Faculty: Lieven Annemans PhD, MSC, Health Economist Ghent University, Senior Consultant Global Health Economic, HEDM and IMS Health, Brussels, Belgium
Course Description: This course is
designed to teach clinicians and new researchers how to
incorporate pharmacoeconomics into study design and data
analysis. Participants will learn how to collect and
calculate the costs of different alternatives, determine
the economic impact of clinical outcomes, and how to
identify, track and assign costs to different types of
health care resources used. The development of economic
protocols and data collection sheets will be discussed.
Different pharmacoeconomic models and techniques will be
demonstrated and practiced in lectures and case studies.
These include cost-minimization, cost-of-illness,
cost-effectiveness, cost-benefit, and cost-utility
analysis. Decision analysis, sensitivity analysis, and
discounting, will all be demonstrated and practiced.
Participants will also learn to compare and evaluate
interventions such as drugs, devices and clinical
services. This course is suitable for those with
little or no experience with pharmacoeconomics.
SATURDAY, 28 October 2006 (Morning)
8:00 - 12:00
Use of Pharmacoeconomics / Economic / Outcomes Research
Information
Elements of Pharmaceutical/Biotech Pricing I -
Introduction Faculty:
Jack Mycka,
President, Optimar Strategic Consulting LLC, Montclair,
NJ, USA; Renato Dellamano PhD, President,
ValueVector (Value Added Business Strategies), Milan,
Italy
Course Description: This course
will give participants a basic understanding of the key
terminology and issues involved in pharmaceutical
pricing decisions. It will cover the tools to build and
document product value including issues, information and
processes employed (including pricing research); the
role of pharmacoeconomics and the differences in payment
systems that help to shape pricing decisions. These
tools will be further explored through a series of
interactive exercises. This course is designed for
those with limited experience in the area of
pharmaceutical pricing and will cover topics within a
global context.
Modeling
Methods
Pharmacoeconomic Modeling
Faculty: Prof. Uwe Siebert, MD, MPH, MSc, ScD, Professor of Public Health; Head of the Department of Public Health, Medical Decision Making and Health Technology Assessment, University of Health Sciences, Medical Informatics and Technology, Hall/Innsbruck, Austria, and Associate Professor of Radiology, Harvard Medical School, Director of the Cardiovascular Research Program, Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA, USA;
Bernhard Bornschein MD, MPH, Senior Scientist, UMIT, Hall/Innsbruck, Tyrol, Austria;
Alexander Göhler MD, Senior Scientist, MGH-Institute for Technology Assessment, Harvard Medical School, Boston, MA, USA
Course Description: This course
will present an introductory discussion of
pharmacoeconomic modeling techniques such as Monte Carlo
analysis, Markov modeling, and probabilistic sensitivity
analysis, including a review of the ISPOR Principles of
Good Practice for Decision Analytic Modeling in Health
Care Evaluations. This course is designed for those
with some familiarity with modeling techniques.
Real World Data Methods
Retrospective Database Analysis
Faculty: Elise Pelletier MS, Senior Research Consultant, PharMetrics, a unit of IMS, Watertown, MA, USA;
Erik Spaepen BA Pharmaceutical Sciences Technologies, Senior Data Analyst, IMS Health, Brussels, Belgium
Course Description: Large
administrative patient databases provide a unique
opportunity to examine retrospectively the effects of
drug use on clinical and economic outcomes in "real
world" settings. This course will take a methodological
approach to the practical usage of existing patient
databases in Europe and cover a discussion of the ISPOR
Checklist for Retroactive database studies -Report of
the ISPOR Task Force on Retrospective Databases and
selected topics related to estimators and sampling
distributions, properties of sampling distributions (unbiasedness,
efficiency, mean square error), and ordinary least
squares (OLS) regression. More complex topics beginning
with the problem of endogeneity, identification,
instrumental variables, sample selection models, and
propensity score models, maximum likelihood methods and
the estimation of limited dependent variables models
including logit, multinomial logit, count models, and
survival models will be discussed. Discussion will
include a reference to the ISPOR Digest of International
Databases and its “real world” applications to
retrospective database analysis. This course assumes
participants have knowledge of statistical methods and
understanding in the analysis of administrative patient
databases.
Quality of Life / Patient-Reported Outcomes /
Preference-Based Methods
Application of Item Response Theory in Patient Outcomes
Measurement
Faculty: Jakob Bue Bjorner, MD, PhD, Chief Science Officer, QualityMetric Incorporated, Lincoln, RI
Course Description: Item
Response Theory measures the mathematical relationship
between an examinee ability and item response, in order
to attain more accurate readings of actual
aptitude/conceptions of health-related devices and
issues. It was developed in response to a growing need
for more advanced tools and models to measure such
constructs. This course will highlight the background of
Item Response Theory as well as discuss in-depth its
applications in patient outcomes research. Instructors
will also evaluate the usefulness of Item Response
Theory in comparison with other patient outcomes
measures. Various software programs used to analyze data
through item response theory (such as PARSCALE and BILOG)
will be incorporated into a number of hands-on exercises
for the course participants. This course is designed
for those with little experience with Item Response
Theory.
SATURDAY, 28 October 2006
(Afternoon) 13:00 - 17:00
Use of Pharmacoeconomics / Economic / Outcomes Research
Information
Case Studies in Pharmaceutical/Biotech Pricing II -
Advanced
Course Description: Case
studies will be employed to lead participants through
the key steps of new product pricing, with focus on the
need to thoroughly analyze the business environment and
its constraints and opportunities and the need to
closely integrate the pricing, reimbursement and PE
strategy for the new product with the clinical
development and marketing strategies. Practical
exercises will allow participants to consolidate the
concepts delivered in the “Elements” introductory
session and expanded here. Areas covered will include
the post-launch issues of reimbursement and pricing
maintenance as a part of life-cycle management in a
global environment. This course is for individuals
who have completed Elements of Pharmaceutical Pricing I
– Introduction or are familiar with both the key
determinants of pharmaceutical pricing and the main
international health systems.
Modeling Methods
Bayesian Methods in Economic Evaluations
Faculty: Keith R. Abrams MSc, PhD, Professor of Medical Statistics, Centre for Biostatistics & Genetic Epidemiology, Department of Health Sciences, University of Leicester, Leicester, U.K.
Course Description: This course
is designed to provide an overview of the Bayesian
approach and its application to health economics and
outcomes research. The course will cover basic elements
of Bayesian statistics, discuss differences between
Bayesian and classical (frequentist) approaches, and
demonstrate how to apply the Bayesian approach to
clinical trials and cost-effectiveness analyses.
Available software will be discussed, and examples of
studies will be presented. This course is for those
with a basic appreciation of statistics and probability.
Quality of Life / Patient-Reported
Outcomes / Preference-based Methods
Faculty: Jan Busschbach PhD, Associated Professor, Department for Medical Psychology and Psychotherapy at Erasmus Medical Center,
Rotterdam, The Netherlands & Viersprong Institute for Studies on Personality Disorders, Halsteren, The Netherlands;
Elly Stolk MSc, Institute for Medical Technology Assessment ((iMTA), Erasmus University Medical Center Rotterdam, The Netherlands.
Course Description: Utility
measurement is a method of determining an individual's
preference for a certain outcome represented by a
quantitative score (utility). During this course,
methods for measuring preference-based outcomes like the
standard gamble, time trade-off, and visual analogue
scale will be demonstrated. Utility measurement however
is not only about mastering these techniques; it is
about using them in such a way that health care
decision-makers can apply the results, for instance in
QALY-analyses. For this purpose, one needs to be aware
of shortcomings of the available utility measures and
potential solutions. Furthermore one should be aware of
the decision-making context and the way results are
interpreted. To equip participants with expertise in the
field of utility measurement, the most important issues
will be discussed: for instance we will consider
potential insensitivity of generic instruments for
particular disease specific problems, and discuss to
what extent adaptation of generic or disease-specific
quality of life instruments may offer a solution. This
will be demonstrated with an exercise. Also the issue of
"whose values count: patient values or values from the
general public?" will be discussed. Finally we turn to
the interpretation in the context of resource
allocation. This course is for those with some
experience with quality-of-life measures in health
economic evaluation.
Instrument Development & Evaluation for Patient- Reported
Outcomes Assessment
Faculty: Andrew Lloyd M. Phil, Research Scientist and Deputy Director, United BioSource Health Care Analytics Group – Europe, London, UK;
Patricia van Hanswijck de Jonge PhD, MSc; Senior Research Associate, Health Care Analytics Group, United BioSource Corporation, London, UK.
Course Description: PRO
instrument development and evaluation includes
psychometric analyses including the use of factor
analysis, and other techniques. The course will cover
the recent draft guidance from the FDA as well as
existing guidance from the EMEA regarding instrument
development. This course is designed for those with
some experience with using PRO instruments.
