Educational Symposia
Sunday, June 1, 2014

5:15 PM - 6:15 PM
Room: Room 518abc (5th Floor)
YOU GET WHAT YOU PAY FOR: WILL ACOS UNDERUSE DRUGS?
Accountable care quality measures focus on a limited number of conditions and do not include those where medications are costly (e.g., rheumatoid arthritis, multiple sclerosis). Where are there gaps that could leave patients vulnerable to mismanagement and suboptimal care? Are current measurement methodologies reliable? Have providers reached the saturation point of how much they can measure? What are possible solutions?
Moderator: Kimberly D. Westrich, MA
Director, Health Services Research, National Pharmaceutical Council, Washington, DC, USA
Speaker: Tom Valuck, MD, JD
Partner, Discern Health, Baltimore, MD, USA
Speaker: Robert Epstein, MD, MS
President & CEO, Epstein Health, LLC, Woodcliff Lake, NJ, USA
Speaker: Andrew Baskin, MD
National Medical Director for Quality and Provider Performance Measurement, Aetna, Blue Bell, PA, USA
National Pharmaceutical Council
(Sponsored by National Pharmaceutical Council)

6:30 PM - 7:30 PM
Room: Room 518abc (5th Floor)
LOST AND FOUND IN TRANSLATION: HOW DOES EVIDENCE PREDICT REIMBURSEMENT AND PRICING OF HIGH VALUE SPECIALTY PRODUCTS?
In an effort to contain health care costs, the use of health technology assessment (HTA) takes different forms in each market – including Germany, France, Canada, and the United States.  Each country has policy makers that use unique methodologies to evaluate a product’s degree of value, which in turn can inform reimbursement, formulary positioning, and/or pricing negotiations. This symposium will focus on understanding how different high-value specialty therapies (oncology and non-oncology) and their evidence dossiers, including endpoint selection, comparator selection, unmet need, efficacy and safety profile – and sometimes price – translate into perceived incremental value, and subsequent degree of reimbursement, coverage policy, and/or pricing. Panelists will review case studies and share experiences and perspectives on how evidence translates into pricing opportunity and reimbursement/access.
Moderator: Mónica Martín de Bustamante
Managing Director, CBPartners, New York, NY, USA
Speaker: Rachel Beckerman, PhD
Principal, Value Demonstration, CBPartners, New York, NY, USA
Speaker: Meghan Gallagher
Director, Global Health Economics and Outcomes Research, Oncology, Sanofi, Cambridge, MA, USA
Speaker: Marc Bardou, MD, PhD
Gastroenterologist, Centre Hospitalier Universitaire Le Bocage, Dijon, France
CBPartners
(Sponsored by CBPartners)
Monday, June 2, 2014

7:15 AM - 8:15 AM
Room: Room 518abc (5th Floor)
BUILDING, EMBEDDING, AND OPTIMISING MARKET ACCESS – FROM TECHNICAL EXCELLENCE TO HEARTS AND MINDS IN BOTH ESTABLISHED AND EMERGING MARKETS
Building and embedding market access capability and processes into every stage of research, development, and commercialisation is critical to the success of any new medicine. During this symposium a series of case studies will be used to highlight the challenges involved in building these capabilities and to demonstrate possible approaches to overcoming these challenges.
OBJECTIVES & INTRODUCTION
Moderator: Colin Wight
Chief Executive, GalbraithWight, Princeton, NJ, USA
HEALTH CARE SYSTEM PROFILING AND SEGMENTATION
Speaker: Raj Saujani
Director, Global Oncology Marketing, Bristol-Myers Squibb, Princeton, NJ, USA
Speaker: Mark Boyden, MBA
Principal Consultant, GalbraithWight, East Sussex, UK
OPTIONS AND APPROACHES TO SATISFY SUB NATIONAL PAYER REQUIREMENTS IN DIFFERENT HEALTH CARE SYSTEM TYPES
Speaker: Mark Boyden, MBA
Principal Consultant, GalbraithWight, East Sussex, UK
SUB NATIONAL PAYER REQUIREMENTS FOR MARKET ACCESS BY HEALTH CARE SYSTEM TYPE
Speaker: Taufi Ryder, BSc (Hons)
Principal Consultant, (formerly Director, Market Access, Emerging Markets, Bristol-Myers Squibb), GalbraithWight, Princeton, NJ, USA
DISCUSSION AND CONCLUSIONS
GalbraithWight
(Sponsored by GalbraithWight)

12:15 PM - 1:15 PM
Room: Room 710a (7th Floor)
PREDICTIVE ANALYTICS: PROVIDING NOVEL APPROACHES TO ENHANCE OUTCOMES RESEARCH LEVERAGING BIG AND COMPLEX DATA
The digitization of patient, hospital, prescription, biological, and other vast data streams heralds a new era in the volume and complexity of health care information. This explosion in “big data” presents a wide range of new opportunities for outcomes researchers, but also significant challenges. Big and complex data is a precondition for novel research approaches, but this needs to be complemented by embracing analytical ideas going beyond traditional statistical methods, including innovative techniques from the fields of predictive analytics and data mining.

Central to these approaches are so-called machine learning algorithms, methods that are ideally suited to uncover robust associations amidst complex, high-dimensional data. Machine learning algorithms have helped advances in our ability to understand the human genome, process vast unstructured data on social media sites to identify drug safety events and underpin the emergence of a range of physician decision-support tools from medical image diagnosis to prediction of unplanned hospital admissions. Predictive analytics holds the key to unlocking some of the potential of big data. Now health care needs to unlock its resistance and lack of familiarity with these techniques and embrace novel analytical methods.

This symposium will review how predictive analytics applied to big and complex data provide opportunities but also pose challenges to outcomes researchers. Case studies will illustrate how such novel analytical approaches enable new ways of doing outcomes research, e.g. comparing traditional methods to machine learning techniques in predicting non-adherence to therapy or examples of the use of predictive analytics to identify patients at risk of future events.

Moderator: Michael Nelson, PharmD
Senior Principal & Regional Leader, Americas, Real-World Evidence Solutions & HEOR, IMS Health, Alexandria, VA, USA
ACADEMIC PERSPECTIVE: ACQUIRING INSIGHT FROM HEALTH DATA USING MACHINE LEARNING: METHODOLOGICAL OVERVIEW AND CASE STUDIES
Speaker: C. David Page, PhD
Professor, Departments of Biostatistics & Medical Informatics and Computer Science, University of Wisconsin, Madison, WI, USA
USING PREDICTIVE ANALYTICS TO DRIVE IMPROVEMENTS IN HEALTH AND COSTS: THE CASE OF NORTHSHORE UNIVERSITY HEALTHSYSTEM
Speaker: Jonathan C. Silverstein, MD, MS, FACS, FACMI
Vice President & Davis Family Chair of Informatics, Head, Center for Biomedical Research Informatics (CBRI) NorthShore University HealthSystem, and Research Associate (Professor of Surgery), University of Chicago Pritzker School of Medicine, Evanston, IL, USA
PREDICTING THE KEY AREAS FOR PREDICTIVE ANALYTICS IN REAL-WORLD EVIDENCE
Speaker: John Rigg, PhD
Senior Manager, Advanced Analytics, Real-World Evidence Solutions, IMS Health, London, UK
INTRODUCTION: EXTENDING THE STATISTICAL TOOLKIT TO MAKE THE MOST OF BIG DATA
Speaker: Michael Nelson, PharmD
Senior Principal & Regional Leader, Americas, Real-World Evidence Solutions & HEOR, IMS Health, Alexandria, VA, USA
QUESTIONS AND ANSWERS
IMS Health
(Sponsored by IMS Health)
Tuesday, June 3, 2014

7:15 AM - 8:15 AM
Room: Room 518abc (5th Floor)
EMERGING ACCESS BARRIERS AND EVIDENCE REQUIREMENTS FOR ONCOLOGY THERAPIES: EXPERIENCES ACROSS THREE COUNTRIES
The past 20 years have seen rapid advances in the treatment of cancer; however, the ability of health care systems to pay for these innovative therapies has lagged, leading to an increased focus on optimally managing access and/or cost in many markets. For manufacturers of these therapies, the relatively small patient populations translates into the need for higher prices to allow for an adequate risk adjusted return on investment, while for other stakeholders, the need to mitigate financial risk combined with the increasing number of treatment alternatives has caused many to ask how much of a premium is too much.  

While the concept of value for money has been prevalent in other therapeutic areas for a number of years, assessing value and potentially managing access to innovative therapies in oncology represents a substantial shift for markets such as the Canada, Germany, and the United States.

This symposium will provide a platform to discuss the current and future trends in assessing value and managing access in oncology for these three key markets, in order to highlight key similarities as well as differences with respect to the process and evidence requirements for manufacturers bringing innovative treatments to market.

INTRODUCTIONS AND OVERVIEW
Moderator: Trent McLaughlin, BSc(Pharm), PhD
Vice President, Xcenda, Palm Harbor, FL, USA
ASSESSMENT OF INNOVATIVE ONCOLOGY THERAPIES IN CANADA: THE PAN CANADIAN ONCOLOGY DRUG REVIEW AND OTHER TOPICS
Speaker: Sandra Anderson, MBA
AmerisourceBergen Specialty Canada, Burlington, ON, Canada
GERMANY: AMNOG AND ONCOLOGY
Speaker: Thomas Mittendorf, PhD
Managing Director, Herescon GmbH, Hannover, Germany
USA: THE AFFORDABLE CARE ACT AND ONCOLOGY
Speaker: Amy Grogg, PharmD
President, Xcenda, AmerisourceBergen Consulting Services, Palm Harbor, FL, USA
DISCUSSION
Xcenda
(Sponsored by Xcenda)

12:15 PM - 1:15 PM
Room: Room 710a (7th Floor)
MEASURING UTILITY FOR ECONOMIC MODELS WITHIN CLINICAL TRIALS: CAN WE DO BETTER?
The quality of utility estimates used in economic analyses is critical to the health technology assessment decision-making processes which determine whether new medicines are made available to patients in many countries. Important improvements in the quality of utility research have been made in recent years, including more frequent measurement of utility (most often using the EQ-5D) in large patient samples alongside Phase 3 trials. However, in practice, these data often provide poor utility estimates for economic models for a number of reasons. Trials designed to evaluate efficacy and safety may not be appropriate or optimal for collection of utility estimates for economic modeling. For example, there may be limited opportunity to collect data for key health states relevant to the economic analysis within the trial follow-up (e.g. cancer trials often provide little data for patients after disease progression). The trial population may not represent patients in routine clinical practice which may introduce bias. For example, older patients or those with co-morbidities or abnormal organ function are often excluded, resulting in a younger and fitter population than in routine clinical practice. Assessments are often made at regular scheduled visits, which may not coincide with the time during which events of interest (e.g. fractures or disease flares) affect quality of life. It is also crucial to consider whether EQ-5D is appropriate for the condition of interest (in terms of validity and responsiveness), and to design appropriate analyses of the data. Commonly, the mean utility, or the mean change from baseline, are reported at a series of time points. These data are often useless for economic models which usually require utility estimates for health states.

The panel will discuss approaches to determining whether to measure utility in a trial (versus an alternative study type), challenges of balancing the requirements for reimbursement and regulatory authorities in a single trial, whether EQ-5D is an appropriate measure (or an alternative measure is justified), optimal timing of assessments, and specification of analyses to utilize the power of patient-level utility data.

Moderator: Sorrel Wolowacz, PhD
Head, Health Economics Europe, RTI Health Solutions, Manchester, UK
Speaker: Andrew Briggs, DPhil, MSc
William R. Lindsay Professor of Health Economics, Department of Health Economics & Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK
Speaker: Jennifer Petrillo, PhD
Director, PRO Specialist, Global HE&OR, Novartis AG, Basel, Switzerland
Speaker: Lynda Doward, MRes
European Head, Patient-Reported Outcomes, RTI Health Solutions, Manchester, UK
RTI Health Solutions
(Sponsored by RTI Health Solutions)
Wednesday, June 4, 2014

7:15 AM - 8:15 AM
Room: Room 518abc (5th Floor)
COMMUNICATING THE VALUE OF INNOVATION FOR ONCOLOGY THERAPY – THE ROAD AHEAD
Payers are sharpening their pencils faced with new cancer therapies that revolutionize treatment but come with a high price tag. As payers become more discriminating in their coverage decisions and enact new cost control strategies, the future requires us to be even more strategic in the development of persuasive evidence and value story communication for innovative oncology products. This symposium will look at the market access challenges posed by a changing payer marketplace and key principles to guide real-world evidence generation from a product lifecycle perspective to support payer decision making for oncology products.
Moderator: Leigh G. Hansen, MS, MBA
Vice President, Market Planning & Strategy - Life Sciences, Truven Health Analytics, Northwood, NH, USA
Speaker: Kathleen A. Foley, PhD
Senior Director of Strategic Consulting, Truven Health Analytics, Cambridge, MA, USA
Speaker: Mason W. Russell, MAPE
Vice President, Strategic Consulting, Truven Health Analytics, Cambridge, MA, USA
Speaker: Ira Klein, MD, MBA, FACP
Chief of Staff & Chief Medical Officer, Aetna Inc., Hartford, CT, USA
Truven Health Analytics
(Sponsored by Truven Health Analytics)

11:45 AM - 12:45 PM
Room: Room 518abc (5th Floor)
BRIDGING TO COMPARATIVE EFFECTIVENESS
As the demand for real-world evidence increases in drug evaluation for pricing and reimbursement decisions, availability of real-world data and feasibility of studies in the real-life are becoming critical issues for manufacturers. In this context, developing approaches or tools to leverage all relevant data is a key success driver for industry and a cornerstone for robust, evidence-based HTA/payer decision making. This symposium will describe the current practice and trends surrounding comparative effectiveness research (CER) studies and “bridging-to-real-world” methodologies for the sake of market access strategy planning and drug evaluations by HTA bodies and payers. Industry, HTA/payer, and scientist viewpoints will be addressed through European and American case studies.
Moderator: Lucien Abenhaim, MD, PhD, MSc
Chairman, LASER ANALYTICA, London, UK
Speaker: Marc Berger, MD
Vice President, Real World Data & Analytics, Pfizer, Inc., New York, NY, USA
Speaker: Billy Amzal, X-Ponts, PhD
Senior Scientific Vice President, LASER ANALYTICA, London, UK
Speaker: Finn Børlum Kristensen, MD, PhD
Secretariat Director, European Network for Health Technology Assessment (EUnetHTA), Copenhagen, Denmark
LASER ANALYTICA
(Sponsored by LASER ANALYTICA)
Contact ISPOR @ info@ispor.org | View Legal Disclaimer
© 2018 International Society for Pharmacoeconomics and Outcomes Research.
All rights reserved under International and Pan-American Copyright Conventions.