Transferability of Cost-Effectiveness Data between Countries

Faculty: Michael Drummond PhD, Professor of Health Economics, University of York, York, UK; Andrea Manca PhD, MSc, Wellcome Trust Fellow in Health Services Research, Centre for Health Economics, University of York, York, UK; Marco Barbieri MSc, Associate Lecturer and Research Associate, University Pompeu Fabra and i3 innovus Research (UK) Ltd, Barcelona, Spain; Samuel Aballea MS, Research Analyst, i3 innovus Research (UK) Ltd, High Wycombe, UK

Course Description: Although the number of countries requiring an economic dossier as part of the submission dossier for public reimbursement of new drugs is growing, the pharmaceutical industry cannot conduct economic evaluations in every potential market. Clinical trials are increasingly done in international settings in order to quickly recruit a sufficient number of patients and to have at least some economic data from multiple countries. However, national decision-makers require country-specific or region-specific data on health care costs and are only willing to accept foreign data or international data when they are translated to their own specific setting. But guidelines on how to do this do not exist. This course starts with a discussion of factors that make economic data more difficult to transfer from one country to other countries than clinical data. Then we will review the methods that have been presented to offer a solution to this problem and their pros and cons. These methods include various types of regression-based methods and Markov models. This course is for those with basic understanding of cost calculation and modeling.

Cost-Effectiveness Analysis alongside Clinical Trials

Faculty: Scott Ramsey MD, PhD, Full Member, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Henry Glick PhD, University of Pennsylvania, School of Medicine, Philadelphia, PA, USA

Course Description: The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. This course will present the design, conduct, and reporting of cost-effectiveness analyses alongside clinical trials based on, in part, the Good Research Practices for Cost-Effectiveness Analysis alongside Clinical Trials: The ISPOR RCT-CEA Task Force Report. Trial design, selecting data elements, database design and management, analysis, and reporting of results will be presented. Trials designed to evaluate effectiveness (rather than efficacy), as well as clinical outcome measures will be discussed. How to obtain health resource use and health state utilities directly from study subjects and economic data collection fully integrated into the study will also be discussed. Analyses guided by an analysis plan and hypotheses, an incremental analysis using an intention to treat approach, and characterization of uncertainty, and standards for reporting results will be presented. This course is an introductory/intermediate level. Familiarity with economic evaluations will be helpful.

Cost Estimation and Assessing Financial (Budget) Impact of New Health Care Technologies
 
Faculty: C. Daniel Mullins PhD, Professor and Chair of Pharmaceutical Health Services Research, University of Maryland, School of Pharmacy, Baltimore, MD, USA ; Stephen Beard MSc, Head of Health Economics (UK), European Operations, RTI Health Solutions, Manchester, UK

Course Description: This course will describe methods to determine the costs associated with a health condition and the budget impact of new technologies for that condition. The course will present incidence and prevalence based costing strategies. Treatment algorithms and event-based approaches will be demonstrated for disease-specific costs from different decision-maker perspectives. Both static and dynamic methods for estimating the budget impact of adding a new drug to a health plan formulary will be presented. Issues related to imputing missing data will also be discussed. This course is designed for those with some experience with pharmacoeconomic analysis.

Pharmacoeconomic Modeling - Advanced

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 provide an in-depth look at modeling techniques and their application in a “real world” setting. It will discuss the ISPOR Principles of Good Practice for Decision Analytic Modeling in Health Care Evaluations and evaluate its implications for the application of various modeling methods. Using a series of related examples, the course will carefully review the practical steps involved in developing and using these kinds of models. This course will cover the practical steps involved in the selection and modeling of data inputs and practical aspects related to the determination of when, why and how to handle stochastic (i.e., first order Monte Carlo Simulations) and probabilistic uncertainty (i.e., second order Monte Carlo Simulations). Participants will have the opportunity to apply the discussed methods in hands-on activities. This course is intended as a follow-up to the short course, “Pharmacoeconomic Modeling”, and is designed for those with intermediate to advance knowledge of modeling methods.

Discrete Event Simulation for Economic Analyses

Faculty: J.Jaime Caro MDCM, FCRPC, FACP, Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics, McGill University, Montreal PQ and Scientific Director, Caro Research Institute, Concord, MA, USA; Jörgen Möller MSc Mech Eng, Simulation Specialist, Caro Research Institute, Concord, MA, USA

Course Description: This course will provide a basic understanding of the key concepts of discrete event simulation. The focus will be on the use of these simulation models to address pharmacoeconomic (and device-related) problems. The course will be structured around practical exercises. Topics to be covered are: Why DES? Dynamic simulation as a tool; Components of a DES; How do you build a model? Modeling of processes and resource use; Modeling of variables and decisions. If time permits, simple animation will be demonstrated. We will use ARENA to build simple models. Participants who wish to have hands-on experience should bring their laptops. Instructors will distribute training versions of Arena. This course is designed for those with some experience with modeling.

Quality of Life / Patient-Reported Outcomes / Preference-based Methods

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