Short Courses

* Program subject to change

Sat 2 Nov8:00 - 17:00FULL DAY SHORT COURSESIntroduction to Health Economics and Outcomes ResearchLevel: IntroductoryTrack: Economic Evaluation

This course is designed to teach clinicians and new researchers how to incorporate health economics into study design and data analysis. Participants will first review the basic principles and concepts of health economic evaluations, then discuss 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. Different health economic models and techniques will be demonstrated, including cost-minimization, cost-effectiveness, cost-benefit, cost-utility, and budget impact analysis. Decision analysis, sensitivity analysis, and discounting will all be demonstrated and practiced.

Faculty Member

Lorne Basskin, PharmD

Charleston University, Charleston, WV, USA

Lorne Basskin received his Bachelor's degree in business at the University of Toronto and worked as an accountant with a national firm and subsequently developed his own consulting business. He later received his PharmD from the University of the Pacific and completed a post-doctoral residency with Valley Medical Center in Seattle in 1995. Dr. Basskin went on to serve as an Associate Professor in Clinical Practice at two different schools of pharmacy in the United States, and was the Director of Post-Graduate and Continuing Education there for seven years. In 2002, Dr. Basskin started his own Medical Education firm, specializing in education for pharmacists and other health care professionals. From 2005 to 2011 he held various positions with HealthSouth Corporation, a for-profit group of 100 rehabilitation and long-term acute care hospitals. Most recently he served as their National Director of Pharmacy Clinical and Information Services and was involved in implementing the Cerner system of electronic medical records throughout the network. After a two year period with Wingate University College of Pharmacy as their Regional Dean, he moved to Asheville, NC, where he carries on a consulting practice specializing in education about health care technology and outcomes research. Dr. Basskin has written and spoken extensively on the topics of Pharmacoeconomics and Outcomes Research, and published a book on the topic in 1998. He has over 40 peer-reviewed publications and has made over 120 presentations on both clinical and research related matters. He is on the Editorial Board of several National Pharmacy and Medical publications and serves as a peer reviewer for several professional organizations. He has written continuing education programs including that of diabetes, asthma, and Medicare reimbursement. Additionally, he has conducted over 100 one and two day workshops on the meaning and use of pharmacoeconomics for health care decision makers and health care researchers.

8:00 - 12:00SHORT COURSE MORNING SESSIONTools for Reproducible Real-World Data AnalysisLevel: IntermediateTrack: Real World Data & Information Systems

This course will focus on the concepts and tools of reproducible research and reporting of modern data analyses. The need for more reproducible tools in health economics and outcomes research is growing rapidly as analyses of real world data become more frequent, involve larger datasets, and employ more complex computations. This course will cover the principles of structuring and organizing a modern data analysis, literate statistical analysis tools, formal version control, software testing and debugging, and developing reproducible reports. Numerous real-world examples and an interactive class exercise will be used to reinforce the concepts and tools introduced. Participants who wish to gain hands-on experience are required to bring their laptops with R and RStudio installed.

Faculty Member

Blythe Adamson, PhD, MPH

Flatiron Health, New York, NY, USA

Blythe Adamson is a Senior Quantitative Scientist at Flatiron Health. She uses health economics, math, epidemiology, and data science to research and identify high-value medicines in development. Her research has included dynamic transmission modeling of infectious diseases, novel microsimulation modeling methods in oncology, and cost-effectiveness studies to inform policy. Dr. Adamson received her PhD in Pharmacoeconomics and Masters in Public Health in Epidemiology from the University of Washington in Seattle. Before joining Flatiron, she worked on the development of HIV vaccines at Fred Hutchinson Cancer Research Center and informed Gates Foundation investing decisions with the Institute for Disease Modeling at Global Good.

Rachael Sorg, MPH

Flatiron Health, New York, NY, USA

Rachael Sorg is a Senior Quantitative Scientist at Flatiron Health, where she focuses on using real-world data derived from electronic health records to gain insights into cancer treatment trends and health outcomes. Prior to joining Flatiron, she worked at Analysis Group, where she conducted health economics and outcomes research using clinical trial, administrative claims, and other real-world data sources. Ms. Sorg received her Master of Public Health focusing on Health Policy from the Yale School of Public Health.

New! Why All the Hype? Nordic Data ExplainedLevel: IntroductoryTrack: Real World Data & Information Systems

Nordic data has become a hot topic in epidemiology, HEOR, and other observational research in recent years, and for good reason. Denmark, Finland, Iceland, Norway, and Sweden maintain datasets covering the entire Nordic population of over 26 million inhabitants for the duration of their lifetimes. The data includes information on demographics, diagnoses, prescription drugs, socioeconomics, PROs, disease severity, and more. All of this data may all be linked through unique, patient-level social security numbers. The coverage and breadth of data available to researchers in the Nordic countries is globally unparalleled. This course focuses on describing the content and structure of the Nordic data in terms of the variety of ways patients are included, how long they are followed up, what variables are available, and the quality of the data. This leads directly into a discussion about how this data can benefit researchers as well as the key limitations. The course will also consider practical aspects of using Nordic data, including data access from legal and procedural perspectives. Comparisons to other well-known European data such as CPRD will be explored. Key applied examples of analyses using Nordic data will be presented to illustrate the usage and possibilities of this data, including registry-based randomized clinical trials. Note: The applied section of the course will have you assess the feasibility of using Nordic data to address your own research questions, in discussion with course leaders. Please be prepared with a research question. No computer programs are needed for this course.

Faculty Member

Fredrik Borgström, MSc, PhD

Quantify Research and LIME/MMC, Karolinska Institutet, Stockholm, Sweden

Fredrik Borgström holds an MSc in Political Science and Economics from Uppsala University, Sweden and a PhD in Health Economics from Karolinska Institutet, Sweden. He has over 18 years’ experience in providing consultancy services to industry, private, and public organizations and institutions within the field of health economics and outcomes research and market access and reimbursement. Prior to co-founding Quantify Research in 2011 he held positions such as vice president at i3 Innovus (Managing the Swedish operations) and director at European Health Economics. Fredrik has participated in and managed numerous projects in several disease areas, including osteoporosis, rheumatoid arthritis, osteoarthritis, oncology, multiple sclerosis, menopausal symptoms, and cardiovascular disease. His research covers methods such as modeling, data collection, and statistical analysis of retrospective and prospective data. Fredrik is an affiliated researcher at the LIME/MMC department at Karolinska Institutet. Fredrik has been lead author and co-author of more than 90 articles published in scientific journals.

Kirk Geale, MSc

Quantify Research AB, Stockholm, Sweden

Ingrid Lindberg, MSc

Quantify Research, Stockholm, Sweden

Ingrid Lindberg is a Sr Research Analyst at Quantify Research, and holds a MSc degree in Economics from Stockholm School of Economics. Ingrid joined the Quantify team in 2017 and has experience in market access, including cost-effectiveness analysis and health economic modelling, as well as observational register-based real-world data studies. Ingrid has primarily worked in the fields of dermatology, and musculoskeletal and inflammatory disease areas in the Nordics as well as select European markets.

Introduction to the Design & Analysis of Observational Studies of Treatment Effects Using Retrospective Data SourcesLevel: IntermediateTrack: Study Approaches

Retrospective studies require strong principles of epidemiologic study design and complex analytical methods to adjust for bias and confounding. This course will provide an overview of the structures of commonly encountered retrospective data sources with a focus on large administrative data, as well as highlight design and measurement issues investigators face when developing a protocol using retrospective observational data. Approaches to measure and control for patient mix, including patient comorbidity and the use of restriction and stratification, will be presented. Linear multivariable regression, logistic regression, and propensity scoring analytic techniques will be presented and include examples using SAS code that can later be used by participants. This course is an introductory course designed to prepare participants to take intermediate and advanced observational research courses.

Faculty Member

Nahila Justo, MBA, MPhil, MSc

Evidera, Stockholm, Sweden

Nahila Justo is the Director Nordic Region, Data Analytics, RWE at Evidera. Prior to joining Evidera, she worked for 12 years in the industry where she designed and led numerous outcomes research studies, including retrospective database analyses and chart reviews; literature reviews; health-economics models; strategic consulting; stakeholder engagement and advocacy pieces. Mrs. Justo experience spans across a wide range of therapeutic areas, including but not limited to different cancers (breast, lung, prostate, ovarian, sarcoma), haematological malignancies (different lymphoma and leukaemia indications), cardiovascular diseases (heart failure, diabetes), immune-moderated diseases (psoriasis, psoriatic arthritis, axial spondylitis), and in the central nervous system (dementia, insomnia, Alzheimer’s disease, multiple sclerosis). Ms. Justo is a PhD Candidate at the Karolinska Institute and holds a Master in Business Administration from the Stockholm School of Economics, an MPhil in European Studies from the University of Salamanca, an MSc in Economics from the Inter-American Development Bank and the University Torcuato Di Tella and a BA and MA in Political Science and International Relations from the National University of Rosario. Her work has been published in peer-reviewed journals including the Oncologist, Value in Health, BMJ Open, Pharmacoepidemiology and Drug Safety, European Radiology, Expert Review in Pharmacoeconomics and Outcomes Research, European Journal of Cancer Care, International Journal of Gynaecological Cancer, and Annals of Oncology.

Bradley Martin, PharmD, PhD, RPh

University of Arkansas for Medical Sciences, Little Rock, AR, USA

Dr. Bradley Martin is currently Professor and was the founding head of the Pharmaceutical Evaluation and Policy (PEP) Division at the University of Arkansas for Medical Sciences College of Pharmacy. The Pharmaceutical Evaluation and Policy Division offers graduate and professional instruction and conducts research in pharmacoeconomics, patient reported outcomes, pharmaceutical economics, and large health claims data base analysis. Dr. Martin received his PharmD from the University of Illinois and earned his PhD in Pharmacy Care Administration from the University of Georgia. Dr. Martin’s research efforts have focused on conducting retrospective observational comparative effectiveness and economic analyses using large administrative data sets and national health surveys. He conducts policy analyses, and develops cost effectiveness models and has contributed to the understanding of the opioid epidemic. Dr. Martin has over 90 peer-reviewed manuscripts published, which have been collectively cited over 4000 times, and his work has been funded by NIH, AHRQ, VA, and a variety of research foundations as well as partnerships with the pharmaceutical industry. Dr. Martin is contributing to national policy research on opioids and health care financing and has recently lead an international effort to improve the conduct and reporting of CER observational research organized by three national associations: ISPOR, NPC, AMCP.

Introduction to Patient-Reported Outcomes AssessmentsLevel: IntroductoryTrack: Patient-Centered Research

Patient-reported outcomes (PROs) are widely used to evaluate the impact of health technologies, practice innovations, or changes in health policy from the patients' perspective. This course is designed to familiarize people with the range of PRO domains and the role they can play in evaluating the effects of healthcare interventions. This includes symptoms (including those that arise as side-effects of treatment), functioning, general health perceptions, and health-related quality of life. The faculty will describe the steps that researchers generally go through in order to develop and test a new PRO measure. This will include qualitative concept elicitation work, item generation, cognitive interviewing, testing measurement models (when appropriate), and finally, assessment of validity and reliability. The course will also cover issues such as the role of the recall period and cultural/linguistic translation of measures. This is an entry level course which assumes only a passing familiarity with patient-reported outcomes.

Faculty Member

Theresa Coles, PhD

Duke University, Durham, NC, USA

Dr. Theresa Coles is an Assistant Professor in the Center for Health Measurement in the Department of Population Health Sciences at Duke University. She specializes in the development and psychometric evaluation (reliability, validity, responsiveness, and responder thresholds) of patient-reported outcome (PRO) measures. She is interested in developing tools, methods, and processes to support patients in communication with clinicians about their health status or goals/expectations, and developing methods to improve the interpretability of PRO scores. Prior to joining the Duke faculty in 2018, Dr. Coles worked in the Patient-Centered Outcomes Assessment group at RTI Health Solutions for almost 10 years, where collaborated with colleagues to develop and evaluate PRO measures for use in clinical trials and clinical practice. Dr. Coles received her PhD in Health Policy and Management (Decision Sciences and Outcomes Research) from the University of North Carolina at Chapel Hill.

Elements of Pharmaceutical/Biotech PricingLevel: IntroductoryTrack: Health Policy & Regulatory

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 health economics, 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.

Faculty Member

Renato Dellamano, PhD

MME Europe & ValueVector (Value Added Business Strategies), Milan, Italy

Dr. Dellamano, President of MME Europe and founder and President of ValueVector, had been for seven years (from 1996 to 2003) the Head of Strategic Pricing at the global Headquarters of the Swiss pharmaceutical giant Hoffmann-La Roche. In his consultancy activity and during his tenure as global pricing lead at Roche, Dr. Dellamano was instrumental in analyzing and developing global pricing and reimbursement strategies for products in numerous therapeutic areas. A Health Economist and a former Professor of Hospital Management, Dr. Dellamano combines a solid methodological background with extensive global and local business experience in the areas of strategic planning, business development, pharmaceutical pricing and reimbursement, market access, and health economics.

Jack Mycka

Medical Marketing Economics LLC (MME), Montclair, NJ, USA

As MME’s Global President & CEO, Jack provides critical global support for strategic marketing and pricing decisions to clients in the biotech and pharmaceutical industries. As a recognized expert consultant since 2001, he has successfully completed engagements encompassing many product classes and therapeutic areas and markets, including chronic care, oncology, injectable, and other specialty products all centered on value and its interaction with pricing, payers, reimbursement, and marketing in general at both MME and predecessor organizations. Medical Marketing Economics (MME) is a global leader in the development of value-based strategies and research for health care goods and services. MME’s value-based solutions provide our clients with unique guidance, insights, marketing strategies, and tactics. We identify and address appropriate opportunities, problems, and questions through practical experience, academic rigor, business acumen, and a passion for our work. We help our clients appreciate, understand, and arrive at informed decisions that capture value and thereby succeed. Please visit www.m2econ.com to learn more about our methods and experience. During his tenure at Roche Laboratories Inc., Jack established that company’s Pharmaceutical Pricing and Contracting Department. As the Director of this group, he successfully increased the size and scope of the group’s activities dramatically to cover a multitude of strategic, tactical, and operational issues involving pricing, reimbursement, and discounting in both the United States and other major global markets. Market segments covered globally, include market access/managed care, biologics, hospital, oncology, government, as well as emerging pricing and reimbursement issues. Previously, Jack spent ten years as a commercial banker in corporate lending, managing relationships for customers ranging in size from multibillion-dollar organizations to entrepreneurial firms and not-for-profit organizations. He received a BS in Finance from Lehigh University.

New! Fitting the Structure to the Task- Choosing the Right Dynamic Simulation Model to Inform Decisions about Healthcare DeliveryLevel: IntroductoryTrack: Methodological & Statistical Research

The course aims to provide a basic overview of common simulation modeling methods that can be applied in health care delivery research. This course will first review of traditional questions posed for health economics and the traditional modelling approaches employed to answer these questions. Faculty will then introduce the types of questions that might be posed when assessing health care delivery and the simulation models that can be used to address these questions using the "ISPOR Dynamic Simulation Modeling Application in Health Care Delivery Research Emerging Good Practices Task Force report" as a basis. Faculty will subsequently detail the specifics of three common simulation modeling approaches (system dynamics, discrete event simulation, and agent based models), the types of problems that each can address, and their advantages and disadvantages. A case study will be used to illustrate the advantages and disadvantages of each type of modeling method.

Faculty Member

Elisabeth Fenwick, PhD

Pharmerit International, Oxford, OXF, United Kingdom

Elisabeth Fenwick is a senior director in the Modeling and Meta-Analysis team at Pharmerit International, based in Oxford in the UK. Liz provides scientific and strategic support to HE projects globally. She has extensive experience in economic evaluation and health economic modeling having worked in the field for over 20 years. She has worked on a variety of projects in a wide range of disease areas including oncology, respiratory, infectious diseases, cardiology, ophthalmology, and orphan diseases. Liz has also contributed to methods in the field, in particular relating to decision analytic modeling and simulation methods, probabilistic decision analytic modeling and value of information analysis. Liz was a member of the ISPOR joint task force on good research practices in modeling and a co-author on the joint taskforce paper on uncertainty and is currently co-chairing the ISPOR task force assessing emerging good practice in value of information analysis for research decisions. Liz is also a member of the editorial board for Pharmacoeconomics. Liz has a PhD and MSc in Health Economics as well as an MSc in Operations Research and joined Pharmerit from ICON plc where she led the modeling team for the global HE group. Prior to her consultancy career, Liz spent over 15 years as an academic working at University of York, McMaster University, and most recently University of Glasgow.

Maarten J. IJzerman, PhD

Office of Health Economics, Melbourne, Australia

Maarten J. IJzerman is a VCCC professor and head of Cancer Health Services Research in the Faculty of Medicine, Dentristry and Health Sciences of the University of Melbourne in Australia. He also holds a fractional appointment as a professor of Health Technology Assessment in the University of Twente, where he was the Vice-Dean in the Faculty of Science. Maarten is an active global researcher with multiple research visits and collaborations in the USA, UK and Canada. He is an active ISPOR member, serves in different ISPOR taskforces and committees, and promotes active collaboration between ISPOR and the European Cancer Organisation (ECCO). In 2016, he joined the European Society for Medical Oncology (ESMO) Cancer Medicines working group dealing with the disparities in access to cancer drugs. Maarten is a member of the board of two hospitals in the Netherlands, responsible for quality and safety and strategy/innovation.

Deborah Marshall, PhD

University of Calgary, Calgary, AB, Canada

Deborah Marshall, PhD is a Professor in the Department of Community Health Sciences, University of Calgary, Arthur J.E. Child Chair in Rheumatology Outcomes Research and former Canada Research Chair, Health Services and Systems Research. Her research program focuses on the measurement of preferences, cost-effectiveness analysis, and simulation modeling of health services and interventions. Deborah has over 20 years of research experience in health technology assessment agencies, academic institutions, and industry settings in Canada, US, and Europe. She is a founding co-investigator of the Patient and Community Engagement Research (PaCER) Program at the University of Calgary co-leads the economics and stated preferences research platforms for the Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease (UCAN CANDU). Deborah is an active member of the ISPOR as the past-President of the Board of Directors, and as a member of the Patient Preferences Special Interest Group. She is a co-author on the three ISPOR Task Force Reports for Good Research Practice – Checklist for Conjoint Analysis in Health, Conjoint Analysis Experimental Design and Statistical Methods for the Analysis of Discrete-Choice Experiments. She also chaired the two reports from the ISPOR Dynamic Simulation Modeling Application in Health Care Delivery Research Emerging Good Practices Task Force.

Introduction to ModelingLevel: IntroductoryTrack: Methodological & Statistical Research

This course gives a brief overview of different decision-analytic model types and provides an introduction to Markov modeling techniques and their practical application in economic evaluation and outcomes research. Faculty will present analytic approaches including deterministic cohort simulation and Monte Carlo microsimulation, and will provide some technical instructions for modelers. Participants learn about the concepts of variability, uncertainty, probabilistic sensitivity analysis (PSA), and cost-effectiveness acceptability curves (CEAC). Additionally, faculty will use the recommendations of the ISPOR-SMDM Joint Modeling Good Research Practices Task Force to explore when and how modeling should be used in economic evaluation and which are the suitable model techniques. This course is designed for those with some familiarity with modeling techniques.

Faculty Member

Uwe Siebert, MD, MPH, MSc, ScD

UMIT- University for Health Sciences, Medical Informatics and Technology, and Harvard Chan School of Public Health, Hall i.T., Austria

New! Health State Utility (HSU) Recommendations for Identification and Use of HSU Data in Cost-Effectiveness ModelingLevel: IntermediateTrack: Patient-Centered Research

This course will be based on the soon to be published Health State Utility (HSU) Good Practices Task Force Report: Recommendations for Identification and Use of HSU Data in Cost-Effectiveness Modelling. https://www.ispor.org/heor-resources/good-practices-for-outcomes-research/article/identification-review-and-use-of-health-state-utilities-in-cost-effectiveness-models A recent review of economic models in cardiovascular disease indicates that the identification of utilities for the models was not based on formal literature review methods, was not transparent, failed to accurately cite original sources and failed to accurately report the actual values used. In addition researchers sometimes adjusted values without clear justification, assumed no benefit over baseline for comparators, and ignored the impact of adverse events. A recent ISPOR Good Practices Task Force, led by John Brazier, was convened to review these issues and to propose guidance for model developers. The course will describe the main recommendations from the the report including the SpRUCE checklist and will also highlight areas where further methodological work is needed. This course requires some knowledge of utilities.

Faculty Member

John E. Brazier, MSc PhD

University of Sheffield, Sheffield, United Kingdom

John Brazier is Professor of Health Economics and Dean of the School of Health and related Research (ScHARR) at the University of Sheffield. He has more than 25 years’ experience of conducting economic evaluations of health care interventions for policy maker and published over 200 peered reviewed papers. He has a particular interest in the measurement and valuation of health for economic evaluation where he has published widely. He is perhaps best known for his work in developing a preference-based measure of health for the SF-36 (SF-6D), but with colleagues has further developed and extended these methods to a number of specific condition including measures in mental health (ReQoL), asthma, cancer, overactive bladder, dementia and epilepsy. His research has also examined issues including methods of reviewing measures, mapping between measures, valuation methods (including the use of DCE) and more recently he has been developing ways to incorporate equity concerns such as burden of disease into the weights applied to QALYs. He has been an adviser to NICE on HTA methods and was a member of the NICE Technology Assessment Committee. He is a member of the Euroqol Executive Group. Currently he is leading a project to develop a new broader generic measure of quality of life for use in economic evaluation. It is funded by the UK MRC and the EuroQoL Research Foundation in collaboration with colleagues at the Universities of Sheffield and Kent, the Office for Health Economics and NICE, together with colleagues in 5 other countries (Australia, Argentina, Germany, USA and Singapore). For more information about the ‘Extending the QALY’ project see: https://scharr.dept.shef.ac.uk/e-qaly/welcome/

Helene Chevrou-Severac, PhD

Celgene International, Boudry, Switzerland

After a PhD in Economics and Econometrics, Hélène Chevrou-Séverac worked for 10 years in the Academic Field as researcher and professor assistant in Health Economics and Applied Econometrics in France and Switzerland. She taught advanced econometric & statistical analyses of real-world data in the field of health economics to PhD students, as well as economic evaluation methods to Master students. In 2007, Hélène joined the medical industry in Health Economics, Reimbursement & Market Access. She developed a strong experience in health economics, market access, HTA, and reimbursement for medical devices and medical nutrition for patients. In 2014, she joined the pharmaceuticals industry as head of Health Economics & HTA for Takeda, where she developed a Centre of Excellence in HTA. Since 2017, she has been working in Celgene International, as global head of Outcomes Research in the Medical Affairs function. Since 2014, Hélène has also been involved in IMI projects on real-world data (GetReal) and big data (HARMONY), working closely with patients’ associations, regulators, and HTA members. She was also a scientific external advisor to the French HTA agency (HAS) at the time of the development of the CEESP.

Andrew Lloyd, DPhil

Acaster Lloyd Consulting Ltd, London, United Kingdom

Andrew Lloyd is the Director of Acaster Lloyd Consulting Ltd, an outcomes research consultancy. Andrew has previously been the VP and Practice Lead at ICON PLC for 4 years, and a Director at Oxford Outcomes and United BioSource Corporation. Prior to 2001 Andrew had academic positions in Leicester, Oxford, and Aberdeen. His main research interests are in the assessment of patient-reported outcomes. Andrew’s work is concerned with assessing HRQL and patient preferences to support economic submissions for reimbursement to bodies like NICE. Andrew sits on the Executive Committee of the EuroQol group. He undertakes teaching at ISPOR and the University of York. He is a co-Editor at Value in Health. Andrew has undertaken work in a broad range of therapeutic areas including oncology, diabetes, asthma, and vascular disease. These projects have included assessments of quality of life; utility estimation; determination of patient preferences through discrete choice experiments; and development and validation of novel patient reported outcomes. He completed his DPhil in the Psychology Department at the University of York in 1997. Andrew has published over 85 peer reviewed articles in journals including: Medical Decision Making, Lancet, Value in Health, British Journal of Cancer and others. He has been keynote speaker at national and international conferences. He was the research co-Chair at the ISPOR European Conference in 2009. Andrew has supervised PhD students in the UK and US.

13:00 - 17:00SHORT COURSE AFTERNOON SESSIONUse of Propensity Scores in Observational Studies of Treatment EffectsLevel: IntermediateTrack: Study Approaches

In observational research, issues of bias and confounding relate to study design and analysis in the setting of non-random treatment assignment where compared subjects might differ substantially with respect to comorbidities. No control over the treatment assignment and the lack of balance in the covariates between the treatment and control groups can produce confounded estimates of treatment effect. Faculty will explain how propensity scores can be used to mitigate confounding through standard observational approaches (restriction, stratification, matching, regression, or weighting). The advantages and disadvantages of standard adjustment relative to propensity score-based methods will be discussed. Details of propensity score methodology (variable selection, use, and diagnostics) will also be discussed. The course will also elaborate briefly on risk adjustment models that collapse predictors of outcomes and their use relative to propensity scores. This course is designed for those with little experience with this methodology but some knowledge of observational databases.

Faculty Member

Jeremy Rassen, ScD

Aetion, Inc., New York, NY, USA

Dr. Jeremy A. Rassen, ScD, is co-founder and chief scientific officer at Aetion, Inc., a company that provides software to evaluate the effectiveness, safety, and value of medical treatments. At Aetion, Dr. Rassen leads the scientific effort around designing methodology for obtaining and communicating medical evidence from real-world data. Dr. Rassen was formerly an assistant professor of Medicine at the Brigham and Women's Hospital and Harvard Medical School, where he focused on methodology for improved validity and reach of pharmacoepidemiology and comparative effectiveness research, including research into propensity score and instrumental variable methods. Before coming to the Brigham and Women’s Hospital, Dr. Rassen worked in Silicon Valley in numerous computer and software companies, including Hewlett-Packard and Epiphany, Inc. His focus was on high-performance software for the creation and analysis of large marketing databases. Dr. Rassen received his Bachelor’s degree from Harvard College and his Doctorate degree in Epidemiology from the Harvard School of Public Health.

John D Seeger, PharmD, DrPH

Optum, Waltham, MA, USA

Dr. John Seeger is a pharmacoepidemiologist and Chief Scientific Officer at Optum Epidemiology. He is also Adjunct Assistant Professor in Epidemiology at the Harvard School of Public Health. Dr. Seeger has conducted dozens of studies that have addressed regulatory drug safety issues across a wide range of drugs and disease conditions. Most of this work has involved the use of health insurance claims databases as platforms for pharmacoepidemiology, so Dr. Seeger's methodological expertise focuses on research issues encountered in such settings. He has worked extensively with propensity scores and related methods that mitigate confounding by collapsing covariates. Additionally, he is a co-Instructor in courses on propensity scores and is the past President of the International Society for Pharmacoepidemiology (ISPE).

New! US Payers – Understanding the Healthcare System™Level: IntroductoryTrack: Health Policy & Regulatory

The US healthcare system is a hybrid system that provides access to care via various channels and means. It can be categorized as: governmental systems (Medicare, Medicaid, Veterans Health Administration, and Department of Defense, etc), private markets (privately sponsored regional and national health plans), and providers assuming responsibility for access and coverage via mechanisms such as Provider Networks, Integrated Delivery Networks (IDNs), Accountable Care Organizations (ACOs), etc. These elements are quite heterogeneous and characterized by different coverage and access mechanisms. This introductory course will cover the roots of the current US system, its evolutionary process, and the consequent independence of these different parts of the system. The focus will be on value and affordability as defined by cost, access, and quality. While all hold value and affordability as important goals, the different stakeholders take various perspectives and define these goals differently. This results in different objectives, incentives, and principles under which they operate. The intent of this course is to better understand characteristics of the different parts of the US healthcare system and the role of various decision makers within it. The course will cover their structure, scope, processes, and perspectives as well as their approach to balancing access, costs and quality. The course will also cover how industry and others produce evidence to support access and reimbursement decisions and how the evidence is used by decision makers. This session will facilitate the increased level of understanding of these disparate systems and emphasize the need to effectively communicate evidence to various access decision makers to support and enhance evidence driven decision making on value and affordability. This course is designed for those having limited experience in understanding the structure of the US Healthcare system, including its various subsystems and how they operate. The course will focus on how these entities differ in perspectives, coverage mechanisms, and the means and evidence they use to define and achieve both value (access and quality) and affordability.

Faculty Member

Finn Børlum Kristensen, MD, PhD

University of Southern Denmark, Hilleroed, Denmark

Finn Børlum Kristensen is an international strategic consultant in HTA and HEOR implementation and management and is a Professor in Health Services Research and HTA at University of Southern Denmark since 1999. He is also External Lecturer at Copenhagen Business School. He headed the Coordinating Secretariat of the European Network for HTA, EUnetHTA (www.eunethta.eu) from its inception in 2006 and was Chairman of the EUnetHTA Executive Committee until 2016. Dr. Kristensen directed the Danish Centre for HTA (DACEHTA) from its establishment in 1997 until 2009. His PhD is in Epidemiology, and he is a medical specialist in public health. He also worked as a primary care physician for several years. He publishes frequently in scientific journals and was editor of a Health Technology Assessment Handbook. He is now a consultant to public and private organisations and companies. Dr. Kristensen served on the ISPOR Board of Directors from 2011-13 and has chaired the ISPOR HTA Council since 2013.

Erin Lopata, PharmD, MPH

Precision for Value, Pittsburgh, PA, USA

Erin is currently a Senior Director on the Access Experience Team at Precision for Value. Erin also serves as an adjunct professor at the University of Pittsburgh School of Pharmacy, where she coordinates and teaches a course orienting students to managed care pharmacy principles. Prior to joining Precision, Erin led commercial formulary development and specialty pharmacy management for UPMC Health Plan. Erin also served as the residency program director and a preceptor for the PGY-1 Managed Care Residency program at UPMC Health Plan. Erin received her PharmD from the University of Pittsburgh School of Pharmacy, and her Master in Public Health (MPH) from the University of Pittsburgh Graduate School of Public Health. She completed a postgraduate year 1 (PGY1) managed care pharmacy practice residency at UPMC Health Plan.

James F. Murray, PhD

Eli Lilly and Company, Carmel, IN, USA

Jim Murray, PhD is a research fellow within Lilly’s Global Patient Outcomes and Real-World Evidence (GPORWE) Center of Expertise (COE). The GPORWE COE is a multi-disciplinary group that supports the other functions within GPORWE and Lilly in the development and commercialization of Lilly products. Jim provides expertise and scientific support for the following topics within the COE for Real World Evidence and the use of RWE in Clinical Development, Observational and Pragmatic Study Design, and Health Policy issues. Jim has been actively involved in ISPOR since its inception. In addition to the development of the US Health System short course, he is actively involved in the development of the ISPOR Competency Framework, the ISPOR Education Council, and the ISPOR Institutional Council. Jim has a Masters in Information Systems and a PhD in Decision Sciences and Operations Research both from the University of Wisconsin Madison.

Laura Pizzi, PharmD, MPH, RPh

Rutgers University, Piscataway, NJ, USA

Dr. Laura Pizzi is professor and director of the Center for Health Outcomes, Policy, and Economics (HOPE) at Rutgers University. For the past 20 years, she has led interdisciplinary teams of outcomes methodologists, statisticians, and clinicians to develop and conduct cost and outcome analyses on pharmacological therapies as well as a variety of non-pharmacological interventions. A particular interest is developing scientific evidence to inform the US translation and implementation of cost-effective interventions to improve the quality of care for older adults. She has testified before the US House of Representatives Committee on Ways and Means on Medicare overspending in beneficiaries with end stage renal disease., co-directed an Agency for Healthcare Research and Quality (AHRQ) evaluation on pharmaceutical quality, and co-edited a text on economic evaluation of health interventions. She is a member of the Editorial Board for the journal PharmacoEconomics, deputy editor of American Health and Drug Benefits, and chair of the ISPOR Faculty Advisor Council. She has published more than 90 peer-reviewed manuscripts and 1110 peer reviewed poster or podium presentations and has over 15 years of teaching and mentoring experience which has been recognized through faculty awards.

Meta-Analysis & Systematic Literature ReviewLevel: IntermediateTrack: Study Approaches

Meta-analysis may be defined as the statistical analysis of data from multiple studies for the purpose of synthesizing and summarizing results, as well as for quantitatively evaluating sources of heterogeneity and bias. A systematic literature review often includes meta-analysis and involves an explicit, detailed description of how a review was conducted. This course highlights and expounds upon four key areas: 1) impetus for meta-analysis and systematic reviews; 2) basic steps to perform a quantitative systematic review; 3) statistical methods of combining data; and 4) an introduction to methods for indirect comparisons. The material includes practical examples from the published literature relevant to pharmacoeconomic and PRO research. This course is designed for those with little experience with meta-analysis and includes interactive exercises. Participants who wish to gain hands-on experience must bring their personal laptops with Microsoft Excel for Windows installed.

Faculty Member

Neil Hawkins, PhD, MSc, MBA, CStat

University of Glasgow, Glasgow, United Kingdom

Neil is a Professor of Health Technology Assessment (HTA) at the University of Glasgow. He was previously Vice President leading the global Health Economics practice at ICON PLC following its acquisition of Oxford Outcomes Ltd, where he was a member of the Board of Directors. Over the previous fifteen years, he has participated in methodological and applied research regarding the relative and cost- effectiveness of health technologies. In addition to participating individual evaluations, Neil has published articles discussing methods for network meta-analysis, cost-effectiveness modeling, value-based pricing, and the placebo effect. More recently, he has become interested in application of HTA “thinking” during the process of technology development and the development of conceptual models of value. Neil received Master’s Degrees in Health Economics (York) and Applied Statistics (Sheffield Hallam), a BSc and PhD in Pharmacology (University of Bristol), and an MBA (University of Oxford). He is also a Chartered Statistician for the Royal Statistical Society, UK. For more details please see: https://neilhawkins.wordpress.com/

Olivia Wu, PhD

University of Glasgow, Glasgow, United Kingdom

Olivia Wu, PhD is director of the Health Economics and Health Technology Assessment (HEHTA) Research Unit and William R Lindsay chair of Health Economics, at the University of Glasgow. She is also director of the Complex Reviews Support Unit, a national methods support unit for evidence synthesis funded by the UK National Institute for Health Research (NIHR). Olivia has expertise in a broad range of health technology assessment (HTA) methodologies and is interested in adapting and applying HTA methodologies in context. She has a particular interest in evidence synthesis and economic evaluations. Her research spans across a wide range of clinical areas and different types of health technologies (eg, pharmacological treatments, medical devices and diagnostic tests). Her work has informed clinical guidelines and health policy decisions, both at national and international levels. In addition to her research, Olivia has been a long-standing member of the NICE Technology Appraisal Committee and advisor to Healthcare Improvement Scotland. She has also been advisor to HTA agencies in Brazil, China, Taiwan and Thailand.

Statistical Methods for Health Economics and Outcomes ResearchLevel: IntroductoryTrack: Economic Evaluation

This course will provide an introduction to statistical concepts with an emphasis on the use of techniques commonly employed in pharmacoeconomics and outcomes research. Faculty will begin by introducing the concept of random variables and will then proceed to discuss the foundations of statistical estimation and the testing of hypotheses, followed by a discussion of the importance of correlating between variables and the use of regression techniques. The differences between a classical (frequentist) approach to statistics and a Bayesian view of probability will also be outlined. This course is intended for participants with little (or rusty!) statistical training.

Faculty Member

James Lewsey, PhD

University of Glasgow, Glasgow, United Kingdom

Jim Lewsey, PhD, is a reader in Medical Statistics and joined the University of Glasgow in 2007 having previously held posts at the London School of Hygiene and Tropical Medicine (2003-2007), University of Otago (2001-2003), Eastman Dental Institute-UCL (1998-2001), and University of Glasgow (1996-1998). He was awarded Chartered Statistician status from the Royal Statistical Society in 2010 and Chartered Scientist from the Science Council in 2012. His personal research interests stem from methodological challenges faced when analyzing observational and experimental medical data and have included prognostic model development in the presence of missing data, continuous outcome monitoring of long-term outcomes, modelling dental caries data, and design of cluster randomized trials. His current methodological interests include multi-state survival analysis and modelling of data from natural experiments, and in his applied research he is developing a portfolio of alcohol research. Jim leads the Analysis of Linked Health Data (ALDA) program within HEHTA and is deputy lead of the IHW research theme 'Data Science - Using routine administrative data and record linkage for research'. Jim is program director and teaches on the MSc in Health Technology Assessment. He also teaches and coordinates a medical statistics course on the Masters in Public Health.

Gerd K. Rosenkranz, PhD

Medical University of Vienna, Vienna, Austria

Gerd Rosenkranz, PhD, studied Mathematics and Physics at the University of Heidelberg (Germany) and worked as a biostatistician with the German Cancer Research Center. After having received his PhD, he was with the pharmaceutical industry for almost 30 years covering preclinical and clinical development of new therapies, mainly with Hoechst (now Sanofi-Aventis) in Frankfurt, Germany and Sandoz/Novartis in Basel, Switzerland. During his 20+ years in Novartis he led the Statistics Oncology Group, later joined the Statistical Methodology Group and became scientific officer biostatistics. In this role he was representing the statistics function in the review of clinical studies and development plans of Novartis Pharmaceuticals in cardiovascular, immunology, respiratory, neurology, among others. Since beginning of 2016 Gerd is a visiting professor with the Statistics Group of the Medical University of Vienna. His main professional interests are design and analysis of clinical trials, in particular missing data, subgroups, and quantitative decision making in clinical projects. He is co-editor of Pharmaceutical Statistics.

Alternative Economic Assessment for Expressing Healthcare Value and Informing Resource Allocation DecisionsLevel: IntroductoryTrack: Economic Evaluation

Various stakeholders are involved in the funding, decision-making, policy-making and delivery of effective healthcare. Each of these areas requires different perspectives and constraints that can’t be addressed by applying a single perspective modeling framework such as conventional cost-effectiveness analysis. Increasingly, alternative methodological frameworks are required for informing stakeholders outside of the HTA process regarding healthcare and how to inform decisions considering known constraints including budget. This course will discuss different established economic frameworks for assessing economic value. Firstly, faculty will explore fiscal health modeling (FHM) which reflects the government perspective on population health and investments in medical technologies. Specifically, the course will cover how government can benefit from investments in healthcare based on future changes in tax revenue and reduced transfer costs attributed to changes in health status. The course will also cover constrained optimization modeling which considers that decision-making is often made under specific constraints including budget, logistics, compliance, among other features. Thirdly, faculty will discuss the social accounting matrix (SAM) analytic framework which reflects multiple perspectives simultaneously and is used in developed and developing countries for assessing new budget policies. In the context of health, we apply SAM to understand how money flows through different economic sectors based on investments in healthcare. The course will discuss the strengths and weaknesses of these different frameworks and applications in resource allocation decisions.The course outline will follow the recently completed work of the ISPOR Task Force on Economic Analysis of Vaccination Programs Chaired by Josephine Mauskopf and Baudouin Standaert and published in Value in Health. Participants who wish to gain hands-on experience must bring their personal laptops with Microsoft Excel for Windows installed.

Faculty Member

Mark Connolly, PhD

Global Market Access Solutions, Groningen, GR, Netherlands

Mark Connolly is health economist with over 19 years of experience gained in the pharmaceutical industry, consulting and academia. He has a wide range of pharmaceutical market access, economic modeling and cost-effectiveness experience supporting new product launches and lifecycle management while working in global and regional roles within the pharma industry. His research interests include the economics of healthcare and understanding the broader public economic impact of investments in healthcare applying government perspective frameworks. Dr. Connolly is also the managing director and founder of Global Market Access Solutions with licensed offices in Switzerland, UK and United States. He also holds a guest research position at the University of Groningen Pharmacoeconomics and Pharmacoepidemiology Unit in the Netherlands.

Nikos Kotsopoulos, PhD

Global Market Access Solutions, Geneva, GE, Switzerland

Nikos is a health economist with 16 years of experience in the pharmaceutical industry and consulting. Extensive pharmaceutical reimbursement and health economic experience gained working in Europe and international markets, having held global and regional positions for the pharmaceutical industry and as strategy consultant. Produced diversified health economic analyses for developed and developing countries with over 30 peer-reviewed articles and abstracts published. His research focuses on the development and implementation of novel analytic frameworks that assess the public economic effects of healthcare investments.

Baudouin Standaert, MD, PhD

GSK, Wavre, Belgium

Baudouin “Bo” Standaert was born in Bruges, Belgium. He studied medicine (MD) at the KU Leuven and Tropical Medicine in Antwerp (1982). During the first 7 years of his career Bo had a mixed work assignment in academia (University of Antwerp and UCL in Brussels) and abroad (Suriname, Burundi, Salomon islands, WHO (Geneva)). In 1988 he became director of the Provincial Institute of Hygiene in Antwerp. The Institute had around 160 employees split into lab and field work in collecting basic health and environmental information. During that period Bo was the representative of Belgium in the scientific board of IARC in Lyon, France for 4 years. His interest in economic evaluations of health care emerged with the collaboration with the University of Antwerp in 1990. At that time different pharmaceutical companies were interested in getting HE-expertise in house. Bo took the decision in 1995 to join AMGEN to become their first health economist in Europe. A small team of 8 people was set up in Brussels coordinating all their HE-activities. In 2005, it was time to move to another international group in Belgium and to start working on vaccines. Bo became the head of the global HE-team of vaccines in GSK, Wavre, Belgium. He started with 3 collaborators, first working on Rotarix and Cervarix and later on Synflorix. The group counts now 12 persons. The HE-team has a wide experience in developing different types of economic assessments from simple back-of-the envelope models to more advanced dynamic and macro-economic models for pandemic infectious diseases such as malaria, TB, HIV, Flu. The HE-team explores new economic value evidence (Quality of Care, absenteeism, herd effect) away from the conventional cost-effectiveness analysis including optimisation modelling, return on investment, and fiscal modelling. Bo has numerous publications in the many different fields he worked on. He obtained his PhD on rotavirus vaccination, exploring new ways of economic assessment, at the University of Groningen, the Netherlands, in 2015. He was the industrial representative of the WHO-IVIR-working group for 9 years. He co-chaired the taskforce on economic evaluation of vaccines for ISPOR (2016-2018) and was recently appointed industrial lead for the European IMI-Vital (2018-2022) project on vaccination in elderly.

Oleksandr Topachevsky, MSc, PGDip

Digital Health Outcomes, Kiev, Ukraine

Oleksandr is a health economist with 10 years of experience within pharmaceutical industry, consulting and government positions. He is a founder of Digital Health Outcomes, company providing specialised digital solutions for HEOR, Clinical and Regulatory domains. He is also a member of the National EML Committee, an advisor to the MoH and a World Bank consultant working on the healthcare reform in Ukraine. Following his MSc in financial economics from Kiev Schevchenko University, he also obtained a Health Economics PGDip degree from the University of York, UK.

Introduction to Health Technology AssessmentLevel: IntroductoryTrack: Health Technology Assessment

This introductory course is designed to teach academic researchers, health policy decision makers, manufacturers, and clinicians about the key elements, methods, and language of health technology assessment (HTA). The course provides an overview of basic HTA principles including benefit assessment (biostatistics, clinical epidemiology, patient-relevant outcomes, risk-benefit assessment), economic evaluation (costing, cost-effectiveness analysis, pharmacoeconomic modeling, budget impact analysis, resource allocation), and ELSI (ethical, legal, and social implications). Using real world examples covering both drugs and devices, the course will review the practical steps involved in developing and using HTA reports in different countries and health care systems. Group discussion will focus on the perspectives of different stakeholders and the implementation of HTA in health care decision making. This course is suitable for those with little or no experience with HTA.

Faculty Member

Uwe Siebert, MPH, MSc, ScD, MD

UMIT - University for Health Sciences, Medical Informatics, and Technology, Hall in Tirol, Austria

Prof. Uwe Siebert, MD, MPH, MSc, ScD, professor of Public Health, Medical Decision Making and Health Technology Assessment (HTA), is the chair of the Department of Public Health, Health Services Research and HTA at UMIT - University for Health Sciences, Medical Informatics and Technology in Austria and the Director of the Division for HTA in the ONCOTYROL – Center for Personalized Cancer Medicine in Austria. He is also adjunct professor of Health Policy and Management at the Harvard T.H. Chan School of Public Health and director of the Program on Cardiovascular Research at the Institute for Technology Assessment and Department of Radiology at the Massachusetts General Hospital, Harvard Medical School, Boston. He is the course director of the Harvard summer course on ‘Decision Analysis in Clinical Research’ and he has an adjunct teaching appointment at the School of Public Health and Epidemiology at the University of Munich. After medical school, he worked for several years as a physician in international public health projects in West-Africa, Brazil, and Germany. He then earned an MPH at the Munich School of Public Health, and completed an MSc in Epidemiology and a ScD in Health Policy and Management with a concentration in decision sciences at the Harvard School of Public Health. Before he started his faculty position at Harvard Medical School, he was the director of the Bavarian Public Health Research and Coordinating Center at the University of Munich, Germany, and completed Visiting Scholarship at the Harvard Center for Risk Analysis. His research interests include applying evidence-based quantitative and translational methods from public health, epidemiology, comparative effectiveness research, health services and outcomes research, economic evaluation and decision sciences in the framework of HTA as well as in the clinical context of routine health care and patient guidance. His current substantive research focuses on cancer, cardiovascular disease, diabetes, hepatitis C, neurological disorders, and others. His methodological research includes evaluations of public health interventions, prevention/screening, diagnostic imaging procedures, personalized medicine, causal inference from “big” data, decision modelling, and study designs controlling for treatment switching. He has been leading projects/work packages in several EU FP7 and H2020 projects (e.g., ELSA-GEN, BiomarCaRE, MedTechHTA, EUthyroid, FORECEE, MDS-RIGHT, EUREGIO-EFH). He teaches courses in decision-analytic modeling, HTA, economic evaluation, analysis of big data, and causal inference at several universities and for industry in Europe, USA, South America, and Asia. Prof. Siebert is the past-president of the Society for Medical Decision Making (SMDM), a member of the Latin America Consortium Advisory Committee of ISPOR, member of the ‘National HTA Strategy’ Expert Group of the Austrian Federal Ministry of Health, member of the Oncology Advisory Council of the Federal Ministry of Health in Austria, member of the Advisory Board of the GÖG - National Austrian Public Health Institute, member of the Austrian Cochrane Collaboration Branch, and a member of several national and international Directors Boards (Society for Medical Decision Making; Austrian Society of Epidemiology, German Network of EbM; German Association for Medical Informatics, Biometry and Epidemiology). He has served as vice president of SMDM, and a member of the ISPOR Board of Directors, the Directors Board of the German Competence Network Heart Failure, the International Expert Committee Advising the Institute for Quality and Efficiency in Health Care (IQWiG) on the Methods for Economic Evaluations of Health Care Interventions, the Harvard Flagship Initiative in Comparative Effectiveness Research, the Extended Board of Directors of the German Association of Health Economics, and the Advisory Board of the Ludwig Boltzmann Institute for HTA in Austria. He is the Clinical Guideline Commissioner for the Association of the Scientific Medical Societies in Germany (AWMF) and the chairman of the Working Groups ‘Health Economics’ and ‘Medical Decision Making’ of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS). He is co-chair of the ISPOR-SMDM Modeling Good Research Practices Task Force, co-chair of the ‘Issues in Methodology Section’ of the SMDM Policy Initiative, and a leadership member of the ISPOR Personalized/Precision Medicine Special Interest Group. He has worked with several HTA Agencies (eg, DAHTA@DIMDI/Germany, IQWiG/Germany, NICE/UK, ANVISA/Brazil, CADTH/Canada, LBI-HTA/Austria, GÖG/Austria) and he advises government agencies, academic institutions and industry regarding the conduction and impact of health technology assessments on policy and reimbursement decisions. He has authored more than 350 publications including HTA reports, textbook chapters, scientific articles, and editorials, and is Editor of the European Journal of Epidemiology, as well as editorial board member of several scientific journals.

Pharmacoeconomic Modeling - ApplicationsLevel: IntermediateTrack: Methodological & Statistical Research

During this course, students will have hands-on experience in constructing and analyzing a decision analysis tree – including Markov models and one-way, two-way, and probabilistic sensitivity analysis – using TreeAge Pro software. Instructors will provide a series of short lecture-based sessions followed by the opportunity for participants to engage in model-building exercises using the software. Sessions will demonstrate how to build a simple decision tree, extend a decision model to incorporate costs and utilities, and replace terminal nodes with state-transition (Markov) models to represent time-varying events. Other more advanced topics will be covered if time permits. Participants are required to bring their personal laptops equipped with software provided to course registrants.

Faculty Member

Shelby Corman, PharmD, MS

Pharmerit International, Bethesda, MD, USA

Shelby is a Director of Health Economics and Outcomes Research (HEOR) with Pharmerit International, a global HEOR consultancy based in Bethesda, MD. She received her PharmD degree from the University of Pittsburgh School of Pharmacy in 2002, after which she completed a specialty residency in Drug Information at the University of Pittsburgh Drug Information Center in conjunction with the University of Pittsburgh Medical Center (UPMC). After completing this training, Shelby joined the faculty at the University of Pittsburgh and worked in formulary management and drug policy at UPMC, while conducting outcomes research in a variety of therapeutic areas. In 2011, Shelby completed a Master of Science degree in Clinical Research (Health Services Research Track) at the University of Pittsburgh School of Medicine, with thesis work focusing on the cost-effectiveness of new medications in comparison to older, standard-of-care therapies. In 2012, Shelby joined Pharmerit International as a scientist specializing in economic modeling, real-world evidence, and strategic market access. Since joining Pharmerit, Shelby has conducted numerous health economic evaluations, medical chart review studies, claims database analyses, and reimbursement dossiers as a consultant to the pharmaceutical, biotechnology, and medical device industries. Her therapeutic areas of expertise include postsurgical pain, infectious diseases, oncology, and solid organ transplant.

Mark S. Roberts, MD, MPP

University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA

Mark S. Roberts, MD, MPP is Professor and Chair of the Department of Health Policy and Management at the University of Pittsburgh Graduate School of Public Health, and directs the Public Health Dynamics Laboratory, a modeling and simulation group at the University. He also holds appointments as professor of Medicine, professor of Industrial Engineering and professor of Clinical and Translational Science. He obtained a bachelor’s degree in Economics from Harvard College, a Doctor of Medicine from Tufts University, and a Master’s in Public Policy from the Kennedy School. He completed training in internal medicine at the Harvard Medical School, where he was a resident and fellow. Over the past 30 years he has conducted several NIH-funded research programs in the use of mathematics, simulation and decision sciences to improve health care decisions and the delivery of care. He was the founding chief of the Section of Decision Sciences and Clinical Systems Modeling, a research section in the department of Medicine. He has published over 170 papers in academic journals, and been funded on over 40 federally funded grants. He was the 2014 Recipient of the Society for Medical Decision Making Lifetime Achievement Award for contributions in decision sciences. Educationally, he has developed and taught courses in decision analysis and cost effectiveness analysis for several universities, professional societies, pharmaceutical companies and other organizations, both domestically and internationally. He has been the Chair of the education committee for the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and is a member of several other national societies, including the recent President of the society for Medical Decision Making. For the federal government, he has been a member of several NIH research grant review panels, and for two years was chair of the Health Care Technology Assessment and Decision Science review panel.

Analysis of Longitudinal Data- Fixed and Random Effects ModelsLevel: IntermediateTrack: Methodological & Statistical Research

Longitudinal data is often encountered by researchers, allowing them to use the time dimension to uncover deeper insights than what is possible with a traditional cross-sectional snapshot. But this advantage comes at a cost: the assumption that each observation is independent is broken due to the fact that patients are measured on multiple occasions over time. Failure to account for this feature when analyzing data can result in bias, and longitudinal methods should be used to account for this problem. Two powerful but simple solutions are the fixed and random effects estimators, both of which have recently become more popular in medical research. A key feature of both is that they model the unobserved differences between patients, and can even control for unobserved confounding. This course will discuss the methods and intuition behind both modelling techniques, alongside practical examples and interactive sessions in STATA. Attendees will gain both knowledge and practical skills in this course. Although not essential, those who have STATA loaded on their laptops are encouraged to bring your laptop in order to participate in interactive sessions.

Faculty Member

Kirk Geale, MSc

Quantify Research AB, Stockholm, Sweden

Alexander Rieem Dun, MSc

Quantify Research, Stockholm, Sweden

Alexander Rieem Dun is a Research Analyst at Quantify Research. He holds a Bachelor of Arts in Chinese and an MSc in Economics from Uppsala University, Sweden. Prior to joining Quantify Research, he worked as a research assistant at Uppsala University at the Department of economics. Since joining Quantify Research, he has worked with real-world evidence studies across a variety of therapies including dermatology and cardiovascular disease. His interest and expertise lies in study design, observational data analysis, analytic methods, and Swedish register data.

New! Digital Real-World Evidence Generation Approaches in Rare Diseases and OncologyLevel: IntroductoryTrack: Real World Data & Information Systems

This course is designed to provide a good understanding of how to plan and undertake real-world evidence (RWE) studies to collect patient-level data through a digital app and across different countries. During this course, the benefits and challenges of developing digital BYOD apps to collect PRO data will be discussed and analyzed. The focus of the course will be on rare diseases and oncology, and specific case studies will be presented. The methods of analysis of such datasets, as well as their value and use to support HEOR/HTA strategies will also be discussed. The course is open to all -no specific prior experience is required, apart from a basic level of understanding of RWE.

Faculty Member

Mark Larkin, PhD

Vitaccess Ltd, Oxford, United Kingdom

Mark is the chief executive office & founder of Vitaccess. He has more than 20 years of experience in consulting, specializing in European P&R for the last 10 years. Mark founded Vitaccess to harness innovative smartphone and dashboarding technology to build the Company's multi award winning MyRealWorldTM platform, offering real-time digital RWE research. Mark has led all Vitaccess' international RWE studies, across oncology and rare/orphan diseases, and led partnerships with patient advocacy organizations (now >30). Mark has a BA and MA in Natural Sciences and a PhD in experimental psychology.

Annabel Nixon, BSc PhD

Chilli Consultancy Ltd, Salisbury, WIL, United Kingdom

Annabel is an expert in patient centered outcomes, with 20 years’ international experience consulting in the pharmaceutical industry in Europe and the USA; specializing in FDA, EMA, and HTA requirements for PROs and other clinical outcome assessments. Annabel was co-chair of the Drug Information Agency (DIA) Study Endpoints community (2012–2016). She has published many research papers and is the lead author of Patient Reported Outcomes: an overview (eBook, paperback). Annabel has provided key PRO support in registry-based studies, including selection of PRO instruments and implementation and analysis strategies.

Jon Spinage, BSc, CITP

Vitaccess Ltd, Oxford, United Kingdom

Jon is director of Technology at Vitaccess. Jon has over 20 years of experience in software development for desktop, web, and mobile, in a variety of industries, including health economics, banking, life insurance, and pensions. He has managed software development projects for a variety of market access applications. Jon is a Chartered IT Professional and a Registered Practitioner in PRINCE2 project management.

Sun 3 Nov8:00 - 17:00FULL DAY SHORT COURSESBayesian Analysis - Overview and ApplicationsLevel: IntermediateTrack: Methodological & Statistical Research

The first portion of this course is designed to provide an overview of the Bayesian approach and its applications to health economics/pharmacoeconomics and outcomes research. The course will cover basic elements of Bayesian statistics, contrasting briefly with classical (frequentist) statistics, and introduce available statistical packages. The second part of the course is a hands-on workshop where participants will be led through a series of exercises using the free Markov Chain Monte Carlo package WinBUGS. Attendees will have the chance to apply the principles they have learned in the morning session to challenging data analysis problems, including the use of Bayesian generalized linear models (GLM) to analyze cost and outcomes data. This course is designed for those with a limited understanding of Bayesian statistical concepts or for those who want a refresher and more practical experience. Participants are encouraged to bring their personal laptops equipped with software provided to course registrants.

Faculty Member

Keith R. Abrams, PhD, MSc, CStat

University of Leicester, Leicester, United Kingdom

Keith Abrams, PhD, is a professor of Medical Statistics in the Department of Health Sciences at the University of Leicester, having previously held appointments at the London School of Hygiene and Tropical Medicine and King’s College School of Medicine and Dentistry, London, UK. He is a Fellow of the Royal Statistical Society, and a Chartered Statistician. His research interests are primarily concerned with the development and application of Bayesian statistical methods in Health Technology Assessment (HTA), in particular their application to clinical trials, evidence synthesis, and decision modelling, and Non-Communicable Disease (NCD) epidemiology. This work is primarily supported with funding from EU, Medical Research Council (MRC), National Institute for Health Research (NIHR) and industry. Professor Abrams has been extensively involved with the UK NIHR Health HTA Programme and UK National Institute for Health & Care Excellence (NICE) appraisal process since their inception. He was a member of the NICE Technology Appraisals Committee for over 8 years until 2015, is a member of the NICE Decision Support Unit and Technical Support Unit, and a NIHR Senior Investigator Emeritus. He has published widely in both substantive and methodological areas including co-Authoring books on Methods for Meta-Analysis in Medical Research, Bayesian Approaches to Clinical Trials and Healthcare Evaluation, and Evidence Synthesis for Decision Making in Healthcare, in addition to co-Editing one of the first texts on Methods for Evidence-based Healthcare.

Christopher S. Hollenbeak, PhD

The Pennsylvania State University, Hershey, PA, USA

Christopher S. Hollenbeak, PhD is Professor and Head of the Department of Health Policy and Administration at the Pennsylvania State University. Dr. Hollenbeak has broad interests in health economics and health outcomes research, with a particular focus on economic issues in surgery. In previous research he has studied modifications to the kidney allocation mechanism, estimated the cost-effectiveness of screening for head and neck cancer, and estimated the burden of surgical site infections after major abdominal and cardiothoracic surgical procedures. Dr. Hollenbeak received his doctorate in Economics from Washington University in St. Louis, where he studied Bayesian econometrics under Ed Greenberg and Siddhartha Chib. He uses Bayesian methods in meta-analysis and to fit nonlinear risk adjustment models for continuous hospital performance measures.

8:00 - 12:00SHORT COURSE MORNING SESSIONNew! Market Access & Value Assessment of Medical DevicesLevel: IntermediateTrack: Health Policy & Regulatory

This course is designed for those with an intermediate knowledge of medical devices and their market access pathways. The focus will be on understanding the areas of United States (US) and European Union (EU) healthcare systems relevant to medical devices (eg, diagnosis-related groups (DRG’s), inpatient versus outpatient), implicit value drivers of medical devices, the stakeholder organizations necessary to engage in order to obtain medical device funding/reimbursement and adoption, and the healthcare system pathways through which medical devices can be implemented. The course will conclude with a primer on performance-based risk-sharing agreements. Market access for medical devices is an evolving, multi-faceted, and multi-stakeholder journey that requires dedicated knowledge. Experience in launching pharmaceutical products can present both challenges and opportunities for medical device companies, as the pathways, evidence requirements, and value domains are materially different. This course will attempt to demystify the medical device landscape and help all stakeholders ensure that appropriate patients benefit from innovation in the medical device space through improving participants’ awareness of marketplace trends and needs to demonstrate clinical and economic value.

Faculty Member

Rachele Busca, PharmD, MSc, MBA

W.L GORE, Verona, Italy

Graduated in Chemistry & Pharmaceutical Technology at Bologna University and completed education in Health Economics & Outcomes Research with a Master at the University of Milan and an MBA at the Bologna Business School. Market Access & Health Economics & Outcomes Research expert / Director level professional with over 10 years of experience in Medical Device, including Health Economics & Outcomes Research, Reimbursement & Access and Value strategies, delivering data and tools to effect reimbursement, funding and Health Technology Assessments at International level. Currently EMEA Leader Health Economics at W.L GORE – a Global Devices manufacturer known for innovation and a modern, distinctive company culture. Previously served for over 7 years the Italian Pharmaceutical business in Bayer, Recordati and consultancy group Pbe. Most recently as Director Pricing and Reimbursement Strategy at BTG and Principal Manager at Medtronic assisting several divisions: interventional pulmonology, cardiology, cardiac disease management, structural heart, peripheral products. Specialties: market access strategies, pricing, HEOR, incorporation of market access requirements into clinical, medical & commercial strategies, new market assessment, due diligence.

Richard Charter, MSc

ValueConnected, Basel, Switzerland

Richard is currently the director of Value Based Healthcare at ValueConnected, a company focusing on aligning key stakeholders to ensure adoption of medical technologies via procurement, reimbursement, and risk sharing agreements. Richard is also currently the co-chair of the ISPOR Medical Devices Interest Group, where he also teaches the short course on Market Access for Medical Devices. Richard is also the co-chair of HTAi Medical Device Interest Group, where he is frequently called on as a guest speaker. Richard is currently the industry advisor to COMED, an EU funded consortium measuring outcomes and costs in medical devices. Richard graduated from SDA Bocconi in Milan with a Masters in Healthcare Management, Economics & Policy, as well as from the University of Guelph in Canada, in Management Economics & Public Policy.

Michael Drummond, MCom, DPhil

University of York, York, United Kingdom

Michael Drummond, BSc, MCom, DPhil is Professor of Health Economics and former Director of the Centre for Health Economics at the University of York. His particular field of interest is in the economic evaluation of health care treatments and programmes. He has undertaken evaluations in a wide range of medical fields including care of the elderly, neonatal intensive care, immunization programmes, services for people with AIDS, eye health care and pharmaceuticals. He is the author of two major textbooks and more than 650 scientific papers, and has acted as a consultant to the World Health Organization and the European Union. He has been President of the International Society of Technology Assessment in Health Care, and the International Society for Pharmacoeconomics and Outcomes Research. In October 2010 he was made a member of the National Academy of Medicine in the USA. He has advised several governments on the assessment of health technologies and chaired one of the Guideline Review Panels for the National Institute for Health and Care Excellence (NICE) in the UK. He is currently Co-Editor-in-Chief of Value in Health and has been awarded 3 honorary doctorates, from City University (London), Erasmus University (Rotterdam) and the University of Lisbon.

Stephen Hull, MHS

Hull Associates LLC, Rockland, MA, USA

Stephen Hull is President and Founder of Hull Associates LLC, a specialized global reimbursement strategy firm focused on medical device, diagnostic, pharmaceutical and biotech technologies. Founded in 2007, Hull Associates has market access and reimbursement experts in all major product areas, and is dedicated to helping clients achieve market access and reimbursement success. With 40+ seasoned partners worldwide, Hull Associates LLC develops and executes strategies for reimbursement and product launches in the US and major global markets, including the Americas; Asia Pacific; Northern & Eastern Europe; The Middle East; and Western Europe. Stephen has an advanced degree in health policy from the Johns Hopkins Bloomberg School of Public Health, and a bachelor’s degree in international relations and French from Colgate University.

Risk-Sharing/Performance-Based Arrangements for Drugs and Other Medical ProductsLevel: IntermediateTrack: Health Policy & Regulatory

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. Issues surrounding 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. This course is designed for those with some experience with health economic analysis.

Faculty Member

Josh Carlson, MPH, PhD

University of Washington, Seattle, WA, USA

Louis P. Garrison, PhD

University of Washington, Seattle, WA, USA

Lou Garrison, PhD, is professor emeritus in The Comparative Health Outcomes, Policy, and Economics Institute in the School of Pharmacy at the University of Washington, where he joined the faculty in 2004. For the first 13 years of his career, Dr. Garrison worked in non-profit health policy at Battelle and then the Project HOPE Center for Health Affairs, where he was the Director from 1989-1992. Following this, he worked as an economist in the pharmaceutical industry for 12 years. From 2002-2004, he was vice president and head of Health Economics & Strategic Pricing in Roche Pharmaceuticals, based in Basel, Switzerland. Dr. Garrison received a BA in Economics from Indiana University, and a PhD in Economics from Stanford University. He has more than 150 publications in peer-reviewed journals. His research interests include national and international health policy issues related to personalized medicine, benefit-risk analysis, and other topics, as well as the economic evaluation of pharmaceuticals, diagnostics, and other technologies. Dr. Garrison was elected as ISPOR President for July 2016-June 2017, following other leadership roles since 2005. He recently co-chaired the ISPOR Special Task Force on US Value Frameworks. He was selected in 2017 by PharmaVOICE as being among “100 of the Most Inspiring People” in the industry. He recently received the PhRMA Foundation and Personalized Medicine Coalition 2018 Value Assessment Challenge First-Prize Award as lead author on a paper on “A Strategy to Support the Efficient Development and Use of Innovations in Personalized and Precision Medicine.”

Adrian Towse, MA, MPhil

Office of Health Economics, London, United Kingdom

Professor Adrian Towse is director emeritus and senior research fellow of the Office of Health Economics in the UK. Adrian’s current research includes incentives for new drugs and vaccines to tackle Antimicrobial Resistance, the use of 'risk-sharing' arrangements between healthcare payers and pharmaceutical companies, including value-based pricing approaches; the economics of pharmacogenetics for healthcare payers and the pharmaceutical industry; economic issues that affect both R&D for and access to treatments for diseases prevalent in the developing world; the economics of medical negligence; and measuring productivity in healthcare. A visiting professor at the London School of Economics and a senior researcher at the Nuffield Department of Population Health at the University of Oxford, Adrian also has been a visiting professor at the University of York. For ten years, he served as the non-executive director of the Oxford Radcliffe Hospitals NHS Trust, one of the UK’s largest hospitals. Adrian was president of ISPOR, for the 2014-15 term. Adrian joined the OHE in 1993 and served as director for 25 years. He holds an MA (Hons) in Politics, Philosophy and Economics from Keble College, Oxford; an MPhil in Management Studies from Nuffield College, Oxford, and the Oxford Centre for Management Studies; and is a member of the Chartered Institute of Management Accountants.

Using Multi-Criteria Decision Analysis in Healthcare Decision Making- Approaches & ApplicationsLevel: IntroductoryTrack: Health Technology Assessment

Many health care decisions – such as portfolio optimization, benefit-risk assessment (BRA), health technology assessment (HTA), and shared decision making (SDM) – require a careful assessment of the underlying options and the criteria used to judge these options. This assessment can be challenging given the trade-offs between multiple value criteria. In light of this, many decision makers have begun investigating the use of multi-criteria decision analysis (MCDA) in support of these decisions. This course provides an introduction to MCDA for health care. The course will focus on the use of MCDA for HTA, and will be organised around the following parts: 1) Introduction to MCDA: What is it and how is it being use in HTA?; 2) Implementing MCDA 1: Practical tips when implementing MCDA; 3) Implementing MCDA 2: Methodological options when designing an MCDA; and 4) Using MCDA for HTA. Challenges and possible solutions. These parts are designed to familiarise participants with the steps involved in undertaking an MCDA, the alternative ways of implementing these steps, and good practice guidelines. The course will also review the current MCDA HTA landscape, including current use of MCDA for HTA and the challenges this poses. The course is designed for those unfamiliar with MCDA, but who have a basic understanding of other evaluation methodologies. The course is designed for those unfamiliar with MCDA, but who have a basic understanding of other evaluation methodologies.

Faculty Member

Nancy Devlin, PhD

University of Melbourne, Melbourne, VIC, Australia

Nancy J. Devlin is director of the Centre for Health Policy at the University of Melbourne in Australia. Previously, she was director of research at the Office of Health Economics in London. Professor Devlin has more than 30 years’ experience in health economics and health outcomes research and serves as an advisor to international healthcare organizations, both in the public and private sectors. She is past-president of the EuroQol Group. She has published more than 100 peer-reviewed journal articles and a number of books in the field. She served as a director on the ISPOR board of directors from 2015-2017 and is now serving as the Society’s president for the 2019-2020 term.

Maarten J. IJzerman, PhD

Office of Health Economics, Melbourne, Australia

Kevin Marsh, PhD

Evidera Ltd, Newport Pagell, BKM, Great Britain

Kevin Marsh, PhD, is Executive Director at Evidera in London, UK. He specializes in the use of preference data and decision analysis to inform health decisions, including pipeline optimisation, authorisation, reimbursement, and prescription decisions. Dr Marsh’s research interests include stated and revealed preference methods, decision modelling, and MCDA. He has applied these and other research techniques for a range of organisations, including both regulatory and industry clients. He actively contributes to the methodological development of these techniques. He is currently co-Chairing the ISPOR Task Force on the Use of MCDA in Health Care Decision-Making, and is a co-Convenor of the Campbell and Cochrane Economic Methods Group. Dr Marsh completed his PhD at the University of Bath, specialising in economic valuation techniques. After a year at Oxford University, he joined the Matrix Knowledge Group in London, before joining Evidera in April 2012.

Budget Impact Analysis I – a 6-Step ApproachLevel: IntermediateTrack: Economic Evaluation

This course will describe the methods used to estimate the budget impact of a new health care technology, and will present six basic steps for estimating budget impact: 1) estimating the target population; 2) selecting a time horizon; 3) identifying current and projected treatment mix; 4) estimating current and future drug costs; 5) estimating change in disease-related costs; and 6) estimating and presenting changes in annual budget impact and health outcomes. Both static and dynamic methods for estimating the budget and health impact of adding a new drug to a health plan formulary will be presented. These six steps will be illustrated using actual budget impact models. This course is designed for those with some experience with pharmacoeconomic analysis.

Faculty Member

Thor-Henrik Brodtkorb, PhD

RTI-HS Nordics, Ljungskile, Sweden

Thor-Henrik Brodtkorb, PhD, is senior director in Health Economics at RTI Health Solutions (RTI-HS). He holds a PhD in Health Technology Assessment from the University of Linköping and has been with RTI-HS for 7 years. He has been teaching courses in decision-analytic modeling at Linköping University as well as presented workshops and short courses on decision-analytic modeling techniques for organizations such as Pharma Industry Sweden, Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). At RTI-HS, Dr. Brodtkorb leads development of cost-effectiveness, cost-utility, cost-consequence, and budget-impact models for pharmaceutical, device, and diagnostic technologies. These models have been used to support reimbursement decisions in more than 15 European countries including NICE in UK, SMC in Scotland, TLV in Sweden, and NOMA in Norway. He has developed models and analyses in the areas of oncology, alcohol dependence, major depressive disorder, Alzheimer’s disease, dermatology, multiple sclerosis, cardiology, orthopedics, and asthma. His research has been presented at professional conferences and published in peer-reviewed journals. He is also a coauthor of the newly published book Budget-Impact Analysis of Health Care Interventions: A Practical Guide.

Stephanie R. Earnshaw, PhD, MS

RTI Health Solutions, Research Triangle Park, NC, USA

Stephanie Earnshaw is Senior Vice President of Health Economics at RTI Health Solutions (RTI‑HS). She received her PhD in Industrial Engineering at North Carolina State University and has been with RTI-HS for over 19 years. She has presented workshops, distance learning, and short courses on decision-analytic modeling techniques for pharmaceutical companies and organizations such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Academy of Managed Care Pharmacy (AMCP), and the Centers for Disease Control and Prevention (CDC). Dr. Earnshaw currently serves on the ISPOR Board of Directors, and she has held an Adjunct Faculty appointment at the University of North Carolina’s Eshelman School of Pharmacy, Division of Pharmaceutical Outcomes and Policy. She is also one of the lead authors of the newly published book Budget-Impact Analysis of Health Care Interventions: A Practical Guide. Dr. Earnshaw’s research focus is in applying decision-analysis techniques to industry-related issues and health care problems. Her areas of specialization include mathematical programming (constrained optimization), network optimization, and Markov, simulation, and other state transition modeling. She has developed innovative mathematical models using these methods to determine pricing strategy, predict clinical outcomes, and allocate resources. In addition, she continues her support for the pharmaceutical, biotechnology, and diagnostic and medical device industry by developing budget-impact and cost-effectiveness models for their health technologies. Therapeutic areas include cardiovascular disease, gastrointestinal disorders, respiratory disease, transplantation, infectious disease, osteoporosis, vaccines, and oncology. She is a member of the International Society for Pharmacoeconomics and Outcomes Research and the Institute for Operations Research and the Management Sciences. She has presented her work at professional conferences and has published in several peer-reviewed journals.

C. Daniel Mullins, PhD

University of Maryland, School of Pharmacy, Baltimore, MD, USA

C. Daniel Mullins, PhD is a professor and chair of the Pharmaceutical Health Services Research Department at the University of Maryland School of Pharmacy. He is founder and executive director of the University of Maryland PATient-centered Involvement in Evaluating effectiveNess of TreatmentS (PATIENTS) Program, an infrastructure to support patient-centered outcomes research and related training activities. He also serves as director of the Community and Collaboration Core within the university’s Institute for Clinical and Translational Research. Dr. Mullins has received funding as a principal investigator from the NIH/NIA, NIH/NHLBI, AHRQ, the Patient-Centered Outcomes Research Institute (PCORI), and various patient advocacy and industry organizations. He has served as a regular member of AHRQ and NCI Study Sections and has chaired PCORI Study Sections. Professor Mullins is one of two editors-in-chief for Value in Health and is author/co-author of more than 225 peer-reviewed articles. He has received an Outstanding Service Award from the Drug Information Association (DIA) and two Service Awards from ISPOR. In 2007, he received the Dr. Patricia Sokolove Outstanding Mentor Award from the University of Maryland Baltimore campus-wide Graduate Student Association. In 2013, he was the recipient of the Dr. Daniel D. Savage Memorial Science Award, the Association of Black Cardiologists’ most prestigious annual award. Also in 2013, he was awarded a University System of Maryland Wilson H. Elkins Professorship. He was named Researcher of the Year in 2014 and received the Martin Luther King Faculty Diversity Award in 2017 for the University of Maryland Baltimore campus and the ISPOR Marilyn Dix Smith Leadership Award.

Cost-Effectiveness Analysis Alongside Clinical TrialsLevel: IntermediateTrack: Economic Evaluation

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, "Good Research Practices for Cost-Effectiveness Analysis alongside Clinical Trials: The ISPOR RCT-CEA Task Force Reports". Trial design, selecting data elements, database design and management, analysis, and reporting of results will all be presented. Trials designed to evaluate effectiveness (rather than efficacy), as well as clinical outcome measures, will also be discussed, including how to obtain health resource use and health state utilities directly from study subjects and economic data collection fully integrated into the study. Analyses guided by an analysis plan and hypotheses, an incremental analysis using an intention to treat approach, characterization of uncertainty, and standards for reporting results will be presented. Familiarity with economic evaluations will be helpful.

Faculty Member

Federico Augustovski, MSc, PhD

University of Buenos Aires, Buenos Aires, B, Argentina

Federico Augustovski, MD, MSc, PhD, is the current director of Health Economic Evaluations and Technology Assessment at the Institute for Clinical Effectiveness and Health Policy (IECS), an independent non-profit organization affiliated to the University of Buenos Aires, a CONICET (National Scientific and Technical Research Council) center, and one of the few INAHTA Health Technology Assessments agencies in Latin America. Federico is the director of the WHO Collaborating Centre in Health Technology Assessment and Economic Evaluations at IECS. He is also the founding editor-in-chief for Latin America section of Value in Health Regional Issues, the ISPOR peer-reviewed journal for Latin America, Asia, and Central & Eastern Europe, Western Asia, and Africa. He is the director of the PAHO affiliated PROVAC Center of Excellence for decision making in vaccines. Federico leads a multidisciplinary team devoted to clinical and economic evaluations of new and existing preventive, diagnostic, and therapeutic technologies that provides research, education, and technical support with public and private health decision makers in Latin America. He is a professor of Public Health at the School of Public Health of the University of Buenos Aires, where he teaches courses for graduate and postgraduate students in Decision Sciences; Patient-Reported Outcomes Development in Health, as well as Health Economic Evaluations. Federico earned his MD with honors at the University of Buenos Aires and is a specialist in family medicine. He practiced family medicine and was a staff physician for more than 20 years at the Family and Community Medicine Division of the Hospital Italiano de Buenos Aires. He received his MSc in epidemiology (Harvard School of Public Health). He was a European Union Scholar in health economics at the Centre for Health Economics at the University of York in the UK. His research production concentrates in health technology assessments and health economic evaluations methods and applications. He has published more than 70 PubMed-indexed papers. Federico has served and serves ISPOR in several capacities during the past 10 years. Among other commitments, he was the first Latin American director on the board of directors, the founder and first president of the Argentine local chapter, the first chair of the Latin American Consortium, chair of the Research Excellence Award, president of Buenos Aires 2013 Regional meeting, member of the Health Science and Policy Council and Vision 2020 teams, as well as several Task Forces.

Shelby D Reed, PhD, RPh

Duke University, Durham, NC, USA

Shelby D. Reed, PhD, RPh, is professor in the Departments of Population Health Sciences and Medicine and the Duke-Margolis Center for Health Policy at Duke University. Dr. Reed has 20 years of experience in economic evaluation, health services research, and health policy. Dr. Reed has extensive expertise in designing and conducting trial-based and model-based cost-effectiveness analyses of medical diagnostics and interventions in numerous therapeutic areas. She was a member of the ISPOR Task Forces that published recommendations for Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials in 2005 and 2015. She has led a wide range of economic and epidemiological studies using secondary data from healthcare claims, clinical trials, surveys, and disease registries. In her evaluations of health policy issues, she has developed computer models to analyze the potential economic impact of trends in clinical trial design, changes in reimbursement policies, financial incentives and the regulatory process in the development of orphan drugs, and the societal value of alternative approaches to identifying drug safety problems. Dr. Reed currently leads the Center for Informing Health Decision at the Duke Clinical Research Institute. Dr. Reed received her pharmacy and doctoral degrees from the School of Pharmacy at the University of Maryland and completed her training at the University of Washington.

Mapping to Estimate Utility Values from Non-Preference-Based Outcome Measures Part 1Level: IntermediateTrack: Patient-Centered Research

Mapping is the term used to refer to studies which estimate health state utility values from some non-preference based outcome measures. It is a practice commonly undertaken in HTA, most typically when clinical trials have not included any preference based instrument which would permit the estimation of QALYs in a cost-utility analysis. Mapping uses a different dataset to bridge this evidence gap. This is an introductory level course that will provide instruction to participants on key issues faced either when conducting, interpreting or using the results of a mapping study. It will draw on the ISPOR Good Practice Guide on Mapping that all faculty were members of. The course will introduce the concept of mapping and highlight the types of areas where it has been used. Using real world examples we will provide an overview of the main considerations for mapping including, how to select an appropriate dataset for mapping, key aspects for undertaking the statistical analysis and producing the optimal mapping model, how to report, interpret and use results from mapping in real world cost-effectiveness studies. A mixture of formal presentations, group discussions and illustrated examples will be used with an emphasis on interactive elements between the faculty and participants.

Faculty Member

Monica Hernandez, MSc, PhD

University of Sheffield, Sheffield, NYK, United Kingdom

Monica Hernandez, BSc, MSc, PhD, is an econometrician and health economist with extensive experience in developing complex statistical and econometric models. She has worked extensively on measurement error and latent variable modelling, and the analysis of observational data. On the latter area of research, she has been an author of two technical Support Documents providing guidance and future research recommendations on the use of observational data for submissions to the National Institute for Health and Care Excellence (NICE). Recently, her research has focused on investigating the properties and policy use of EQ-5D, leading to the development of new methods for analyzing and mapping preference based measures. Monica has developed Stata user-written commands to allow practitioners to use those newly developed methods. She was a member of the ISPOR Good Practice Guideline Task Force on Health Utilities Mapping on which this short course is based.

Andrea Manca, MSc, PhD

University of York, Heslington, York, United Kingdom

Andrea Manca is an applied health economist with more than 20 years’ experience in the area of economic evaluation for healthcare decision-making. He has evaluated a wide range of technologies (therapeutic medical devices, drugs, diagnostics and non-pharmaceutical interventions) in a number of different clinical areas, including oncology, cardiology and respiratory diseases, diabetes, chronic pain, surgical interventions, obstetrics, and gynecology. His research interests focus on developing methodological solutions to address the issues that arise when analyzing and interpreting health economics and outcomes research data to inform person-centered healthcare decision-making. This involves the use of advanced statistical and decision modelling techniques for the analysis of cost effectiveness and outcomes data, including quantitative evidence synthesis and health econometrics methods. Andrea received the ISPOR Award for Excellence in Methodology in Pharmacoeconomics and Health Outcomes Research (2008), and a number of other national scholarships and awards from the BackCare Society (2004), the Wellcome Trust (2007), and the UK National Institute of Health Research (2009). He is a former co-editor (currently serving on the EAB) of the scientific journal Value in Health and member of the ISPOR Bernie O'Brien New Investigator Award panel. Andrea is deputy chair of the UK NIHR Doctoral Research Fellowship scheme and member of the Technology Appraisal Committee of the National Institute for Health and Care Excellence (NICE) for England and Wales. Andrea holds a MSc in Health Economics (1998) and a PhD in Economics (2005), both by the University of York, UK. His full CV can be found here: https://www.york.ac.uk/che/staff/research/andrea-manca/

Allan Wailoo, MA, MSc, PhD

University of Sheffield, Sheffield, United Kingdom

Allan Wailoo, PhD, is a professor of Health Economics in the School of Health and Related Research (ScHARR), University of Sheffield, UK where he has worked since 2000. He directs the National Institute for Health and Care Excellence’s Decision Support Unit and is co-director (with Mark Sculpher) of the UK Department of Health Policy Research Unit for Economic Evaluation. He is a member of NICE’s Medical Technologies Appraisal Committee and co-editor for the ISPOR journal Value in Health and recently chaired the ISPOR Task Force on Good Practices in Mapping on which this short course is based. He has published numerous papers on mapping methods and has wider research interests in all areas of economic evaluation and related methods.

Transferability and Relevance of Cost-Effectiveness Data between CountriesLevel: ExperiencedTrack: Economic Evaluation

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 relevant estimates on health care costs and patient outcomes. More and more, they are only willing to accept foreign or international data when transferable to their own decision-making context. However, little guidance exists on how to do this. This course starts with a discussion of factors that make economic data more difficult to transfer from one country to another than clinical data, and will focus on the report of the ISPOR Good Practices on Economic Data Transferability Task Force. In this respect, faculty will discuss the transferability of health state valuations based on the EQ-5D instrument and the transferability of lost productivity data. Next, faculty 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-study while working in small groups. A stepwise procedure will illustrate how to select a foreign cost-effectiveness model for adaptation to your own decision-making context. Finally, a detailed approach on how to adapt a cost-effectiveness model calculation will be illustrated using the case of breast cancer treatment. During the course, faculty will present transferring issues encountered when assessing model-based economic evaluations. 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.

Please note: The statistical methods used to analyze multinational trial data and to transfer these data to a specific country are beyond the scope of this course.

Faculty Member

Silvia Evers, PhD, LLM

Maastricht University, Maastricht, Netherlands

Silvia Evers studied Health Sciences (Mental Health Sciences; Health Policy & Administration), Epidemiology, and Law (Labour and Social; Health Law). Since the early nineties, she has been working as a researcher in the field of Economic Evaluations/Health Technology Assessment at the Institute for Rehabilitation Research, the Maastricht University (Epidemiology; Health Economics; Medical Sociology), the National Institute for Public Health and the Environment (Centre for Care Studies), the University of Amsterdam (Pedagogics), and the University Hospital Maastricht (Neurosurgery). Next to research she has been working as a legal (Ethical Commission Psychology) and policy advisor at the faculty of Psychology of Maastricht University, where she headed the Research Institute of the Faculty Board. Currently she holds a chair on Public Health Technology Assessment at the Maastricht University, Department of Health Services Research. Next to that, she has worked at the Trimbos Institute, the Centre of expertise on mental health and addiction in the field of HTA research since 2013. At the Maastricht University, she is program leader of the program ‘Creating value-based healthcare’ and profile coordinator of the HTA-trace of the Health Sciences Research Master. She is involved as an HTA-project leader, promotor and supervisor in numerous (clinical) trials funded both nationally (ZonMw, NWO, industry, etc), and internationally (EU, OECD). She is a coordinator and a senior lecturer in HTA and Health Economic courses. Her chief current research efforts are directed towards the methodology of economic evaluation of public health interventions, meta-analysis, and quality of life analysis. She has a special interest in the application of these methods looking at innovative interventions in the field of brain related and mental diseases, public health, youth, and rehabilitation. She is a member of several national and international working groups, editor for several journals, and a referee for various research programs.

Manuela Joore, PhD

Maastricht University Medical Centre+, Maastricht, Netherlands

Manuela A. Joore graduated from Health Policy, Economics and Management (Maastricht University) in 1996. Following her graduation she has worked as a researcher in the field of Health Technology Assessment at the Maastricht University Medical Center and Maastricht University. She got her PhD in Economics in 2002 (Maastricht University) on the topic of health economic evaluation. Since 2006 Manuela has been teaching methods of Health Technology Assessment at Maastricht University and at other organizations. She is the developer and coordinator of the 'Cost-effectiveness modelling methods' course of the Health Sciences Research Master. She is a member of the 'Scientific Advisory Committee' of the National Health Care Institute. She is also a member of the 'Rational Pharmacotherapy' committees of the Netherlands Organisation for Health Research and Development (ZonMw). She is on the HTA board of the Dutch Centre for Personalised Cancer Treatment. Manuela leads a health economics evidence review group for the National Institute for Health and Care Excellence in the United Kingdom. She holds a chair on 'Health Technology Assessment and decision-making' at Maastricht University. Her research focus is on (mostly model-based) health economic evaluation in a large variety of clinical areas. She uses economic evaluation to inform decision making regarding the (further) development, reimbursement, and use of healthcare technologies. She is (co-)author of over 120 peer-reviewed papers and is/was supervisor of 16 PhD students. She is involved in numerous Health Technology Assessment studies as an HTA-project leader and promotor. The total number of national and international grants obtained as a (co-)applicant adds up to more than 30 with a total sum of more than 13 million Euros.

New! Probabilistic Graphical Models with Openmarkov, an Open-Source ToolLevel: IntermediateTrack: Methodological & Statistical Research

This course will introduce probabilistic graphical models (PGMs), such as Bayesian networks, influence diagrams and decision analysis networks, and discuss their advantages over traditional techniques; for example, influence diagrams and decision analysis networks are equivalent to decision trees containing thousands of branches, Markov influence diagrams can model state-transition problems without multiplying the number of states and decision analysis networks can evaluate large models with unordered decisions. OpenMarkov, an open-source tool, allows to build PGMs for complex problems using a graphical user interface, without writing any code, such as spreadsheet formulas, macros or functions. For beginners, the course will be an introduction to medical diagnosis and decision making. For participants who have already conducted cost-effectiveness analyses it will be interesting to see that building and evaluating a PGM is easier, faster and less error-prone than building and debugging an equivalent model using a spreadsheet, a (Markov) decision tree or a programming language, such as R, MATLAB or C++. Participants are invited to bring their own laptops with OpenMarkov installed.

Faculty Member

Francisco Javier Diez, PhD

Universidad Nacional de Eduación a Distancia (UNED), Madrid, Spain

F. J. Díez is full professor of artificial intelligence at UNED, the largest Spanish university. He built DIAVAL, one of the first Bayesian networks for medicine. He has been principal investigator in several national and international projects and published his work in some the most relevant journals of AI, including Artificial Intelligence and Artificial Intelligence in Medicine, and health decision analysis, such as Medical Decision Making and Pharmacoeconomics. He is the leader of a research group that built OpenMarkov, an open-source tool for PGMs, especially tailored to medicine, which has been used in more than 30 countries. He has been teaching probabilistic graphical models to computer science students for 25 years. He is the director of a modular program that has taught around 2,000 health professionals since 1996.

Understanding Survival Modeling with Application to HTALevel: IntermediateTrack: Methodological & Statistical Research

Time-to-event (survival) analysis is an important element in many economic analyses of health care technologies. This is particularly true in oncology given the requirement to estimate lifetime costs and outcomes (i.e. extrapolate) beyond the follow-up typically observed in clinical trials. Cost-effectiveness estimates can be sensitive to the methods applied in modelling survival data. Recommendations for selecting a parametric survival model have been recently been published; following a review of extrapolation modelling in National Institute for Health and Care Excellence (NICE) technology appraisals. The purpose of this course is to provide participants with an understanding of the fundamentals of survival analysis and key issues to be considered when comparing alternative survival models for inclusion in cost-effectiveness analysis. This will include an understanding of differences between partitioned survival and Markov-based approaches.

Faculty Member

Andrew Briggs, DPhil

University of Glasgow, Glasgow, United Kingdom

Andrew is a professor of Health Economics and the London School of Hygiene & Tropical Medicine. Previously, he held the William R Lindsay Chair in Health Economics at the University of Glasgow. Following a sabbatical at Memorial Sloan Kettering Cancer Center, New York in 2016/17 he remains a visiting investigator, collaborating with Dr. Peter Bach on value frameworks for oncology medications. Andrew has expertise in all areas of health economic evaluation -- he has published over 200 articles in the peer-reviewed literature. He has particularly focused on statistical methods for cost-effectiveness analysis. This includes statistical methods for estimation of parameters for cost-effectiveness models as well as statistical analysis of cost-effectiveness alongside clinical trials. He also has a more general interest in epidemiological methods, in particular the use of prognostic scoring methods for predicting health outcomes and the relationship with heterogeneity in cost-effectiveness. Andrew took a leadership role as co-chair of the Joint Society for Medical Decision Making (SMDM) and ISPOR Task Force on Modelling Methods. The Task Force, which was responsible for producing a set of seven papers covering all aspects of modeling methods applied to medical decision making and health technology assessment. He is also the author of two successful textbooks, one published by OUP entitled Decision Modelling for Health Economic Evaluation, and another published by Wiley entitled Statistical Methods for Cost-Effectiveness Analysis. In addition to his academic activities, Andrew is also director & principal of Avalon Health Economics, a small consultancy company based in New Jersey, USA, which focuses on providing support to companies bringing products to market in both US and ex-US.

Andrew Davies, MSc

University of Glasgow, Glasgow, United Kingdom

Andrew Davies is senior health economist at the University of Glasgow. He was until recently principal health economist at ICON Health Economics and has over 15 years’ experience of cost-effectiveness modeling in health. He has lead modeling projects in a wide range of clinical areas, including cardiovascular disease, oncology, neurology, and psychiatry. In recent years he has been closely involved with the UK Risk Share Scheme for Multiple Sclerosis Disease Modifying Therapies. He regularly conducts projects for the development of global cost-effectiveness models with a focus on submissions to bodies such as NICE. These frequently involve analysis of survival data, developing suites of risk equations based on randomized and observational data to support extrapolation and examination of heterogeneity in cost-effectiveness models.

James Lewsey, PhD

University of Glasgow, Glasgow, United Kingdom

13:00 - 17:00SHORT COURSE AFTERNOON SESSIONReimbursement Systems for Pharmaceuticals in EuropeLevel: IntermediateTrack: Health Policy & Regulatory

Unlike marketing authorization for pharmaceuticals, mainly regulated at the European level by EMA, pricing and reimbursement decisions in Europe are managed by individual member states. Health care services are generally covered by a single public health insurer operating under the Ministry of Health supervision. As a monopoly buyer, this situation provides a leading position for the public health insurer to set reimbursement conditions. Therefore, based on each country’s set of regulations, processes, and values, wide variations exist in pricing and reimbursement decisions of pharmaceuticals. Using up-to-date governmental regulation sources and the ISPOR Global Health Care Systems Roadmap, this course will discuss health technology decision-making processes for reimbursement decisions for pharmaceuticals in France, Germany, Hungary, Italy, Poland, Spain, Sweden, and the UK. The course will describe these reimbursement systems, as well as compare, and bring into contrast their key characteristics. 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 Member

Mondher Toumi, MD, MSc, PhD

Aix Marseille University, Marseille, France

Professor Mondher Toumi is a MD by training and holds two MSc in Biostatistics, and in Biological Sciences (option pharmacology) and a PhD in Economic Sciences. He is professor of Public Health at Aix-Marseille University. After working for 12 years as a research manager in the Department of Pharmacology at the University of Marseille, he joined the Public Health Department in 1993. In 1995, he entered the pharmaceutical industry and worked there for 13 years. Mondher Toumi was appointed global vice president at Lundbeck A/S in charge of health economics, outcome research, pricing, market access, epidemiology, risk management, governmental affairs, and competitive intelligence. In 2008, he founded Creativ-Ceutical, an international consulting firm dedicated to support health industries and authorities in strategic decision-making. In February 2009 he was appointed professor at Lyon I University in the Department of Decision Sciences and Health Policies. The same year, he was appointed director of the chair of Public Health and Market Access. He launched the first European University Diploma of Market Access (EMAUD) an international course already followed by more than 350 students. Additionally, he recently created the Market Access Society to promote research and scientific activities around market access, public health and health economic assessment. Since 2009, he also chaired the Annual Market Access Day, a purely academic event. He is editor in chief of the Journal of Market Access and Health Policy (JMAHP), which is PubMed index. Since September 2014, he joined the research unit EA3279 of the Public Health Department, at Aix-Marseille University (France) as full professor. Mondher Toumi is also visiting professor at Beijing University (Third Hospital). He has been an active member of ISPOR from its creation. He served as co-chair of the Research Review Committee ISPOR Europe in 2012 and 2013. He contributed to Short Courses in ISPOR Asia and Europe. He is member of the Editorial Board of Value and Outcome Spotlight. From 2010 he contributed to ISPOR conferences with more than 196 posters and podium presentations and 11 issue panels and workshops. He co-Chaired two consecutive SIGs on orphan drugs. He also supported ISPOR African and Nigerian Chapter. He is a recognized expert in health economics and an authority on market access and risk management. He has more than 200 scientific publications and oral communications and has contributed to several books. He just finished a book on Market Access soon to be available.

Advanced Methods for Addressing Selection Bias in Real-World Effectiveness and Cost-Effectiveness StudiesLevel: IntermediateTrack: Methodological & Statistical Research

Reimbursement agencies require real-world evidence on the effectiveness and cost-effectiveness of new drugs and medical devices. In many settings, randomised controlled trial (RCT) data is unavailable or insufficient. Where non-randomised data is used to estimate treatment effectiveness and cost-effectiveness, the main methodological challenge is selection bias from confounding by indication. Standard regression or propensity score methods are frequently used to adjust for selection bias, but estimates of treatment effectiveness may be highly sensitive to the chosen parametric form of these models, and evidence that relies on such methods may be viewed as insufficient by reimbursement agencies. While new, more advanced methods for allowing for confounding cannot offer a panacea, they have been shown to provide estimates of treatment effectiveness that are relatively robust. This course offers an in-depth description of ‘cutting edge’ methods for addressing this form of selection bias. These methods include flexible regression which uses machine learning for model selection, propensity score matching with regression adjustment, and Genetic Matching, a recently developed approach that extends propensity score matching. The course introduces the participants to these methods using the R software, through a series of real world data examples. Faculty will also demonstrate sensitivity analyses that convey to decision makers the extent to which the estimates of effectiveness and cost-effectiveness are robust to that assumption of no unobserved confounding. Participants who wish to have hands-on experience must bring their personal laptops with appropriate software installed.

Faculty Member

Richard Grieve, PhD

London School of Hygiene and Tropical Medicine (LSHTM), London, United Kingdom

Richard Grieve is a professor of Health Economics Methodology at the London School of Hygiene and Tropical Medicine (LSHTM). He holds a senior research fellowship from the National Institute of Health Research (NIHR), which aims to improve analytical methods for decision-making. Since 2002, Richard has led a research programme on the design and analysis of observational studies for establishing relative effectiveness and cost-effectiveness. Richard has provided scientific advice to NICE and has contributed to Decision Support Unit (DSU) Technical Support Documents on the appropriate use of observational data. Richard also advises the Department of Health in England on how to improve the use of evidence from observational studies for policy-making purposes. Richard has published more than 90 articles in peer-reviewed journals, and secured about £25 million in research grants from the research councils, NIHR, and the DoH.

Noemi Kreif, PhD

Centre For Health Economics, York, United Kingdom

Noemi Kreif is a research fellow at the Centre for Health Economics, at the University of York. She holds a PhD in Health Economics from the London School of Hygiene and Tropical Medicine and she has recently held a UK Medical Research Council Early Career Fellowship in the economics of health, on statistical methods to address confounding in economic evaluation. Her methodological work includes translating advanced causal inference methods to health economic evaluation and decision modelling, in the complex settings of time-varying confounding, and more recently, for the economic evaluation of health system level interventions.

Stephen Oneill, MEconSc, PhD

National University of Ireland, Galway, Galway, Ireland

Stephen O’Neill is a lecturer in Economics (Health Economics & Ageing) at the National University of Ireland Galway and a Visiting Research Fellow at London School of Hygiene and Tropical Medicine (LSHTM). Stephen's primary research interests are in health economics and micro-econometric methods. Stephen is particularly interested in translating methods from other fields within economics and from disciplines such as biostatistics, epidemiology, political analysis, and sociology, to the health economics domain. Stephen completed a first degree in Economics at University College Dublin followed by a Masters in Economic Policy (Evaluation and Planning) and PhD in Economics at National University of Ireland Galway (NUIG). Along with Prof. Owen O’Donnell (Erasmus University Rotterdam), Prof. Tom Van Ourti (Erasmus University Rotterdam), and Dr. Brendan Walsh (Economic and Social research Institute), Stephen is the author of conindex, a command for the Stata statistical package, which computes a variety of inequality measures, including the concentration index and Gini coefficient.

Multi-Criteria Support Systems for Group Decision MakingLevel: IntermediateTrack: Health Technology Assessment

MCDA models combine multiple dimensions of value (“attributes”) into a single metric, hence allowing evaluation of healthcare interventions in comprehensive ways using specific decision-makers’ values. Using different approaches, all MCDA models have two common features: (a) elicitation of decision makers’ values, and (b) transforming the performance of candidates (on multiple dimensions of value) into common scales (“data scaling”). This course emphasizes how to accomplish these key steps when groups (vs. individuals) are the decision makers (or are advising a final single decision maker). Various MCDA models differ substantially on the number of decisions required (by decision makers) to complete the models, a complexity that is exacerbated in settings with group decision making (voting), versus individual decision making. This course will review the virtues and complications of different MDCA models and provide hands-on testing of several voting methods to combine individuals’ preference weights into a group weights. Separately, we will explore various data-scaling mechanisms used in multi-criteria models, the errors they might introduce, and examine ways to simplify these processes. Finally, we will explore methods to create decision cut-offs (maximum willingness to pay) in multi-criteria models, akin to those used in cost-effectiveness analysis (CEA) when multiple factors interact under budget constraints. This intermediate-level course presumes at least an introductory familiarity with multi-criteria decision analysis (MCDA) models. It is designed to supplement (rather than as an alternative to) previous ISPOR Short-Courses that discuss MCDA at an introductory level.

Faculty Member

Guru Madhavan, PhD, MBA

National Academies of Science, Engineering, and Medicine, Washington, DC, USA

Guru Madhavan is a senior program officer and director of studies at the National Academies of Sciences, Engineering, and Medicine, where his portfolio of work has included leading: a global health program on infectious diseases, the creation of a decision support platform to help prioritize new vaccine development, and the analyses for making prescription medicines affordable and toward a national strategy for cancer control in the United States. He has given invited briefings at several state and federal agencies, Capitol Hill, European Commission, and the World Health Organization. He has served as a technical adviser to the US Department of Health and Human Services and has been a strategic consultant for technology startup firms and nonprofit organizations. A systems engineer by background, he received his MS and PhD in biomedical engineering and an MBA from the State University of New York. He has worked in the medical device industry as a research scientist developing cardiac surgical catheters for ablation therapy and advised the development and testing of neuromuscular stimulators for improving blood circulation. He has served two-terms as a vice-president and member of the board of directors of IEEE-USA. His honors include the Association for the Advancement of Medical Instrumentation’s AAMI–Becton Dickinson Award for Professional Achievement, the IEEE–USA Professional Achievement Award, and the Washington Academy of Sciences’ Krupsaw Award for engineering sciences and education. He has also received the inaugural Innovator Award and the Cecil Medal from the presidents of the National Academies of Sciences, Engineering, and Medicine. He was a founding member of the Global Young Academy and has been named a distinguished young scientist by the World Economic Forum. He has co-edited eight books and is author of Applied Minds: How Engineers Think (W.W. Norton) that has been published in multiple foreign markets and languages.

Charles E. Phelps, PhD, MBA

University of Rochester, Gualala, CA, USA

Charles E Phelps, PhD, University Professor and Provost Emeritus of the University of Rochester (Rochester, NY USA), health economist, has published major theoretical and applied research in health economics and particularly in cost-effectiveness analysis since beginning his career at the RAND Corporation, including a founding role in the RAND Health Insurance Experiment. During his time on the active faculty of the University of Rochester (1984 – 2010), he served for five years as chair of the (currently named) Department of Public Health Sciences, and then (for 13 years) as Provost of the University of Rochester. His more recent work has focused on expanding cost-effectiveness analysis using multi-criteria decision analysis (MCDA) models, voting theory (to improve use of MCDA models in group settings), and systems approaches to evaluating health care. His textbook, Health Economics, is in its sixth edition (2017) and (with Stephen T. Parente) published in 2017 a new book entitled “The Economics of US Health Care Policy.” He was elected to the Institute of Medicine (now the National Academy of Medicine) in 1991. Professor Phelps served as a member of the ISPOR Task Force on Value in Health in 2016-2017.

Risk-Sharing/Performance-Based Arrangements in Central & Eastern Europe- Implementation of Managed Entry AgreementsLevel: IntermediateTrack: Health Policy & Regulatory

During the recent years, Managed Entry Agreements (MEAs) have become instrumental in ensuring the access of the innovative medicines. This course is designed for health care professionals (including public decision-makers, academia and industry) involved in pricing and reimbursement decisions who are wishing to understand the applicability and technical aspects of managed entry agreements (MEAs) in countries with severe economic constraints and explicit cost-effectiveness criterion. The topic will be introduced with key features of pricing and reimbursement systems in Central-Eastern European countries to understand why special methods are needed to facilitate evidence-based reimbursement policies of new health technologies. Faculty will present an economic model to explain the methodology and implications of managed entry agreements in cost-effectiveness and budget impact analysis. Participants will then have the opportunity to apply what they have learned through a hands-on exercise on making pricing and reimbursement decisions. A decision algorithm will be presented to support evidence and value based policy decisions of high-cost new technologies in CEE countries. A series of password protected economic models will add more and more complexity to a pragmatic case study on a new pharmaceutical product in oncology. To close the course faculty will lead a discussion on the applicability of a pragmatic decision tool illustrating the pros and cons of different managed entry agreements and their usefulness in CEE settings. Participants who wish to gain hands-on experience must bring their laptops with Microsoft Excel for Windows installed.

Faculty Member

Rok Hren, PhD, MSc

University of Ljubljana, Ljubljana, Slovenia

Rok Hren has more than 15 years of commercial experience in pharmaceutical industry, with more than 12 years on a board level in both (i) line management, which has included full P&L responsibility for operations in Slovenia and Romania, and (ii) leadership regional functions in Central and Eastern Europe. He regularly presents on the topic of pharmaceutical economics and policies at conferences in Europe and is well experienced in healthcare media business. He received his PhD in Physiology and Biophysics from Dalhousie University, Canada and MSc in International Health Policy (Health Economics) with Distinction from London School of Economics and Political Science, UK while he was a post-Doctoral Fellow at Nora Eccles Harrison Cardiovascular Research and Training Institute, University of Utah Medical School, USA. He is also a professor at the University of Ljubljana and past president of ISPOR Slovenia Regional Chapter. In total, his publications gathered 300/394 citations (excluding self-citations) in WoS/Scopus (as of September 10, 2016).

Zoltan Kalo, PhD

Semmelweis University and Syreon Research Institute, Budapest, Hungary

Zoltán Kaló is a professor of Health Economics at the Center for Health Technology Assessment of Semmelweis University in Budapest, Hungary. Before moving to Semmelweis University in July 2019 he was the founder and co-director of an international master program in Health Policy, Planning, and Financing at Eötvös Loránd University (ELTE). Dr. Kaló is also the founder and leader of Syreon Research Institute, an international research corporation specializing in health policy, health economic modeling, and technology assessment. He has 25 years of international experience in academia and industry, specializing in health systems design, HTA implementation, health economics and outcomes research, patient access, and pricing policies of healthcare technologies. Dr. Kaló serves as a policy advisor to public decision makers and global healthcare corporations. He is a Scientific Committee member of the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). He was a director of ISPOR between 2012-2014, and the chair of ISPOR Central and Eastern European Network Executive Committee between 2013-2015.

Katarzyna Kolasa, PhD

Kozminski University, Warszawa, Poland

Katarzyna Kolasa has more than 20 years of academic and business experience in the healthcare sector. She holds a PhD degree in health economics and is an author of more than 60 publications. Katarzyna Kolasa reviews manuscripts submitted to Health Policy, Value in Health, Expert Review of Pharmacoeconomics & Outcomes Research, International Journal for Equity in Health and International Journal of Technology As-sessment. Katarzyna Kolasa heads the Health Economics & Healthcare Management Division (HeM) at the Kozminski University. She is the leader of the International Master Pro-gram Health Economics & Big Data at the Kozminski University financed by the re-search grant of the National Center for Research and Development which was listed as the best project in the POWER 2018 call. In the past, she worked at both global and regional Health Economics & Outcomes Re-search (HEOR) functions at AstraZeneca and BiogenIdec being based in Sweden and Switzerland respectively. At Bristol Myers Squibb and Lundbeck she was leading Mar-ket Access teams in Central Eastern European (CEE) and Nordic Region. Her practical skills in the field of health economics were developed at the Kalmar County Council in Sweden as well. For the last five years, she has been developing experience with the pricing &reimbursement challenges in the field of medical devices. Since 2016, Katarzyna has been representing Straub Medical as Global Market Access Lead being the External Principal Consultant for that Swiss family owned company. Before that, Katarzyna was employed as a Senior HEOR Director at GE Healthcare. Her extensive knowledge in the field of health economics was acquired at University of York, University of Lund, and University of Bergen as well as during International Doc-toral Courses in Health Economics and Policy organized by the Swiss School of Public Health. Katarzyna was nominated by the Ministry of Science to represent Poland in the COST Action CA17117, COST Association „Towards an International Network for Evidence-based Research in Clinical Health Research”. Since January 2019, she is working on the establishment of Global Special Interest Group for Digital Health at ISPOR.

Budget Impact Analysis II- Applications & Design IssuesLevel: IntermediateTrack: Economic Evaluation

This course covers the concrete application of the six-step approach for developing budget impact analyses and provides hands-on learning with two different budget impact models programmed in Excel. The course will review the basics of budget impact analysis, interpretation of results, simplicity versus accuracy and face validity, and how budget impact analyses are used by payers and other decision makers. Technical topics will include static versus dynamic budget impact models, considerations for device and diagnostic technologies, and realistic features such as patient copayments and use of generics. The instructors will walk through two different budget impact analyses programmed in Excel (one static and one dynamic) and work with participants on hands-on exercises to enhance these models. The instructors will also review good practices for building budget impact models and provide a number of Excel tips. The Excel-based budget impact models used for the course will be provided to participants in advance of the conference. This course is designed for those who have basic knowledge of budget impact analyses and desire exposure to these analyses in Excel. Participants who wish to gain hands-on experience must bring their personal laptops with Microsoft Excel for Windows installed.

Faculty Member

Thor-Henrik Brodtkorb, PhD

RTI-HS Nordics, Ljungskile, Sweden

Anita Brogan, PhD

RTI Health Solutions, Manchester, LAN, United Kingdom

Anita Brogan is Head of Decision Analytic Modeling within the Health Economics division at RTI Health Solutions (RTI-HS). She holds a PhD in Operations Research from the University of North Carolina and has been with RTI-HS for 16 years. She has presented workshops, distance learning courses, and short courses on decision-analytic modeling techniques in a variety of venues, including meetings of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Academy of Managed Care Pharmacy (AMCP). Dr. Brogan has held an adjunct professorship in the Fermanian School of Business at Point Loma Nazarene University. She is also a coauthor of the book Budget-Impact Analysis of Health Care Interventions: A Practical Guide. In her role at RTI-HS, Dr. Brogan uses analytical techniques to assess and present the clinical and economic value of emerging pharmaceutical and biotechnology products. She leads development of user-friendly and transparent cost-effectiveness, cost-utility, and cost-consequence models; budget-impact models; resource allocation models; and infectious disease transmission models programmed in Microsoft Excel and other platforms. She has experience with numerous types of modeling procedures, including Markov and other stochastic models, simulation, regression, linear and nonlinear programming, and various types of sensitivity analysis. Dr. Brogan has developed models and analyses in the areas of HIV, hepatitis C, RSV, influenza, cystic fibrosis, spinal surgery, mental health, women’s health, oncology, osteoporosis, chronic pain, age-related macular degeneration, bone healing, hospital-acquired infection, financial portfolio optimization, and vehicle routing. Her research has been presented at various professional conferences and published in peer-reviewed journals.

Stephanie R. Earnshaw, PhD, MS

RTI Health Solutions, Research Triangle Park, NC, USA

New! Mapping to Estimate Utility Values from Non-Preference-Based Outcome Measures. Part 2Level: IntermediateTrack: Patient-Centered Research

Mapping is the term predominantly used to refer to studies that employ individual patient level data to estimate health state utility values from some non-preference based outcome measures. It is a practice undertaken in HTA, usually but not exclusively, when clinical trials have not collected preference-based instruments (a requirement to be able to derive QALYs in a cost-utility analysis). Using a mixture of lectures and practical exercises, this course will teach participants how to analyses individual patient level data to derive estimates of health state utilities from non-preference based outcome measures.This is an intermediate level course that will help participants to conduct mapping studies consistent with ISPOR Good Practices. It is a practical, computer-based course that requires participants to be familiar with the concept of mapping, associated good practices, and have a reasonable degree of competency with statistics and the use of the software Stata. Faculty will provide instruction on how to organize the data, pre-modeling checks, and detailed teaching on the implementation of methods that are recommended for mapping. These include both direct methods (where the health utility scores are the dependent variable) and indirect methods (where responses to the descriptive system of a preference based instrument are modeled). Computer code and pre-programmed Stata commands will be the basis for much of the practical instructions. Participants are encouraged to bring their personal Laptop computer with Stata 14 installed for use during the practical exercises. Attendees who do not own a copy of Stata can purchase an educational version (lasting 6 months) here http://www.stata.com/order/new/edu/gradplans/student-pricing/nodl/ for a small cost.

Faculty Member

Monica Hernandez, MSc, PhD

University of Sheffield, Sheffield, NYK, United Kingdom

Andrea Manca, MSc, PhD

University of York, Heslington, York, United Kingdom

Allan Wailoo, MA, MSc, PhD

University of Sheffield, Sheffield, United Kingdom

New! Creating Natural, Flexible Models with DICE SimulationLevel: IntroductoryTrack: Methodological & Statistical Research

DICE simulation is emerging as a standard approach to designing and building models for health technology assessment (HTA) because it is very transparent, simple to use and yet flexible enough to implement everything from cohort Markov to discrete event simulation in plain Excel. This course will provide a detailed understanding of the DICE concepts, its components and how it works. A discrete event simulation and a Markov model will be constructed live to illustrate how quick and easily DICE models are implemented and modified and highlight the advantages and disadvantages of DICE. This course is designed for those with some familiarity with modeling. For this course, participants are required to bring a fully charged personal laptop equipped with Microsoft Excel installed, a version 2007 or later. It needs to be a Windows version so if it is on a Mac, a Windows emulator and Windows Excel is needed.

Faculty Member

J. Jaime Caro, MDCM, FRCPC

Evidera, Waltham, MA, USA and University McGill, Canada, Waltham, MA, USA

J. Jaime Caro, MDCM, FRCPC, FACP, is chief scientist at Evidera where he advances Evidera’s leadership in developing and applying novel techniques in modeling, health economics, comparative effectiveness, epidemiology, and outcomes research. Dr. Caro is also adjunct professor of Medicine, Epidemiology and Biostatistics at McGill University, and professor in Practice at the London School of Economics. He also lends his teaching ability to other academic institutions such as Thomas Jefferson University School of Population Health. Dr. Caro continues to pioneer new methodologies. In an effort to provide an alternative to the well-known cost per QALY technique and avoid many of the latter’s problems, he is working on a broader approach to valuing health benefits. He is also further developing DICE, the unified approach to health economic modeling that he has created. Working with health technology assessment agencies and academic groups, he is formalizing this innovation to enable rapid, standardized and less error-prone development of decision-analytic model. Previously, Dr. Caro adapted an engineering technique – discrete event simulation – to model diseases and their treatment and extended it further to simulate the design of clinical trials and other types of studies, something which has been particularly effective in helping design pragmatic clinical trials. He has also applied the technique to provide comparative effectiveness information in the absence of head-to-head trials in a new method called Simulated Treatment Comparison. In response to increasingly frequent requests by authorities to provide data to support the value of new interventions, Dr. Caro has applied simulation techniques to make post-marketing registries more feasible and efficient – an approach called SAVES. On behalf of the German health technology assessment agency, he proposed an innovative approach to the assessment of health technologies, involving the efficiency frontier. As part of his work with governments, he has helped the World Bank Institute and the InterAmerican Court for Human Rights address the growing problem of Supreme Courts overriding health care system decisions and ordering them to provide treatments that had been considered unwarranted. After leading the Quality Assurance for Modeling Studies Task Force, jointly sponsored by ISPOR, Academy of Managed Care Pharmacy and the National Pharmaceutical Council, and the ISPOR-SMDM Good Modeling Practices Task Force, endorsed by the Society for Medical Decision Making, Dr. Caro was recently named co-chair of the ISPOR Science and Research Committee and has been awarded the Marilyn Dix Smith Leadership Award.

Jörgen Möller, MSc

Evidera, Hammersmith, United Kingdom

Jörgen Möller, MSc, is Vice President, Modeling Technologies with Evidera in London, UK. He specializes in simulating complex systems and played a key role in simulating the re-design of the Swedish national postal distribution system, the extension of Stockholm-Arlanda Airport, and the utilization of surgical theatres at Eskilstuna Hospital. Intrigued by the dearth of simulation in pharmacoeconomics and outcomes research, Mr. Möller joined Caro Research in 2003 as a specialist in discrete event simulation (DES) and has been instrumental in implementing DES as a modeling tool in medicine. His focus has been on translating methods from operations research to pharmacoeconomics and on developing guidelines for this type of modeling. Mr. Möller has created more than a dozen DES models in the areas of devices and pharmaceuticals. He also conducts advanced training courses in DES and the ARENA-software. Mr. Möller received an MSc-degree in mechanical engineering at Lund University, Sweden.

Value of Information (VOI) AnalysisLevel: IntermediateTrack: Economic Evaluation

Value of Information (VOI) techniques provide the analytic framework to estimate the value of acquiring additional evidence to inform a decision problem. VOI analysis is increasingly used to inform research prioritization decisions as it allows evaluating the extent to which new evidence might improve expected benefits by reducing the level of uncertainty in the current evidence base and compares that improvement with the cost of conducting the research. The course will provide a thorough understanding of the concepts and methods used in VOI analysis for participants with a working-knowledge of model-based cost-effectiveness analysis and its role in healthcare decision making. The course is based on the recommendations of the ISPOR Value of Information Task Force Reports and will 1) provide participants with an introduction to the fundamentals of VOI; 2) explain why VOI is important to decision makers; 3) identify the types of healthcare decisions that can be supported by VOI, as well as its limitations; 4) describe how the methods should be used and how the results should be interpreted, and 5) explain how VOI can support decision making in different contexts. Participants are provided with the opportunity to engage with concrete applications of the six-step approach for VOI analyses, including identification and characterization of different sources of uncertainty, calculation of the Expected Value of Perfect Information (EVPI), Expected Value of Perfect Parameter Information (EVPPI), Expected Value of Sample Information (EVSI) and Expected Net Benefit of Sampling (ENBS) and interpretation / presentation of results. To help participants engage with the course content, the instructors will walk through each step of the VOI analyses using worked examples (e.g. on VOI of next-gen sequencing studies, immunotherapy trials, and other emerging technologies). They will guide participants through hands-on exercises in Excel and R, show available online VOI tools, and lead discussions on the topic. This course is designed for beginners in VOI analysis that have some experience with probabilistic decision modelling. Participants are required to bring a laptop with Excel and/or R installed (software choice depending on their own preference).

Faculty Member

Elisabeth Fenwick, PhD

Pharmerit International, Oxford, OXF, United Kingdom

Erik Koffijberg, PhD

University of Twente, Enschede, Netherlands

Dr H. (Erik) Koffijberg, PhD, MSc, is Associate Professor in the field of Health Technology Assessment at the University of Twente, the Netherlands. Dr Koffijberg has published > 90 scientific papers in peer reviewed journals, and secured > 4M€ in funding for research on methods, and on applications, in the field of health technology assessment. He has performed applied research in this field, such as cost-effectiveness, risk-benefit, and budget impact analyses. He also contributed to methodological research in this field, amongst others on the topics of (early) HTA of new tests and clinical prediction rules; optimizing screening strategies, and prioritizing research, based on systematic reviews and meta-analyses. His work focuses foremost on impact assessment of diagnostic technologies on healthcare and healthcare delivery, in the medical fields of cardiology, neurology and oncology. Dr. Koffijberg teaches BSc, MSc, and postgraduate (external) courses on topics such as Health Technology Assessment, Health Economic Modeling, Discrete Event Simulation in Healthcare, and Advanced Diagnostic Research. He has been/is PI in several large (international) research consortia: HEART-Impact trial (Effect of Using the HEART Score in Patients With Chest Pain in the Emergency Department); CREW study (Dutch National Consortium to Promote Cardiovascular Healthy Aging in Women); TANGO study (Systems modeling of the nation-wide organization of WGS in the Netherlands); RED-CVD study (Reviving Early Diagnosis of CardioVascular Disease). Dr. Koffijberg is member of the Dutch Society for Health Economics (VGE), the ISPOR taskforce group on VOI analysis, and the multi-stakeholder Value of Diagnostic Information Platform.

Lotte Steuten, PhD, MSc

Office of Health Economics, London, WA, United Kingdom

Professor Lotte Steuten is Vice President and Head of Consulting of the Office of Health Economics, and honorary visiting professor at City, University of London (UK). Lotte’s research interest focuses on the development and application of health economic analysis and health technology assessment (HTA), with the aim to accelerate patient access to high value health care services and treatments. She specializes in quantitative methods for estimating and comparing the expected health and economic benefits of new approaches and interventions in disease prevention, diagnostics and treatment, and prioritizing data collection to efficiently build the evidence for new interventions. After obtaining her PhD she has acquired >15 years of international expertise in leading health economics and HTA projects to inform a wide range of decision problems, working effectively with various academic and non-academic stakeholders including patients, care providers, payers, policy makers, innovators and manufacturers. Prior to joining OHE, Lotte was an associate member at the Hutchinson Institute for Cancer Outcomes Research (HICOR) at the Fred Hutchinson Cancer Research Center, and an affiliate associate professor in the Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute at the University of Washington, Seattle. She co-founded Panaxea bv, a health innovation consultancy firm with offices in the Netherlands, Belgium and Germany, and served as its Chief Executive and Scientific Officer for nearly 10 years. Lotte has published nearly 100 original peer reviewed journal articles and is a frequent presenter and panellist at conferences on health innovation and economics worldwide.

Network Meta-Analysis in Relative Effectiveness ResearchLevel: IntermediateTrack: Study Approaches

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 know how all the treatment options rank against each other and the level of differences in treatment effects between all the available options. Network meta-analysis provides an integrated and unified method that incorporates all direct and indirect comparative evidence about treatments. Based in part on the ISPOR Task Force Reports on Indirect Treatment Comparisons, the fundamentals and concepts of network meta-analysis will be presented. The evaluation of networks presents special challenges and caveats, which will also be highlighted in this course. The material is motivated by instructive and concrete examples. The ISPOR-AMCP-NPC questionnaire for assessing the credibility of a network meta-analysis will also be introduced. This course requires at least a basic knowledge of meta-analysis and statistics.

Faculty Member

Sarah Goring, MSc

SMG Outcomes Research, Vancouver, BC, Canada

Sarah Goring has more than 15 years of experience in health economics and outcomes research (HEOR). Previously a Principal at ICONplc, Sarah is now an independent consultant, providing scientific leadership on a broad range of HEOR projects including epidemiological and burden of illness studies, health services research, systematic reviews, and evidence synthesis. Sarah has a particular interest in methodological innovations; she has applied and developed novel methods relating to fractional polynomials, simulated treatment comparisons, matching adjusted indirect comparisons, and issues in network structure and disconnected networks. Sarah has a B.Sc. in mathematics from the University of Victoria and an M.Sc. in health care and epidemiology from the University of British Columbia. Sarah is a co-editor of a Springer textbook on Health Services Research and has co-authored more than 50 research contributions.

Jeroen P Jansen, PhD

Precision Xtract, Oakland, CA, USA

Jeroen P. Jansen is the chief scientist – Evidence Synthesis and Decision Modeling at Precision Xtract and adjunct professor of Health Research & Policy (Epidemiology) at Stanford University. In addition, he is lead scientific advisor - Open Source Value Project (OSVP) at the Innovation and Value Initiative (IVI) where he oversees the development of open-source cost-effectiveness models. He has 15 years of research experience in the areas of evidence synthesis and economic modeling. He was an associate editor of the Research Synthesis Methods Journal; and is co-author of a textbook on network meta-analysis for decision-making. Dr. Jansen has published extensively on both applied and methods research in his areas of expertise. Notable contributions are the development of guidance for consumers and producers of network meta-analysis studies (ISPOR, PRISMA), as well as the development of methods for network meta-analysis of time-to-event data, repeated measures, and integration of patient level data with study level data. Previously, he was a founder of Redwood Outcomes, a health economics and outcomes research firm that was acquired by the Precision Medicine Group.

ISPOR Europe 2019

2-6 November 2019
Copenhagen, Denmark

Short Courses

The Professional Society for
Health Economics and Outcomes Research

ISPOR Europe 2019

2-6 November 2019Copenhagen, Denmark

Short Courses

2-6 November 2019
Copenhagen, Denmark