Educational Symposia
Sunday, May 17, 2015

5:15 PM - 6:15 PM
Room: Grand Ballroom, Salon H (Level 5)
BIOSIMILARS ON THE RED CARPET: THE PHARMACOECONOMICS OF THEIR AMERICAN DEBUT
Appetizers will be provided prior to the presentation for Symposium attendees

As of March 2015, when the FDA approved the first biosimilar drug in the United States, biosimilars started to make a much-anticipated impact in the U.S. pharmaceutical market. Biosimilars are expected to offer cost savings, with efficacy and safety that are comparable to innovator products. Yet the overall value of a biosimilar is determined by more than pricing. As with all therapeutics, optimizing economic efficiency is part of the health care decision-making process. Based on the European experience with biosimilars, significant impact of this new class of drugs in the U.S. market will require buy-in from specialists, physicians, payers, and patients. What type of decision-analytic models are needed for formulary/reimbursement, clinical use, and prescribing decisions? This session will review issues related to biosimilar uptake by major U.S. stakeholders, including cost-effectiveness models and other analyses such as opportunity cost and cost-minimization. Representative payer and provider decision makers will discuss what each would require to establish a value proposition for biosimilars and to actualize their market penetration and appropriate use. Lessons learned from European biosimilar models will be discussed. Cost-effectiveness and budget-impact analyses for both long- and short-term decision making will be presented, with an emphasis on building and interpreting these models for biosimilars in the U.S..Through a moderated-panel format, this symposium will offer insights into the methodologies that can provide needed information to key stakeholders as biosimilars make their debut in the United States, and to reaffirm cost-effectiveness throughout their life cycle.

Moderator: Edward Li, PharmD, BCOP
Associate Professor, Department of Pharmacy Practice, University of New England College of Pharmacy, Portland, ME, USA
Speaker: Tanya Bentley, PhD
Director, Health Economics and Outcomes Research, Partnership for Health Analytic Research, LLC, Beverly Hills, CA, USA
Speaker: Edward Li, PharmD, BCOP
Associate Professor, Department of Pharmacy Practice, University of New England College of Pharmacy, Portland, ME, USA
Speaker: Bill Martin
Vice President, Pharmaceutical Strategies and Account Management, Accredo Health Group, Inc., Memphis, TN, USA
ProCE
(Sponsored by ProCE)

6:30 PM - 7:30 PM
Room: Grand Ballroom, Salon H (Level 5)
PRICING INNOVATION FOR NEW THERAPIES IN ADVANCED CANCERS: ADDRESSING AFFORDABILITY & THE PRACTICAL APPLICATION OF INNOVATIVE PRICING METHODS
Pricing of innovative medicines today uses the same approach which has been used for decades, and brings unnecessary uncertainty into both budget impact and cost-effectiveness calculations for payers & health care commissioners. There are better, more innovative techniques that can be used to set prices of new medicines, in a way which brings greater certainty to healthcare systems, and also helps with affordability.

This symposium will discuss the relative affordability of new therapies for advanced cancers, current pricing models and their drawbacks, methods for innovation in pricing from new medicines in advanced cancers, and practical application of innovative pricing models.

Presentation Titles 
1. A review of current approaches to pricing for innovative medicines for advanced cancers, including risk sharing, and the uncertainties generated from these approaches
2. Building a more sustainable model in pricing of new medicines for advanced cancers
3. Practical application of new pricing methods in different health care systems

Moderator: Colin Galbraith Wight
Chief Executive, GalbraithWight Ltd., Princeton, NJ, USA
Speaker: Thomas Lönngren, PhD(h) Pharmacy
Strategic Advisor, NDA Group, Stockholm, Sweden
Speaker: Mark Boyden, MBA
Principal Consultant, Galbraithwight Limited, Polegate, UK
Speaker: Mig Sleeper
Managing Director, Asera Consulting, Surrey, UK
GalbraithWight
(Sponsored by GalbraithWight)
Monday, May 18, 2015

7:15 AM - 8:15 AM
Room: Grand Ballroom, Salon H (Level 5)
DOES REAL WORLD EVIDENCE, IN THE GUISE OF PATIENT REGISTRIES, ADD ANY VALUE TO THE DECISION-MAKING PROCESS?
Breakfast will be provided prior to the presentation for Symposium attendees

Real world evidence, such as large scale patient registries, have often been proposed as potential sources of clinical, economic, patient reported, and safety outcomes evidence that can aid decision making in health care. The impact on payer reimbursement decisions will be discussed.

Moderator: Manpreet Sidhu, MBA, PhD
Principal, US Health Economics and Epidemiology, ICON, Morristown, NJ, USA
Speaker: Gina Nicholson, MPH
Senior Health Economist, Health Economics & Epidemiology, ICON, plc., El Segundo, CA, USA
Speaker: Christopher M. Blanchette, PhD, MBA
Associate Dean, Research & Public Engagement, University of North Carolina at Charlotte, Charlotte, NC, USA
Speaker: Alex Exuzides, PhD
Director, Health Economics, ICON, plc., San Francisco, CA, USA
Speaker: Lina Eliasson, PhD
Lead Outcomes Researcher, ICON PRO, Oxford, UK
ICON
(Sponsored by ICON)

12:15 PM - 1:15 PM
Room: Grand Ballroom, Salon C, D, E (Level 5)
EQ-5D-5L: DEVELOPMENT OF THE FIRST NATIONAL TARIFFS
The development of the EQ-5D-5L and value sets to support its use in outcomes-based studies, including economic evaluations of health care interventions, has been a major initiative undertaken by the EuroQol Group in recent years.  In this symposium the approach to harmonizing development of value sets through a standardized protocol across countries will be briefly discussed. Next, the new EQ-5D-5L value set for England will be presented, and insights from that study will be discussed. A user (industry) perspective on accessing and applying the value sets will be presented.  Finally, future directions for initiatives and applications beyond economic evaluations will be outlined.
Moderator: A. Simon Pickard, PhD
Professor, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA
Speaker: Ben van Hout
Professor, HEDS, ScHARR, The University of Sheffield, Sheffield, UK
Speaker: Kristina Secnik Boye
Director, Health Outcomes, Eli Lilly, Indianapolis, OH, USA
Speaker: Jan van Busschbach
Professor, Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands
EuroQol Research Foundation
(Sponsored by EuroQol Research Foundation)
Tuesday, May 19, 2015

7:15 AM - 8:15 AM
Room: Grand Ballroom, Salon H (Level 5)
DEVELOPMENTS IN MEDICAL BIG DATA RESEARCH: UNITED STATES AND CHINA
The rapid adoption of electronic medical record (EMR) systems and the expansion of health care coverage, combined with burgeoning patient-centric online content, have provided exciting new data sources in the United States and China. As additional dimensions (e.g., vital signs, laboratory results, biomarker and genomics data, physician notes, assessment of patient symptoms) to health care data have become available and are linked to traditional medical and pharmacy care data, they present new opportunities for creating more holistic real-world evidence. Researchers may use these new data elements to characterize quality of health care services, drug effectiveness, adverse event experiences, patient-reported outcomes, disease progression, and functionality. The recent advent of analytical techniques and natural language processing algorithms further provides a channel through which information from text-based data can be efficiently extracted. In this session, Howard Birnbaum will serve as moderator. Lisa Pinheiro will discuss recent analytical techniques. Mei Sheng Duh will discuss social media, big data, and patient-reported outcomes in the health care field. Nabarun Dasgupta will discuss how mobile apps and social media are increasing the efficiency of voluntary adverse event reporting to the FDA. Eric Wu, will discuss China in the world of big data.
Moderator: Howard G. Birnbaum, PhD
Principal, Analysis Group, Inc., Boston, MA, USA
Speaker: Lisa Pinheiro
Vice President, Analysis Group, Montreal, QC, Canada
Speaker: Mei Sheng Duh, MPH, ScD
Managing Principal, Analysis Group, Boston, MA, USA
Speaker: Nabarun Dasgupta, PhD
Chief Data Scientist & Co-founder, Epidemico, Raleigh, NC, USA
Speaker: Eric Wu, PhD
Managing Principal, Analysis Group, Boston, MA, USA
Analysis Group
(Sponsored by Analysis Group)

12:15 PM - 1:15 PM
Room: Grand Ballroom, Salon C, D, E (Level 5)
DISSEMINATION OF HEALTH ECONOMIC EVIDENCE TO US PAYERS UNDER FDAMA SECTION 114 – LESSONS FROM THE PAST AND NEW GUIDANCE EXPECTED
Section 114 of the FDA Modernization Act of 1997 created the opportunity for pharmaceutical companies to provide health care economic information to managed care formulary committees. As formulary committees seek more health economic information regarding products, pharmaceutical companies are closely evaluating what information can and cannot be shared within the confines of Section 114. Increased pressure by multiple stakeholders has led the FDA to consider drafting guidance to clarify parameters that may be proactively disseminated. However, due to the complexity of this topic, continued delays exist in releasing the draft guidance by the FDA.

Trends in sharing health economic information under Section 114 will be discussed. Perspectives of how pharmaceutical companies are handling the dissemination of health economic information as well as receipt of information by managed care will be shared and discussed in detail.

Moderator: Jay Jackson, PharmD, MPH
Vice President, Xcenda, Palm Harbor, FL, USA
Speaker: Eleanor M Perfetto, PhD, MS
Professor, Pharmaceutical Health Services Research, University of Maryland, School of Pharmacy, Baltimore, MD, USA
Speaker: Jan Hansen, PhD
Vice President, Global Health Outcomes, Allergan, Irvine, CA, USA
Speaker: John W. McKnight, PharmD, BCPS
Director, HPS Clinical Strategies, Humana, Louisville, KY, USA
Xcenda
(Sponsored by Xcenda)
Wednesday, May 20, 2015

7:15 AM - 8:15 AM
Room: Grand Ballroom, Salon H (Level 5)
BRIDGING THE REAL-WORLD EVIDENCE (RWE) DIVIDE WITH PAYERS AND INTEGRATED DELIVERY NETWORKS (IDNS): MAKING PHARMA A TRUE COLLABORATOR IN EVIDENCE
Breakfast will be provided prior to the presentation for Symposium attendees

Real-world evidence (RWE) has deep roots in outcomes research, pharmaco-epidemiology, and phase IV studies.  In fact, there are thousands of experts sitting in pharma companies every day producing thousands of RWE studies with the intention of informing payer decisions. They are leveraging new electronic data sources, interrogation technology, novel analytic methodologies, and deeper understanding of health care issues and tradeoffs.  But whereas regulators are already seeing the benefits from improved safety and drug utilization studies, payers have not adopted RWE as widely.  And where they do use it, they widely restrict the input coming from pharma companies.  Why?  We wanted to know, too.  

This symposium is the result of several steps in exploration of this situation. The exploration included leveraging direct experience supporting pharma as well as engaged payers and Integrated Delivery Networks (IDN) directly on this topic. Research on 100+ known cases of RWE use in payer decisions was conducted. A joint symposium with the Johns Hopkins Center for Drug Safety and Effectiveness (including pharma, academic, and payer participants) was held, and RWE-specific research in a survey with 70 US payers was conducted. This symposium will discuss how RWE has informed payer and IDN decisions to date and other findings from the research and case studies. Tangible opportunities for life sciences to accelerate engagement and impact of RWE and its generation will also be explored. Faculty will include representatives of payers, IDNs, academics, and senior experts from IMS Health.

INTRODUCTION
Moderator: G. Caleb Alexander, MD, MS
Co-Director, Center for Drug Safety and Effectiveness & Associate Professor, Johns Hopkins School of Public Health, Center for Drug Safety and Effectiveness, Baltimore, MD, USA
COULD PHARMA BE THE CATALYST FOR IDNS AND PAYERS TO USE RWE MORE EXTENSIVELY?
Speaker: Marla Kessler, MBA
Vice President & Regional Leader, America, IMS Health, New York, NY, USA
THE IDN PERSPECTIVE
Speaker: Jim Peters, MBA
Senior Vice President, Chief Strategic Industry Partnerships Officer, Geisinger Health System, Danville, PA, USA
THE PAYER PERSPECTIVE
Speaker: Ira Klein, MD, MBA, FACP
National Medical Director, Clinical Thought Leadership, Office of the CMO, AETNA, Hartford, CT, USA
IMPLICATIONS FOR PHARMA – A MODERATED PANEL
Speaker: G. Caleb Alexander, MD, MS
Co-Director, Center for Drug Safety and Effectiveness & Associate Professor, Johns Hopkins School of Public Health, Center for Drug Safety and Effectiveness, Baltimore, MD, USA
IMS Health
(Sponsored by IMS Health)

11:45 AM - 12:45 PM
Room: Grand Ballroom, Salon H (Level 5)
THE REAL WORLD: HOW INTEGRATED DATA IS USED TO IMPROVE PATIENT CARE
This symposium will focus on how integrated health information can be used to improve patient care. Speakers will discuss ways that access to actionable information can inform patients’ decision making, support physicians’ treatment recommendations, and achieve payers’ goal of aligned behaviors. This symposium will include speakers from multiple large US health plans and will focus on the use of observational data sources by payers, providers, and patients in service of individual and population health management. Dr. Richard Migliori (UnitedHealth Group) will address ways that integrated delivery systems use observational data to improve care, with focus on synchronization of data systems and methods of providing timely, complete, and actionable information to providers and patients.  Dr. Migliori will describe UnitedHealth Group’s strategy of harnessing data, sifting it, processing it through rules engines, and pushing information back to providers and patients. The process Dr. Migliori will describe enables providers and patients to make information-based decisions and develop personalized care plans. Dr. Michael Kolodziej (Aetna, Oncology Solutions) will describe ways in which providers use data and information to inform treatment recommendations.  Using cancer treatment as an example of complex disease management, Dr. Kolodziej will focus on how both providers and patients can make better decisions about treatment by using integrated data. The tools for generating actionable information and the role that these tools can play in driving treatment decisions will be described by the first two speakers. A third critical component of using data to improve patient care is the engagement of providers and patients in the process. Dr. Sam Ho, UnitedHealthcare will discuss how payers and providers use integrated data to implement payment strategies. A discussion regarding how infrastructure can be built to encourage, achieve, and maintain alignment in patient and provider behavior will be included.  Leadership from UnitedHealthcare will also discuss the role of financial incentives in achieving provider and payer goals.
Moderator: Henry J. Henk, PhD
Vice President & Principal Consultant, Optum, Eden Prarie, MN, USA
Speaker: Aylin Altan, PhD
Vice President, HEOR, Optum Labs, Eden Prairie, MN, USA
Speaker: Richard Migliori, MD
Executive Vice President, Medical Affairs & Chief Medical Officer, UnitedHealth Group, Minnetonka, MN, USA
Speaker: Michael Kolodziej, MD, FACP
National Medical Director, Oncology Solutions, Aetna, Hartford, CT, USA
Speaker: Sam Ho, MD
Executive Vice President, Chief Medical Officer, UnitedHealthcare & UnitedHealthcare Medicare & Retirement, Cypress, CA, USA
Optum
(Sponsored by Optum)
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