PROGRAM - Tuesday, May 24, 2011
 

PROGRAM - TUESDAY, MAY 24, 2011
7:00AM-8:00AM
EDUCATIONAL SYMPOSIUM (Sponsored by RTI)
PHARMACEUTICAL BENEFIT-RISK ASSESSMENT - WHAT SHOULD WE DO IN THE ABSENCE OF REGULATORY GUIDANCE? Symposium Description »
8:00AM - 8:30AM
EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION II
8:30AM - 9:30AM
RESEARCH PODIUM PRESENTATIONS - SESSION II
8:30AM - 9:30AM

RESEARCH ON METHODS: COST-EFFECTIVENESS ANALYSIS

CE1: COST-EFFECTIVENESS SENSITIVITY ANALYSIS METHODS: A COMPARISON OF ONE-WAY SENSITIVITY, ANALYSIS OF COVARIANCE, AND EXPECTED VALUE OF PARTIAL PERFECT INFORMATION
Campbell J1, McQueen RB1, Libby A1, Briggs A2
1University of Colorado, Aurora, CO, USA, 2University of Glasgow, Glasgow, UK

CE2: A NOVEL WAY OF ESTIMATING COST-EFFECTIVENESS RATIOS FROM CLINICAL TRIALS WITH MISSING DATA: A SIMULATION STUDY
Gagnon DD1, Engelhart L2
1Thomson Reuters, Santa Barbara, CA, USA, 2DePuy, Inc., Raynham, MA, USA

CE3: COST-EFFECTIVENESS ANALYSIS AND BUDGET IMPACT ASSESSMENT: A GRAPHICAL WAY TO COMBINE THE TWO FOR THE AID OF DECISION MAKERS
Paulden M, Pham B
University of Toronto, Toronto, ON, Canada

CE4: USING DYNAMIC TRANSMISSION MODELS TO ESTIMATE THE COST EFFECTIVENESS OF VACCINES: FOUR DIFFERENT METHODS AND THEIR RELEVANCE FOR DECISION MAKERS
Mauskopf J1, Talbird SE1, Standaert B2
1RTI Health Solutions, Research Triangle Park, NC, USA, 2GlaxoSmithKline Biologicals, Wavre, Belgium

8:30AM - 9:30AM

RESEARCH ON METHODS: DATABASE ANALYSIS

DS1: INTEGRATING DATA SOURCES TO CONDUCT COMPREHENSIVE ONCOLOGY BASED OUTCOMES RESEARCH
Albright F1, Bollu V2, Kuo KL3, Raimundo K1, Barney R3, Stenehjem D3, Brixner D3
1University of Utah College of Pharmacy, Salt Lake City, UT, USA, 2Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 3University of Utah, Salt Lake City, UT, USA

DS2: A VALIDATION STUDY OF ALGORITHMS FOR IDENTIFYING METASTATIC BREAST, LUNG, OR COLORECTAL CANCER IN ADMINISTRATIVE CLAIMS DATA
Whyte JL1, Engel-Nitz NM2, Teitelbaum A2, Gomez Rey G2, Kallich J1
1Amgen Inc., Thousand Oaks, CA, USA, 2i3 Innovus, Eden Prairie, MN, USA

DS3: AVAILABILITY OF LABORATORY RESULTS DATA IN A U.S. CLAIMS DATABASE
Horne LN, Ming EE, Doyle C
AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA

DS4: BURDEN OF PROOF…PROOF OF PRINCIPLE: REPLICATION QUANTIFICATION, REPLICATION AND VALIDATION… STANDARDS OF EVIDENCE IN OUTCOMES RESEARCH SURROGATE ENDPOINTS FOR ALL-CAUSE MORTALITY
Simons WR
Global Health Economics & Outcomes Research Inc, Summit, NJ, USA

8:30AM - 9:30AM

DRUG USE AND PATIENT SAFETY

DU1: COMPARATIVE SAFETY OF STIMULANT AND ATOMOXETINE ASSOCIATED WITH THE RISK OF SUBSTANCE USE DISORDER AMONG ADOLESCENTS WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER
Bhattacharjee S1, Chen H2, Bhatara V3, Aparasu RR2
1West Virginia University, Morgantown, WV, USA, 2University of Houston, Houston, TX, USA, 3University of South Dakota Sanford School of Medicine, Sioux Falls, SD, USA

DU2: PREVALENCE AND PREDICTORS OF POTENTIALLY SIGNIFICANT DRUG-DRUG INTERACTIONS IN THE ELDERLY
Dudash K1, Negri G2, Baccarini S3, Rabinowitz C1, Maio V1
1Thomas Jefferson University, Philadelphia, PA, USA, 2Local Health Authority Parma, Parma, Italy, 3Ospedale di Fidenza - San Secondo, Fidenza, Parma, Italy

DU3: IMPACT OF THE FDA'S ANTIPSYCHOTIC BLACK BOX WARNING ON PSYCHOTROPIC DRUG PRESCRIBING IN ELDERLY PATIENTS WITH DEMENTIA IN OUTPATIENT AND OFFICE-BASED SETTINGS
Desai VC, Heaton PC, Kelton C
University of Cincinnati, Cincinnati, OH, USA

DU4: THE LONG TERM UTILIZATION OF STIMULANTS IN CHILDREN AND ADOLESCENTS: A MEDICAID STUDY
Sudharshan L, Chen H
University of Houston, Houston, TX, USA

8:30AM - 9:30AM

INFECTION OUTCOMES RESEARCH

IN1: MEASUREMENT OF SYMPTOMS AND IMPACT OF INFLUENZA: DEVELOPMENT OF THE SYMPTOM INTENSITY AND IMPACT OF INFLUENZA QUESTIONNAIRE (FLU-IIQ)
Osborne RH1, Norquist J2, Elsworth G1, Busija L3, Mehta V4, Herring T4, Gupta S4
1Deakin University, Melbourne, Victoria, Australia, 2Merck Sharp & Dohme Corp, North Wales, PA, USA, 3The University of Melbourne, Melbourne, Victoria, Australia, 4Merck Research Laboratories, North Wales, PA, USA

IN2: ASSOCIATION BETWEEN DRUG TOLERABILITY AND ECONOMIC IMPACT FOR PROPHYLAXIS OF INVASIVE FUNGAL INFECTION AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT
Gao X1, Ji X1, Stephens JM1, Schlamm H2, Tarallo M2
1Pharmerit International, Bethesda, MD, USA, 2Pfizer Inc, New York, NY, USA

IN3: COSTS ASSOCIATED WITH HCV AND RELATED COMPLICATIONS IN THE UNITED STATES FROM A MANAGED CARE PAYER'S PERSPECTIVE
McAdam Marx C1, Hane CA2, Biskupiak J1, Deniz B3, McGarry L4, Brixner D1
1University of Utah, Salt Lake City, UT, USA, 2Ingenix, Eden Prairie, MN, USA, 3Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA, 4i3 Innovus, Medford, MA, USA

IN4: CARDIOVASCULAR DISEASE SCREENING IN HIV-INFECTED PATIENTS – A COST-EFFECTIVENESS ANALYSIS
Nolte JEH1, Neumann T2, Neumann A3, Manne J4, Mostardt S3, Abbara S5, Brady TJ5, Hoffmann U5, Gazelle GS1, Wasem J3, Goehler A1
1Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA, 2University Hospital Essen, Essen, Germany, 3University Duisburg-Essen, Essen, Germany, 4Harvard School of Public Health, Boston, MA, USA, 5Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

8:30AM - 9:30AM

IMPACT OF MEDICATION COMPLIANCE

MC1: COMPARISON OF REFILL GAP ANALYSIS METHODOLOGIES IN A POPULATION OF PATIENTS WITH RHEUMATOID ARTHRITIS RECEIVING ADALIMUMAB OR ETANERCEPT
Carter C, Bolge S, Ingham M, Schmeichel-Mueller C
Centocor Ortho Biotech Services, LLC, Horsham, PA, USA

MC2: ASSESSING PREDICTORS OF MEDICATION ADHERENCE IN UNCONDITIONAL QUANTILE REGRESSION FRAMEWORK
Borah B
Mayo Clinic, Rochester, MN, USA

MC3: IMPACT OF MULTIPLE MEDICATION COMPLIANCE ON CARDIOVASCULAR OUTCOMES IN PATIENTS WITH TYPE II DIABETES AND COMORBID HYPERTENSION CONTROLLING FOR ENDOGENEITY BIAS
An JJ, Nichol MB
University of Southern California, Los Angeles, CA, USA

MC4: LONG TERM PERSISTENCE WITH ACEI/ARB THERAPY AFTER ACUTE MYOCARDIAL INFARCTION: AN ANALYSIS OF THE 2006-2007 MEDICARE 5% NATIONAL SAMPLE DATA
Lokhandwala T, Yang Y, Thumula V, Bentley JP, Strum M, Banahan BF, Null KD
University of Mississippi, University, MS, USA

9:45AM-10:45AM
RESEARCH PODIUM PRESENTATIONS - SESSION III
9:45AM-10:45AM

HEALTH CARE DECISION-MAKER'S CASE STUDIES

CASE1: THE USE AND PERCEIVED BENEFITS OF ELECTRONIC PRESCRIBING BY BLUE CROSS BLUE SHIELD OF LOUISIANA PHYSICIANS
Soonthornsima O1, Campbell C2, Shi L2
1Blue Cross Blue Shield of Louisiana, Baton Rouge, LA, USA, 2Tulane University, New Orleans, LA, USA

CASE2: IMPLEMENTING A VALUE-BASED FORMULARY PILOT IN A U.S. COMMERCIAL SELF- INSURED EMPLOYER GROUP
Watkins J1, Sullivan SD2, Wong E1, Yamamoto S1, Ramsey S3
1Premera Blue Cross, Mountlake Terrace, WA, USA, 2University of Washington, Seattle, WA, USA, 3Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA

CASE3: DETERMINING THE COST EFFECTIVENESS OF A HOSPITAL HEALTH SYSTEM'S USE OF REFERENCE LABORATORIES
Yoder K1, Zema C2
1Excela Health, Greensburg, PA, USA, 2St. Vincent College, McKenna School of Business, Economics and Government, Latrobe, PA, USA

CASE4: INTEGRATING OUTCOMES INTO DECISION-MAKING ON REIMBURSING HIGH COST DRUGS – A FUNDER CASE STUDY OF THE BIOLOGICAL AGENTS FOR TREATING RHEUMATOID ARTHRITIS
Mcgee SA, Nel C

Discovery Health, Johannesburg, South Africa

9:45AM-10:45AM

RESEARCH ON METHODS: ECONOMIC EVALUATIONS

EE1: SYSTEMATIC REVIEW OF GUIDELINES FOR HEALTH ECONOMIC EVALUATIONS
Melnyk P, Wagner M, Dourdin N, Rindress D
BioMedCom Consultants Inc., Dorval, QC, Canada

EE2: VALIDATION OF THE UPDATED CHARLSON COMORBIDITY INDEX (CCI) TO PREDICT HEALTHCARE UTILIZATION FOR DIABETIC PATIENTS USING ADMINISTRATIVE DATA
Cheng LI1, Rascati KL1, Trice S2, Lawson K1, Barner JC1
1The University of Texas at Austin, Austin, TX, USA, 2Department of Defense, Fort Sam Houston, TX, USA

EE3: PERFORMANCE OF DIFFERENT COMORBIDITY MEASURES IN PREDICTING HEALTHCARE EXPENDITURE IN PATIENTS WITH DEMENTIA
Johnson ML, Mehta S, Chitnis AS, Bhowmik D, Dwibedi N, Kamble P
University of Houston, Houston, TX, USA

EE4: BOOTSTRAPPING USED TO PROVIDE ROBUST MEAN AND VARIANCE ESTIMATES FOR COMPARING PATIENTS TREATED WITH LIRAGLUTIDE TO A LARGE COMPARISON COHORT
McAdam Marx C1, Ye X1, Bouchard J2, Aagren M2, Conner C3, Brixner D1
1University of Utah, Salt Lake City, UT, USA, 2Novo Nordisk Inc, Princeton, NJ, USA, 3Novo Nordisk, Redmond, WA, USA

9:45AM-10:45AM

EVOLVING CONCEPTS IN OUTCOMES RESEARCH

EV1: DEVELOPMENT OF A GUIDANCE FOR INCLUDING PATIENT-REPORTED OUTCOMES (PROS) IN POST-APPROVAL CLINICAL TRIALS OF ONCOLOGY DRUGS FOR COMPARATIVE EFFECTIVENESS RESEARCH (CER)
Basch EM1, Abernethy A2, Mullins CD3, Tiglao MR4, Tunis SR4
1Memorial Sloan-Kettering Cancer Center, New York, NY, USA, 2Duke University Medical Center, Durham, NC, USA, 3University of Maryland School of Pharmacy, Baltimore, MD, USA, 4Center for Medical Technology Policy, Baltimore, MD, USA

EV2: PAYERS AND PROS: BEYOND QOL
Miller KL, Stevens CA
PAREXEL Consulting, Waltham, MA, USA

EV3: A COMPARATIVE EFFECTIVENESS INDEX TO INFORM CLINICAL DECISIONS
Horowicz-Mehler N1, Doyle J1, Arikian S2, Hagan M3
1Quintiles Global Consulting, Hawthorne, NY, USA, 2Genesis BioPharma, Hoboken, NJ, USA, 3New York, NY, USA

EV4: MORE BANG FOR YOUR BUCK: TAKE A RISK WHEN ANALYSING INTERVIEW DATA
Roberts G
Double Helix Consulting Group, London, UK

9:45AM-10:45AM

ANALYSIS OF MEDICARE POLICY AND RESOURCE USE

MD1: USING COST-EFFECTIVENESS INFORMATION TO ALLOCATE MEDICARE RESOURCES – HOW MUCH MORE HEALTH FOR THE MONEY?
Chambers JD1, Cohen JT1, Neumann PJ1, Lord J2, Buxton M2
1Tufts Medical Center, Boston, MA, USA, 2HERG, Brunel University, Uxbridge, Middlesex, UK

MD2: PRESCRIPTION DRUG COST AND USE IN THE MEDICARE PART D POPULATION - USES OF A NEW LIMITED DATA SET
Powers CA1, Varghese A1, Hsu VD2, O'Donnell J3, Schneider K3
1Centers for Medicare and Medicaid Services, Baltimore, MD, USA, 2Buccaneer, A Vangent Company, Owings Mills, MD, USA, 3Buccaneer, A Vangent Company, West Des Moines, IA, USA

MD3: EVALUATING THE WILLINGNESS-TO-PAY OF MEDICARE BENEFICIARIES FOR PART D PLAN ASSISTANCE
Patel RA, Walberg MP, Na J, Hsiou D, Panchal V, Woelfel JA, Galal SM, Carr-Lopez SM, Chan EK
University of the Pacific, Stockton, CA, USA

MD4: EVALUATION OF AN INTERVENTION TO REDUCE POLY-PHARMACY IN MEDICARE PART D
Livengood KB, Harrell T, Abarca J
WellPoint, Inc., Indianapolis, IN, USA

9:45AM-10:45AM

EXAMINING THE QALY

QA1: COST-EFFECTIVENESS OF DUTASTERIDE AS A CHEMOPREVENTION IN PROSTATE CANCER: REDUCE WITHIN-TRIAL ANALYSIS
Earnshaw SR1, Chirila C1, McDade C1, Black L2, Andriole GL3
1RTI Health Solutions, Research Triangle Park, NC, USA, 2GlaxoSmithKline, Research Triangle Park, NC, USA, 3Washington University School of Medicine in St. Louis, St. Louis, MO, USA

QA2: CROSS-WALKING CANCER-SPECIFIC INSTRUMENTS TO THE EQ-5D AND SF-6D
Teckle P1, Peacock S1, van der Hoek K1, Chia S2, Melosky B2, Gelmon K2
1Canadian Centre for Applied Research in Cancer Control (ARCC), Vancouver, BC, Canada, 2Medical Oncology, British Columbia Cancer Agency, Vancouver, BC, Canada

QA3: DOES COST-EFFECTIVENESS ANALYSIS DISCRIMINATE AGAINST PATIENTS WITH SHORTER LIFE EXPECTANCY?
Paulden M, Culyer AJ
University of Toronto, Toronto, ON, Canada

QA4: IS THE AIM OF THE HEALTH CARE SYSTEM TO MAXIMISE QALYS? AN INVESTIGATION OF ‘WHAT ELSE MATTERS' IN THE NHS.
Praet C1, Shah K2, Devlin N3, Sussex J3, Parkin D4, Appleby J5
1Merck, London, UK, 2Office of Health Economics, University of Sheffield, London, UK, 3Office of Health Economics, London, UK, 4NHS South East Coast, London, UK, 5King's Fund, London, UK

10:45AM-11:00AM
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION II
11:00AM-12:45PM
WELCOME & SECOND PLENARY SESSION

WELCOME
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

 

INCOMING PRESIDENTIAL ADDRESS
Scott D. Ramsey MD, PhDMark Sculpher PhD
Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK

  ISPOR 2011 ISPOR VALUE IN HEALTH PAPER OF THE YEAR AWARD
Presented by: Michael Drummond, PhD, University of York, Heslington, York, UK, and C. Daniel Mullins, PhD, University of Maryland, Baltimore, MD, USA, Value in Health Co-Editors-in-Chief

AWARDEE:
A.E. Ades, PhD, Department of Community Based Medicine, University of Bristol, Bristol, UK
ISPOR AWARDS FOR EXCELLENCE IN METHODOLOGY AND APPLICATION OF PHARMACOECONOMICS AND HEALTH OUTCOMES RESEARCH
Moderator & Presented by: Kevin Schulman, MD, MBA, Chair, ISPOR Awards Committe & Professor of Medicine and Business Administration, Director, Center for Clinical and Genetic Economics, and Associate Director, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Rajesh Balkrishnan, PhD, Chair, ISPOR Award for Excellence in Methodology in Pharmacoeconomics and Health Outcomes Research Committee and Associate Professor, Department of Clinical, Social and Administrative Sciences, The University of Michigan, Ann Arbor, MI, USA

ISPOR AWARD FOR EXCELLENCE IN METHODOLOGY IN PHARMACOECONOMICS AND HEALTH OUTCOMES RESEARCH

AWARDEE: Martin Hoyle, PhD, Senior Research Fellow, Peninsula College of Medicine & Dentistry (PCMD), Universities of Exeter and Plymouth, Exeter, UK

ISPOR AWARD FOR EXCELLENCE IN APPLICATION OF PHARMACOECONOMICS AND HEALTH OUTCOMES RESEARCH

AWARDEE: Craig J. Currie, PhD, Reader in Diabetes Pharmacoepidemiology, Department of Primary Care and Public Health, School of Medicine, Cardiff University, The Pharma Research Centre, Cardiff MediCentre, University Hospital of Wales, Cardiff, UK

Evolution of Comparative Effectiveness Research: Learning from the Past; Challenges for the Future
In the American Recovery and Reinvestment Act (ARRA) of 2009, US Congress appropriated $1.1 billion to jump-start the nation's efforts to accelerate comparative effectiveness research (CER). How were these funds spent? How will the results from these studies impact health care decisions? In the Patient Protection and Affordable Care Act of 2010, US Congress established the Patient-Centered Outcomes Research Institute (PCORI) to identify priorities for and establish, update and carry out a national comparative outcomes research project agenda. What will be the process for developing research priorities? Who will be conducting the research? Will the study results impact health care? These questions will be addressed during this plenary session.
Moderator:  
J. Sanford (Sandy) Schwartz, MD, Leon Hess Professor of Medicine, Health Care Management and Economics, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA
Speakers:  
Carolyn M. Clancy, MD, Director, Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, Rockville, MD, USA
Bruce M. Psaty, MD, PhD, Professor, Medicine, Epidemiology and Health Services, University of Washington and Investigator, Group Health Research Institute, Group Health Cooperative, Seattle, WA, USA
12:45PM-1:15PM
ISPOR SCIENTIFIC AND SERVICE AWARDS PRESENTATIONS
1:15PM-2:45PM
LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION II
1:30PM-2:30PM
EDUCATIONAL SYMPOSIUM (Sponsored by UBC)
PERSONALIZED HEALTH CARE AND COMPARATIVE EFFECTIVENESS RESEARCH: REALIZING THE EVIDENCE ON "WHAT WORKS FOR WHOM AND WHEN" Symposium Description »
2:45PM-3:45PM
ISSUE PANELS – SESSION II
2:45PM-3:45PM Health Policy Development Using Outcomes Research Issues
IP6: WHEN IS THE EVIDENCE ADEQUATE? DIFFERENT PERSPECTIVES FROM KEY HEALTH CARE DECISION-MAKERS
Moderator: Robert W. Dubois, MD, PhD, Chief Science Officer, National Pharmaceutical Council, Washington, DC, USA
Panelists: Bryan R. Luce, PhD, MBA, Senior Vice President, Science Policy, United BioSource Corporation, Bethesda, MD, USA; Steven Pearson, MD, MSc, President, Institute for Clinical and Economic Review, Boston, MA, USA; Robert S. Epstein, MD, MS, Chief Medical Officer, Senior Vice President, Medical Affairs, Medco Health, Franklin Lakes, NJ, USA
2:45PM-3:45PM IP7: HOW DO WE STOP PAYING FOR LOW-VALUE CARE?
Moderator: Sarah Garner, PhD, Associate Director R&D NICE, Research and Development, NICE, London, UK
Panelists: 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; Mark Fendrick, MD, Professor/ Co-Director, Division of General Medicine, Department of Internal Medicine and Department of Health Management and Policy, University of Michigan Center for Value-Based Insurance Design, Ann Arbor, MI, USA; Adam Elshaug, MPH, PhD, Harkness Fellow/Senior Research Fellow, School of Population Health and Clinical Practice, Adelaide University/AHRQ, Rockville, MD, USA
2:45PM-3:45PM IP8: IDENTIFICATION, WEIGHTING AND PRIORITIZATION OF MULTIPLE ENDPOINTS FOR COMPARATIVE EFFECTIVENESS RESEARCH – WHAT HAVE WE LEARNED FROM GERMANY?
Moderator: Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK
Panelists: Axel Mühlbacher, PhD, Harkness Fellow in Health Care Policy and Practice, Duke Clinical Research Institute/ Fuqua School of Business, Duke University, Durham, NC, USA; John F.P. Bridges, PhD, Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Maarten J. IJzerman, PhD, Professor & Chair, Department of Health Technology & Services Research, University Twente, Enschede, The Netherlands
2:45PM-3:45PM IP9: WILL THE PROPOSED VALUE BASED PRICING WORK IN THE UK?
Moderator: Stephen Beard, MSc, Head of Health Economics (Europe), RTI Health Solutions, Sheffield, UK
Panelists: Ron Akehurst, Professor of Health Economics, Dean of School of Health & Related Research, ScHARR, The University of Sheffield, Sheffield, UK; James Raftery, PhD, Professor of Health Technology Assessment, Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK; Trevor Leighton, Vice President, Pricing & Reimbursement, Shire AG, Eysins, Switzerland
2:45PM-3:45PM Patient-Reported Outcomes Research Issues
IP10: HOW CAN PATIENT-REPORTED OUTCOMES BECOME A PART OF COMPARATIVE EFFECTIVENESS RESEARCH?
Moderator: C. Daniel Mullins, PhD, Professor, Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy, Baltimore, MD, USA
Panelists: Amy Abernethy, MD, Associate Professor, Duke University, Durham, NC, USA; Albert Wu, MD, MPH, Professor, Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
3:45PM-4:00PM
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION II
4:00PM-5:00PM
WORKSHOPS – SESSION III
4:00PM-5:00PM Clinical Outcomes Research
W13: USE OF SIMULATION TO INFORM THE DESIGN OF PRAGMATIC COMPARATIVE EFFECTIVENESS TRIALS
Discussion Leaders: David Wilson, MA, Research Scientist, United BioSource Corporation, Lexington, MA, USA; J. Jaime Caro, MDCM, FRCPC, FAC, Senior Vice President of Health Economics, United BioSource Corporation, Lexington, MA, USA; K. Jack Ishak, PhD, MSc, Director, & Research Scientist Biostatistics, United BioSource Corporation, Dorval, QC, Canada; Myoung Kim, PhD, MA, MBA, Director, Health Economics & Outcomes Research, Ortho-McNeil Janssen Scientific Affairs, Raritan, NJ, USA
4:00PM-5:00PM Economic Outcomes Research
W14: MICROECONOMIC TOOLS FOR UNDERSTANDING, MODELING, AND INFLUENCING HEALTHCARE DECISION MAKING
Discussion Leaders: F. Reed Johnson, PhD, Distinguished Fellow and Principal Economist, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, USA; Juan Marcos Gonzalez, PhD, Research Economist, RTI Health Solutions, Research Triangle Park, NC, USA; Deborah A. Marshall, MHSA, PhD, Associate Professor, Canada Research Chair, Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada
4:00PM-5:00PM Health Care Policy Development Using Outcomes Research
W15: PRACTICAL EXPERIENCES WITH THE USE OF BEST-WORST SCALING IN ECONOMIC EVALUATION
Discussion Leaders: Terry Flynn, PhD, Head of Social Policy & Economic Evaluation, Centre for the Study of Choice (CenSoC), University of Technology, Sydney, Sydney, NSW, Australia; John F.P. Bridges, PhD, Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomsberg School of Public Health, Baltimore, MD, USA; Christine Poulos, PhD, Senior Economist, Health Preference Assessment, RTI International, Research Triangle Park, NC, USA
4:00PM-5:00PM W16: THE EVOLVING ROLE OF THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ) IN COMPARATIVE EFFECTIVENESS RESEARCH (CER)
Discussion Leaders: Jean Slutsky, PA, MSPH, Director, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, Rockville, MD, USA; Nina A. Thomas, MPH, Vice President, Clinical Affairs & Health Economics, Doctor Evidence, LLC, New York, NY, USA; Steven Blume, MS, Research Scientist, Center for Health Economics and Science Policy, United BioSource Corporation, Bethesda, MD, USA
4:00PM-5:00PM Patient-Reported Outcomes & Preference-based Research W17: PATIENT-REPORTED OUTCOME (PRO) ASSESSMENTS IN CLINICAL TRIALS: NAVIGATING THE EMA AND FDA REGULATORY FRAMEWORK
Discussion Leaders: Ingela Wiklund, PhD, Senior Research Leader, Center for Health Outcomes Research, United BioSource Corporation, London, UK; Olivier Chassany, PhD, MD, Medical Manager, Department of Clinical Research and Development, Assistance Publique-Hopitaux de Paris, Paris, France; Kathleen W. Wyrwich, PhD, Senior Research Leader, Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA
4:00PM-5:00PM Use of Real World Data
W18: METHODS UTILIZING LONGITUDINAL DATA TO ESTIMATE OF CASUAL EFFECTS IN HEALTH ECONOMICS: ESTIMATION OF TREATMENT EFFECT USING OBSERVATIONAL DATA
Discussion Leaders: William Crown, PhD, President, i3 Innovus, Waltham, MA, USA; Nilay Shah, PhD, RPh, Associate Consultant, Mayo Clinic, Rochester, MN, USA; Henry J. Henk, PhD, Director, HEOR, i3 Innovus, Eden Prairie, MN, USA
PURPOSE: The purpose of this workshop is to 1) provide a brief review of the interpretation of treatment effects captured through typical analytic methods (e.g., cross sectional data analysis) for analyses of observational data and 2) a review of longitudinal (panel) data analysis methods for CER analyses of observational data.
5:15PM-6:15PM
ISPOR FORUMS - SESSION II
5:15PM-6:15PM CONSIDERATIONS FOR USING MIXED MODES FOR PATIENT-REPORTED OUTCOMES DATA COLLECTION IN CLINICAL TRIALS AND VALIDATION OF COMPUTERIZED SYSTEMS TO CAPTURE OUTCOMES DATA

With the increasing use of electronic modes of patient reported outcomes (PRO) data collection (ePRO) in clinical trials, mixed modes of data collection are feasible from an operational perspective.  However, will using mixed modes compromise the quality of the data? What are the benefits of using mixed modes in clinical trials?  Forum panelists will discuss the issues to consider and offer recommendations when using mixed modes in the clinical trial setting.  In addition, a short overview of the practical, user-friendly guide for clinical trial sponsor use on the requirements and documentation needed from a data collection systems manufacturer to demonstrate systems validation will be presented.  Presented by the ISPOR Patient Reported Outcomes Special Interest Group & ISPOR PRO Task Forces

Speakers: Sonya Eremenco, MA, Chair, ISPOR Mixed Methods and ePRO Manager, United BioSource Corporation, Bethesda, MD, USA; Antonia V. Bennett, PhD, Post-Doctoral Research Scholar, Health Outcomes Research Group, Dept. of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA; Stephen Joel Coons, PhD, MS, MEd, Director, Patient-Reported Outcomes Consortium, Critical Path Institute, Tucson, AZ, USA; Jean Paty, PhD, Founder and Senior Vice President, Scientific, Quality and Regulatory Affairs, invivodata, inc., Pittsburgh, PA, USA; Arthur S. Zbrozek, RPh, MSc, MBA, Chair, ISPOR ePRO Systems Validation Working Group and Senior Director and Group Leader, Commercial Development, Global Health Economics, CSL Behring, Biotherapies for Life, King of Prussia, PA, USA

5:15PM-6:15PM DIFFERENCES ON DIFFERENCES: DOES PERSPECTIVE MATTER WHEN CONSIDERING HETEREOGENEITY OF PATIENT TREATMENT EFFECTS

Differences in how individual patients respond to given treatments are of increasing relevance for many stakeholders, including regulators, payers, and the pharmaceutical industry.  Specific points of emphasis and concern among these stakeholders will be discussed and contrasted.  Presented by the ISPOR Institutional Council

Moderator: Mark J. Cziraky, PharmD, Vice President, Research Development and Operations, HealthCore, Wilmington, DE, USA

Speakers: Richard J. Willke, PhD, Head, Global Health Economics & Outcomes Research, Global Market Access, Primary Care, Pfizer, Inc, New York, NY, USA; Richard Migliori, MD, Executive Vice President, Business Initiatives and Clinical Affairs, United Health Group, Minnetonka, MN, USA; Steve E. Phurrough, MD, MPA, Chief Operating Officer/Senior Clinical Director, Center for Outcomes and Evidence, Center for Medical Technology Policy, Baltimore, MD, USA
5:15PM-6:15PM DESIGNING CONJOINT EXPERIMENTS: A GUIDE TO ALTERNATIVE STRATEGIES

Stated-preference researchers face a choice among a growing list of experimental-design methods.  This forum presents the ISPOR Conjoint Analysis Experimental Design Task Force preliminary guide to the advantages, limitations, and practical implementation of alternative approaches.  Presented by the ISPOR Conjoint Analysis Experimental Design Task Force

Moderator:  John F.P. Bridges, PhD, Assistant Professor, Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
Speakers: F. Reed Johnson, PhD, Distinguished Fellow and Principal Economist, Health Preference Assessment Group, RTI Health Solutions, RTI International, Research Triangle Park, NC, USA; Brian Bresnahan, PhD, Research Assistant Professor, Department of Radiology, University of Washington, Seattle, WA, USA; Dean Regier, PhD, Assistant Member, Fred Hutchinson Cancer Research Center and Assistant Professor, Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, WA, USA; Deborah Marshall, PhD, Canada Research Chair, Health Services and Systems Research and Associate Professor, Department of Community Health Sciences, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada; Barbara Kanninen, PhD, Principal, BK Econometrics, LLC, Arlington, VA, USA & Senior advisor to Stratus Consulting, Boulder, CO, USA

5:15PM-6:15PM PHARMACOECONOMICS IN BRAZIL: REGULATORY TRENDS AND FUTURE PERSPECTIVES

Brazil, a country of 200 million people includes 45 million who have private health insurance.  How does it influence the rest of Latin America?  What steps is the Brazilian government taking in order to increase the use of pharmacoeconomics?  This forum will discuss regulatory trends and the current and future state of pharmacoeconomics in Brazil.  Presented by the ISPOR Brazil Chapter 

Speakers: Stephen Doral Stefani, MD, Medical Auditor, Head of Oncology Unit, UNIMED and Mother of God Cancer Institute, Porto Alegre, Brazil; Gabriela Tannus, MBA, MSc, President, Axia.Bio, Sao Paulo, Brazil; João Paulo dos Reis Neto, MD, Director, CAPESESP (Health and Preventative Care Fund for Civil Servants of the National Health Foundation), Rio de Janeiro, Brazil

5:15PM-6:15PM HEALTH TECHNOLOGY REIMBURSEMENT IN THE CEE REGION: EXPERIENCES OF COST CONTAINMENT MEASURES IN POLAND AND THE SOUTH CENTRAL EUROPEAN REGION

During the last 18 months, there have been many changes in approaches to health technology reimbursement in the Central and Eastern European (CEE) region.  The purpose of this session is to evaluate and address the changing reimbursement environment and to discuss the short and long term impact of the implementation of cost containment measures.  The effects of cost containment measures will also be evaluated.  Policies and the most optimal pathways to financing a new health technology will be debated.  Presented by the ISPOR Poland, Greece and Serbia Regional Chapters

Moderator: Karina Jahnz-Rozyk, MD, PhD, President ISPOR Poland Chapter and Professor, Head of Department of Immunology & Allergology, Military Institute of Health Service, Warsaw, Poland

Speakers:  Joanna Lis, MD, PhD, President-Elect, ISPOR Poland Chapter and Health Economics Manager, Sanofi Sanofi- Synthelabo, Warsaw, Poland;  John Yfantopoulos, PhD, President-Elect, ISPOR Greece Chapter and Professor, Health Economics and Social Policy, University of Athens, Athens, Greece, and President, National Centre for Social Research, Athens, Greece; Vladimir Zah, PhD(c), President, ISPOR Serbia Chapter and Consultant, Health Economics, Belgrade, Serbia
5:15PM-6:15PM A CHECKLIST FOR POPULATION SELECTION IN ONCOLOGY OUTCOMES RESEARCH USING RETROSPECTIVE DATABASES

The use of secondary data sources in oncology research is becoming a more accepted approach for reporting patient outcomes and estimating cancer-related costs.  However, the ascertainment of study cohorts from these data sources is complex despite the availability of various algorithms to identify cancer patients.  Researchers must be able to critically evaluate and select from published algorithms or develop their own.  This process is further complicated if selection requires identification of disease stage or clinical subgroups.  The forum will give an overview and explain the importance and challenges in identifying cancer patients in large databases; including outlining previously published algorithms, both validated and unevaluated, to identify breast cancer patients and discuss the advantages and disadvantages of each validated algorithm with critical assessment why some of these validated algorithms have not been more widely applied.  A draft checklist of the factors to consider when selecting and implementing an algorithm to define a study population will be outlined.  Presented by the ISPOR Oncology SIG

Moderator: Kathy L. Schulman, MA, Co-Chair, ISPOR Oncology Good Outcomes Research Practices Working Group of the ISPOR Oncology SIG and Principal, Outcomes Research Solutions, Inc., Bolton, MA, USA;

Speakers: Karina Berenson, MPH, Co-Chair, ISPOR Oncology Good Outcomes Research Practices Working Group of the ISPOR Oncology SIG and Associate Director, Covance Market Access Services Inc., Gaithersburg, MD, USA; Jonas de Souza, MD, Postdoctoral Fellow, Section of Hematology/Oncology, The University of Chicago Medical Center, Chicago, IL, USA

5:15PM-6:15PM
ISPOR-AMCP FORUM
5:15PM-6:15PM Drug Information used in the Managed Care Pharmacy P&T Decision Making Process: Current Practice and Insights

Health care organization pharmacy and therapeutics (P&T) committees evaluate and determine evidence-based, cost-effective formulary coverage of pharmaceutical agents. Within managed care organizations, there are numerous approaches to the evaluation and preparation of drug information for P&T committees. However, there are key drug information elements assessed that are relatively consistent across organizations. It is common for health care professionals to request drug information for evaluation and consideration in the drug review process. This session will provide insight from managed care pharmacy professionals with experience and expertise in preparing for and participating in the P&T decision-making process to explore and review best practices. Presented by the Academy of Managed Care Pharmacy (AMCP) and ISPOR

Moderator: Diana Brixner, RPh, PhD, Professor and Chair, Department of Pharmacotherapy and Executive Director, Pharmacotherapy Outcomes Research Center, University of Utah, Salt Lake City, UT, USA

Speakers: Sherry Andes, PharmD, BCPS, BCPP, PAHM, Senior Drug Information Specialist, Clinical Services, informedRx (an SXC Company), Louisville, KY, USA; Kelly Chillingworth, RPh, CGP, Regional Manager, Clinical Strategies and Integration, MedImpact Healthcare Systems, Inc., San Diego, CA, USA

6:15PM-7:15PM
POSTER AUTHOR DISCUSSION HOUR – SESSION II
6:15PM-7:45PM
EXHIBITORS’ WINE & CHEESE RECEPTION & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION II
8:00PM-11:30PM