Retrospective Database Analysis
Faculty: William H. Crown PhD, President, i3 Innovus, Waltham, MA, USA; Onur Baser MS, PhD, President, STATinMED Research, Director of Analytic Group, M-SCORE, and Assistant Professor of Surgery, Department of Surgery, University of Michigan, Ann Arbor, MI, USA

Course Description: Large administrative claims databases provide a unique opportunity to examine retrospectively the effects of drug use on clinical and economic outcomes in "real world" settings. This course will cover a discussion of the "ISPOR Checklist for Retrospective Database Studies - Report of the ISPOR Task Force on Retrospective Databases" - Report of the ISPOR Task Force on Retrospective Databases and selected topics related to estimators and sampling distributions, properties of sampling distributions (unbiasedness, efficiency, mean square error), and ordinary least squares (OLS) regression. OLS model assumptions and the implications of violations (e.g., heteroscedasticity, multicollinearity, autocorrelation) will also be discussed. More complex topics beginning with the problem of endogeneity, identification, instrumental variables, sample selection models, and propensity score models, maximum likelihood methods and the estimation of limited dependent variables models including logit, multinomial logit, count models, and survival models will be discussed. This course will assume participants have knowledge of statistical methods through OLS regression and experience in the analysis of administrative claims databases.

Propensity Scores and Observational Studies of Treatment Effect
Faculty: John Seeger PharmD, DrPH, Chief Scientist, i3 Drug Safety, Waltham, MA, USA

Course Description: A large part of the evidence about the effectiveness of different treatments is based on observational research. Issues of bias and confounding relate to study design and analysis in the setting of non-random treatment assignment where compared subjects might differ substantially with respect to comorbidities. This course will outline the key concerns in the conduct of observational research of treatment effect and explain methods for causal inference in observational settings. With no control over the treatment assignment and the lack of balance in the covariates between the treatment and control groups can produce confounded estimates of treatment effect. We will explain how propensity scores can be used to mitigate confounding, through standard observational approaches (restriction, stratification, matching, regression, or weighting). The advantages and disadvantages of standard adjustment relative to propensity score-based methods will be discussed. Details of propensity score methodology (variable selection, use, and diagnostics) will also be discussed. The course will also elaborate briefly on risk adjustment models that collapse predictors of outcomes (disease risk scores such as the Charlson Comorbidity Index, and Chronic Disease Scores) and their use relative to propensity scores. This is an introductory course, designed for those with little experience with this methodology but some knowledge of observational databases.

PMC24    A PREDICTION MODEL TO IDENTIFY SUBJECTS WITH HORMONE REFRACTORY PROSTATE CANCER (HRPC) FROM A MANAGED CARE ADMINISTRATIVE CLAIMS DATABASE
Alemayehu B¹, Buysman E², Parry D³, Nathan F^1
1AstraZeneca, Wilmington, DE, USA, ²i3 Innovus, Eden Prairie, MN, USA, ³AstraZeneca, Macclesfield, Cheshire, UK

PGI10     BURDEN OF SURGICALLY RESECTED GASTROINTESTINAL STROMAL TUMORS (GIST) IN THE US
Rubin JL¹, Sanon M¹, Taylor DC¹, Coombs J², Thompson D^1
1i3 Innovus, Medford, MA, USA, ²Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA

PHC8     REGIONAL DISPARITIES AND ECONOMIC OUTCOMES ASSOCIATED WITH MINIMALLY INVASIVE AND CONVENTIONAL SURGERIES OF THE CHEST, ABDOMEN, AND PELVIS
Moore M¹, Hochheiser L², Gunnarsson C³, Ladapo J⁴, Borah B^5
1Ethicon Endo-Surgery, Inc., Cincinnati, OH, USA, ²University of Vermont, Jackson, WY, USA, ³S2 Statistical Solutions, Inc, Cincinnati, OH, USA, ⁴Beth Israel Deaconess Medical Center, Boston, MA, USA, ⁵i3 Innovus, Eden Prairie, MN, USA

PMS18     ESTIMATION OF COSTS RELATED TO ADVERSE EVENTS IN NSAID TREATMENT OF OSTEOARTHRITIS – A COMPARISON BETWEEN CELECOXIB AND IBUPROFEN USING A VALIDATED MODEL
Svedbom A¹, Borgstrom F¹, Holmstrom S², Miltenburger C^3
1i3 Innovus, Stockholm, Sweden, ²NicOx, Sophia Antipolis, France, ³i3 Innovus, Berlin, Germany

PMS20     A COMPARISON OF DIFFERENT METHODS OF ESTIMATING FRACTURE RISK AND FRACTURE RISK REDUCTION IN COST-EFFECTIVENESS ANALYSES OF THE OSTEOPOROSIS TREATMENT BAZEDOXIFENE
Borgström F¹, Coelho J², Ström O², McCloskey E³, Odén A⁴, Johansson H⁵, Kanis JA^6
1i3 Innovus, Stockholm, Sweden, ²i3 Innovus, Stockholm, Stockholm, Sweden, ³Osteoporosis Centre, Sheffield, Sheffield, UK, ⁴University of Sheffield, Gothenbourg, Gothenbourg, Sweden, ⁵University of Sheffield, Gothenbourg, Gothebourg, Sweden, ⁶University of Sheffield, Sheffield, Sheffield, UK

PMS25     COST-EFFECTIVENESS IN OSTEOARTHRITIS PAIN RELIEF TREATMENT WITH NSAIDS – A DETERMINATION AND ESTIMATION OF KEY DRIVERS
Svedbom A¹, Borgstrom F¹, Holmstrom S², Miltenburger C^3
1i3 Innovus, Stockholm, Sweden, ²NicOx, Sophia Antipolis, France, ³i3 Innovus, Berlin, Germany

PMC62     ASSESSING THE QUALITY OF CONJOINT ANALYSIS APPLICATIONS IN HEALTH: A PILOT EVALUATION OF THE ISPOR CHECKLIST FOR GOOD RESEARCH PRACTICE IN CONJOINT ANALYSIS
Marshall DA¹, Hauber AB², Bridges JF³, Cameron R⁴, Weaver L², Dionne J⁴, Johnson FR^2
1University of Calgary, Calgary, AB, Canada, ²RTI Health Solutions, Research Triangle Park, NC, USA, ³Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA, ⁴McMaster University, Hamilton, ON, Canada

W2     TRANSFERABILITY OF ECONOMIC EVALUATIONS FROM SETTING TO SETTING WITHIN THE UNITED STATES
Discussion Leaders:  Michael F. Drummond DPhil, Professor of Health Economics, Centre for Health Economics, University of York, York, UK; Amy K O'Sullivan PhD, Associate Director, i3 Innovus, Medford, MA, USA; David W. Lee PhD, Senior Director, GE Healthcare, Health Economics and Outcomes Research, Waukesha, WI, USA

W4      ASSESSING HETEROGENEITY OF TREATMENT EFFECTS
Discussion Leaders:  Bijan J. Borah PhD, Senior Researcher, i3 Innovus, Eden Prairie, MN, USA; Nilay D. Shah PhD, Assistant Professor, Mayo Clinic, Division of Health Care Policy and Research, Rochester, MN, USA; Henry Joe Henk PhD, Director, i3 Innovus, Health Economics & Outcomes, Eden Prairie, MN, USA

IP2     MODEL CALIBRATION: LOCUS FOCUS OR HOCUS POCUS?
Moderator:  David Thompson PhD, Vice President, i3 Innovus, Health Economics and Outcomes Research, Medford, MA, USA
Panelists:  Milton C. Weinstein PhD, Professor, Health Policy and Management, Harvard School of Public Health, Boston, MA, USA; Alistair McGuire PhD, Chair in Health Economics, LSE Health and Social Care, London, UK

IP5     ASSESSMENT AND APPRAISAL OF CANCER MEDICINES: DO THEY DESERVE A SPECIAL TREATMENT?
Moderator: Michael F. Drummond DPhil, Professor of Health Economics, Centre for Health Economics, University of York, York, UK
Panelists: Adrian Towse MPhil, Director, Office of Health Economics, London, UK; Mark Sculpher PhD, Professor of Health Economics, Centre for Health Economics, University of York, York, UK; Scott Ramsey MD, PhD, Associate Member, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

CN4     LEVERAGING MULTIPLE DATA SOURCES TO EVALUATE COST AND SURVIVAL IN FOLFOX OR FOLFIRI TREATED STAGE IV COLORECTAL CANCER PATIENTS
Harley C¹, Seal B², Shetty S^3
1i3 Innovus, Eden Prairie, MN, USA, ²Sanofi-Aventis, Bridgewater, NJ, USA, ³UnitedHealthcare, Edina, MN, USA

CO3     ESTIMATING DRUG COSTS IN ECONOMIC EVALUATIONS IN IRELAND AND THE UK: AN ANALYSIS OF PRACTICE AND RESEARCH RECOMMENDATIONS
Hughes DA¹, Tilson L², Drummond MF^3
1Bangor University, Bangor, UK, ²National Centre for Pharmacoeconomics, Dublin, Ireland, ³University of York, York, Heslington, UK

PIN35    COST-EFFECTIVENESS OF MARAVIROC FOR HIV IN MEXICO
Contreras-Hernandez I¹, Becker DL², Chancellor JV³, Kühne F⁴, Mould-Quevedo J⁵, Marfatia S^6
1Social Security Mexican Institute, Mexico City, Mexico, ²i3 Innovus, Burlington, ON, Canada, ³i3 Innovus, Uxbridge, Middlesex, UK, ⁴i3 Innovus, Uxbridge, UK, ⁵Pfizer Mexico, Mexico City, Mexico, ⁶Pfizer, New York, NY, USA

PRS31    ASSOCIATION BETWEEN COMPLIANCE AND RESPIRATORY-RELATED COSTS FOR PATIENTS WITH COPD TREATED WITH MAINTENANCE THERAPY
Halpern R¹, Curtice TG², Marfatia A³, Woodruff KB³, Shah H^2
1i3 Innovus, an Ingenix Company, Eden Prairie, MN, USA, ²Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA, ³Pfizer, New York, NY, USA

PRS39    ADHERENCE AMONG COPD SUBJECTS ON TIOTROPIUM AND FLUTICASONE/SALMETEROL
Halpern R¹, Marfatia A², Woodruff KB², Shah H^3
1i3 Innovus, an Ingenix Company, Eden Prairie, MN, USA, ²Pfizer, New York, NY, USA, ³Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA

IP6     HETEROGENEITY AMONG HOMO SAPIENS: IMPLICATIONS FOR CLINICAL DEVELOPMENT, CLINICAL PRACTICE, AND PRICING AND REIMBURSEMENT
Moderator:  William Crown PhD, President, i3 Innovus, Waltham, MA, USA
Panelists: Marc L. Berger MD, Vice President, Eli Lilly, Global Health Outcomes, Indianapolis, IN, USA; Victor M. Montori MD, Associate Professor, Mayo Clinic, Rochester, MN, USA; Ernst Berndt PhD, Professor, Massachusetts Institute of Technology, Sloan School, Cambridge, MA, USA

IP7     USE OF THE QALY FOR ECONOMIC EVALUATION: PRAGMATIC CHOICE OR UNJUSTIFIED EVIL?
Moderator: Louis Garrison PhD, Professor and Associate Director, Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle, WA, USA
Panelists: Michael F. Drummond DPhil, Professor of Health Economics, Centre for Health Economics, University of York, York, UK; J. Jaime Caro MDCM, FRCPC, FAC, Senior Vice President, Health Economics, United BioSource Corporation, Health Care Analytics, Lexington, MA, USA

W9     ANALYSIS OF EFFECTIVENESS AND COST-EFFECTIVENESS IN PATIENT REGISTRIES
Discussion Leaders: Maria Malmenäs MSc, Manager Biostatistics, Outcome Surveys, Shire Human Genetic Therapies, Global Medical Affairs, Danderyd, Sweden; Margaret Hux MSc, Lead Analyst, i3 Innovus, Burlington, ON, Canada; Mike Novotny MBA, MA, CEO, Medrio, San Francisco, CA, USA; Lusine Abrahamyan MD, MPH, PhD(c), Graduate Student, University of Toronto, Research Institute, The Hospital for Sick Children, Toronto, ON, Canada

W14     VALUE BASE PRICING, WHAT IS IT AND IS IT RELEVANT FOR THE US?
Discussion Leaders:  Alistair McGuire PhD, Chair in Health Economics, LSE Health and Social Care, London, UK; Monique Martin MSc, MBA, Vice-President UK Operations, i3 Innovus, Uxbridge, Middlesex, UK; Stephen Clark BA, Vice President, Market Access and Reimbursement, i3 Innovus, Eden Prairie, MN, USA

PMH22      ECONOMIC EVALUATION OF AGOMELATINE FOR MAJOR DEPRESSIVE DISORDER IN SWEDEN 
Clapham E¹, Berg J², Ekman M², Jonsson L^2
1i3 Innovus, Stockholm, Stockholm, Sweden, ²i3 Innovus, Stockholm, Sweden

PMH34      TREATMENT BURDEN AND COSTS OF LISDEXAMFETAMINE DIMESYLATE USERS COMPARED WITH USERS OF OTHER LONG-ACTING TREATMENTS IN PATIENTS WITH ATTENTION-DEFICIT HYPERACTIVITY DISORDER 
Christensen L¹, Sasane R², Hodgkins P², Harley C^3
1i3 Innovus, Ann Arbor, MI, USA, ²Shire Pharmaceuticals, Wayne, PA, USA, ³i3 Innovus, Eden Prairie, MN, USA

PMH63      EFFECTS OF FISCAL INCENTIVES AND SOCIOECONOMIC FACTORS ON ANTIDEPRESSANT ADHERENCE 
Able S¹, Engel-Nitz NM², Fang Y², Ball D^1
1Eli Lilly and Company, Indianapolis, IN, USA, ²i3 Innovus, Eden Prairie, MN, USA

PMH76    PREDICTORS OF HIGHER HEALTH CARE EXPENDITURES IN PATIENTS WITH ATTENTION-DEFICIT HYPERACTIVITY DISORDER 
Christensen L¹, Sasane R², Hodgkins P², Harley C^3
1i3 Innovus, Ann Arbor, MI, USA, ²Shire Pharmaceuticals, Wayne, PA, USA, ³i3 Innovus, Eden Prairie, MN, USA 

PMH87    TREATMENT PATTERNS BY RACE/ETHNICITY AND INCOME LEVELS AMONG ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) SUBJECTS TREATED WITH SHORT-, INTERMEDIATE-AND LONG-ACTING STIMULANTS 
Christensen L¹, Sasane R², Hodgkins P², Harley C^3
1i3 Innovus, Ann Arbor, MI, USA, ²Shire Pharmaceuticals, Wayne, PA, USA, ³i3 Innovus, Eden Prairie, MN, USA 

Building a Bridge Over Troubled QALYs: Developing Consensus
Thought leaders have been debating the QALY’s methodology, assumptions, and ultimate user value over the past several years. Stimulated by this debate, ISPOR convened an ISPOR invitational QALY Consensus Development Workshop, November 2007, funded by AHRQ, where participants debated alternative paradigms and measures, assumptions underlying the QALY, potential value of current systems, and decision-maker needs. A summary of the arguments presented and consensus statements and recommendation developed at the workshop will be presented.

For more information on this QALY invitational workshop, see:
http://www.ispor.org/meetings/Invitational/WorkshopPhila1107.asp