PROGRAM - Monday, May 23, 2011
 

PROGRAM - MONDAY, MAY 23, 2011
7:00AM - 8:00AM
EDUCATIONAL SYMPOSIUM (Sponsored by United BioSource Corporation)
NAVIGATING THE NEW COMPARATIVE EFFECTIVENESS LANDSCAPE: THE ROLE OF HEALTH INFORMATION TECHNOLOGY (HIT) Symposium Description »
8:00AM - 8:30AM
EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION I
8:30AM - 10:30AM
WELCOME & FIRST PLENARY SESSION

MEETING PROGRAM OVERVIEW
Mark S. Roberts MD, MPPMark S. Roberts MD, MPP
Program Committee Chair & Professor and Chair, Department of Health Policy and Management, University of Pittsburgh Graduate School of Public Health & Professor of Medicine, Industrial Engineering and Clinical and Translational Science, University of Pittsburgh, Pittsburgh, PA, USA

 

PRESIDENTIAL ADDRESS
Michael Barry PhDScott D. Ramsey, MD, PhD
2010-2011 ISPOR President, Member, Fred Hutchinson Cancer Research Center and Professor, Department of Medicine, University of Washington, Seattle, WA, USA

  ISPOR 2011 AVEDIS DONABEDIAN OUTCOMES RESEARCH LIFETIME ACHIEVEMENT AWARD
Announced by: Sean D. Sullivan, PhD, RPh, Chair, ISPOR Avedis Donabedian Lifetime Achievement Award in Health Outcomes Committee, Professor and Director, University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA

Michael Barry PhDAWARDEE: Sir Michael Rawlins, MD, FRCP, FFPM, FMedSci, Chairman, National Institute of Health & Clinical Excellence (NICE), London, UK
  HEALTH CARE REFORM IN THE UNITED STATES - ONE YEAR LATER
In 2010, US Congress passed major health care reform legislation [the "Affordable Care Act" and the "Reconciliation Act"]. The Medicare prescription drug "doughnut hole" will be phased out. Employers will be penalized if they do not offer health care coverage and US citizens are required to have "health care coverage" by 2014. Small businesses can purchase qualified coverage via state-based health insurance exchanges by 2014. How will these changes affect health care management organizations and providers and health technology producers (drug, device, and diagnostics)? What is the clinical impact of this law? What is the impact of this act on outcomes research? These questions will be addressed during this plenary session as well as a legal and political analysis of this law will be presented.

Moderator:
Mark S. Roberts, MD, MPP, Professor and Chair, Department of Health Policy and Management, University of Pittsburgh Graduate School of Public Health & Professor of Medicine, Industrial Engineering and Clinical and Translational Science, University of Pittsburgh, Pittsburgh, PA, USA
Speakers:  

Robert I. Field, JD, MPH, PhD, Professor of Law, Earle Mack School of Law at Drexel University, Professor of Health Management and Policy, Drexel University School of Public Health, Philadelphia, PA, USA

Allan M. Korn, MD, Senior Vice President, Chief Medical Officer, Office of Clinical Affairs, Blue Cross and Blue Shield Association, Chicago, IL, USA
Steve E. Phurrough, MD, MPA, Chief Operating Officer and Senior Clinical Director, Center for Medical Technology Policy, Baltimore, MD, USA
10:30AM-11:00AM
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION I
11:00AM-12:00PM
ISSUE PANELS - SESSION I
11:00AM-12:00PM Health Policy Development Using Outcomes Research Issues
IP1: IS FDA/CMS PARALLEL REVIEW WORTHWHILE? IS IT FEASIBLE?

Moderator: Peter J Neumann, ScD, Professor and Director, The Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA
Panelists: Scott Gottlieb, MD, Resident Fellow, American Enterprise Institute for Public Policy Research, Washington, DC, USA; Sean R. Tunis, MD, MSc, Founder and Director, Center for Medical Technology Policy, Baltimore, MD, USA; James Chambers, MPharm, MSc, Project Director, The Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA
11:00AM-12:00PM IP2: PAYING FOR VALUE - WHICH TO GO FOR: THE NEW UK APPROACH OR THE NEW GERMAN LAW OR NEITHER?
Moderator: J. Jaime Caro, MDCM, FRCPC, FAC, Senior Vice President of Health Economics, United BioSource Corporation, Lexington, MA, USA
Panelists: Peter L. Kolominsky-Rabas, MD, PhD, MBA, Director, Centre for Health Technology Assessment (HTA) and Public Health (IZPH), University of Erlangen-Nurnberg, Erlangen, Germany; Alistair J. McGuire, PhD, Professor and Head of Social Policy, LSE Health and Social Care, London, UK
11:00AM-12:00PM IP3: ASSESSMENTS OF RELATIVE EFFICACY: DO THE BENEFITS JUSTIFY THE COSTS?
Moderator: Benedikte Lensberg, MSc, Project Leader, i3 Innovus, Uxbridge, Middlesex, UK
Panelists: Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK; Kalipso Chalkidou, MD, Director, NICE International, National Institute for Health and Clinical Excellence, London, UK; Adrian Towse, MA, Director, Office of Health Economics, London, UK
11:00AM-12:00PM Economic Outcomes Research Issues
IP4: WHAT CAN WE LEARN FROM SUCCESSES AND FAILURES IN PERSONALIZED MEDICINE? IMPLICATIONS FOR EVOLVING HEALTH ECONOMICS AND OUTCOMES RESEARCH PRACTICES

Moderator: Eric C Faulkner, MPH, Senior Director, Market Access and Outcomes Strategy, RTI Health Solutions, Research Triangle Park, NC, USA
Panelists: Bruce Quinn, PhD, MD, Senior Health Policy Specialist, Foley Hoag, Boston, MA, USA; Kostas Trakas, PhD, MSc, Senior Director, Worldwide Health Economics & Pricing, CNS, Johnson & Johnson Pharmaceutical Services LLC, Toronto, ON, Canada; Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy, University of Washington, Seattle, WA, USA
11:00AM-12:00PM Clinical Outcomes Research Issues
IP5: DEBATING THE VALUE AND FUTURE DIRECTIONS OF PATIENT REGISTRIES IN COMPARATIVE EFFECTIVENESS RESEARCH

Moderator: Nancy Dreyer, PhD, MPH, Chief of Scientific Affairs, Senior Vice President, Outcome, Cambridge, MA, USA
Panelists: Charles E. Barr, MD, MPH, Medical Director, Head of Registries, Medical Affairs, Genentech, Inc., South San Francisco, CA, USA; John Spertus, MD, MPH, Professor, Clinical Director of Outcomes Research, University of Missouri-Kansas City, Mid America Heart Institute of Saint Luke's Hospital, Kansas City, MO, USA; Robert McDonough MD, JD, MPP, Head, Clinical Policy Research and Development, Aetna, Hartford, CT, USA
12:00PM-1:45PM
LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION I
12:30PM-1:30PM
EDUCATIONAL SYMPOSIUM (Sponsored by IMS)
NEW PATIENT-LEVEL DATA FROM SENTINEL, ACA AND RECENT COMMERCIAL ENDEAVOURS: IMPLICATIONS FOR OUTCOMES RESEARCH Symposium Description »
1:45PM-2:45PM
RESEARCH PODIUM PRESENTATIONS - SESSION I
1:45PM-2:45PM

CANCER OUTCOMES RESEARCH

CN1: MONOTHERAPY OF ANDROGEN DEPRIVATION THERAPY VERSUS RADICAL PROSTATECTOMY AMONG VETERANS WITH LOCALIZED PROSTATE CANCER: A COMPARATIVE EFFECTIVENESS ANALYSIS OF RETROSPECTIVE COHORTS
Liu J, Shi L, Sartor O
Tulane University, New Orleans, LA, USA

CN2: ESTIMATED EFFECTS OF THE NATIONAL BREAST AND CERVICAL CANCER EARLY DETECTION PROGRAM ON CERVICAL CANCER MORTALITY
Ekwueme DU1, Uzunangelov V2, Hoerger T2, Saraiya M1, Miller J1, Hall I1, Benard V1, Royalty J1, Li C1
1Center for Disease Control and Prevention, Atlanta, GA, USA, 2RTI International, Research Triangle Park, NC, USA

CN3: THE VALUE OF RESEARCH FOR ERCC1 TESTING IN STAGE I NON-SMALL CELL LUNG CANCER
Roth J1, Carlson JJ2, Steuten L3, Veenstra D1
1University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA, 2University of Washington, Seattle, WA, USA, 3University of Twente, Enschede, The Netherlands

CN4: PALONOSETRON VERSUS OTHER 5-HYDROXYTRYPTAMINE3 RECEPTOR ANTAGONISTS FOR PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING AMONG MEDICARE PATIENTS WITH CANCER
Craver C1, Gayle J1, Balu S2, Buchner D2
1Premier, Inc, Charlotte, NC, USA, 2Eisai Inc., Woodcliff Lake, NJ, USA

1:45PM-2:45PM

COMPARATIVE EFFECTIVENESS RESEARCH

CO1: COMPARATIVE EFFECTIVENESS ANALYSIS OF TNF BLOCKERS IN RHEUMATOID ARTHRITIS (RA) PATIENTS IN A REAL-WORLD SETTING
Bonafede RP1, Pearson D2, Babich J3, Chastek B4, Becker L4, Watson C5, Chaudhari S6, Harrison DJ7, Gandra SR7
1Providence Arthritis Center, Portland, OR, USA, 2Ventura County Medical Center, Ventura, CA, USA, 3Carolina Bone & Joint, Charlotte, NC, USA, 4i3 Innovus, Eden Prairie, MN, USA, 5Amgen, Newbury Park, CA, USA, 6KForce Clinical Research, Tampa, FL, USA, 7Amgen Inc., Thousand Oaks, CA, USA

CO2: REAL-WORLD COST-EFFECTIVENESS ANALYSIS OF CANCER DRUGS: COMPARATIVE EFFECTIVENESS RESEARCH USING RETROSPECTIVE CANADIAN REGISTRY DATA BEFORE AND AFTER DRUG APPROVAL
Khor S1, Krahn M2, Hodgson D3, Bremner K4, Luo J5, Hoch J1

1Cancer Care Ontario, Toronto, ON, Canada, 2Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto, ON, Canada, 3Princess Margaret Hospital, Toronto, ON, Canada, 4University Health Network, Toronto, ON, Canada, 5The Institute For Clinical Evaluative Sciences, Toronto, ON, Canada

CO3: PROJECT LIBRA: A NEW ANALYTIC TOOL FOR COMPARATIVE EFFECTIVENESS ANALYSES OF MULTIPAYER CLAIMS DATABASES
Mark T1, Pepitone A2, Hatzmann M1, Navathe A3, Goodrich K3, Chang S1
1Thomson Reuters, Washington, DC, USA, 2Thomson Reuters, Santa Barbara, CA, USA, 3Assistant Secretary for Planning and Evaluation, Washington, DC, USA

CO4: POTENTIAL COST SAVINGS FROM COMPARATIVE EFFECTIVENESS RESEARCH: LESSONS FROM COURAGE STUDY
Bonakdar tehrani A, Howard D
Emory University, Atlanta, GA, USA

1:45PM-2:45PM

EFFECTS OF DRUG MANAGEMENT PROGRAMS ON PATIENTS

DM1: IMPACT OF A PHARMACY REFILL MANAGEMENT SYSTEM ON OUTCOMES IN END STAGE RENAL DISEASE (ESRD) PATIENTS
Rubin JL1, Wilson SM1, Golomb J2
1DaVita Clinical Research, Minneapolis, MN, USA, 2DaVita Rx, San Bruno, CA, USA

DM2: 12-MONTH OUTCOMES OF A PHARMACIST-PROVIDED TELEPHONE MEDICATION THERAPY MANAGEMENT (MTM) PROGRAM
Moczygemba L1, Barner JC2, Gabrillo E3
1Virginia Commonwealth University, Richmond, VA, USA, 2The University of Texas at Austin, Austin, TX, USA, 3Scott & White Health Plan Prescription Services, Temple, TX, USA

DM3: IMPACT OF MONTHLY PRESCRIPTION CAP ON MEDICATION PERSISTENCY AMONG PATIENTS WITH DIABETES, HYPERTENSION, OR HYPERLIPIDEMIA
Wang CC, Wei D, Farley J
University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

DM4: EVALUATION OF CLINICAL LABORATORY-PHARMACY LINKAGE DECISION SUPPORT IN THE USE OF POTASSIUM SUPPLEMENTS
Yu S, Galanter W, Lin FJ, Lambert B
University of Illinois at Chicago, Chicago, IL, USA

1:45PM-2:45PM

EMPLOYEE HEALTH & PRODUCTIVITY OUTCOMES RESEARCH

OR1: THE ASSOCIATION BETWEEN SELF-PERCEIVED COGNITIVE DIFFICULTIES AND LEVEL OF DEPRESSION AMONG EMPLOYEES WITH CURRENT DEPRESSION
Lawrence C1, Roy A2, Harikrishnan V2, Yu S2, Dabbous OH2
1Xcenda AmerisourceBergan Consulting Services, Palm Harbor, FL, USA, 2Takeda Pharmaceuticals International, Deerfield, IL, USA

OR2: ASSESSING THE RELATIONSHIP BETWEEN MEDICATION ADHERENCE AND EMPLOYEE PRODUCTIVITY
Loeppke R1, Haufle V2, Jinnett K3
1U.S. Preventive Medicine, Inc., Brentwood, TN, USA, 2Alere, Rosemont, IL, USA, 3Integrated Benefits Institute, San Francisco, CA, USA

OR3: THE DIRECT AND INDIRECT COSTS ASSOCIATED WITH HYPOGONADISM AMONG U.S. PRIVATELY-INSURED EMPLOYEES
Kaltenboeck A1, Foster S2, Thomas N2, Ivanova J1, Diener M1, Bergman R1, Birnbaum H3, Swindle R2
1Analysis Group, Inc., New York, NY, USA, 2Eli Lilly and Company, Indianapolis, IN, USA, 3Analysis Group, Inc., Boston, MA, USA

OR4: ASSOCIATIONS BETWEEN JOBLESSNESS AND ALL-CAUSE HEALTH SERVICES UTILIZATION IN US DIABETIC WORKING AGE ADULTS
Davis-Ajami ML1, Nahata M1, Seiber E1, Reardon G2, Balkrishnan R3
1The Ohio State University, Columbus, OH, USA, 2Informagenics, LLC, Worthington, OH, USA, 3University of Michigan, Ann Arbor, MI, USA

1:45PM-2:45PM

CASE STUDIES IN ADDRESSING SELECTION BIAS

SB1: COMPARISON OF DIFFERENCE-IN-DIFFERENCE, PROPENSITY SCORE MATCHING AND INSTRUMENTAL VARIABLES IN ESTIMATING COST DIFFERENCES BETWEEN TWO COHORTS
Cao Z, Song X
Thomson Reuters, Cambridge, MA, USA

SB2: ZEROS AND NON-REPORTEDHEALTHCARE AND WORKPLACE PRODUCTIVITY DATA: AN APPLICATION OF TWO-STAGE ESTIMATION TECHNIQUES MEASURING INPATIENT COSTS AND ABSENTEEISM ASSOCIATED WITH LOW BACK AND NECK PAIN
Simons WR1, Chow W2, Biondi D2, Benson C2, Kim M2
1Global Health Economics & Outcomes Research Inc,, Summit, NJ, USA, 2Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, NJ, USA

SB3: INNOVATIVE DESIGN FOR A COMPARATIVE EFFECTIVENESS STUDY OF SCHIZOPHRENIA TREATMENTS: ANALYSIS OF RECORD REVIEW DATA INCORPORATING RANDOMIZATION AND PROPENSITY SCORE MATCHING
McCarrier KP1, Durkin MB2, Dirani R2, Markowitz M2, Slabaugh SL2, Martin ML1
1Health Research Associates, Inc, Seattle, WA, USA, 2Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA

SB4: A METHODOLOGY FOR ASSESSING TREATMENT EFFECT IN THE PRESENCE OF DISEASE SEVERITY AND COMORBIDITY IN RETROSPECTIVE OBSERVATIONAL STUDIES
Kiri VA
PAREXEL International, Uxbridge, London, UK

3:00PM-4:00PM
WORKSHOPS - SESSION I
3:00PM-4:00PM Clinical Outcomes Research
W1: CONDUCTING & INTERPRETING INDIRECT TREATMENT COMPARISON AND NETWORK META-ANALYSIS: LEARNING THE BASICS

Discussion Leaders: Jeroen P. Jansen, PhD, MSc, Research Director, Mapi Values, Boston, MA, USA; Neil Hawkins, PhD, Director, Oxford Outcomes Ltd, Oxford, UK; Joseph C. Cappelleri, PhD, MPH, Pfizer Inc, New London, CT, USA; Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA
3:00PM-4:00PM Economic Outcomes Research
W2: CHALLENGES AND SOLUTIONS IN CONDUCTING RETROSPECTIVE HEALTH ECONOMICS AND OUTCOMES RESEARCH STUDIES FOR ORPHAN DRUGS AND DISEASES

Discussion Leaders: Peter Sun, MD, PhD, Vice President, Health Economics & Outcomes Research, Kailo Research Group, Fishers, IN, USA; Zhimei Liu, PhD, Associate Director, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; Amy Guo, PhD, Senior Director, Health Economics & Outcomes Research, US CD&MA, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; Jie Zhang, PhD, Director, Novartis Pharmaceuticals Corporation Medical, East Hanover, NJ, USA
3:00PM-4:00PM Health Care Policy Development Using Outcomes Research
W3: PATIENT-CENTERED BENEFIT-RISK ANALYSIS: THE CASE FOR ANALYTIC HIERARCHY PROCESS
Discussion Leaders: Maarten J. IJzerman, PhD, Professor & Chair, Department of Health Technology & Services Research, University Twente, Enschede, The Netherlands; John F.P. Bridges, PhD, Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomsberg School of Public Health, Baltimore, MD, USA; Sonal Singh, MD, MPH, Assistant Professor, Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA
3:00PM-4:00PM Patient-Reported Outcomes & Preference-based Research
W4: CHOOSING PRO STATISTICAL ENDPOINTS TO MAXIMIZE SUCCESSFUL OUTCOMES

Discussion Leaders: Dennis D. Gagnon, MA, MABE, Senior Director, Strategic Consulting, Thomson Reuters, Santa Barbara, CA, USA; Margaret Rothman, PhD, Senior Director, Worldwide Market Access, Worldwide Market Access, Johnson & Johnson Pharmaceutical Services, LLC, Raritan, NJ, USA
3:00PM-4:00PM Use of Real World Data
W5: USING CMS MEDICARE CLAIMS PUBLIC USE FILES (PUFS) FOR COMPARATIVE EFFECTIVENESS RESEARCH (CER)
Discussion Leaders: Samuel C. "Chris" Haffer, PhD, Program Manager - Information & Methods Group, Office of Research, Development, & Information, Centers for Medicare and Medicaid Services (CMS), Baltimore, MD, USA; Craig G. Coelen, PhD, President, IMPAQ International, LLC, Columbia, MD, USA; Elizabeth C. Hair, PhD, Senior Research Scientist, Public Health, NORC at the University of Chicago, Bethesda, MD, USA; Jane Hyatt Thorpe, JD, Associate Research Professor, Department of Health Policy, School of Public Health and Health Services, George Washington University Medical Center, Washington, DC, USA
3:00PM-4:00PM W6: POWERFUL DATA, MEANINGFUL ANSWERS: INTRODUCTION TO THE HEALTHCARE COST AND UTILIZATION PROJECT
Discussion Leaders: Claudia Steiner, MD, MPH, Senior Research Physician, Center for Delivery, Organization and Markets (CDOM), Agency for Healthcare Research and Quality (AHRQ), Rockville, MD, USA; Elizabeth Stranges, MS, Research Leader, Thomson Reuters, Evanston, IL, USA
4:00PM-4:15PM
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION I
4:15PM-5:15PM
WORKSHOPS - SESSION II
4:15PM-5:15PM Clinical Outcomes Research
W7: NEW METHODS TO ADJUST FOR SELECTIVE CROSSOVER IN SURVIVAL ANALYSIS: IN ASSESSMENTS OF COST-EFFECTIVENESS OF CANCER THERAPIES

Discussion Leaders: Thomas E. Delea, MSIA, Senior Research Consultant, Policy Analysis Inc. (PAI), Brookline, MA, USA; Mei-Sheng Duh, MPH, ScD, Managing Principal, Analysis Group, Inc., Boston, MA, USA; Lee-Jen Wei, PhD, Professor, Biostatistics, Harvard University, Boston, MA, USA; James Robins, MD, Professor of Epidemiology, Harvard School of Public Health, Boston, MA, USA
4:15PM-5:15PM Economic Outcomes Research
W8: BRICS & MORTAR: BUILDING EMERGING MARKETS INTO GLOBAL HEOR PROGRAMS

Discussion Leaders: David Thompson, PhD, Senior Vice President, Health Economics & Strategic Consulting, i3 Innovus, Medford, MA, USA; Gabriela Tannus, MSc, President, Axia.Bio, Sao Paulo, SP, Brazil; Jianwei Xuan, PhD, Senior Director/Team Leader, Pfizer, New York, NY, USA
4:15PM-5:15PM Health Care Policy Development Using Outcomes Research
W9: USING COMPARATIVE EFFECTIVENESS RESEARCH (CER) TO SUPPORT A VALUE BASED HEALTH CARE SYSTEM, EXAMPLES FROM THE UNITED STATES AND EUROPE
Discussion Leaders: Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA; Feng Pan, PhD, Senior Research Associate, Center for Health Economics and Science Policy, United BioSource Corporation, Bethesda, MD, USA; Corinna Sorenson, MPH, MHSA, Research Officer, European Health Policy, Health & Social Care, London School of Economics and European Health Technology Institute for Socio-Economic Research, London, UK
4:15PM-5:15PM W10: DEVELOPING BETTER EVIDENCE OF PRODUCT SAFETY
Discussion Leaders: Joshua S. Benner, PharmD, ScD, Research Director and Fellow, Engelberg Center for Health Care Reform, The Brookings Institution, Washington, DC, USA; Judy Racoosin, MD, MPH, Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA; Jeffrey S. Brown, PhD, Assistant Professor, Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, MA, USA; Paul Stang, PhD, Senior Director of Epidemiology, Johnson & Johnson and Principal Investigator, Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Philadelphia, PA, USA
4:15PM-5:15PM Patient-Reported Outcomes & Preference-based Research
W11: PATIENT PREFERENCES AND POLICIES: THE ROLE OF HEALTH-PREFERENCE DATA IN REGULATORY DECISION MAKING
Discussion Leaders: F. Reed Johnson, PhD, Distinguished Fellow and Principal Economist, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA; Axel Mühlbacher, PhD, Harkness Fellow in Health Care Policy and Practice, Duke Clinical Research Institute/ Fuqua School of Business, Duke University, Durham, NC, USA; Derek S. Brown, PhD, Research Health Economist, RTI International, Research Triangle Park, NC, USA
4:15PM-5:15PM Use of Real World Data
W12: INVERSE PROBABILITY-WEIGHTED LEAST SQUARES REGRESSION FOR ESTIMATING POPULATION MEAN COSTS OF ALTERNATIVE INTERVENTIONS USING OBSERVATIONAL DATA

Discussion Leaders: Anthony O'Hagan, PhD, Professor, Department of Probability and Statistics, University of Sheffield, Sheffield, UK; Michelle L. Gleeson, PhD, Senior Research Associate, Outcomes Insights, Inc., Westlake Village, CA, USA; Mark D. Danese, PhD, President, Outcomes Insights, Inc., Westlake Village, CA, USA; Robert I. Griffiths, ScD, Vice President, Outcomes Insights, Inc., Westlake Village, CA, USA
5:30PM-6:30PM
ISPOR FORUMS - SESSION I
5:30PM-6:30PM WHEN SEEING IS BELIEVING - COMPARATIVE EFFECTIVENESS: ISPOR GOOD RESEARCH PRACTICES ON PROSPECTIVE OBSERVATIONAL CLINICAL STUDIES

Well-designed observational research has an important role in generating data about comparative effectiveness in real-world clinical practice.  Key issues to consider when designing an observational study and perspectives on when to perform a prospective observational study versus a pragmatic clinical trial will be discussed.  Presented by the ISPOR Prospective Observational Clinical Studies Task Force

Speakers: Marc Berger, MD, Co-Chair, ISPOR Prospective Observational Clinical Studies Task Force and Executive Vice President and Senior Scientist, Ingenix Life Sciences, New York, NY, USA; Sharon-Lise Normand PhD, Co-Chair, ISPOR Prospective Observational Clinical Studies Task Force and Professor of Health Care Policy (Biostatistics), Harvard Medical School, Department of Health Care Policy, Boston, MA, USA; Art Sedrakyan, MD, PhD, Associate Professor and Director, Comparative Effectiveness Program at Hospital Special Surgery and New York Presbyterian, Weill Cornell Medical College, New York, NY, USA; Adrian Towse, MA, Director, Office of Health Economics, London, UK; Nancy Dreyer PhD, MPH, Chief of Scientific Affairs & Senior Vice President, Outcome, Cambridge, MA, USA; Fred Anderson PhD, Research Professor of Surgery, Director, Center for Outcomes Research,
University of Massachusetts Medical School, Worcester, MA, USA

5:30PM-6:30PM PHARMACOECONOMIC GUIDELINES IN ASIA: FOCUS ON THE CHINA GUIDELINES FOR PHARMACOECONOMIC EVALUATIONS

In order to keep up with the economic progress in China and dynamic changes in the country's health care system, The China Guidelines for Pharmacoeconomic Evaluations were recently updated. The forum will introduce the development of the China PE guidelines and will discuss the course of future actions, followed by comments from clinicians and industry. Experiences and lessons from the implementation of pharmacoeconomic guidelines in other Asian countries will be shared. Presented by the ISPOR Asia Consortium

Moderator and Speaker: Shanlian Hu, MD, MSc, President, ISPOR Chinese MDA-PE and Professor, Training Center for Health Management, School of Public Health, Fudan University, Shanghai, China

Speakers: Bong-Min Yang, PhD, 2010-2012 Chair, ISPOR Asia Consortium Executive Committee and Professor of Economics, School of Public Health, Seoul National University, Seoul, South Korea; Gordon G. Liu, PhD, President, ISPOR Beijing Chapter and Professor and Executive Director, Health Economics and Management Institute, Guanghua School of Management, Peking University, Beijing, China; Jiuhong Wu, PhD, Vice President, ISPOR Beijing Chapter and Director, Pharmacy Department, 306 Hospital of PLA, Beijing, China; Jianwei Xuan, PhD, MD, 2010-2012 Chair, ISPOR Asia Consortium Industry Committee and Senior Director & Asia Lead, Outcomes Research, Emerging Markets, Pfizer Inc, New York, NY, USA

5:30PM-6:30PM CAREER OPTIONS IN THE WAKE OF HEALTH CARE REFORM AND RECESSION

The United States Government will possibly implement the largest change in its health care system, through the Patient Protection and Affordable Care Act of 2010, while facing the worst economic times since the Great Depression of 1930's.  What impact would this situation have on a graduate’s career development? Which area has the potential for the greatest increase in job opportunities? What additional skills would employers be looking for? All this and more will be discussed by a panel of experts from academia, pharmaceutical industry and consulting organization at the ISPOR Student Forum.  Organized by the ISPOR Student Council

Moderators: Zeba M. Khan, RPh, PhD, ISPOR Student Network Faculty Advisor and Vice President, Pricing and Market Access, Celgene Corporation, Summit, NJ, USA; Urvi Desai, BPharm, PhD (c), ISPOR Student Network Chair 2010-2011 and Department of Pharmacotherapy and Outcomes Sciences, Virginia Commonwealth University School of Pharmacy, Richmond, VA

Speakers: Chris L Pashos, PhD, Vice President, United BioSource Corporation, Lexington, MA, USA; C. Daniel Mullins, PhD, Co-Editor-in-Chief, Value In Health and Professor, Pharmacoeconomics and Associate Director of Center on Drugs and Public Policy, University of Maryland School of Pharmacy, Baltimore, MD, USA; Jens Grueger, PhD, Vice President and Head of Global Market Access, Primary Care Business Unit, Pfizer, New York, NY USA

5:30PM-6:30PM CONTENT VALIDITY IN NEWLY DEVELOPED PATIENT REPORTED OUTCOMES INSTRUMENTS FOR MEDICAL PRODUCT EVALUATION: WHAT IS SUFFICIENT FOR REGULATORY SUBMISSIONS?

The importance of patient reported outcomes (PRO) instrument content validity is stressed both by the US Food and Drug Administration Guidance (US Food and Drug Administration, 2009) and European Medicines Agency Reflection Paper on the Regulatory Guidance for the Use of Health Related Quality of Life (HRQL) Measures (EMEA, 2006).  Developing content for, and assessing respondent understanding of, newly-developed PRO Instruments for medical product evaluation, including the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies will be discussed.  Presented by the ISPOR PRO Good Research Practices on Establishing and Reporting Evidence of Content Validity Task Force

Moderator: Donald L. Patrick, PhD, MSPH,
Professor, Department of Health Services, University of Washington, Seattle, WA, USA

Speakers: Laurie B. Burke, RPh, MPH, Director, Study Endpoints and Label Development, Office of New Drugs, CDER, FDA, Washington, DC, USA; Chad Gwaltney, PhD, Assistant Professor (Research), Department of Community Health, Brown University, Providence, RI, USA and Senior Scientist, PRO Consulting, Pittsburgh, PA, USA; Nancy Kline Leidy, PhD, Senior Vice President of Scientific Affairs, United BioSource, Bethesda, MD, USA; Mona L. Martin, RN, MPA, Executive Director, Health Research Associates, Inc, Seattle, WA, USA; Lena Ring PhD, Principal Scientist in PRO Strategy, HEOR, R&D, AstraZeneca, Södertälje, Sweden and Associate Professor, Pharmaceutical Outcomes Research, Department of Pharmacy, Uppsala University, Sweden

5:30PM-6:30PM DEVELOPING EVIDENCE TO SUPPORT REIMBURSEMENT AND VALUE-BASED PRICING: ISSUES AND CHALLENGES FOR STAND-ALONE VERSUS COMPANION DIAGNOSTICS

Stand-alone diagnostics and companion diagnostics, developed in tandem with a biopharmaceutical, often face very different challenges related to evidence generation.  As payer’s emphasis on diagnostics continues to grow in many markets, what are the options to balance evidence generation and value-based pricing?  This forum will evaluate the key challenges facing stand-alone and companion diagnostics in the US and evaluate emerging options for aligning value demonstration with value-based payment, including the implications of emerging policy initiatives such as, accountable care organization models, stakeholder partnering, comparative effectiveness, and the evolving architecture for managing diagnostic test reimbursement and payment.  Similarities or differences with other markets than the US will be addressed in the discussion.  Presented by the ISPOR HTA Special Interest Group

Moderator: Annie Chicoye, PhD, Co-Chair, ISPOR Health Technology Assessment (HTA) of Medical Devices and Diagnostics Working Group and Vice-President, Development, Health Management Institute, ESSEC Business School, Cergy Pontoise, France

Speakers:
Eric Faulkner, MPH, Senior Director, RTI Health Solutions and Executive Director, Genomics Biotech and Emerging Medical Technology Institute, National Association of Managed Care Physicians, Research Triangle Park, NC, USA; Laura Housman, MPH, MBA, Executive Director, Market Access and Pricing, Novartis Molecular Diagnostics, Cambridge, MA, USA;Susan Garfield, MSc, Vice President, Bridgehead International, Wayland, MA, USA

5:30PM-6:30PM RUSSIAN FEDERATION HEALTH CARE SYSTEM: ISSUES AND PROSPECTS

The most current issues of drugs supply to patients in the Russian Federation, including the recent legislation implemented to improve Russia’s drugs supply system will be presented.  Aspects of health care modernization, standardization of medical technologies, and access to quality medical care will also be discussed.  Presented by the ISPOR Russia Regional Chapter 

Moderator: Oleg Borisenko, MD, PhD, Executive Director, ISPOR Russia Regional Chapter and Head of Laboratory for Quality Management in Health Care and Evidence-Based Medicine, Department of Standardization in Health Care, Academic Institute of Public Health and Management in Health Care, Moscow State Medical University, Moscow, Russia  

Speaker: Pavel Vorobiev, MD, PhD, MSc, President, ISPOR Russia Regional Chapter, Professor and Head of the Research Department of Health Care Standardization, Sechenov Medical Academy, Moscow, Russia

6:30PM-7:00PM
ISPOR ANNUAL BUSINESS MEETING
 

Call To Order: Scott D. Ramsey, MD, PhD, 2010-2011 ISPOR President
Executive Director’s Report: Marilyn Dix Smith RPh, PhD, ISPOR Executive Director
Treasurer’s Report: Karen Rascati, RPh,PhD, ISPOR Treasurer
Value In Health Co-Editors-In-Chief Report: C. Daniel Mullins, PhD and Michael Drummond, PhD
ISPOR CONNECTIONS Editors-In-Chief Report: David Thompson, PhD
Member Open Discussion: ISPOR Members
New Business: Scott D. Ramsey, MD, PhD, 2010-2011 ISPOR President

6:30PM-7:30PM
POSTER AUTHOR DISCUSSION HOUR  - SESSION I
6:30PM-8:30PM
EXHIBITORS' OPEN HOUSE RECEPTION & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION I