Program

  Monday 10 November, 2003
7:00-9:00 ISPOR Central and Eastern European Discussion Group Breakfast (by invitation only)

EUROPEAN UNION ACCESSION IMPACT FOR REGULATORY FRAMEWORK AND FINANCIAL CONSEQUENCES IN CENTRAL AND EASTERN EUROPEAN COUNTRIES: HEALTH CARE AND THE PHARMACEUTICAL SECTOR

Moderator: Pawel Sztwiertnia MD, ISPOR CEE Discussion Group Leader and Deputy Director, Public Sector Financing Department, Ministry of Finance, Poland

Social security protection schemes in the EU, changes in the procedure for health care intervention marketing authorization, data exclusivity, guidelines for pharmacoeconomic analysis as part of a legal framework, and drug reimbursement and cost containment topics will be discussed.
 
8:00-9:00 Contributed Poster Presentations – Session I Viewing Alemania Room (Mezzanine Level)

See poster presentations Session I
9:00-9:15 ISPOR Distinguished Service Awards & ISPOR Research Excellence Awards Presentation Catalunya Room (-2 Level)

Presented by: Sean Sullivan PhD, 2003-2004 ISPOR President and Professor, University of Washington, Seattle, WA, USA
9.00-10.30 Second Plenary Session  Catalunya Room (-2 Level)
 
OPPORTUNITIES AND THREATS OF DIRECT-TO-CONSUMER ADVERTISING
A health care system focussing on patients and a more symmetric relationship between physicians are some of the trends of change that is taking place in Europe. The European Parliament has acknowledged that patients have a legitimate need and right of access to information on health and drugs. Pharmaceutical companies may want to provide direct information to patients on drug treatments and a controversy has been generated on the benefits and harms of these practices for the health care systems, patients and health outcomes and the industry itself.

Moderator: Xavier Badia Llach PhD, Managing Director, Health Outcomes Research Group, Barcelona, Spain

The Industry Perspective

Speaker: Jeffrey L. Sturchio PhD, MSD, External Human Health Affairs, Whitehouse Station, NJ, USA

Major diffusion of information on health and treatments may be of benefit to society at large. The experience of the American pharmaceutical companies will be presented.

The Patient Perspective

Speaker: Charles Inlander, President, People’s Medical Society, Allentown, PA, USA

The consumer is becoming the driving force in heath care. This new consumer is demanding, empowered and savvy; expecting accountability and openness from health care providers and health product producers. In his presentation, consumer health advocate Charles Inlander will look at health care from the other end of the stethoscope, giving the consumer's perspective and offering strategies for providers and producers on how to meet the challenges that this new customer is posing.

The Decision-Maker’s Perspective

Speaker: Albert Jovell PhD, Director General, Fundació Biblioteca Josep Laporte, Barcelona, Spain
 
10.30-11.00 Break
11.00-12.00 Podium Presentations - Session I (4 podium groups with 4 presentations per group, 15 minutes per presentation)
  Values and Valuation - I Sitges Room (-2 Level)
Moderator: Lieven Annemans PhD, MS, Mman, Director, HEDM, University of Ghent, Meise, Belgium

VV1

 RISK ADJUSTMENT AND REFERENCE POINTS
Happich M1, Muehlbacher A2, 1GSF - Research Center for Environment and Health, Neuherberg, Bavaria, Germany; 2Technical University, Berlin, Germany 

VV2

 DESIGN AND VALIDATION OF A NEW WEB-BASED STANDARD GAMBLE INTERVIEW
Ramsey SD1, Clarke L2, Howlader N1, Cross JA1, Starks H3, Patrick D3, 1Fred Hutchinson Cancer Research Center, Seattle, WA, USA; 2Cornerstone Systems Northwest, Lynden, WA, USA; 3University of Washington, Seattle, WA, USA

VV3

 HOW STABLE ARE SOCIAL PREFERENCE WEIGHTS FOR EQ-5D: RESULTS FROM A PARTIAL REPLICATION STUDY
Macran S, Kind P, Outcomes Research Group, York, United Kingdom.

VV4

DEVELOPING A PREFERENCE-BASED MEASURE FOR POSTMENOPAUSAL HEALTH
Brazier JE1, Zoellner YF2, Platts M1, Towers I1, 1University of Sheffield, Sheffield, United Kingdom; 2Solvay Pharmaceuticals, Hannover, Germany
Diabetes
  Diabetes Ibiza/Menorca Room (-1 Level)
Moderator: Peter Davey MD, FRCP, Head of Pharmacoeconomics, University of Dundee, Dundee, Scotland, United Kingdom

DB1

ACARBOSE FOR THE PREVENTION OF TYPE II DIABETES IN CANADA: AN ECONOMIC EVALUATION
Getsios D1, Caro JJ2, Caro I3, Klittich W2, O'Brien JA2, 1Caro Research Institute, Hammonds Plains, NS, Canada; 2Caro Research Institute, Concord, MA, USA; 3Caro Research Institute, Dorval, QC, Canada

DB2

 PIOGLITAZONE MONOTHERAPY IS ASSOCIATED WITH A SIGNIFICANTLY LOWER INCIDENCE OF CARDIOVASCULAR EVENTS THAN IS INSULIN THERAPY IN PATIENTS WITH TYPE 2 DIABETES: A RETROSPECTIVE PROPENSITY-ADJUSTED COHORT ANALYSIS
Rajagopalan R1, Xu Y1, Rosenson RS2, Khan M1, Murray FT1, 1TAKEDA Pharmaceuticals North America, Inc, Lincolnshire, IL, USA; 2The Feinberg School of Medicine, Chicago, IL, USA

DB3

 COST-EFFECTIVENESS OF ROSIGLITAZONE-METFORMIN COMBINATION IN OVERWEIGHT PATIENTS WITH TYPE 2 DIABETES IN GERMANY
Shearer A1, Bagust A1, Schoeffski O2, Reitberger U3, Goertz A4, Behrens MV, 1University of York, York, United Kingdom; 2University Erlangen-Nuremberg, Nuremberg, Germany; 3Kendle International Inc, Munich, Germany; 4GlaxoSmithKline, Munich, Germany; 5GlaxoSmithKline, Uxbridge, United Kingdom

DB4

TYPE OF DIABETES AND ADHERENCE TO SELF-MONITORING OF BLOOD GLUCOSE (SMBG)
Vincze G, Barner JC, Lopez DA, University of Texas at Austin, Austin, TX, USA
  Health Care Planning and Management Girona Room (-2 Level)
Moderator: Randel Richner MPH, Vice President, Federal Affairs, Boston Scientific Corp, Natick, MA USA

HP1

A PROBLEM SHARED IS A PROBLEM HALVED? COST ACCEPTABILITY OF SHARED CARE VS HOSPITAL TREATMENT
Davies LM, O'Neill PK, Fargher EA, Symmons DP, Tricker K, Manchester University, Manchester, Gtr. Manchester, United Kingdom

HP2

 THE IMPACT OF TREATMENT MANAGEMENT ALGORITHMS AND EVALUATED TIME HORIZON ON ANTIVIRAL TREATMENT COSTS IN CHRONIC HEPATITIS C
Siebert U1, Sroczynski G1, Wasem J2, Aidelsburger P3, Rossol S4, Wong JB5, 1Harvard University, Boston, MA, USA; 2University Duisburg-Essen, Essen, Germany; 3University of Greifswald, Greifswald, Germany; 4University of Heidelberrg, Ruesselsheim, Germany; 5Tufts University School of Medicine, Boston, MA, USA

HP3

 END STAGE RENAL DISEASE IN FRANCE: PLANNING EVOLUTION OF HEALTH CARE NEEDS USING A MARKOV MODEL
Grenêche S1, d'Andon A1, Joseph A2, Landais P3, 1JNB-Développement, Paris, France; 2Baxter SAS, Maurepas, France; 3Hôpital Necker, Paris, France

HP4

CHILDHOOD VACCINATION AGAINST VARICELLA IN FRANCE: AN ECONOMIC EVALUATION OF DIFFERENT STRATEGIES
Coudeville L, Brunot A, CRESGE - Université Catholique de Lille, Lille, France
  Methods Catalunya Room (-2 Level)
Moderator: Bernie J. O’Brien PhD, Professor, Department of Clinical Epidemiology & Biostatistics, McMaster University, St. Joseph’s Hospital, Hamilton, Ontario, Canada

MD1

A TALE OF TWO STUDIES: A COMPARISON OF ECONOMIC DATA FROM A CLINICAL TRIAL TO A CROSS-SECTIONAL DATABASE
Crawford B, Evans C, Mapi Values, Boston, MA, USA

MD2

THE PARAMETRIC BOOTSTRAP: RECONCILING PARAMETRIC AND NON PARAMETRIC METHODS IN THE ESTIMATION OF CONFIDENCE INTERVALS FOR INCREMENTAL COST-EFFECTIVENESS RATIOS?
Lilliu H, Clp-santé, Paris, France

MD3

THE IMPLICATIONS OF COMBINING HETEROGENEOUS PATIENT POPULATIONS IN META-ANALYSES
Boler A, Howard P, Heron Evidence Development, Letchworth, Hertfordshire, United Kingdom

MD4

STOCHASTIC ANALYSIS OF AN RANDOMIZED CONTROLLED TRIAL IN REHABILITATION OF LOW BACK PATIENTS: REPRESENTATION OF UNCERTAINTY WHEN EFFECT DIFFERENCE IS SMALL
Schweikert B1, Jacobi E1, Knab J2, Leidl R1, 1University of Ulm, Ulm, Germany; 2University Hospital of Essen, Essen, Germany
12.00-13.00 Lunch, Exhibits & Contributed Poster Presentations – Session I
Alemania Room (Mezzanine Level)

 Lunch Sponsored by CARO Research
 
    See poster presentations Session I
13.00-14.00 Contributed Podium Presentations – Session II (4 podium groups with 4 presentations per group)
  Values and Valuation - Session II  Sitges Room (-2 Level)
Moderator: John E Brazier PhD, Professor, School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom
VV5 ASTHMA TREATMENT PREFERENCE STUDY – A CONJOINT ANALYSIS OF PREFERRED DRUG TREATMENTS
Berggren F1, Ställberg B2, Tornling G1, Fält K3, Andersson S1, Karlsson G1, Johansson G4, 1AstraZeneca R&D Lund, Sweden; 2Trosa Primary Care Centre, Trosa, Sweden; 3KW Partners, Stockholm, Sweden; 4Nyby Primary Care Centre, Uppsala, Sweden
VV6 TRANSFORMING THE UNIFIED PARKINSON'S DISEASE RATING SCALE INTO A UTILITY SCALE
Siebert U1, Bornschein B2, Spottke A3, Dodel R3, 1Harvard University, Boston, MA, USA; 2University of Munich, Munich, Germany; 3University of Bonn, Bonn, Germany
VV7 WILLINGNESS TO PAY FOR HEARING AIDS IN THE NETHERLANDS
Grutters J, Chenault M, Anteunis L, Moore M, University Hospital Maastricht, Maastricht, The Netherlands
VV8 CLINICAL INCONTINENCE SCORE RELATES TO HEALTH UTILITY VALUES
Deutekom M, Dijkgraaf MGW, Terra MP, Dobben AC, Stoker J, Academic Medical Center, Amsterdam, The Netherlands
  Gastrointestinal Disorders Ibiza/Menorca Room (-1 Level)
Moderator: Sean Sullivan PhD, 2003-2004 ISPOR President & Professor, University of Washington, Seattle, Washington, USA
GD1 COST-UTILITY ANALYSIS OF "ON DEMAND" RABEPRAZOLE AND ESOMEPRAZOLE FOR SYMPTOMATIC GASTRO OESOPHAGEAL REFLUX DISEASE
Hughes DA1, Dubois D2, 1University of Liverpool, Liverpool, United Kingdom; 2Johnson & Johnson Pharmaceutical Services, LLC, Beerse, Belgium
GD2 A COST CONSEQUENCE ANALYSIS OF A NEW ENDOSCOPIC, INJECTABLE TREATMENT AND EXISTING INTERVENTIONS IN GASTRO-OESOPHAGEAL REFLUX DISEASE
Boler A1, Wenk-Lang A2, Howard P1, 1Heron Evidence Development, Letchworth, Hertfordshire, United Kingdom; 2Boston Scientific International, La Garenne Colombes, France
GD3 COSTS OF GASTROENTERITIS IN THE NETHERLANDS
van den Brandhof WE1, De Wit GA1, de Wit MAS2, van Duijnhoven YTHP1, 1National Institute of Public Health, Bilthoven, The Netherlands; 2National Institute of Public Health and the Environment, Bilthoven, The Netherlands
GD4 POTENTIAL HOSPITAL SAVINGS RELATED TO THE ADMINISTRATION OF ESOMEPRAZOLE TABLETS THROUGH GASTRIC TUBES IN PATIENTS CURRENTLY TREATED WITH INJECTABLE PPIS
Duru G1, Bernard-Chabert B2, Begue D3, Longin J4, Barthelemy P5, Lamarque H5, 1Université Lyon 1, Lyon, France; 2C.H.U Reims, Reims, France; 3Université de Pharmacie Paris V, Paris, France; 4NAXIS, Lyon, France; 5Laboratoire AstraZeneca, Rueil Malmaison, France
  Cardiovascular Diseases - Session I Girona Room (-2 Level)
Moderator: Pedro Plans-Rubio MD, MBA, Evaluation Unit, G.D. Public Health, Department de Sanitat, La Cenia, Sant Pol, Spain
CV1 A COST-BENEFIT MODEL FOR PERINDOPRIL IN SECONDARY STROKE PREVENTION
Hartzema AG, Winterstein AG, Kwon S, University of Florida, Gainesville, FL, USA
CV2 THE ECONOMIC BURDEN OF STROKE IN SPAIN
Lopez Bastida J1, Serrano Aguilar P1, Monton Alvarez F2, Duque González B1, 1Canarian Health Service, Santa Cruz de Tenerife, S/C de Tenerife, Spain; 2Ntra. Sra. de la Candelaria, Universitary Hospital, Santa Cruz de Tenerife, S/C de Tenerife, Spain
CV3 PROSPECTIVE COHORT STUDY IN HIP FRACTURE: RISK AND ECONOMIC IMPACT OF VENOUS THROMBO-EMBOLIC COMPLICATIONS (VTE) IN REAL LIFE
de Pouvourville G1, Gabriel S2, Zazzo JF3, 1CREGAS- INSERM, Le Kremlin Bicêtre, France; 2Sanofi Synthelabo, Bagneux, France; 3Antoine Beclere, Clamart, France
CV4 IRBESARTAN IS PROJECTED TO BE COST AND LIFE SAVING IN THE FRENCH SETTING FOR TREATMENT OF PATIENTS WITH TYPE 2 DIABETES, HYPERTENSION, AND MICROALBUMINURIA
Palmer AJ1, Annemans L2, Roze S1, Lamotte M3, Lapuerta P4, Gabriel S5, Chen R4, Carita P5, Villadary I5, Rodby R6, de Zeeuw D7, Parving HH8, 1CORE Center for Outcomes Research, Binningen, Basel, Switzerland; 2Ghent University, HEDM, Meise, Belgium; 3Health Economics Disease Management (HEDM), Meise, Belgium; 4Bristol-Myers Squibb, Princeton, NJ, USA; 5Sanofi Synthelabo Recherche, Bagneux, France; 6Collaborative Study Group, Section of Nephrology, Rush Presbyterian/St. Luke's Medical Center, Chicago, IL, USA; 7University of Groningen, Groningen, The Netherlands; 8Steno Diabetes Center, Gentofte, Denmark
 
  Making Evaluations Work Catalunya Room (-2 Level)
Moderator: Mike Drummond PhD, Professor of Health Economics, Centre for Health Economics, University of York, United Kingdom
ME1 ASSESSING GENERALISABILITY OF COST-EFFECTIVENESS ESTIMATES IN MULTINATIONAL STUDIES: APPLICATION TO A TRIAL OF MOXIFLOXACIN IN COMMUNITY-ACQUIRED PNEUMONIA (CAP)
Aballéa S1, Hux M2, Quilici S1, Drummond M3, 1Innovus Research UK, High Wycombe, United Kingdom; 2Innovus Research Inc, Burlington, ON, Canada; 3University of York, York, United Kingdom
ME2 A USER-FRIENDLY TOOL FOR EVALUATING AND IMPROVING THE TRANSFERABILITY OF ECONOMIC EVALUATION RESULTS BETWEEN COUNTRIES
Welte R1, Feenstra TL2, Jager JC2, Leidl R1, 1University of Ulm, Ulm, Germany; 2National Institute of Public Health and the Environment, Bilthoven, The Netherlands
ME3 ESTIMATING COST-EFFECTIVENESS IN THE ABSENCE OF HEAD-TO-HEAD CLINICAL TRIALS – EXAMPLES OF TWO RECENT TECHNOLOGY ASSESSMENTS FOR NICE
Hawkins N1, Palmer S1, Sculpher M1, Epstein D1, Ades AE2, Lu G2, 1University of York, York, North Yorkshire, United Kingdom; 2University of Bristol, Bristol, United Kingdom
ME4 HOW FREQUENTLY ARE ECONOMIC EVALUATIONS USED IN DECISION MAKING?
Bloom BS, University of Pennsylvania, Philadelphia, PA, USA
 
14.00-14.15 Break
14.15-15.15 Concurrent Issues Panels (4 Sessions)
  THE USE OF PATIENT-REPORTED OUTCOMES DATA IN ECONOMIC EVALUATION STUDIES: DO OUTCOMES RESEARCHERS AND HEALTH ECONOMISTS UNDERSTAND EACH OTHER? Sitges Room (-2 Level)

Moderator: Agota Szende MSc, Research Associate, MEDTAP International, London, United Kingdom

Panelists: Xavier Badia PhD, General Director, Health Outcomes Research Group, Barcelona, Spain; Nancy Leidy PhD, Global Scientific Director, MEDTAP International, Bethesda, MD, USA; Mark Nuijten PhD, MD, MBA, Director of European Business Development, MEDTAP International, Amsterdam, The Netherlands; Klas Svensson MS, Senior Statistical Scientist, AstraZeneca R&D, Lund, Sweden

While both patient reported outcomes (PRO) and health economic evaluation research are getting more and more specialised, there is an increasing number of borderline areas where a better understanding of both disciplines is needed. The issues panel will debate three of these most important areas: a) The utilization of PRO data in health economic models. How should and how should not PRO data be used in models to predict health utility, mortality, and health care utilization?; b) The integration of PRO data in cost-effectiveness ratios. What are the advantages and disadvantages of integrating PRO data in cost-effectiveness ratios, given the alternative ways of interpreting PRO results?; c) Disease-specific utility instrument development methods. Should the elicitation of preferences of patients or the public be the standard practice in disease-specific utility instrument development?

EVALUATING THE CLINICAL IMPORTANCE OF DIFFERENCES IN PRO MEASURES - CONCEPTS, METHODS AND INTEGRATION INTO CLINICAL DRUG DEVELOPMENT AND INTO THE REGULATORY PROCESS Girona Room (-2 Level)
Moderator: Michael Friedman PhD, Director, Dept. of Biostatistics, Purdue Pharma, Stamford, CT, USA

Panelists: George Wells PhD, Professor, Dept. of Epidemiology and Community Medicine, U. of Ottawa, Ottawa, Canada; Patrick Marquis MD, Managing Director, Mapi Values, Boston, USA

The panel will address the following issues: 1) What are the key concepts and metrics enabling us to interpret differences in PRO measures? How should these metrics be empirically evaluated? 2) How helpful is the concept of the minimal clinically important difference, given that importance of treatment effectiveness is often evaluated in the context of a cost/benefit analysis? How should the various concepts of important differences be incorporated into clinical study protocols, data analyses and clinical and regulatory decisions? How critical are the differences among the perspectives of patients, researchers, industry and society?

 ADJUSTING INTERNATIONAL DRUG PRICES TO LOCAL CONDITIONS: DIFFERENTIAL PRICING VS. EQUITY PRICING Ibiza/Menorca Room (-1 Level)

Moderator: Fernando Antoñanzas, Professor of Economics, Universidad de La Rioja, Logroño, and SOIKOS, Barcelona, Spain

Panelists: Adrian Towse MA, Mphil, Director, The Office of Health Economics, London, United Kingdom; Joan Rovira PhD, Senior Health Economist, HNP, The World Bank, Washington DC, USA

One of the approaches suggested in the on-going debate on the access of developing countries and poor people to new on-patent drugs is the establishment of different prices adjusted to the economic conditions of the country. Although all these schemes represent an alternative to a single international price, there are different options in designing and implementing such a pricing system. Schemes differ in relation to the criteria for selecting the products, the mechanism for attaining the expected prices, the number of clusters or segments, the way prices are determined at country level and so on.

METHODOLOGICAL AND PRACTICAL CHALLENGES IN USING ECONOMIC EVALUATION IN DRUG REIMBURSEMENT DECISIONS Catalunya Room (-2 Level)


Moderator: Michael Drummond PhD, Professor of Health Economics, Centre for Health Economics, University of York, United Kingdom

Panelists: Mark Sculpher PhD, Professor, University of York, York, United Kingdom; Annemarie Jansen PhD, Policy Advisor Pharmacoeconomics, College Voor Zorgverzekeringen (CVZ), The Netherlands; Per Carlsson, Associate Professor, Linköping University and Pharmaceutical Benefits Board, Sweden; Martin Backhouse, Head of Health Economics, RDI, Novartis, Basel, Switzerland; Lou Garrison PhD, Vice President, Health Economics, Roche, Switzerland

There is now considerable experience, from different jurisdictions, of attempts to use cost-effectiveness studies in drug reimbursement and coverage decisions. Several contentious methodological issues have been raised such as the use of indirect clinical comparisons, extrapolation beyond the period observed in clinical studies, the use of probabilistic models, the adaptation of economic data from other jurisdictions and the incorporation of equity considerations. Also, there are several contentious practical issues, such as setting the priorities for drug evaluation, the level of prescription of data requirements, the treatment of commercial-in-confidence data, the role of independent assessments and the need for transparency in the reimbursement process.
 
15.15-15.30 Break
15.30-16.30 Issues Panels – Session II (4 panels)
  HOW MUCH EVIDENCE IS ENOUGH? APPLICATION OF VALUE OF INFORMATION THEORY TO REIMBURSEMENT DECISIONS Girona Room (-2 Level)
Moderator: Peter Neumann ScD, Associate Professor of Policy and Decision Sciences, Harvard School of Public Health, Boston, MA, USA

Panelists: Mark Sculpher MSc, PhD, Professor, University of York, Heslington York, United Kingdom; Neil Hawkins PhD, Statistician, Centre for Health Economics, University of York, York, United Kingdom;
Hans Severans PhD, Universiteit Maastricht, Nymegen, The Netherlands

Limited information about the long-term outcomes and costs of new therapies is available at the time of drug product launch. Increasingly reimbursement authorities use this as an argument to ask for additional information and delay decision-making. The reimbursement authority issues and the consequences of these actions will be discussed.

 CHALLENGES FOR LOCAL COMPANIES IN ATTAINING THE TARGETED PRICE AND MAXIMUM REIMBURSEMENT  Ibiza/Menorca Room (-1 Level)
Moderator: Jeanni van Loon MSc, General Manager Mapi Values Netherlands, Houten, The Netherlands

Panelists: Annemarie Jansen PhD, Policy Advisor Pharmacoeconomics, College Voor Zorgverzekeringen (CVZ), The Netherlands; Guido van den Boom PhD, Health Outcome Manager Novartis Pharma, Arnhem, The Netherlands; Jens Grueger PhD, Head of Health Economics Department, Novartis Pharmaceuticals, Basel, Switzerland

By means of a dramatization (play-role) in a fictitious country, the pitfalls for the respective parties (i.e. local HE manager, headquarters, and the reviewer) in preparing the dossier for an imaginary drug will be shortly presented. In the last 20 minutes the audience will be encouraged to participate in an interactive discussion on how to overcome the pitfalls and how to deal with the increasing number of countries encountering the same problems. The program will be concluded with solutions and guidance on how to avoid the pitfalls from a multi-party perspective.

WHAT INCENTIVE DO PHARMACEUTICAL FIRMS  HAVE FOR PHARMACOGENOMICS? Sitges Room (-2 Level)

Moderator: Adrian Towse PhD, Director, Office of Health Economics, London, United Kingdom

Panelists: David Veenstra PharmD, PhD, Assistant Professor, Pharmaceutical Outcomes Research and Policy Program (PORPP) and Institute for Public Health Genetics, University of Washington, Seattle, WA, USA; James Jarrett MA, Research Associate, Cambridge Genetics Knowledge Park, Cambridge, UK, University of East Anglia, Norwich, UK; Sarah Wordsworth MSc, Genetics Programme Leader, Health Economics Research Centre, University of Oxford, UK

There is some evidence that using pharmacogenomics to individualize drug therapy may in some cases offer improved drug effectiveness and reduce side effects. However, because of the need to target pharmacogenomics, producers may see a limited and therefore unacceptable market and will not invest. On the other hand, pharmacogenomics could have the potential to create monopolies for producers and therefore the possibility of lucrative investment opportunities.

THE ROLE OF STANDARDIZED ECONOMIC DISEASE MODELS FOR HEALTH TECHNOLOGY ASSESSMENT AND REIMBURSEMENT Catalunya Room (-2 Level)

Moderator: Joan Rovira PhD, Senior Health Economist, HNP, The World Bank, Washington DC, USA

Panelists: Lou Garrison PhD, Vice President, Health Economics, Roche, Switzerland; Ron Akehurst BS, Dean of School of Health & Related Research, ScHARR, The University of Sheffield, Sheffield, UK

Traditionally, manufacturers have provided a variety of disease state models to support economic submissions for reimbursement. Recently, health technology assessment and reimbursement authorities have started to publish standard models, e.g. the Multiple Sclerosis developed by NICE. Some medical specialist associations, e.g. the American Diabetes Association, are investing into the development of sophisticated models. There have been suggestions that future submissions for reimbursement should be based on these standardized models, in order to facilitate the assessment of model results. Will this be helpful to make assessments of different technologies/drugs in the same indication comparable? Will it stifle innovative modeling approaches? Will it bias against innovative technologies, as the models do not recognize new modes of action or outcomes?
 
16.30-17.00 Break
17.00-18.00 ISPOR Forums
 
Medical Device And Diagnostics Council Forum  Catalunya Room (-2 Level)

Diagnostic Testing Provides Actionable Information - Actual Value Versus Perceived Value: Are There Any Discrepancies?

Organizer: ISPOR European Medical Device and Diagnostics Council, Chair, Markus Siebert MS, Business area Director – Economic Affairs, EUCOMED, Brussels, Belgium

The issues to be discussed during this forum are how to show the value of diagnostics and the issues (and politics) of converting value to reality
(i.e. reimbursement and screening programs).



 Quality Of Life Special Interest Group Forum

Translation and Cultural Adaptation: Is it Time for a Harmonized Approach to linguistic Validation?

Speakers will present two sets of guidelines, one developed by ISPOR, the other by the EMEA/ERIQA group. Each set outlines principles of good practices for performing and linguistically validating translations and cultural adaptations of patient reported outcomes instruments. The need for guidelines, either developed and maintained by separate groups or a harmonized single set, will be discussed from the perspective of the pharmaceutical industry.

Moderator: Pennifer Erickson PhD, Co-founder, O.L.G.A., State College, PA, USA

ISPOR's Principles of Good Practice for Translation and Cultural Adaptation
Speaker: Diane Wild MSc, Director, Oxford Outcomes, Oxford, United Kingdom

EMEA/ERIQA Guidelines for Translation and Cultural Adaptation
Speaker: Catherine Acquadro MD, ERIQA Group Coordinator, Mapi Research, Lyon, France

Industry Perspectives on the Role of Guidelines
Speaker: TBD

Discussion

Polish Chapter Forum Tibidabo Room (Mezzanine Level)

Pharmacoeconomics in Poland, Current Status and Development Perspectives

Following international experience, economic evaluation of healthcare programmes is starting to play an increasing role in Poland. Polish pharmaceutical market worth 3 billion USD coupled with cost containment policies requires practical applications of pharmacoeconomics. One has to be aware of its role and potential, as well as barriers in its development. Educational activities should remain within the scope of interest.

Moderator: Aleksander Mazurek, PhD MD, National Institute of Public Health, Warsaw, Poland

Polish Pharmaceutical Market And Pharmacoeconomics – Introduction

Speaker: Paweł Kawalec, MD; Drug Management Department; Collegium Medicum; Jagiellonian University; Krakow, Poland

Basic informations on pharmaceutical industry, reimbursement and influence of pharmacoeconomics on polish health care decision-makers.

Pharmacoeconomics In Poland – Barriers And Perspectives

Speaker: Marcin Czech, PhD MD MBA Clinical Research Health Economics Manager, Servier, Warsaw, Poland and Warsaw Business School, Warsaw, Poland

The potential role of pharmacoeconomics in decision-making and management at different levels of health care system in Poland will be described.

Educational Initiatives

Speaker: Tomasz Hermanowski PhD, Warsaw Business School, Warsaw, Poland

There is a need to develop and introduce educational programmes in pharmacoeconomics in Poland. The one recently created at Business School, Warsaw University of Technology, focuses on pharmaceutical law, marketing and pharmacoeconomics.

ISPOR Russian Chapter Forum Menorca Room (-1 Level)

The Formation of Pharmacoeconomics in Russia

During this forum, the following will be presented: quality healthcare management in Russia; experience of pharmacoeconomic researchers in Russia; the formulary system of the Russian public health services; and drug supply in Russia

Moderator: Pavel Vorobyov MD, President of RSPOR, Professor, Head of Department, Moscow Medical Academy, Moscow, Russia

Quality Management in Russia

Speaker: Pavel Vorobyov MD, President of RSPOR, Professor, Head of Department, Moscow Medical Academy, Moscow, Russia

An introduction to quality health care management, including a Russian healthcare and clinical guidelines development program, will be presented.

Experience of Pharmacoeconomic Researchers in Russia

Speaker: Maria Avksentieva PhD, Assistant, Russian Society of Pharmacoeconomics and Outcomes Research, Moscow, Russia

An overview of pharmacoeconomic research in Russia since 1998 will be presented.

The Formulary System of the Russian Public Health Services

Speaker: Maria Sura MD, Executive Director, Russian Society for Pharmacoeconomics and Outcomes Research, Moscow, Russia

The work experiences, standards, and rules of choice of the essential drug list of the Russian Federation Ministry of Health Formulary Committee as well as hospital and other formulary committees will be presented.

The Drug Supply in Russia

Speaker: Alexander Bykov PhD, Pharmacoeconomics Manager, Sanofi-Synthelabo, Moscow, Russia

The main characteristics of the healthcare environment in Russia with a focus on key factors of the pharmaceutical markets will be presented. Macroeconomic stabilization; fiscal management; the stabilization of political challenges; and the strengthening of state regulation mechanisms will be discussed.

Risk Management Special Interest Group Forum  Sitges Room (-2 Level)

Exploring Risk Assessment in the Development of Pharmaceuticals in Europe 

Moderator and Speaker: Anthony Lockett, PhD, MD, DMS, Director, Product Services, Covance, Leeds, West Yorkshire, UK and ISPOR Risk Management Special Interest Group member

Speaker: Peter Davey MD, FRCP, Head of Pharmacoeconomics, University of Dundee, Department of Clinical Pharmacology, Ninewells Hospital & Medical School, Dundee, Scotland

Speakers will discuss risk assessment in developing & marketing pharmaceuticals in Europe. In addition, the role of outcomes research in product risk assessment in Europe will be discussed. A practicing clinician’s viewpoint as well as formal risk assessment framework for pharmaceuticals and the role of outcomes research will be presented.



ISPOR Vision 2010 Committee Forum Vilanova Room (-2 Level)

Committee Members: Ron Akehurst BS, Dean of School of Health & Related Research, ScHARR, The University of Sheffield, Sheffield, UK;
Marc Berger MD, (co-chair) Vice President, Outcomes Research & Management, Merck & Company, Inc., West Point, PA, USA; J. Lyle Bootman PhD, Dean & Professor, University of Arizona, College of Pharmacy, Tucson, AZ, USA; Jon Clouse RPh, MS, Consultant, United Health Care, Brevard, NC, USA; Isao Kamae MD, DrPh, Professor of Health Sciences and Informatics, Graduate School of Medicine, Kobe University, Kobe, Japan; Bryan Luce PhD, MBA, Senior Research Leader & CEO, MEDTAP International, Bethesda, MD, USA; Gerry Oster PhD, (co-chair) Vice President, PAI, Brookline, MA, USA; Karen Rascati RPh, PhD, Professor, University of Texas, Austin, TX, USA; Sean Sullivan PhD, RPh, MS, Professor and Director, University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA

The mission of the ISPOR Vision 2010 Committee is to recommend long-term strategic initiatives to enhance the effectiveness and efficiency of the organization as well as recommend areas of growth and address the dialectics of the organization. The ISPOR Vision 2010 Committee members will discuss the following questions being addressed by the Committee:

  • How should ISPOR foster a new generation of leaders?

  • What can be done to foster new and sustained membership?

  • How do we advance more and varied international participation in ISPOR?

  • Are there additional opportunities to enhance the financial health of ISPOR?

  • Should ISPOR expand it focus beyond pharmacoepidemiology to patient safety?

  • What should be the role of ISPR in communicating / education end-users

  • How should ISPOR work with other stakeholder organizations such AMCP, ISOQOL? of information?
18.00-20.00 Exhibitors’ Wine & Cheese Reception & Poster
Presentation –Session II  Alemenia Room (Mezzanine Level)
 
    See poster presentations Session II

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