED BY SINGLE-ARM STUDIES: AN ANALYSIS OF RECENT ONCOLOGY EXAMPLES Discussion Leaders: Cyrus A. Chowdhury, MS, CBPartners, New York, NY, USA; Rachel Beckerman, PhD, CBPartners, New York, NY, USA; Meghan Gallagher, MSc, Sanofi, Cambridge, MA, USA; Mónica Martín de Bustamante, AB, BE, CBPartners, Basel, Switzerland W15: EVIDENCE-BASED DETERMINISTIC SENSITIVITY ANALYSES: CASE STUDIES USING ISPORSMDM GUIDELINES FOR UNCERTAINTY ANALYSES Discussion Leaders: Anju Parthan, PhD, OptumInsight, Cambridge, MA, USA; Milton C. Weinstein, PhD, Harvard School of Public Health, Boston, MA, USA; Kelly Fust, MS, OptumInsight, Cambridge, MA, USA W16: THE ROLE OF EVIDENCE SYNTHESIS AND VALUE OF INFORMATION ANALYSIS FOR RESEARCH PRIORITISATION, COMMISSIONING, AND CLINICAL TRIAL DESIGN Discussion Leaders: Karl Claxton, PhD, University of York, York, UK; Nicky Welton, PhD, University of Bristol, Bristol, UK; Claire McKenna, PhD, University of York, York, UK; Hendrik Koffijberg, PhD, University Medical Center Utrecht, Utrecht, The Netherlands 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, RTI Health Solutions, Research Triangle Park, NC, USA; Deborah Marshall, PhD, MHSA, University of Calgary, Calgary, AB, Canada; Axel C. Mühlbacher, PhD, IGM Institute, Neubrandenburg, Germany W18: APPLICATION OF OBSERVATIONAL METHODS TO VACCINE UTILIZATION STUDIES Discussion Leaders: H. Keri Yang, PhD, MPH, MS, Merck & Co, Inc., West Point, PA, USA; Josephine A. Mauskopf, PhD, RTI Health Solutions, Research Triangle Park, NC, USA; Shuvayu Sen, PhD, Merck & Co., Inc., Whitehouse Station, NJ, USA 17:15-19:00

EXHIBITORS’ RECEPTION & POSTERS - IV

17:30-18:30 ISPOR FORUMS - II RARE DISEASE TERMS AND DEFINITIONS USED IN OUTCOMES RESEARCH, AND CHALLENGES IN ASSESSING AND APPRAISING DIAGNOSTICS AND TREATMENTS FOR RARE DISEASES Assessments of relevant terminology and definitions, as well as challenges to the evaluation of diagnostics and treatments for rare diseases, will be discussed. Presented by the ISPOR Rare Disease Special Interest Group VIHRI: RESOURCES AND TIPS FOR WRITING QUALITY AND WELL-SUPPORTED PAPERS The Value in Health Regional Issues (VIHRI) Editorial Board will provide guidance to equip prospective VIHRI submitters with strong writing skills and resources to improve the quality of manuscripts. Presented by the VIHRI Editorial Board

15:00-16:00 ISSUE PANELS - III IP11: DEMONSTRATING TREATMENT BENEFIT USING CLINICAL OUTCOME ASSESSMENTS IN GLOBAL CLINICAL TRIALS: HOW RELIABLE ARE THE ASSESSMENTS FROM CROSS-CULTURAL SETTINGS? Moderator: Antoine Regnault, PhD, Mapi, Lyon, France Panelists: Donald L. Patrick, PhD, MSPH, Seattle Quality of Life Group, University of Washington, Seattle, WA, USA; Paulo Carita, MD, Sanofi-Aventis R&D, Chilly-Mazarin, France; Mira Pavlovic, DrPH, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France IP12: HEALTH ECONOMICS OF PERSONALIZED MEDICINE – DO WE NEED A COMPREHENSIVE RESEARCH PROGRAM? Moderator: Scott Ramsey, PhD, MD, Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA Panelists: Maarten J. IJzerman, PhD, University of Twente, Enschede, The Netherlands; Uwe Siebert, MD, MPH, MSc, ScD, University for Health Sciences, Medical Informatics and Technology (UMIT), ONCOTYROL, and Harvard University, Hall i. T., Austria; Mark J. Sculpher, MSc, PhD, University of York, York, UK IP13: SHOULD OFF-LABEL AGENTS BE USED AS COMPARATORS IN HEALTH TECHNOLOGY ASSESSMENTS? Moderator: Jeanette Kusel, MSci, Costello Medical Consulting Ltd., Cambridge, UK Panelists: Eldon Spackman, PhD, University of York, York, UK; Andrew Walker, PhD, Scottish Medicines Consortium (SMC), University of Glasgow, Glasgow, UK; Christin Andersson, PhD, Dental and Pharmaceutical Benefits Agency, 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? Moderator: Lisbet Coulton, BA, Tanwood Consulting Ltd., Leatherhead, Surrey, UK Panelists: Shelley Gandhi, MSc, NDA Regulatory Science Ltd., Leatherhead, UK; Thomas Lonngren, PhD, MRPharmS, FRCP, Pharm Executive Consulting, Uppsala, Sweden; Gérard de Pouvourville, PhD, ESSEC Business School, Cergy-Pontoise, France

USE OF RISK-SHARING IN PHARMACEUTICAL PRICING AND REIMBURSEMENT DECISIONS IN CENTRAL & EASTERN EUROPE The advantages and disadvantages of risk-sharing arrangements amongst the key stakeholders in CEE will be discussed as an approach to address the financing of high-cost medicines. Presented by the ISPOR CEE Network: ISPOR Bulgaria, Croatia, Greece, Poland, and Romania Regional Chapters THE USE OF PHARMACOECONOMIC PRINCIPLES IN LOCAL DRUG POLICY DECISIONS IN RUSSIA, POLAND, AND UKRAINE Presented in Russian and English This forum will focus on the use of pharmacoeconomic principles in local drug policy decisions in Russia, Poland, and Ukraine. Presented by the ISPOR CEE Network: ISPOR Poland, Russia, and Ukraine Regional Chapters PHARMACOECONOMICS AND OUTCOMES RESEARCH IN ASIA: WHAT IS NEXT? This forum will describe the current status of pharmacoeconomics and outcomes research in countries in Asia and explore future developments. Presented by the ISPOR Asia Consortium HEALTH CARE AND HTA CONCERNS IN SPAIN A recent change to the health care status in Spain implementing a series of new measures to restrict demand and supply of health care services and products has affected hundreds of thousands of people within the country. Can decision makers provide more acceptable solutions? This forum will explore the possibilities. Presented by the ISPOR Spain Regional Chapter 18:00-19:00

POSTER AUTHOR DISCUSSION HOUR - IV

19:30-23:30 ISPOR SOCIAL EVENT (Separate registration required) Enjoy buffet dinner, self-guided tours, and panoramic views at the Guinness Storehouse! (See www.ispor.org for details)

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CON GRESS PROGRAM C ONT I NUE D WEDNESDAY, 6 NOVEMBER

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 his 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. Moderator: J. Jaime Caro, MDCM, FRCPC, FACP, Adjunct Professor of Medicine & Adjunct Professor of Epidemiology and Biostatistics, McGill University, Montreal, QC, Canada Speakers: Karl Claxton, PhD, Professor of Economics, Centre for Health Economics, University of York, Heslington, York, UK; Rob Baltussen, PhD, Associate Professor, Health Economics, Department of Primary and Community Care & Head of Research, Nijmegen International Center for Health Systems Research and Education (NICHE) Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands; Andrew Thomson, PhD, MSc, Head of Epidemiology, VRMM, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK (invited)

7:30-8:30 EDUCATIONAL SYMPOSIUM COMPLETING THE PUZZLE TO DELIVER THE BENEFITS OF REAL WORLD DATA IN HEALTH OUTCOMES RESEARCH How large volumes of individually linked patient level data have been federated from within the English National Health Service (NHS) to complete the puzzle and deliver real benefits to researchers will be presented. The use of data in services associated with clinical trials and interventional studies will also be discussed, and an update on work focusing on health economics and the development of applications for near real time feasibility and patient recruitment within the realms of health outcomes research will be provided. (Sponsored by CPRD) 8:45-14:45

POSTERS - V

8:45-9:45 WORKSHOPS - IV W19: CAN WE USE COMPARATIVE EFFECTIVENESS APPROACHES TO ASSESS HARMS ACROSS TREATMENTS? Discussion Leaders: Edward J. Mills, PhD, Stanford University, Stanford, CA, USA; Kristian Thorlund, PhD, MStat, McMaster University, Hamilton, ON, Canada; Christopher O’Regan, MSc, Merck Sharp and Dohme Ltd, Enfield, UK W20: MCDA IN HTA: TRANSLATING THEORY TO PRACTICE THROUGH AN INTERACTIVE WORKSHOP Discussion Leaders: Jerome Cheynel, MSc, Medaxial Group, London, UK; Ruth Zeidman, PhD, Medaxial Group, London, UK; Shahrul Mt-Isa, PhD, Imperial College London, London, UK; Kevin Bowrin, Msc, Pfizer Ltd., Tadworth, Surrey, UK W21: CHOOSING THE FIRST TIER CONTINENT FOR MEDICAL DEVICES – 510(K)/PMA VERSUS CE-MARK Discussion Leaders: Manfred Scheppach, MSc, AiM GmbH, Lörrach, Germany; Michael Weißer, MSc, AiM GmbH, Lörrach, Germany; Judy Rosenbloom, FASE, JR Associates, Reseda, CA, USA; Jo Ellen Slurzberg, BA, JR Associates, Reseda, CA, USA W22: TESTING THE MEASUREMENT EQUIVALENCE OF ELECTRONICALLY MIGRATED PATIENTREPORTED OUTCOME (PRO) INSTRUMENTS: CHALLENGES AND SOLUTIONS Discussion Leaders: Sonya Eremenco, MA, United BioSource Corporation, Bethesda, MD, USA; Paul O’Donohoe, BSc, CRF Health, London, UK; Diane Wild, MSc, Oxford Outcomes, an ICON plc Company, Oxford, UK; J. Jason Lundy, PhD, Critical Path Institute, Tucson, AZ, USA W23: GARBAGE IN – GARBAGE OUT: DETECTING DATA ERRORS AND MANAGING SUCH ERRORS IN RETROSPECTIVE RESEARCH Discussion Leaders: Rolin L. Wade, RPh, MS, IMS Health, Parsippany, NJ, USA; Richard Chapman, MS, PhD, Avalere Health, Washington, DC, USA 9:45-10:00

12:30-12:45 ISPOR 16th ANNUAL EUROPEAN CONGRESS RESEARCH PRESENTATION AWARDS 12:45-13:45

LUNCH, EXHIBITS & POSTERS - V

12:45-13:45

POSTER AUTHOR DISCUSSION HOUR - V

13:45-14:45 WORKSHOPS - V W24: METHODS FOR DEALING WITH TREATMENT SWITCHING IN CLINICAL TRIALS Discussion Leaders: Keith R. Abrams, PhD, University of Leicester, Leicester, UK; Michael J. Crowther, MSc, University of Leicester, Leicester, UK; Nicholas R. Latimer, PhD, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Joshua Ray, MSc, F. Hoffmann-La Roche Ltd., Basel, Switzerland W25: NAVIGATING THE PITFALLS AROUND PROGRESSION-FREE SURVIVAL ESTIMATION Discussion Leaders: Edit Remak, MSc, United BioSource Corporation, Budapest, Hungary; John William Stevens, PhD, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Martin Hoyle, MA, MSc, PhD, University of Exeter Medical School, Exeter, UK; Noemi Muszbek, MSc, United BioSource Corporation, London, UK W26: INCLUSION OF CLINICAL TRIAL DATA AND OTHER EVIDENCE IN CLINICAL PRACTICE GUIDELINES: AN IMPORTANT OPPORTUNITY FOR INDUSTRY Discussion Leaders: Adele R. Weston, PhD, Optum, Sydney, Australia; Deborah Marshall, PhD, MHSA, University of Calgary, Calgary, AB, Canada W27: MANAGING UNCERTAINTY: THE NEW WAY FORWARD FOR MARKET ACCESS Discussion Leaders: Antoni Gilabert, PhD, Catalan Autonomous Region Health Service, Barcelona, Spain; Thomas Mueller, MD, Federal Joint Committee (G-BA), Berlin, Germany; Meriem Bouslouk, DMD, MSc, Federal Joint Committee (G-BA), Berlin, Germany; Mondher Toumi, MD, PhD, University Claude Bernard Lyon 1, Lyon, France W28: ELICITING FORMAL PATIENT PREFERENCES FOR ASSESSING BENEFITS AND RISKS OF MEDICINES Discussion Leaders: Shahrul Mt-Isa, PhD, Imperial College London, London, UK; Kimberley Hockley, MPH, Imperial College London, London, UK; Susan Shepherd, MSc, Amgen (UK) Limited, Uxbridge, UK

BREAK, EXHIBITS & POSTERS - V

10:00-11:00 ISSUE PANELS - IV IP16: IS OPEN ACCESS TO CLINICAL TRIAL DATA GOOD FROM THE MARKET ACCESS PERSPECTIVE? Moderator: Radek Wasiak, PhD, United BioSource Corporation, London, UK Panelists: Sylvie Gabriel, MD, IPSEN Pharma, Boulogne Billancourt, France; Jerome Dinet, PharmD, IPSEN Pharma, Boulogne Billancourt, France; Rebecca Lumsden, PhD, Association of the British Pharmaceutical Industry, London, UK IP17: HOW CAN HEALTH ECONOMIC MODELLERS WIN THE TRUST OF DECISION MAKERS? Moderator: Samuel Aballea, MSc, Creativ-Ceutical, Paris, France Panelists: Stefano Capri, PhD, Institute of Economics, Castellanza, Italy; Genevieve Meier, MSc, GlaxoSmithKline Vaccines, Wavre, Belgium; Paul Tappenden, MSc, PhD, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK IP18: HOW MULTIDISCIPLINARY DOES EDUCATION FOR FUTURE HEALTH CARE DECISION MAKERS NEED TO BE? Moderator: Siegfried Walch, PhD, Management Center Innsbruck (MCI), Innsbruck, Austria Panelists: Francesca Scandurra, PhD, VIBRANT MED-EL, Innsbruck, Austria; JL (Hans) Severens, PhD, Erasmus University Rotterdam, Rotterdam, The Netherlands; Terje Hagen, PhD, University of Oslo, Oslo, Norway IP19: COMPARING THE CHALLENGES OF COMPARATIVE EFFECTIVENESS RESEARCH IN FRANCE, ITALY, AND THE NETHERLANDS: CURRENT SITUATION AND PERSPECTIVES Moderator: Jeanni van Loon, MSc, Mapi, Houten, The Netherlands Panelists: Francois Meyer, MD, Haute Autorite de Sante (HAS), Paris, France; Entela Xoxi, PharmD, Italian Medicines Agency (AIFA), Rome, Italy; Caroline van der Meijden, PhD, Health Care Insurance Board (CVZ), Diemen, The Netherlands IP20: 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, TwoLegs Consulting LLC, Newton, MA, USA Panelists: Laurie B. Burke, RPh, MPH, U.S. Food and Drug Administration, Silver Spring, MD, USA; Mira Pavlovic, DrPH, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France; Julia A. Gaebler, PhD, Biogen Idec, Weston, MA, USA

14:45-15:00

11:15-12:30 WELCOME & 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

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BREAK & EXHIBITS VIEWING

15:00-16:00 WORKSHOPS - VI W29: ENHANCING THE VALUE OF HEALTH ECONOMIC MODELING THROUGH NOVEL APPLICATION OF REAL WORLD EVIDENCE (RWE) Discussion Leaders: Amy O’Sullivan, PhD, IMS Health, Waltham, MA, USA; Christopher M. Blanchette, PhD, MBA, University of North Carolina, Charlotte, NC, USA; Julie Munakata, MS, IMS Health, San Francisco, CA, USA W30: SUSTAINABILITY OF OFF-PATENT DRUG POLICIES IN THE QUEST FOR VALUE Discussion Leaders: Diana Brixner, PhD, RPh, University of Utah, Salt Lake City, UT, USA; Nikolaos Maniadakis, MSc, PhD, National School of Public Health, Athens, Greece; Jie Shen, PhD, Abbott, Basel, Switzerland; Zoltan Kalo, MD, MSc, PhD, Syreon Research Institute, Budapest, Hungary 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, European Medicines Agency, London, UK; Francois Meyer, MD, Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France; Nicholas Moore, University of Bordeaux, Bordeaux, France; Massoud Toussi, MD, PhD, MBA, IMS Health, Paris, France W32: COMBINATION PRODUCTS – NEW CHALLENGES FROM BOTH A REGULATORY AS WELL AS A REIMBURSEMENT STANDPOINT Discussion Leaders: Manfred Scheppach, MSc, AiM GmbH, Lörrach, Germany; Michael Weißer, MSc, AiM GmbH, Lörrach, Germany; Judy Rosenbloom, FASE, JR Associates, Reseda, CA, USA; Jo Ellen Slurzberg, BA, JR Associates, Reseda, CA, USA W33: THE CORRELATION BETWEEN PATIENT-REPORTED OUTCOMES AND CLINICIAN-REPORTED OUTCOMES Discussion Leaders: Eric Gemmen, MA, Quintiles Outcome, Rockville, MD, USA; Shital Kamble, PhD, Quintiles Outcome, Rockville, MD, USA; Rebecca Dawsey, BA, TransPerfect, Atlanta, GA, USA

For more information: www.ispor.org

ISPOR 16th Annual European Congress 2-6 November 2013 • The Convention Centre Dublin, Dublin, Ireland FIRST Name

LAST NAME

registration form

Degrees

Member ID#

position organization mailing Address City

State

Telephone

Fax

Pre-CONGRESS Short Courses SATURDAY, 2 NOVEMBER

Zip

Country EMAIL

THROUGH 17 september 2013

AFTER 17 september 2013

fee

All Day Course 9:00-18:00 Regular: f300 (US$401) Student: f150 (US$200) Regular: f400 (US$535) Student: f200 (US$268) q INTRODUCTION TO HEALTH ECONOMIC / PHARMACOECONOMIC EVALUATIONS $ ________________ Morning Courses 9:00-13:00 Regular: f150 (US$200) Student: f75 (US$100) Regular: f200 (US$268) Student: f100 (US$134) q INTRODUCTION TO DATABASE ANALYSIS OF OBSERVATIONAL STUDIES OF TREATMENT EFFECTS $ ________________ q INTRODUCTION TO PATIENT-REPORTED OUTCOMES ASSESSMENT: INSTRUMENT DEVELOPMENT & EVALUATION $ ________________ q INTRODUCTION TO MODELING $ ________________ q STATISTICAL METHODS FOR PHARMACOECONOMICS & OUTCOMES RESEARCH $ ________________ q COST-EFFECTIVENESS ANALYSIS ALONGSIDE CLINICAL TRIALS $ ________________ q ELEMENTS OF PHARMACEUTICAL / BIOTECH PRICING $ ________________ Afternoon Courses 14:00-18:00 Regular: f150 (US$200) Student: f75 (US$100) Regular: f200 (US$268) Student: f100 (US$134) q INTRODUCTION TO HEALTH TECHNOLOGY ASSESSMENT (HTA) $ ________________ q META-ANALYSIS & SYSTEMATIC LITERATURE REVIEW $ ________________ q USE OF PROPENSITY SCORES IN OBSERVATIONAL STUDIES OF TREATMENT EFFECTS $ ________________ q INTRODUCTION TO PATIENT PREFERENCE METHODS USED FOR QALYS $ ________________ q PHARMACOECONOMIC MODELING – APPLICATIONS $ ________________

SUNDAY, 3 NOVEMBER Morning Courses 8:00-12:00 Regular: f150 (US$200) Student: f75 (US$100) Regular: f200 (US$268) Student: f100 (US$134) q BAYESIAN METHODS IN ECONOMIC EVALUATIONS – INTRODUCTION $ ________________ q DISCRETE EVENT SIMULATION FOR ECONOMIC ANALYSES – CONCEPTS $ ________________ q PATIENT REGISTRIES $ ________________ q USE OF INSTRUMENTAL VARIABLES IN OBSERVATIONAL STUDIES OF TREATMENT EFFECTS $ ________________ q REIMBURSEMENT SYSTEMS IN EUROPE $ ________________ q TRANSFERABILITY OF COST-EFFECTIVENESS DATA BETWEEN COUNTRIES $ ________________ q CONJOINT ANALYSIS – THEORY & METHODS $ ________________ Afternoon Courses 13:00-17:00 Regular: f150 (US$200) Student: f75 (US$100) Regular: f200 (US$268) Student: f100 (US$134) q BAYESIAN METHODS IN ECONOMIC EVALUATIONS – APPLICATIONS $ ________________ q DISCRETE EVENT SIMULATION FOR ECONOMIC ANALYSES – APPLICATIONS $ ________________ q Advanced Econometric Methods for Estimating Treatment Effects in Observational Studies $ ________________ q Applying Mixed Methods to Establish Content Validity of PRO, CLINRO, and OBSRO Assessment Instruments $ ________________ q NETWORK META-ANALYSIS IN RELATIVE EFFECTIVENESS RESEARCH $ ________________ q RISK-SHARING / PERFORMANCE-BASED ARRANGEMENTS FOR DRUGS AND OTHER MEDICAL PRODUCTS $ ________________ q COST ESTIMATION AND ASSESSING FINANCIAL (BUDGET) IMPACT OF NEW HEALTH CARE TECHNOLOGIES $ ________________

CONGRESS REGISTRATION (4-6 NOvember) THROUGH 17 september 2013 after 17 september 2013 Standard Clinical Practitioners (Clinical Practice, Hospital) Full-Time Government and Academia Full-Time Students (must provide current enrollment docs) One Day Registration (per day)**

CONGRESS enhancements

Mem: f500 (US$669) Non-Mem: f605 (US$809) Mem: f350 (US$468) Non-Mem: f454 (US$608) Mem: f250 (US$334) Non-Mem: f354 (US$474) Mem: f100 (US$134) Non-Mem: f126 (US$169) Mem: f300 (US$401) Non-Mem: f404 (US$541)

Mem: f600 (US$803) Non-Mem: f705 (US$943) Mem: f450 (US$602) Non-Mem: f555 (US$742) Mem: f350 (US$468) Non-Mem: f454 (US$608) Mem: f125 (US$167) Non-Mem: f151 (US$202) DAY: __ 4 Nov __ 5 Nov __ 6 Nov



SHORT COURSE PROGRAM: Continuing Education Accreditation (CPE & CME) ISPOR Social Event Tuesday, 5 November. Buffet dinner at the Guinness Storehouse! (Fee subject to change)

Mem/Non-Mem: f75 (US$100) Mem/Non-Mem: f90 (US$121)

fee

$ ________________ $ ________________ $ ________________ $ ________________ $ ________________ fee

$ ________________ $ ________________

PAYMENT INFORMATION TOTAL FEE $ __________________ Please enclose a check payable in US dollars to: International Society for Pharmacoeconomics and Outcomes Research or ISPOR and send to the ISPOR address below. Charge to: m VISA m MasterCard m American Express

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Name: _______________________________________________________________ Authorized Signature: ________________________________________________ Mail Details: If not paying by credit card online, send registration form and payment to: International Society for Pharmacoeconomics and Outcomes Research, 505 Lawrence Square Blvd South, Lawrenceville, NJ 08648 USA • Tel: 609-586-4981 • Fax: 609-586-4982 • E-Mail: [email protected] • Internet: www.ispor.org Payment Details: Payment can be made by check, bank transfer ($40USD additional charge) or credit card (Visa, MasterCard, American Express). All credit card payments will be charged in USD. Phone charges will NOT be accepted. If payment is being made by your company, please make sure your name is indicated on the check stub or correspondence for bank transfer. Exchange rate as of January 2013 (1.34). The US$ prices should be used as a reference only. All credit card payments to ISPOR are charged in US $ at the exchange rate prevailing at the time of the transaction. Due to this exchange, credit card statements may vary. * Membership Details: If ISPOR cannot verify your current membership, you will be charged the non-member registration rate. When you register as a non-member, you receive an ISPOR membership which includes a one year online subscription to Value in Health - the journal of the International Society for Pharmacoeconomics and Outcomes Research. ** One Day Registration Details: One day registration cannot be combined. More Information & Cancellation Details: Cancellation fee before 17 September 2013 is US $100. No refunds given after 17 September 2013.

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