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ISPOR Seventh
Annual European Congress
24-26 October 2004, CCH Congress Centrum Hamburg, Hamburg, Germany |
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PROGRAM - Tuesday, October 26, 2004 |
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7.30 –8.45 |
Roundtable
Discussions |
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Coffee
Sponsored by MEDTAP International
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Requirements for Economic Information: International Comparisons
Discussion
Leader: Anita Burrell, MA, MBA, Director,
Global Health Outcomes & Research of Outcomes, Aventis Pharma,
Bridgewater, NJ, USA
This session will discuss the growing international requirements for the
provision of economic information for new active substances (NAS). An
overview of the data requirements for the National Institute for
Clinical Excellence in the UK will be compared with the data requested
in the Academy of Managed Care Pharmacy (AMCP) dossier used by Managed
Care Organisations (MCO's) in the USA. The impact of meeting the data
requirements will be the focus of a lively discussion with the
attendees.
Naturalistic Studies: An Alternative to Randomized Clinical Trials (Rcts)?
Discussion
Leader: J. Jaime Caro, MDCM, FRCPC, FACP,
Scientific Director, Caro Research Institute, Concord, MA, USA
This session will focus on naturalistic study designs and randomized
clinical trials to discuss whether RCTs are the only way to evaluate new
medical technologies and whether there are appropriate alternatives to
better capture the real world dimensions of the patients' response to
medical treatment.
Providing Relevant Health Economics Evidence for
Innovative Pharmaceuticals: What Can Be Delivered When?
Discussion Leader: Jens Grueger PhD, Global
Head, Pricing & Health Economics, Novartis Pharma AG, Basel, Switzerland
Most major markets require comprehensive evidence of the value of
innovative pharmaceuticals, either for market access, for formulary
listing or for provision of guidance on the appropriate use of the
pharmaceutical. Manufacturers are making efforts to provide this data,
however, there are methodological and logistic limitations as to what
data can realistically be generated as part of the phase III trial
program. While phase IIIb studies offer more flexibility, they are still
not "naturalistic", and the size and duration of these trials is often
not sufficient to answer questions about long-term effectiveness of new
drugs, specifically for chronic therapies. Some degree of modelling of
trial outcomes beyond trial duration, and in other clinical settings or
against additional comparators will be required to augment the clinical
trial data. We will discuss how to optimise the generation of policy
relevant value evidence! and processes to make sure that this data can
be used to update market access decisions as new data becomes
available.
Commissioning and Supervising Studies for Outcomes Research: Challenges
of External International Collaboration
Discussion
Leader: Anne Marciniak MD, MPhil, MSc, MBA,
Director, Worldwide Outcomes Research, Pfizer Ltd., Sandwich, Kent, UK
Outcomes Research projects often involved the complex collaboration of
researchers from multiple disciplines, horizons and countries. For
example developing a quality of life instrument for use in multinational
clinical trials may involve psychologists, clinicians, sociologists,
statisticians, from academia, CRO and industry, across multiple
countries. Organising such projects implies choosing the right mix of
people and keeping momentum and motivation over long periods of time. It
may also give rise to ethical and various other conflicts of interest.
Participants will discuss their experience of such projects and share
critical components of success. |
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8.00– 9.00
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Contributed Poster Presentations – Session II Viewing (see poster
presentations
at:
http://www.ispor.org/congresses/germany1004/index.asp) |
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9.00– 9.10 |
Contributed Research Poster
Presentation Awards Presentation
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9.10
–10.30 |
Third
Plenary Session
“GREYING SOCIETIES – CHALLENGES FOR OUTCOMES RESEARCH, QOL-RESEARCH AND
HEALTH ECONOMICS”
Moderator:
Wolfgang Greiner PhD,
Associate Professor, University of Hannover, Hannover, Germany
Aging Population – Burden or
Blessing?
Speaker: Alan Williams, Professor,
University of York, Heslington, UK
Trends and Implications for
Outcomes Research
Speaker: Clemens Tesch-Roemer,
Professor, German Center Gerontology, Germany
Challenges for outcomes research
Speaker:
Stefan Felder,
Professor, University of Magdeburg, Magdeburg, Germany
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10.30
–10.45 |
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Break - Coffee
Sponsored by MEDTAP International
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10.45
–11.45 |
Contributed Podium
Presentations - Session IV
(4 podium groups with 4 presentations per group)
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Neurological/Pain
Moderator:
Mike Aristides MSc, Director, M-TAG Limited, London, UK
NP1
HEALTH-RELATED QUALITY OF LIFE IN NEUROMUSCULAR DISEASES
Spottke EA1,
Mylius V2, Claus D3,
Grothe C1, Heuss D4, Kiefer
R5, Klockgether T1, Schrank
B6, Schröder R1, Vielhaber S7,
Walbert T1, Dodel R1,
Schepelmann K2, 1Friedrich-Wilhelms-University,
Bonn, Germany; 2Philipps-University, Marburg,
Germany; 3Clinic Darmstadt, Darmstadt, Germany;
4University Erlangen, Erlangen, Germany; 5University
Muenster, Muenster, Germany; 6Clinic of Diagnostics,
Wiesbaden, Germany; 7Otto-von-Guericke University,
Magdeburg, Germany
NP2
COST ASSOCIATED WITH PERSISTENCY AMONG PATIENTS WITH PARTIAL
SEIZURE DISORDER SWITCHING TO OXCARBAZEPINE MONOTHERAPY
Lee
WC1,
Arcona S2, Thomas SK2,
Wang Q1, Hoffmann MS1,
Pashos CL3, 1Abt Associates Inc,
Bethesda, MD, USA; 2Novartis Pharmaceuticals
Corporation, East Hanover, NJ, USA; 3Abt Associates
Inc, Cambridge, MA, USA
NP3 A
COST-UTILITY MODEL OF TREATMENT OF NEWLY DIAGNOSED EPILEPSY IN
GERMANY COMPARING TOPIRAMATE, CARBAMAZEPINE AND VALPROATE
Remák E1,
Steinhoff B2, 1MEDTAP International
Inc, London, UK; 2Klinik und Ambulanz für Erwachsene
Epilepsiezentrum Kork, Kehl, Germany
NP4
12-MONTHS COSTS OF PARKINSON’S DISEASE IN GERMANY - RESULTS OF A
PROSPECTIVE STUDY
Spottke EA1,
Peter H2, Reuther M1,
Campenhausen S1, Berger K3,
Machat O4, Koehne-Volland R4,
Klockgether T1, Oertel WH2,
Dodel R1, 1Friedrich-Wilhelms-University,
Bonn, Germany; 2Philipps University, Marburg,
Germany; 3MERG Medical Economics Research Group,
Munich, Germany; 4Metronomia, Munich, Germany
Eye/Ear/Skin
Moderator:
Karin Berger
MSc,
Managing
Director, Medical Economics Research Group, Munich, Germany
EE1
SUNBURNS ACCORDING TO GENDER
Guitera P1,
Dubertret L1, Myon E2,
Perez N3, Nocera T3, Martin
N2, Taieb C2, 1Hopital
Saint Louis, Paris, France; 2IRPF,
Boulogne-Billancourt, France; 3Avene Dermatological
Laboratories, Lavaur, France
EE2
LIVING WITH A DERMATOSIS: A NATIONAL SURVEY OF DEPRESSIVE
SYMPTOMATOLOGY IN BELGIUM
Lambert J1,
De la Brassinne M1, Myon E2,
Weckx H3, Monnier F3,
Martin N2, Taieb C2, 1Royal
Belgium Society of Dermatology, Brussels, Belgium; 2Health
Economics & Quality of Life Dept, Boulogne-Billancourt, France;
3AVENE Dermatological Laboratories, Brussels, Belgium
EE3
COST-EFFECTIVENESS OF TREATMENT FOR MODERATE-TO-SEVERE PSORIASIS
Hankin CS1,
Feldman SR2, Pearce D2,
1BioMedEcon, San Jose, CA, USA; 2Wake Forest
University School of Medicine, Winston-Salem, NC, USA
EE4
COMPARING TREATMENT COSTS ASSOCIATED WITH SCREENING FOR GLAUCOMA
VS NOT SCREENING: EVALUATING THE ECONOMIC IMPACT OF THE NEW
HEDIS MEASURE
Goldberg LD1,
Walt JG2, Lee J2, 1Goldberg,
MD and Associates, Battle Ground, WA, USA; 2Allergan
Inc, Irvine, CA, USA
Cost
Studies
Moderator:
Jacob Drapkin,
Director,
Reimbursement Systems, Ethicon Endosurgery, Cincinnati, OH, USA
CS1
TEGASEROD IS COST-EFFECTIVE IN THE TREATMENT OF PATIENTS WITH
IBS: AN ECONOMIC ANALYSIS OF THE TENOR (TEGASEROD IN NORDIC
COUNTRIES) STUDY
Jonsson
B1,
Bracco A2, Drummond MF3,
Ricci JF2, Nyhlin H4, 1Stockholm
School of Economics, Stockholm, Sweden; 2Novartis
Pharma AG, Basel, Switzerland; 3University of York,
York, UK; 4Ersta Hospital, Stockholm, Sweden
CS2
COST-EFFECTIVENESS OF COMPETING ANTIPSYCHOTIC MONOTHERAPIES IN
ACUTE BIPOLAR MANIA IN THE UK
McGarry
LJ1,
Thompson D1, Knudsen AP2,
Trakas K3, Cookson JC4,
Weinstein MC2, 1Innovus Research, Inc,
Medford, MA, USA; 2Harvard School of Public Health &
Innovus Research, Inc, Boston, MA, USA; 3Johnson &
Johnson Pharmaceutical Services L.L.C, Raritan, NJ, USA; 4Royal
London, St. Clement’s Hospital, London, England, UK
CS3
IRBESARTAN IS PROJECTED TO BE COST AND LIFE SAVING COMPARED TO
STANDARD BLOOD PRESSURE CONTROL ALONE FOR TREATMENT OF PATIENTS
WITH TYPE 2 DIABETES, HYPERTENSION, AND MICROALBUMINURIA IN
SPANISH, SWEDISH AND SWISS SETTINGS
Palmer AJ1,
Roze S1, Valentine WJ1,
Annemans L2, Gabriel S3,
Chen R4, 1CORE Center for Outcomes
Research, Binningen/Basel, Switzerland; 2HEDM, Meise,
Belgium; 3Sanofi-Synthélabo, Bagneux, France; 4Bristol-Myers
Squibb, Princeton, NJ, USA
CS4
ANTIPSYCHOTIC PATTERNS AND TREATMENT COST IN FRANCE
Riou-França L1,
Westerloppe J2, Launois R1,
1REES France, Paris, France; 2Bristol-Myers
Squibb, Rueil-Malmaison, France
Health Policy
II
Moderator:
Matthias von
der Schulenburg,
Professor,
University of Hannover, Hannover, Germany
HP5
WHAT HAPPENS WHEN A PHARMACEUTICAL PRODUCT IS REMOVED OUT OF
REIMBURSEMENT?
Le
Pen C,
Aremis Consultants and Paris Dauphine University, Paris, France
HP6
MODELLING USE OF HOSPITAL SERVICES AS A FUNCTION OF NEEDS AND
SUPPLY IN ITALY
Petrelli A1,
Picariello R1, Costa G2,
1Piedmont Region, Grugliasco (TO), Italy; 2University
of Turin, Italy
HP7
STRATEGIES OF PRIORIZATION BASED ON THE SOCIAL WELFARE FUNCTION
Plans-Rubio P,
General Direction of Public Health, Barcelona, Spain
HP8
EXPLAINING THE LACK OF SUCCESS OF GENERIC DRUGS IN BELGIUM: A
POLICY PERSPECTIVE
Simoens S,
Laekeman G, Katholieke Universiteit Leuven, Leuven,
Belgium
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11.45
–13.15 |
Lunch,
Exhibits & Contributed Poster Presentations –
Session II
(see poster
presentations at the ISPOR website page at:
http://www.ispor.org/congresses/germany1004/index.asp)
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Lunch sponsored by Aegisnet |
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13.15
–14.15 |
ISPOR Forums
ISPOR
MEDICAL DEVICE & DIAGNOSTICS FORUM
HOSPITAL COSTING OF MEDICAL DEVICE THERAPY IN THE
DRG ENVIRONMENT
Increasingly European health care systems are switching
to a DRG based hospital financing system. Even though the rational to
introduce DRG based financing systems may differ between the countries
all variations of DRG systems do share a common set of features. The
introduction of DRGs in Europe will create new challenges and
opportunities for providers and purchasers of health care and the
health care industry. Europe will best benefit form DRGs if they are
willing to learn form countries with a DRG history such as the United
States.
Moderator:
Jenifer Ehreth PhD, Director Reimbursement and Government Affairs,
Medtronic Europe, Tolochenaz, Switzerland
Impact Of DRGs On The Introduction Of New Technologies - Experience
From The United States
Speaker: Deborah
Williams, MS, Director, United States House of Representatives,
Ways and Means Subcommittee on Health, Washington, DC, USA
Experiences in the United States with mechanisms to encourage the
adoption of new technology in the Diagnosis-Related Group (DRG)
environment will be presented. Both the hospital and the United
States government perspectives will be presented.
Hospital Incentives Under a DRG System –
European
Perspectives
Speaker: Karl-Peter Pfeiffer MD, Professor, University of
Innsbruck, Innsbruck, Austria
Many countries in Europe
are implementing DRGs into their health care system.
Challenges in providing hospital incentives as well
as mechanisms to stimulate adoption of innovation under a DRG
system will be discussed.
Open Discussion
ISPOR
CENTRAL &
EASTERN EUROPEAN
FORUM
(Hall 4)
FORMULARY
DEVELOPMENT AND REIMBURSEMENT SYSTEMS IN CENTRAL AND EASTERN EUROPE:
CURRENT STATUS AND FUTURE DIRECTION
This forum will
discuss the use of pharmacoeconomics in health care decisions,
including formulary development in the public and private sectors
and reimbursement systems in Central and Eastern Europe.
Formulary
Development and Reimbursement Systems in Russia
Speaker:
Pavel Vorobiev MD, PhD,
President, ISPOR
Russia Chapter and President, Newdiamed, Moscow, Russia
Formulary
Development and Reimbursement Systems in Poland
Speaker:
Aleksander P. Mazurek,
President, ISPOR Polish Chapter and
Professor, Institute of Public Health, Warsaw, Poland
Formulary
Development and Reimbursement Systems in Hungary
Speaker:
Imre Boncz MD, MSc, National Health Insurance Fund
Administration, Budapest, Hungary
Formulary
Development and Reimbursement Systems in Latvia
Speaker:
Daiga Behmane, Director, Medicines’ Pricing and Reimbursement
Agency, Riga, Latvia
Formulary
Development and Reimbursement Systems in the Slovak Republic
Speaker:
Angelika Szalayova, Chief of Drug Department, Slovakian Ministry
of Health, Kosice, Slovak Republic
Formulary
Development and Reimbursement Systems in the Czech Republic
Speaker:
Tomas Sechser MD, Head of Clinical Pharmacology, Institute for
Clinical and Experimental Medicine, Prague, Czech Republic
ISPOR
RCT-CEA TASK FORCE FORUM
ISPOR TASK FORCE ON DEVELOPING STANDARDS FOR ECONOMIC ANALYSIS ALONGSIDE
CLINICAL TRIALS
Co-Chairs: Scott Ramsey MD, PhD, Associate Member, Fred Hutchinson
Cancer Research Center, Seattle, WA, USA and Richard Willke PhD, Senior
Director, Group Leader, Worldwide Outcomes Research, Pfizer, Inc.,
Bridgewater, NJ, USA
Task Force Leadership Group Leaders: Andrew Briggs Dphil, University of
Oxford, Health Economics Research Centre, Institute of Health Sciences,
Headington, Oxford, UK; Ruth Brown MS, Director, MEDTAP International,
London, UK; Martin Buxton PhD, Professor, Brunel University, Health
Economics Research Group, Uxbridge, Middlesex, UK; Anita Chawla PhD,
Associate Director, Health Economics, Genentech, South San Francisco,
CA, USA; John Cook PhD, Director, Merck Research Laboratories,
Biostatistics & Research Data Systems Vaccines, Blue Bell PA, USA;
Henry
Glick PhD, Health Economist, University of Pennsylvania, Division of
Internal Medicine, Philadelphia PA ,USA; Jens Grueger PhD, Head of
Health Economics Department, Novartis Pharmaceuticals AG, Basel,
Switzerland; Bengt Liljas PhD, Market Access Director, AstraZeneca,
Lund, Sweden; Diana Petitti MD, Director of Research & Evaluation,
Kaiser Permanente, Pasadena, CA,USA; Shelby Reed PhD, Assistant Research
Professor, Duke Clinical Research Institute, Durham, NC, USA
During this forum, the draft guidance document for the design, conduct,
and reporting of economic analyses that are conducted as part of
clinical trials developed by the ISPOR Randomized Clinical Trial - Cost
Effectiveness Analysis (RCT-CEA) Task Force will be presented. The ISPOR
Task Force was formed to develop a document that would enhance the
credibility and usefulness of cost-effectiveness analyses to
decision-makers worldwide. The following topics are presented in this
draft document: Introduction & Rationale for Standards in Economic
Analysis Alongside Clinical Trials, Trial Design Issues, Choosing Data
Elements, Database Design Issues, Analysis of Data, Reporting The
Results, Research Agenda For Methods And Reporting. A Question and
Answer period will follow.
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14.00 |
Contributed
Research Podium Presentation Awards Posted
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14.15
–14.30 |
Break
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Coffee
Sponsored by MEDTAP International
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14.30
–15.30 |
Contributed Workshops III
(5
workshops in 5 categories) |
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Clinical study
methodology issues including pharmacoepidemiology (COS)
W15: PARAMETRIC
SURVIVAL MODELS AND DECISION MODELS: RELATING CONTINUOUS HAZARDS TO
DISCRETE-TIME TRANSITION PROBABILITIES
Briggs A
HERC - University of Oxford, Oxford, UK
Compliance issues (CMP)
W16: ESTIMATING
MEDICATION PERSISTENCY USING ADMINISTRATIVE CLAIMS DATA
Sikka R1, Aubert R2
1Boston University School of Medicine, Boston, MA, USA;
2Medco Health Solutions, Franklin Lakes, NJ, USA
Cost study
methodology issues (CS)
W17: PROPENSITY
SCORE METHODS AND OTHER SAMPLE SELECTION MODELS: AN APPLIED EXAMPLE
USING RETROSPECTIVE ADMINISTRATIVE CLAIMS DATA
Schultz J1, Riedel AA1,
Crown WH2, Harley C1
1Ingenix Pharmaceutical Services, Eden Prairie, MN, USA;
2Ingenix, Auburndale, MA, USA
Health care policy
development issues using outcomes research (HP)
W18: USE AND
INTEGRATION OF FREELY AVAILABLE U.S. PUBLIC USE FILES TO ANSWER
PHARMACOECONOMIC QUESTIONS: DECIPHIRING THE ALPHABET SOUP
Cisternas M,
Noe L
Ovation Research
Group, Highland Park, IL, USA
Risk assessment/risk
management issues (RK)
W19: TOWARDS A MORE
EFFICIENT CLINICAL DEVELOPMENT PROCESS WITH SCENARIO ANALYSES
Van Loon J1, Van Genugten ML1,
Piercy J2, Postma MJ3
1Mapi Values, Houten, The Netherlands; 2Adelphi
Group, Bollington, UK; 33University of Groningen, Groningen,
The Netherlands
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15.30
–15.45 |
Break
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Coffee
Sponsored by MEDTAP International
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15.45
–16.45 |
Contributed Workshops IV
(5 workshops in 4 categories) |
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W20: DISEASE
REGISTRIES: TRICKS AND TIPS IN THE ANALYSIS OF OBSERVATIONAL DATA
Silva SJ, Pasta DJ, Miller DP
Ovation Research Group, San Francisco, CA, USA
Cost study
methodology issues (CS)
W21: THE ANALYSIS OF
INCOMPLETE (COST) DATA – THE APPROPRIATENESS OF AVAILABLE METHODS IN
DIFFERENT SITUATIONS
Oostenbrink JB, Al MJ
Erasmus MC, Rotterdam, The Netherlands
Formulary
development research issues (FS)
W22: COMMUNICATING
THE VALUE: DEVELOPING MESSAGES FOR PAYERS
Lucero M, Neighbors D
RTI Health Solutions, Research Triangle Park, NC, USA
Health care policy
development issues using outcomes research (HP)
W23: NEW CONCEPTS
OF CAUSAL INFERENCE IN MEDICAL DECISION MAKING AND OUTCOMES RESEARCH
Siebert U
Harvard Medical
School, Boston, MA, USA
Health care policy
development issues using outcomes research (HP)
W24:
INFECTIOUS-DISEASES-RELATED BIOTERRORISM AND PANDEMIC THREATS: ASSESSING
PHARMACOECONOMIC IMPACTS AND COST-EFFECTIVENESS OF RESPONSES
Bos JM1, Versmoren DR2,
Mesrobian X3, Van Genugten ML4,
Postma MJ2
1The Netherlands Vaccine Institute, Bilthoven, Utrecht, The
Netherlands; 2University of Groningen, Groningen, The
Netherlands; 3MAPI values, Boston, MA, USA; 4MAPI
values, Houten, Utrecht, The Netherlands |
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7th Annual European Congress Main Pagee
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