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SHORT COURSES - Sunday, 4 November 2012
Short Course Program Overview Short Courses Saturday, 3 November 2012 Short Courses Sunday, 4 November 2012
SUNDAY, 4 NOVEMBER 2012 - MORNING COURSES 8:00 - 12:00
8:00-12:00
Sold out Bayesian Methods in Economic Evaluations - Introduction
Room: Hall 9
Track: Modeling Methods

Level:

Introductory. This course is for those with a basic appreciation of statistics and probability.

Faculty:

Christopher S. Hollenbeak, PhD, Associate Professor, Surgery and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA

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.


 
Discrete Event Simulation for Economic Analyses - Concepts
Room: Hall 4/5
Track: Modeling Methods

Level:

Introductory. This course is designed for those with some familiarity with modeling.
Faculty:
J. Jaime Caro, MDCM, FRCPC, FACP J. Jaime Caro, MDCM, FRCPC, FACP, Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics, McGill University, Montreal PQ and Senior Vice-President of Health Economics, United BioSource Corporation, Lexington, MA, USA
Jörgen Möller, MSc Mech Eng Jörgen Möller, MSc Mech Eng, Vice-President, Modeling, United BioSource Corporation, Eslov, Sweden
Course Description:

This course will provide a basic understanding of the key concepts of discrete event simulation. Topics to be covered are: how does it work; what are the components; where is it used; for which problems is DES well suited; what are the advantages and disadvantages of DES; PSA as a simple task. The focus will be on the use of these simulation models to address pharmacoeconomic (and device-related) problems. Faculty will also discuss the recently published ISPOR-SMDM guidelines on DES.

 
Sold out Patient Registries
Room: Hall 10
Track:

Observational Data Methods

Level:

Introductory. This course is designed for those with some or no experience with patient registries.
Faculty:
Leanne Larson, MHA Leanne Larson, MHA, Vice President, Evidence Development, PAREXEL International, Waltham, MA, USA
Caroline Parry

Caroline Parry, Project Director, PACE, PAREXEL International, Uxbridge, UK

Course Description: This course is designed to provide an overview of patient registries and its applications in identifying real world clinical, safety, and patient-perspective issues. The advantages and disadvantages of patient registry versus other real world data collection will be presented. The course will address safety and clinical objectives as well as regulatory trends and requirements. Key operational components, challenges and measures of program success will be discussed. Management issues - including creating effective partnerships with patient-oriented organizations and facilitating long-term program operations within a changing organizational structure - will be addressed.
 
NEW! Instrumental Variables
Room: Hall 8
Track: Observational Data Methods

Level:

Intermediate. This course is suitable for those with some knowledge of econometrics.

Prerequisite: Previous attendance at the short course "Introduction to Analysis of Retrospective Database Studies" – or equivalent knowledge – is recommended.
Faculty:
Benjamin M. Craig, PhD Benjamin M. Craig, PhD, Assistant Member, Health Outcomes and Behavior, Moffitt Cancer Center & Associate Professor, Department of Economics, University of South Florida, Tampa, FL, USA
Antoine C. El Khoury, PhD, MS, Director, Market Access and Health Economics, Johnson and Johnson, Horsham, PA, USA and Adjunct Assistant Professor, Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA
Bradley C. Martin, PharmD, PhD Bradley C. Martin, PharmD, RPh, PhD, Professor and Head, Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA
Course Description:

In any non-randomized study, selection bias is a potential threat to the validity of conclusions reached. Failure to account for sample selection bias can lead to conclusions about treatment effectiveness or treatment cost that are not really due to the treatment at all, but rather to the unobserved factors that are correlated with both treatment and outcomes. Sample selection models provide a test for the presence of selection bias. These models also provide a correction for selection bias, enabling an investigator to obtain unbiased estimates of treatment effects. This course will discuss the various models and their applications and, in particular, will address instrument variables (two-stage least squares, intuition, RCTs), including an overview of examples from the current literature. Participants will benefit from interactive exercises using instrumental variables and sample selection techniques using STATA. For those who have STATA loaded on their laptops, you are encouraged to bring your laptop.

 
Sold out Reimbursement Systems in Europe
Room: Roof Garden
Track: Use of Pharmacoeconomics / Economic / Outcomes Research Information

Level:

Intermediate. This course is designed for individuals with intermediate experience within a single health care system wishing to broaden their appreciation of other reimbursement systems.
Faculty:
James Furniss

James Furniss, Vice President, GfK Bridgehead, Melton Mowbray, UK

Geoffrey (Geoff) Wilson

Geoffrey Wilson, PhD, MSc, Reimbursement Leader, Europe, Middle East, Africa Region, GE Healthcare, Buckinghamshire, England, United Kingdom

Caroline Conti, PharmD, MBA

Caroline Conti, PharmD, MBA, Consultant, GfK Bridgehead, London, UK

Timothy A.J. Fitzgerald, MSc

Timothy A.J. Fitzgerald, MSc, Managing Director, GfK Bridgehead, Melton Mowbray, UK

Marco Rauland, PhD

Marco Rauland, PhD, Vice President Europe, GfK Bridgehead, Nürnberg, Germany

Course Description:

Unlike market access which is mostly regulated at the European level by either EMA for pharmaceuticals or EC for devices, reimbursement decisions in Europe is the responsibility of each country. European health care systems are primarily government payer models. Therefore, based on each country's set of laws and values, wide variations exist in health technologies (drugs, diagnostics, devices). Using the ISPOR Global Health Care Systems Roadmap, this course will discuss health technology decision-making processes for coverage and reimbursement decisions in various European countries. Faculty will systematically describe the reimbursement systems across Western, Central & Eastern Europe and compare and contrast the key characteristics among them.

 
Transferability of Cost-Effectiveness Data between Countries
Room: Hall 7
Track:

Economic Methods

Level:

Advanced. This course is for those with advanced understanding of economic evaluations of health care programs and experience in the critical assessment of cost-effectiveness studies.
Faculty:
JL (Hans) Severens, PhD, Professor of Evaluation in Health Care, Institute of Health Policy and Management, Erasmus University Rotterdam and Department of Health Organization, Policy, and Economics, CAPHRI, Maastricht University, Maastricht, The Netherlands
Sylvia Evers Silvia Evers, PhD LLM, Chair, Public Health Technology, Maastricht University, Department of Health Services Research, Faculty of Health, Medicine and Life Science and at the School for Public Health and Primary Care (Caphri) and the Netherlands School of Primary Care Research (CaRe) Maastricht, The Netherlands
Manuela Joore Manuela Joore, PhD, Associate Professor, Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands
Saskia Knies

Saskia Knies, MPhil, PhD, Advisor, Pharmacoeconomics/HTA, Dutch Healthcare Insurance Board, Diemen, The Netherlands

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. However, national decision makers require country-specific or region-specific data or estimates on health care costs and patient outcomes. More and more, they are only willing to accept foreign or international data when they are transferable to their own specific decision making context. However, little guidance on how to do this exists. 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, and will focus on the report of the ISPOR Good Practices on Economic Data Transferability Task Force. Then we will review the methods that have been presented to assess the transferability of foreign cost, effects and cost-effectiveness estimates and their pros and cons. This topic will be practically covered in a case (working in small groups), that will be discussed subsequently. Methods available focus on trial-based economic evaluation. However, we will present transferring issues encountered when assessing model-based economic evaluations. Finally, we will discuss the transferability of health state valuation based on the EQ-5D instrument. The statistical methods to analyze multinational trial data and to transfer these data to a specific country are beyond the scope of this course. 

 
Conjoint Analysis - Theory & Methods
Room: Hall 6
Track:

Patient-Reported Outcomes / Preference-Based Methods

Level:

Intermediate. This course is designed for clinicians, policymakers, researchers, and patient advocates/researchers with some familiarity with conjoint analysis or other stated-preference methods.

Faculty:
A. Brett Hauber, PhD, Senior Economist and Vice President, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA
John F.P. Bridges, PhD, Assistant Professor, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
Course Description:

Course participants will learn the conceptual and empirical basis for using conjoint analysis to elicit preferences in outcomes research. The course will introduce participants to both the conceptual basis for quantifying decision-maker preferences for medical interventions and the practical design and analytical issues that must be addressed in order to obtain valid empirical preference estimates. The course will be structured following the good research practice guidelines and discussion being prepared by the ISPOR Good Research Practices for the Application of Conjoint Analysis in Health Task Force. The course will include lectures and interactive group exercises and group discussion.

SUNDAY, 4 NOVEMBER 2012 - AFTERNOON COURSES - 13:00 - 17:00
13:00-17:00
Bayesian Methods in Economic Evaluations - Advanced
Room: Hall 9
Track: Modeling Methods

Level:

Advanced.
Prerequisite: Basic knowledge of a Bayesian approach will be assumed equivalent to attendance at the "Bayesian Methods in Economic Evaluations - Introduction” short course.
Faculty:

Keith R. Abrams, PhD, Professor of Medical Statistics, Department of Health Sciences, University of Leicester, Leicester, UK

Course Description:

This course considers the use of a Bayesian approach to both with-trial and model-based economic evaluation. The specific use and advantages of a Bayesian approach to subgroup analyses and missing data analyses in trial-based economic evaluations is considered. The use of a Bayesian approach to probabilistic decision tree and Markov models is also presented, including the use of comprehensive decision modeling (involving the seamless integration of meta-analyses within an economic decision model). All methods are illustrated using examples implemented within the freely available WinBUGS software.
[Details and downloads at www.mrc-bsu.cam.ac.uk/bugs]


13:00-17:00
Sold out Discrete Event Simulation for Economic Analyses - Applications
Room: Hall 10
Track:

Modeling Methods

Level:

Intermediate. This course is designed for those with some understanding of discrete event simulation (equivalent to attendance at the short course “Discrete Event Simulation for Economic Analysis – Concepts”) and who wish to have more practical modeling experience.

Prerequisite:

Attendance at the short course “Discrete Event Simulation for Economic Analysis - Concepts” - or equivalent knowledge - is required.

Faculty:
J. Jaime Caro, MDCM, FRCPC, FACP, Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics, McGill University, Montreal PQ and Senior Vice-President of Health Economics, United BioSource Corporation, Lexington, MA, USA
Jörgen Möller, MSc Mech Eng, Vice-President, Modeling, United BioSource Corporation, Hammersmith, UK and Associate Researcher, Division of Health Economics, Faculty of Medicine, Lund University, Sweden
Tereza Lanitis, MSC

Tereza Lanitis, MSC, Research Associate, Modeling and Simulation, Health Economics, United Biosource Corporation, London, UK

Course Description:

This course is structured around practical discrete event simulation exercises. Topics to be covered are: components of a DES; how do you build a model; modeling of processes and resource use; modeling of variables and decisions. Simple animation will be demonstrated. We will use ARENA to build entry level models. Instructions for downloading training version of Arena will be distributed prior to the course. Participants who wish to have hands-on experience should bring their personal laptops with Arena installed.


 
Sold out Advanced Retrospective Database Analysis
Room: Hall 6
Track:

Observational Data Methods

Level: Advanced.
Prerequisite: The short course “Introduction to Retrospective Database Analysis” is a prerequisite for this course. Participants must have knowledge of statistical methods through OLS regression and experience in the analysis of administrative claims databases
Faculty:

William H. Crown, PhD, President, HEOR and Late Phase Research, OptumInsight Life Sciences, Waltham, MA, USA

Course Description:

Large administrative claims databases provide an opportunity to examine retrospectively the effects of drug use on clinical and economic outcomes in real world settings. This course will describe analytic techniques for estimation of treatment effects and statistical properties of estimators including bias, efficiency, and mean square error. It will briefly review the assumptions underlying ordinary least squares regression (OLS) and the implications of violations (e.g., heteroscedasticity, multicollinearity, autocorrelation). Particular emphasis will be placed on model specification including structural equation models and alternative statistical estimators when OLS is not the appropriate methodology. Maximum likelihood estimation will be discussed along with the concepts of endogeneity and instrumental variables estimation.  


 
Content Validity of PRO, ClinRO and ObsRO Assessments
Room: Hall 8
Track:

Patient-Reported Outcomes / Preference-Based Methods

Level:

Advanced. This course assumes attendees have a basic understanding of qualitative interviewing methods and measurement properties of PRO instruments.

Faculty:
Donald L. Patrick, PhD, MSPH, Professor, University of Washington, Seattle Quality of Life, Seattle, WA, USA
Mona L. Martin, RN, MPA, Executive Director, Health Research Associates, Inc, Seattle, WA, USA
Chad Gwaltney, PhD, Senior Scientist, PRO Consulting, Pittsburgh, PA, USA and Assistant Professor (Research), Department of Community Health, Brown University, Providence, RI, USA
Nancy Kline Leidy Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs, United BioSource Corporation, Bethesda, Maryland, USA
Course Description:

This course will focus on establishing the content validity of patient-reported outcomes, clinical outcomes and caregiver reported outcomes assessments that are intended for use as the basis for medical product claims in the US and Europe. The evidences for supporting content validity take into account the recommendations of the FDA Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, and the EMA Reflection Paper on the Regulatory Guidance on the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products.

After this course, participants will be able to: define the essential evidences needed for establishing and documenting content validity of assessments planned for use in applications for regulatory approval of desired medical product claims. Examples will be given throughout on each evidence requirement. Participants will take part in several practical exercises that are part of the iterative process for determining and establishing evidence of content validity for instruments.  Faculty will also reference the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modifications PRO Task Force Report.

 
Network Meta-Analysis in Relative Effectiveness Research
Room: Hall 7
Track: Outcomes Research Methods
Level: Intermediate. This course requires at least a basic knowledge of meta-analysis and statistics.
Faculty:

Jeroen P. Jansen, PhD, Vice President, Health Economics & Outcomes Research, MAPI Consultancy, Boston, MA, USA

Course Description:

For several medical questions of interest, many treatment options exist for the same indication. These treatments may have been compared against placebo or against each other in clinical trials. Knowing whether one specific treatment is better than placebo or some other specific comparator is only a fragment of the big picture, which should incorporate all available information. Ideally, one would like to know how all the different treatment options rank against each other and how big the differences are in effect size between all the available options. Network meta-analysis offers a quantitative method of integrating all the data from all the available comparisons. Based in part on two ISPOR Task Force reports, the fundamentals and concepts of network meta-analysis will be presented, which is especially useful when there is little or no evidence from direct comparisons. Network meta-analysis provides an integrated and unified analysis that incorporates all direct and indirect comparative evidence about treatments. The material in this course is motivated by instructive and real examples. Instructors will highlight the value of network meta-analysis and indirect treatment comparisons for decision-making; the concepts and assumptions of network meta-analysis (indirect and missed treatment comparisons); and the statistical models for network meta-analysis of different types of outcomes (i.e. dichotomous, continuous and time-to-event) and how heterogeneity and inconsistency can be captured.


 
Sold outRisk-Sharing/Performance-Based Arrangements for Drugs and Other Medical Products
Room: Roof Garden
Track: Use of Pharmacoeconomics / Economic / Outcomes Research Information
Level: Intermediate.
Prerequisite:

It would be helpful for individuals taking this course to have completed the short course “Elements of Pharmaceutical/Biotech Pricing I – Introduction ” or to be familiar with both the key determinants of pharmaceutical pricing and the main international health systems.

Faculty:
Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy, University of Washington, Seattle, WA, USA
Adrian Towse, MA, MPhil,Director, Office of Health Economics, London, UK
Josh Carlson, PhD, Research Assistant Professor, Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy, University of Washington, Seattle, WA, USA
Course Description: There is significant and growing interest among both the payers and producers of medical products for arrangements that involve a “pay-for-performance” or “risk-sharing” element. These payment schemes involve a plan by which the performance of the product is tracked in a defined patient population over a specified period of time and the level of reimbursement is tied by formula to the outcomes achieved. Although these agreements have an intrinsic appeal, there can be substantial barriers to their implementation. The theory and practice, including incentives and barriers, will be analyzed along with several examples of performance-based schemes from Europe, the United States, and Australia. A hypothetical case study will be used in an interactive session to illustrate a systematic approach to weighing their applicability and feasibility.

 
Sold out Cost Estimation and Assessing Financial (Budget) Impact of New Health Care Technologies
Room: Hall 4/5
Track: Economic Methods
Level:

Intermediate. This course is designed for those with some experience with pharmacoeconomic analysis. 

Prerequisite: The short course "Statistical Methods for Pharmacoeconomics & Outcomes Research" is recommended as a precursor to this course.
Faculty:
Josephine Mauskopf, PhD, Vice President, Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA
C. Daniel Mullins, PhD, Professor and Chair of Pharmaceutical Health Services Research, University of Maryland, School of Pharmacy, Baltimore, MD, USA
Stephanie R. Earnshaw, PhD, MS

Stephanie R. Earnshaw, PhD, MS, Vice President, Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA

Course Description:

This course will guide participants through a 6-step process for budget impact analysis, describing the methods to determine costs associated with a health condition and the budget impact of new technologies for that condition. Instructors will also 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, and issues related to imputing missing data will also be discussed. Discussions will conclude with a summary of the ISPOR Principles of Good Practice for Budget Impact Analysis Report.

 
Short Course Program Overview Short Courses Saturday, 3 November 2012 Short Courses Sunday, 4 November 2012

 

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