ISPOR Forums
Monday, June 2, 2014
6:15 PM - 7:15 PM
ISPOR FORUMS - SESSION I

6:15 PM - 7:15 PM
Room: Room 518abc (5th Floor)
ISPOR CLINICIAN REPORTED OUTCOMES GOOD MEASUREMENT PRACTICES
Moderator:

John H. Powers, III, MD, FACP, FIDSA, Senior Medical Scientist, SAIC in Support to Collaborative Clinical Research Branch (CCRB), Division of Clinical Research (DCR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and Associate Clinical Professor of Medicine, George Washington University School of Medicine, Washington, DC, USA

Speakers:

Laurie B. Burke, RPh, MPH, Former Associate Director for Study Endpoints and Labeling Office of New Drugs, CDER, U.S. Food & Drug Administration (FDA) and Founder, LORA Group, LLC, Royal Oak, MD, USA

Patrick Marquis, MD, MBA, President, Twolegs Consulting, Newton, MA, USA

Ashley Slagle, PhD, MS, Endpoints Reviewer, SEALD, ONDIO, CDER, U.S. Food & Drug Administration (FDA), Silver Spring, MD, USA

DESCRIPTION:

Task Force members will present the US (FDA) and European Medicines Agency (EMA) regulatory perspectives, define which outcome assessments should be considered ClinROs, and recommend ClinRO measures to document treatment benefit in clinical trials. Identification of the concept of measurement and context of use, evaluation of the measure’s measurement properties, and rules for implementation will be included. Presented by the ISPOR Clinician Reported Outcomes Good Measurement Practices Task Force


6:15 PM - 7:15 PM
Room: Room 710b (7th Floor)
SIMULATION MODELING APPLICATIONS IN HEALTH CARE DELIVERY RESEARCH — EMERGING GOOD PRACTICES
Moderator:

Deborah A. Marshall, PhD, Canada Research Chair, Health Services and Systems Research and Associate Professor, Department of Community Health Sciences, Faculty of Medicine, University of Calgary, Alberta Bone and Joint Health Institute, Calgary, AB, Canada

Speakers:

William Crown, PhD, Chief Scientific Officer, Optum Labs, Cambridge, MA, USA

Maarten J. IJzerman, PhD, Professor of Clinical Epidemiology & Health Technology Assessment (HTA) and Head, Department of Health Technology & Services Research, MIRA Institute for Biomedical Technology & Technical Medicine, University of Twente, Enschede, The Netherlands

DESCRIPTION:

Health care delivery system interventions are complex, multidimensional interventions among the interconnected elements of a system - beyond a specific drug or technology - including people, processes, and technology. They can be evaluated using simulation modeling techniques such as discrete event simulation (DES), system dynamics (SD), and agent-based simulation (ABS). These techniques provide “what if” scenarios to inform decisions considering intended and unintended consequences of an intervention from multiple dimensions. This discussion will focus on the problems for which each simulation method is appropriately applied in the context of evaluations for health care delivery interventions. Presented by the ISPOR Simulation Modeling Applications in Health Care Delivery Research - Emerging Good Practices Task Force


6:15 PM - 7:15 PM
Room: Room 710a (7th Floor)
RARE DISEASES: CHALLENGES IN ASSESSMENT AND APPRAISAL OF DIAGNOSTICS & TREATMENTS
Moderator:

Chris L. Pashos, PhD, Vice President, Global Outcomes and Epidemiology Research, Takeda Pharmaceuticals International, Inc., Cambridge, MA, USA

Speakers:

Mondher Toumi, MD, MSc, PhD, Professor & Chair of Decision Sciences, Department of Public Health and Market Access, University Claude Bernard Lyon I, Paris, France

Christopher Blanchette, PhD, MBA, Associate Dean for Research, College of Health and Human Services, University of North Carolina at Charlotte, Charlotte, NC, USA

Daria Korchagina, PhD, Pricing & Market Access Analyst, Creativ-Ceutical, Paris, France

DESCRIPTION:

Properly assessing treatments for rare diseases involves addressing various challenges, unique or of special interest, to these diseases.  HTA/appraisal-related challenges include the appropriateness of standard HTA decision frameworks, the differences in evidence requirements, the paucity of information, the various definitions for rare diseases, and uncertainty management.  Disease and research-related challenges include the difficulty in diagnosis, lack of treatment options, heterogeneity of the disease and its course, as well as the geographic dispersal and difficulty in identifying patients.  Global issues such as rare disease policy and equity in access to innovation add further complications. Findings to date will be presented. Presented by the ISPOR Rare Disease SIG:  Challenges in Assessment and Appraisal of Diagnostics & Treatments Working Group Presented by the ISPOR Rare Disease SIG: Challenges in Assessment and Appraisal of Diagnostics & Treatments Working Group


6:15 PM - 7:15 PM
Room: Room 519ab (5th Floor)
WHAT IS VALUE IN HEALTH DOING FOR ITS AUTHORS?
Moderator:

Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK bio

Speakers:

C. Daniel Mullins, PhD, Co-Editor-in-Chief, Value in Health and Professor, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, USA

DESCRIPTION:

This forum will provide attendees with the opportunity to meet with the editors of Value in Health. Session topics include: What makes a great paper? How will my paper be reviewed? How can I volunteer to be a reviewer for Value in Health? What advice do you have for editors on how we can enhance publicity for our articles that we publish? The editors will also be on hand to answer any other questions you may have about publishing in Value in Health. Presented by the Co-Editors-in-Chief of Value in Health


6:15 PM - 7:15 PM
Room: Room 520ad (5th Floor)
THE EVOLUTION OF HEALTH TECHNOLOGY ASSESSMENT IN LATIN AMERICA: ARE WE THERE YET?
Moderator:

Gabriela Tannus, MBA, MSc, 2012-2014 ISPOR Latin America Consortium Executive Committee Chair and Owner & Health Economics Director, Axia.Bio, Sao Paulo, Brazil

Speakers:

Federico Augustovski, MD, MSc, PhD, Director, Economic Evaluations & HTA Department, Institute for Clinical Effectiveness and Health Policy (IECS), Professor of Public Health, University of Buenos Aires and Staff Physician, Family and Community Medicine Division, Italian Hospital of Buenos Aires, Buenos Aires, Argentina

Manuel Antonio Espinoza, MD, MSc, PhD, Assistant Professor, Faculty of Medicine, Department of Public Health, Catholic University of Chile and Scientific Coordinator, National Centre for Pharmacoeconomics, Institute of Public Health of Chile, Santiago, Chile

Rosa Maria Galindo-Suarez, MHE, Prioritization Deputy General Director, Ministry of Health, Mexico City, Mexico

DESCRIPTION:

As early as 2002, there were no national health technology assessment (HTA) guidelines in existence in Latin America. However, growing access to state-of-the-art information, coupled with burgeoning health care costs over the past decade in countries where access to health care is often a constitutional right, has propelled the need for mechanisms to evaluate the incorporation of health technologies with efficiency to the fore.  While not all Latin American countries have embraced HTA, some have truly begun the reformation process in order to better implement cost-effective health care. Speakers from Argentina, Brazil, Chile, and Mexico will discuss the journey towards implementing HTA, where they stand now in the face of so many institutional changes, and what still needs to be achieved in order to effectively cover their populations. Presented by the ISPOR Latin America Consortium


6:15 PM - 7:15 PM
Room: Room 520be (5th Floor)
CAPACITY BUILDING IN PHARMACOECONOMICS IN THE ARABIC-SPEAKING COUNTRIES: CHALLENGES & OPPORTUNITIES IN EDUCATION AND TRAINING
Moderator:

Ola Ghaleb Al Ahdab, PhD, President, ISPOR United Arab Emirates Chapter and Pharmaceutical Advisor & Project Manager, Registration and Drug Control Department, Ministry of Health, Abu Dhabi, United Arab Emirates

Speakers:

Daoud Al-Badriyeh, BPharm, PhD, President, ISPOR Qatar Chapter and Assistant Professor of Pharmacoeconomics, College of Pharmacy, Qatar University, Doha, Qatar

Abdulaziz H. Al-Saggabi, MSc, PharmD, President of ISPOR Saudi Arabia Regional Chapter, Drug Policy & Economics Center, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia

Ibrahim Al-Abbadi, PhD, MBA, BPharm, President, ISPOR Jordan Chapter and Dean, Faculty of Pharmacy, Yarmouk University, Irbid, Jordan

Gihan Hamdy Elsisi, RPh, MSc, Head of Pharmacoeconomic Unit and Part-time Lecturer of Pharmacoeconomics, Central Administration for Pharmaceutical Affairs, Ministry of Health, Faculty of Pharmacy Helwan University, Cairo, Egypt

DESCRIPTION:

This forum will discuss the current status of Pharmacoeconomic (PE) education in the Arabic-speaking countries. Speakers will particularly focus on the development of undergraduate and graduate level programs, as well as training opportunities. In countries such as Jordan, Saudi Arabia, Qatar, United Arab Emirates, Egypt and Kuwait, PE education is still at the early stage of development. Capacity building is imperative for the delivery of health care system, HTA implementation and collaboration between different stakeholders in the region. However, steps have been taken to address this issue such as establishing postgraduate PE degrees and utilizing regional and international expertise in the field to provide “training of trainers." The aim of conducting long-term training programs is to address local needs that focus on producing integrated teaching modules and providing the right tools which are relevant to most stakeholders. For example, in the United Arab Emirates, “Introduction to Pharmacoeconomics” has been incorporated into pharmacy practice course for the 4th year pharmacy students in University of Sharjah, while the entire “Pharmacoeconomics” course was considered by the Ministry of Higher Education as a core subject for post-graduate MScPharm degree program in Ajman University. In order to enhance the knowledge and skills in topics such as formulary management, rational drug selection, budget impact analysis and introduction to HTA, many activities focusing on continuous education are being organized regularly for doctors and health care professionals in the region. The needs for PE education in the Arabic-speaking countries are great and can be further addressed by enhancing teaching materials, developing evidence-based training programs, and increasing basic level training opportunities in health economics. Presented by the ISPOR Arabic Network


6:15 PM - 7:15 PM
Room: Room 520cf (5th Floor)
DEFINING AND INCORPORATING BIG DATA IN HEALTH ECONOMICS AND OUTCOMES RESEARCH TO INFORM DECISIONS IN HEALTH CARE: IMPLICATIONS FOR CLINICAL PRACTICE, GOVERNMENT POLICY, AND STUDENTS' CAREER PATHS
Moderator:

Zeba M. Khan, RPh, PhD, ISPOR Student Network Advisor and Vice President, Strategic Market Access & Policy, Celgene Corporation, Summit, NJ, USA

Amanda Harrington, MS, ISPOR Student Network Chair and Graduate Research Assistant, University of Arizona, Tucson, AZ, USA

Speakers:

Abraham G. Hartzema, MSPH, PhD, FISPE, Professor and Eminent Scholar, Perry A. Foote Chair in Health Outcomes Research, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA

Wenhui Wei, PhD, MS, MBA, Director, Evidence Based Medicine, Medical Affairs, Sanofi US, Bridgewater, NJ, USA

Marcus Wilson, PharmD, President, HealthCore, Wilimington, DE, USA

DESCRIPTION:

The term 'big data' has become a buzz word in the field of health economics and outcomes research; however, there is debate as to how it is defined and in what capacity it should be used. To explore this topic further, a group of panelists will discuss how big data is defined, sources of big data in the health care space, who is using big data, and how big data is being incorporated to inform health care decisions. Speakers will discuss the current paradigm and how young researchers can prepare themselves for future opportunities to work with big data in the health care environment. Presented by the ISPOR Student Council

Tuesday, June 3, 2014
6:15 PM - 7:15 PM
ISPOR FORUMS - SESSION II

6:15 PM - 7:15 PM
Room: Room 518abc (5th Floor)
PRO AND OBSRO MEASUREMENT IN RARE DISEASE CLINICAL TRIALS — EMERGING GOOD PRACTICES
Moderator:

Margaret Vernon, PhD, Senior Research Scientist, Outcomes Research, Evidera, London, UK

Speakers:

Katy Benjamin, PhD, Director, Patient Reported Outcomes, ICON Commercialisation and Outcomes, Bethesda, MD, USA

Laurie B. Burke, RPh, MPH, Former Associate Director for Study Endpoints and Labeling Office of New Drugs, CDER, U.S. Food & Drug Administration (FDA) and Founder, LORA Group, LLC, Royal Oak, MD, USA

Eleanor Perfetto, PhD, MS, Professor, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, USA

DESCRIPTION:

The task force will present on methods for measuring and analyzing PROs and ObsROs associated with evaluating the efficacy of rare disease treatments within the context of clinical trials, including: special considerations for RD PRO instruments; optimal strategies for using observer reports; methods for PRO instrument selection, adaptation, and validation; study recruitment; and modes of instrument administration. Conformance to regulatory guidance for the evaluation and proof of treatment benefit using PRO endpoints will be evaluated in terms of how PRO measures and methods can be developed or adapted to satisfy these guidances while recognizing the unique challenges of RD.  Recommendations will be made for ways to work within these frameworks. Presented by the ISPOR PRO and ObsRO Measurement in Rare Disease Clinical Trials — Emerging Good Practices Task Force


6:15 PM - 7:15 PM
Room: Room 519ab (5th Floor)
CONJOINT ANALYSIS - STATISTICAL ANALYSES, RESULTS & CONCLUSIONS GOOD RESEARCH PRACTICES
Moderator:

A. Brett Hauber, PhD, Senior Economist and Vice President, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA

Speakers:

Deborah A. Marshall, PhD, Canada Research Chair, Health Services and Systems Research and Associate Professor, Department of Community Health Sciences, Faculty of Medicine, University of Calgary, Alberta Bone and Joint Health Institute, Calgary, AB, Canada

Juan Marcos González, PhD, Senior Research Economist, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA

DESCRIPTION:

The forum will discuss work to date on the appropriate use and limitations of statistical methods for analyzing data from conjoint-analysis studies. The range of options for estimating data from discrete-choice experiments, including simple-sum approaches, generalized linear methods, conditional logit, random-parameters logit, hierarchical Bayes, and latent-class analysis will be discussed. The goal of this task force is to provide researchers with an understanding of the implicit and explicit assumptions required to apply different analysis methods to conjoint analysis data. Finally, we will make recommendations for day-to-day use. It will help researchers and reviewers judge the appropriateness of different statistical methods for a given choice problem and evaluate the strengths and limitations of conjoint-analysis studies. Presented by the ISPOR Conjoint Analysis - Statistical Analyses, Results & Conclusions Good Research Practices Task Force


6:15 PM - 7:15 PM
Room: Room 710a (7th Floor)
RARE DISEASE TERMINOLOGY & DEFINITIONS USED IN OUTCOMES RESEARCH
Moderator:

Zeba Khan, PhD, RPh, Vice President, Strategic Market Access & Policy, Celgene, Summit, NJ, USA

Speakers:

Trevor Richter, PhD, MSc, Research Manager, Health Economics, Canadian Agency for Drugs and Technologies in Health (CADTH), Ottawa, ON, Canada

Robert Babela, PhD, MSc, Head of Department of Public Health, HM, St. Elizabeth University, Bratislava, Slovak Republic

DESCRIPTION:

There are many concepts and terms that describe rare diseases, their treatments, and other related health technologies. There are national and international differences; definitions themselves vary according to factors besides disease prevalence/incidence, i.e., according to context (e.g., among jurisdictions, and stakeholders such as rare disease organizations) and application (HTA, payers). The working group conducted primary research in 32 countries around the world. The issues around the similarities and differences in stakeholder definitions (e.g., government/policy vs. the reality of HTA and/or how the EMA’s definition compares to each country’s) will be presented. Presented by the Rare Disease SIG: Terminology & Definitions Used in Outcomes Research Working Group


6:15 PM - 7:15 PM
Room: Room 710b (7th Floor)
HOW VARIATION IN HTA PROCESSES AND REQUIREMENTS FOR MOLECULAR DIAGNOSTICS CREATES CHALLENGES FOR MANUFACTURER, PAYER, AND CLINICAL STAKEHOLDERS
Moderator:

Susan Garfield, DrPH, Senior Vice President, Market Access, Health, GfK Market Access, Wayland, MA, USA

Speakers:

Michael Longacre, BS, North American Market Access, Global Health Economics and Reimbursement, Beckman Coulter, Inc., Yamhill, OR, USA

Julie Polisena, MSc, Scientific Advisor, Canadian Agency for Drugs and Technologies in Health (CADTH), Ottawa, ON, Canada

Eric Faulkner, Director, Global Market Access, Quintiles, Durham, NC, USA

DESCRIPTION:

Diagnostics are playing an increasingly important role in treatment decision making and directing care. Payers and market access decision makers are rapidly developing health technology assessment (HTA) methodologies to evaluate these diagnostics. These frameworks, however, are not uniform, can be unclear, and are evolving real-time. Several HTA bodies are currently reviewing or have just completed reviews of, molecular diagnostics involved in treatment selection, providing new data on process, requirements, and outcomes in different markets. This forum will present an in-depth analysis of current practice and case studies identified by the ISPOR Working Group providing detailed insights on the latest developments in diagnostic HTA. A framework for considering payer/HTA interaction for diagnostics in development will be provided. Presented by the ISPOR Medical Devices and Diagnostics Special Interest Group


6:15 PM - 7:15 PM
Room: Room 520cf (5th Floor)
HEALTH CARE IN AFRICA: CAN BIG DATA IMPROVE OUTCOMES?
Moderator:

Anthony Waka Udezi, PhD, Assistant Dean of Pharmacy and Senior Lecturer, Department of Clinical Pharmacy, University of Benin, Benin City, Nigeria

Speakers:

Gihan Hamdy Elsisi, RPh, MSc, Head of Pharmacoeconomic Unit and Part-time Lecturer of Pharmacoeconomics, Central Administration for Pharmaceutical Affairs, Ministry of Health, Faculty of Pharmacy Helwan University, Cairo, Egypt

Ernest Attuquaye Quaye, BPharm, MPH, Principal Pharmacist, Medical Department, Ghana Cocoa Board, Accra, Ghana

Jacques Snyman, MBChB, MPharmMed, MD, President, ISPOR South Africa Chapter and Director, Product Development, Agility Global Health Solutions, Pretoria, South Africa

DESCRIPTION:

The availability of data in both private and state sectors is used to determine policy and interventions. This forum will focus on the current state of “big data” in context of health care in Africa. A detailed analysis of challenges that prevent the “big data” from being adopted and used will be examined from the perspectives of countries such as Egypt, Ghana, Nigeria, South Africa, and Uganda. Speakers will provide practical examples of how “big data” predicts hospitalization with 80% accuracy. Questions whether Africa is ready for the application of “big data” and if it would in fact improve patient care and outcomes in the region, will be examined. Furthermore, speakers will describe handling diverse data sets, their challenges and real-life outcomes in enabling better planning and enriching policy processes. Presented by the ISPOR Africa Network


6:15 PM - 7:15 PM
Room: Room 520ad (5th Floor)
EXPERIENCES IN UPDATING THE COLOMBIAN BENEFITS PLAN: THE ROLE OF THE NATIONAL HTA AGENCY AND THE MINISTRY OF HEALTH
Moderator:

Andrés Felipe Ruíz, MD, Pharmacoepidemiology Assistant, Audifarma S.A, Bogotá, Colombia

Speakers:

Diego Rosselli, MD, MEd, MHP, Associate Professor, Clinical Epidemiology and Biostatistics Department, Pontificia Universidad Javeriana Medical School, Bogotá, Colombia

Hector E. Castro, MD, MSc, Director, Health Technology Assessment Institute (IETS), Bogotá, Colombia

Clarice Alegre Petramale, MD, PhD, Director, National Commission for Incorporation of Technologies (CONITEC), Ministry of Health, Brasília-DF, Brazil

DESCRIPTION:

In December 2013, updates were made to the list of technologies covered by the general health system in Colombia. It was then, for the first time, that the newly created Colombian Health Technology Assessment Institute (IETS) collaborated on this methodology, resulting in the development of methods by IETS for prioritization, technology assessment, and budget impact of health technologies. This collaboration between IETS and the Ministry of Health has allowed for a greater number of newer technologies to be included in the health plan and decreased barriers to access. This forum will share and discuss the Colombian experience on updating the list of health technologies funded by the health care system. Presented by the ISPOR Colombia Regional Chapter


6:15 PM - 7:15 PM
Room: Room 520be (5th Floor)
FACING NEW CHALLENGES IN PHARMACOECONOMIC DEVELOPMENT IN RUSSIA AND POLAND
Moderator:

Pavel Vorobiev, MD, PhD, MSc, President, ISPOR Russia Chapter and Professor & Head of the Research Department on Healthcare Standardization Problems, Post-Graduate Education Department, Sechenov Moscow Medical Academy, Moscow, Russia

Speakers:

Karina Jahnz-Rozyk, PhD, MD, Past-President, ISPOR Poland Chapter and Professor & Head of Department of Immunology & Allergology, Military Institute of Medicine, Warsaw, Poland

Petr V. Novikov, MSc, Professor, Department of Clinical Genetics & Head, Research Clinical Institute for Pediatrics, Pirogov State Medical University, Moscow, Russia

Marina V. Zhuravleva, MSc, Professor & Main Clinical Pharmacologist, Department of Health, Moscow City Government, Moscow, Russia

DESCRIPTION:

With the rapid expansion of pharmacoeconomics and outcomes research in Central and Eastern Europe (CEE), new controversial issues have emerged that threaten to undermine further development of the science in countries of the CEE region. One key example includes the concern of how reimbursement of biosimilar drugs may be approached. This forum will focus on several common issues that Russia and Poland are currently facing as pharmacoeconomics evolves in their respective countries. Presented by the ISPOR Russia and Poland Regional Chapters

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