Educational Symposia
Saturday, 29 October 2016

18:30 - 19:30
Room: Hall F2 (L0)
HOW TO SPEED UP HEALTH TECHNOLOGY ASSESSMENT (HTA) DECISION-MAKING IN ONCOLOGY – BALANCING PATIENT ACCESS WITH UNCERTAINTY OVER DATA
This symposium will discuss how to effectively assess the clinical and economic value of novel cancer therapies, in order to improve patient access to these innovative treatments. The challenges which HTA bodies face will be reviewed, including the issue of balancing rapid patient access with uncertainty over less mature evidence.
Moderator: David Chao, BMBCh, FRCP, DPhil
Consultant Medical Oncologist, The Royal Free Hospital, London, UK
Speaker: Isabelle Durand-Zaleski, MD, PhD
Professor of Health Economics, Hôpital de l'Hotel Dieu, URC Eco, Paris, France
Speaker: Martin Buxton, BA
Emeritus Professor, Health Economics Research Group (HERG), Brunel University, Uxbridge, UK
Bristol-Myers Squibb
(Sponsored by Bristol-Myers Squibb)
Sunday, 30 October 2016

17:30 - 18:30
Room: Hall D (L -2)
THE EVOLVING ROLE OF REAL-WORLD DATA IN EVIDENCE SYNTHESIS TO MEET DEMANDS FOR EVIDENCE-BASED MEDICINE
HHealth technology assessment agencies are increasingly relying on real world data (RWD) to inform decision making. While RWD informing treatment effectiveness is often unavailable for newly licensed agents, such data may exist for current standards of care. In this symposium, we will discuss the types of RWD that are most useful to health care decision makers, the benefits of using RWD to contextualize treatment effectiveness versus efficacy, and emerging methods and challenges associated with synthesizing RWD and RCTs. We will discuss the implications of early drug approval on HTA evaluations, case studies of the use of real world evidence to support HTA decisions, and the challenges to adopting real world evidence in HTA We will debate the benefits and disadvantages of identifying and utilizing RWD for use in evidence synthesis and comparative effectiveness. In particular we will focus on the payer perspective and how RWD may contribute to a greater understanding of the clinical effectiveness of treatments in practice. In presenting this perspective we will also give consideration to the challenges associated with meta-analysis of this data alongside clinical trials and the current and potential methodologies in development for overcoming these issues. In conclusion we will focus on interpreting and critiquing such studies as relates to their potential for reducing uncertainty in the decision making process.
Speaker: Juliette C Thompson, BSc
Lead Systematic Reviewer, ICON Health Economics & Epidemiology, Abingdon, UK
Speaker: Olivia Wu, PhD
Professor & Director, HEHTA Research Unit, Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK
Speaker: Sarah M Goring, MSc
Director, Epidemiology, ICON Epidemiology, Vancouver, BC, Canada
Speaker: Neil Hawkins, PhD CStat
Professor in HE and HTA, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
ICON plc
(Sponsored by ICON plc)

18:45 - 19:45
Room: Hall D (L -2)
BALKANS TOWARDS TOMORROW: PAVING BETTER ACCESS FOR PATIENTS
Although countries in the Balkans region show uneven progress in health technology assessment, most of them face similar financial barriers and dynamic environment. In this framework, the speakers of this educational symposium will try to pinpoint current patient access constrains, while proposing pragmatic solutions for improving health outcomes in the future. During the symposium, the audience will have the opportunity to capture a variety of perspectives offered by distinguished members of the panel, originating from different geographies and backgrounds. Benchmarking versus other European countries will also offer greater understanding of the current differences in terms of time and quality of access for patients. Mr. Koehring will look at barriers to patient access to care accross the region, while highlighting case studies from several countries. Professor Dimopoulos will try to highlight the opportunities for patient access through clinical trials and early access programmes. Professor Maniadakis will touch upon Greek reforms and translated outcomes for patients. Dr. Marius Geantă is Co-Founder of the Center for Innovation in Medicine, a non-governmental organisation based in Bucharest, Romania. His current interests focus on personalised medicine in Romania, working as expert in personalised medicine for European Development Platform and acting as National Task Force Manager for Romania of Public Health Genomics Network.
Moderator: Ioannis Petrakis, MPharm, Msc, MPH
Market Access, HEOR & Gov Affairs Head, MCO Balkans, Takeda MCO Balkans, Marousi Athens, Greece
Speaker: Martin Koehring, MA
Senior Editor & Global Editorial Lead, Healthcare, The Economist Intelligence Unit, London, UK
Speaker: Meletios A. Dimopoulos, MD, PhD
Professor, Alexandra Hospital, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece
Speaker: Nikos Maniadakis, Professor
Professor, Athens, Greece, Department of Health Services Management, National School of Public Health, Athens, Greece, Athens, Greece
Speaker: Marius Geantă, MD
President and Co-Founder Center for Innovation in Medicine, Center for Innovation in Medicine, Bucharest, Romania
Takeda
(Sponsored by Takeda)
Monday, 31 October 2016

7:30 - 8:30
Room: Hall D (L -2)
THE BIOSIMILAR EFFECT: HOW REAL-WORLD EVIDENCE WILL INFLUENCE ADOPTION OF BIOSIMILAR SPECIALTY THERAPIES
As biosimilar specialty therapies have been available in Europe for the past decade and are beginning to gain approval in the US, many questions remain about their potential adoption by providers, patients and payers. With a different threshold of traditional clinical research required for regulatory approval than their branded counterparts, real-world health economics and outcomes research becomes paramount to make critical value comparisons and effective decisions on therapy use. This symposium will explore how stakeholder value assessments will be vital to compare and position biosimilars and their branded counterparts, with a focus on the specialty therapeutic areas of oncology and rheumatology.
Moderator: Bruce A Feinberg, DO
Vice President/Clinical Affairs Chief Medical Officer Specialty Solutions, Cardinal Health, Dublin, OH, USA
Speaker: Sue Naeyaert, BPharm, Grad.Dip.Sc(Pharm), MCom
Global Head Pricing, Market Access and Policy, EMD Serono, Washington, DC, USA
Speaker: Graham Foxon, MBA, PhD
Managing Director, Remap Consulting, Cheshire, UK
Speaker: Florian Turk, MSc
Head, Global Payor Marketing, Sales and Relations, Sandoz International GmbH, Holzkirchen, Germany
Speaker: Frank R. Ernst, PharmD, MS
Senior Director and Chief Science Officer, HEOR, Cardinal Health Specialty Solutions, Dublin, OH, USA
Cardinal Health
(Sponsored by Cardinal Health)

12:45 - 13:45
Room: Hall D (L -2)
INCREASING EUROQOL (EQ-5D) FROM 3 TO 5 LEVELS: IMPLICATIONS FOR USERS - DOES "NEW" MEAN "BETTER"?
Over the past 25 years EQ-5D has virtually become the de facto standard generic measure of health-related quality of life in clinical and economic evaluation of healthcare interventions. Its initial design was dictated by the need for instrument brevity and compactness. However, as a reaction to concerns about potential lack of sensitivity in the original 3L system, the number of response levels per EQ-5D dimension has been increased from 3 to 5, raising in turn the number of EQ-5D health states from 243 to 3,125. This change was expected to lead to improved performance in the new 5L version. Despite improvements in technical attributes in the 5L version, for example in ceiling effects, it cannot be assumed that these automatically lead to improved performance in its use as an HrQoL outcome measure, particularly when used in cost-effectiveness applications. There is no straightforward relationship between improved measurement properties and reduced ceiling effects and outcomes relevant for users such as discriminative power, responsiveness and impact on cost-effectiveness. Evidence is now emerging that reveals the consequences of moving from one version of EQ-5D to another. In this symposium, we examine the interplay between the level structure, value set characteristics, and population characteristics. Studies that employed both the 3 and 5 level versions will be used to illustrate the impact of using different versions of the EQ-5D on cost-effectiveness. The symposium will be structured around the key questions: What changes might result from any alterations in the value set for the original 3L version? What consequences occur when the 3L descriptive system is replaced by the 5L version? How does the use of a new 5L value set based on the revised descriptive system impact on cost-effectiveness evaluation? These topics are not specific to EQ-5D alone but are relevant when considering the possible substitution of any HrQoL measure with an alternative. They raise fundamental issues for instrument developers and end-users alike. In short - does “new” always mean “better”?
Moderator: Andrew Lloyd, DPhil
Director, Bladon Associates Ltd, Oxford, UK
Speaker: Paul Kind
Professor of Health Outcome Measurement, Academic Unit of Health Economics, Institute of Health Sciences, University of Leeds, Leeds, UK
Speaker: Bas Janssen, PhD
Senior Researcher, EuroQol Office, EuroQol Research Foundation, Rotterdam, The Netherlands
Speaker: Allan Wailoo, MA, MSc, PhD
Professor of Health Economics, School of Health and Related Research, University of Sheffield, Sheffield, UK
EuroQol Research Foundation
(Sponsored by EuroQol Research Foundation)
Tuesday, 1 November 2016

7:30 - 8:30
Room: Hall D (L -2)
NEW VALUE FRAMEWORKS IN THE UNITED STATES: INSIGHTS FROM PAYERS, CONSIDERATIONS FOR MANUFACTURERS, AND IMPLICATIONS FOR OTHER REGIONS OF THE WORLD
Prior to mid-to-late 2015, there was little interest in the application of formal value assessments in the United States (US), despite efforts to implement healthcare reform at the national level. This fundamentally changed in 2015 with the release of several US-focused value constructs, including the Memorial Sloan Kettering Cancer Center (MSKCC) DrugAbacus, American Society of Clinical Oncology (ASCO) Value Framework, and the Institute for Clinical and Economic Review (ICER) Evidence Reports. Each has since refined and released – formally or informally – updated tools and methodologies. Moreover, many manufacturers, payers, and other stakeholders have garnered at least one year of tangible experience with drugs that have been evaluated using these methodologies. The MSKCC DrugAbacus and ASCO’s net health benefit (NHB) evolved specifically in response to the rising cost of oncology therapies, whereas the ICER framework is more broadly applicable, with the goal of informing population level policy decisions. ICER conducted its first evaluation of oncology drugs in an assessment of multiple myeloma therapies earlier this year, thereby further underscoring the impact of these therapies. The specific enduring implications of these value constructs on stakeholder decision-making remains to be determined; however, it is evident that the landscape has been transformed. We will present these constructs, discuss the strengths and weaknesses of each, share perspectives regarding how pharma and US payers view value constructs, and examine implications for other regions of the world.
Moderator: Jay Jackson, PharmD, MPH
Vice President, Global Health Economics and Outcomes Research, Xcenda, Palm Harbor, FL, USA
Speaker: Denise Globe, PhD
ED and Head of Health Economics & Outcomes Research, US Oncology CD&MA Health Economics, Novartis Pharmaceuticals, East Hanover, NJ, USA
Speaker: Kristen Migliaccio-Walle, BS
Director, Global Health Economics, Xcenda, LLC, Palm Harbor, FL, USA
Speaker: Ken O'Day, PhD, MPA
Director, Global Health Economics, Xcenda, LLC, Palm Harbor, FL, USA
Speaker: Daniel C. Malone, PhD, RPh, FAMCP bio
Professor of Pharmacy, College of Pharmacy & Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA
Xcenda
(Sponsored by Xcenda)

12:30 - 13:30
Room: Hall D (L -2)
NOVEL APPROACHES TO EVIDENCE-DRIVEN DESIGN AND STUDY SAMPLE-FRAME VALIDATION
Already for two decades, shortening the time to market is a mantra for pharmaceutical companies, benefiting both the society and manufacturers. Key drivers of improved development timelines and better managed pipeline value attrition have been organizational change programs, substantial regulatory realignment and also fundamentally different approaches in research. But there is still scope for improvement. Real-world data (RWD) starts to complement classical methods for clinical development which revolved around understanding clinical outcomes from published studies and key opinion leader insights. During this symposium, we will explore the value and show practical cases of how RWD can drive efficiency directly (e.g. understanding competing recruitment pressure or selecting the right sites) and indirectly (protocol endpoint feasibility) as well as improve the effectiveness of studies for example through increasing their external validity. The latter is especially important – and critical - for post authorization safety studies, as regulators and payers continue to demand proofs of effectiveness and safety in the real world where observational, non-interventional studies are still abundant. Panelists will showcase how real-world evidence-driven design improves clinical development and late phase studies from three angles: Impact on time to market from the pharmaceutical industry point of view, how a CRO can become a smarter one using RWD to drive study design and how a regulator perceives needs and epidemiological options for better external validation. Faculty will include senior experts from the pharmaceutical industry, regulators and IMS Health.
Moderator: Jacco Keja, PhD
Senior Principal, Real-World Evidence Solutions & HEOR, EPI, QMS, London, UK and Lecturer Erasmus University, QuintilesIMS, Rotterdam, The Netherlands
Speaker: Jacco Keja, PhD
Senior Principal, Real-World Evidence Solutions & HEOR, EPI, QMS, London, UK and Lecturer Erasmus University, QuintilesIMS, Rotterdam, The Netherlands
Speaker: Natalia Balko
Principal, Real-World Evidence Solutions, QuintilesIMS, London, UK
Speaker: Andrew Bate, PhD
Senior Director, Epidemiology Group Lead, Analytics & Worldwide Safety, Pfizer Ltd, Surrey, UK
Speaker: Solomon Iyasu, MD, MPH
Vice President, Pharmacoepidemiology, Center for Observational Real-World Evidence, Merck and Co., North Wales, PA, USA
QuintilesIMS
(Sponsored by QuintilesIMS)
Wednesday, 2 November 2016

7:30 - 8:30
Room: Hall F2 (L0)
VALUE OPTIMIZATION IN HCV: BEYOND HEALTH ECONOMICS
Since 2014, with the introduction of Direct Acting Antiviral agents (DAA's) the HCV landscape has dramatically changed and many patients have been treated since the introduction of these products. In many countries however, to date, treatment has been restricted to more severe patients. Furthermore in most of the countries a significant proportion of patients are still undiagnosed. This educational symposium will discuss some of the Health Economics aspects of treating HCV patients with DAA’s. Furthermore, experts in the field will present if and how disease eradication can become a reality and the different actions stakeholders can take to make disease eradication a realistic ambition.
Moderator: Zoltan Kalo, MD, PhD
Professor of Health Economics & Head of the Institute of Economics, Eötvös Loránd University, Budapest, Hungary
Speaker: Homie Razavi, PhD, MBA
Managing Director, Center for Disease Analysis, Denver, CO, USA
Speaker: Rafael Bengoa, PhD
Director, Institute for Health & Strategy, Bilbao, Spain
AbbVie
(Sponsored by AbbVie)
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