PROGRAM - TUESDAY, MAY 6, 2008

PROGRAM - TUESDAY, MAY 6, 2008
7:15AM-8:15AM   ISPOR FORUMS (Open Forum with breakfast)
   
ISPOR Health Technology Assessment SIG Forum

NAVIGATING THE HEALTH TECHNOLOGY ASSESSMENT PROCESS AROUND THE WORLD

Health technology assessment (HTA) is increasingly playing an important role in informing reimbursement and pricing decisions across the world. This forum will present the results from a global survey assessing current methods in health technology assessment and its application in reimbursement decisions; will present models of the health-care decision making processes specifically for coverage and reimbursement of emerging new technologies, and will introduce the Global Health Care Systems Road Map, an initiative to provide an overview of country-specific health care delivery systems, reimbursement and pricing approval processes, using the examples of Canada and France.

Moderator: Jalpa A. Doshi PhD, Co-Chair HTA and Good Research Practice for Reimbursement Decisions Working Group and Research Assistant Professor of Medicine, General Internal Medicine, Director, Economic Evaluations Unit, Center for Evidence-Based Practice, University of Pennsylvania, Philadelphia, PA, USA

Speakers:
Jennifer Stephens PharmD, Co-Chair HTA and Good Research Practice for Reimbursement Decisions Working Group and Clinical Director, PharMerit International, Bethesda, MD, USA
Karl Matuszewski, MS, PharmD, HTA of Emerging New Technologies Working Group and Senior Director, Clinical Knowledge Service Clinical Practice Advancement Center, University HealthSystem Consortium, Oak Brook, IL, USA
W. Neil Palmer, Global HTA Used in Health Care Reimbursement Working Group and Vice President, Pricing & Reimbursement, RTI Health Solutions, Ottawa, ON, Canada;
Annie Chicoye PhD, Global HTA Used in Health Care Reimbursement Working Group and Senior Principal, Aremis Consultants, Neuilly sur Seine, France

   
ISPOR Fellowship Standards Task Force Forum

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Pharmacoeconomic and Outcomes Research Fellowship Standards

This Forum provides an opportunity to discuss the upcoming publication of the Task Force report “Joint ACCP and ISPOR Guidelines for Pharmacoeconomic and Outcomes Research Fellowship Training Programs”.  Several PEOR fellowship mentors and their fellows will briefly discuss their experiences and its relationship to the Fellowship Guidelines.  A floor discussion will be open to all participants, including fellows, preceptors of fellows, academics and other interested parties, to meet and share their thoughts and ideas about Pharmacoeconomic fellowships.

Moderator: Alan Bakst, PharmD, MBA, Chair, ISPOR Fellowship Standards Task Force and Senior Director, Global Health Economics and Reimbursement, Baxter Healthcare Corporation, McGaw Park, Il, USA

Speakers:
Svetlana Denevich PharmD, Pharmacoeconomics and Outcomes Research Fellow, Abt Associates, Lexington, MA, USA
Shiraz Gupta PharmD, Manager, Global Health Economics & Outcomes Research, Abbott Laboratories, Abbott Park, Il, USA
A. Simon Pickard, PhD, Assistant Professor, Pharmacy Practice & Pharmacy Administration, Assistant Director, Center for Pharmacoeconomic Research, College of Pharmacy, University of Illinois, Chicago, IL, USA
Prabashni Reddy RPh, MS, PharmD, Director of the Center for Drug Policy, Partners Healthcare, Charlestown, MA, USA
Robert Wittenberg PharmD, Fellow, University of Illinois at Chicago & TAP Pharmaceutical Products, Inc., Northbrook, IL, USA

8:30AM-8:45AM   INCOMING PRESIDENTIAL ADDRESS
   

Chris L. Pashos PhDChris Pashos PhD
2007-2008 ISPOR President-Elect and
Vice President and Executive Director of HERQuLES, Abt Associates, Lexington, MA, USA

 

     
8:45AM-10:00AM   SECOND PLENARY SESSION:
    Drug Safety and Risk-Benefit Decision-Making

Both delayed market entry of life-saving therapies and withdrawals of products from the market underscore the need to determine risk-benefit of a new technology early and often in a product’s life cycle. Interest in developing single risk-benefit metrics is reappearing but will these advances lead to improved decision-making? This session will explore how regulators and payers determine the risk-benefit tradeoffs and act upon that information.

Moderator/Speaker:
Adrian Levy PhD
Associate Professor, University of British Columbia, Vancouver, BC, Canada

Speakers:
Gerald J. Dal Pan MD Gerald J. Dal Pan MD MHS,
Director, Office of Surveillance and Epidemiology, FDA, Silver Spring, MD, USA
Robert Powell PharmD Robert Powell PharmD
Associate Director, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
F. Reed Johnson PhD F. Reed Johnson PhD
Senior Fellow and Principal Economist, RTI International, Research Triangle Park, NC, USA
Robyn Lim PhD Robyn Lim PhD
Scientific Advisor, Progressive Licensing Project, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, ON, Canada
     
10:00AM-10:30AM   ISPOR AWARDS PRESENTATION
     
10:30AM-10:45AM   BREAK, EXHIBITS, POSTER PRESENTATIONS VIEWING - SESSION II
     
10:45AM-11:45AM   ISPOR FORUMS (5 concurrent session)
   
ISPOR Medication Compliance & Persistence SIG Forum
Assessment, Determinants & Economics of Medication Compliance & Persistence

Moderator: Femida Gwadry-Sridhar PhD, RPh, MSc, ISPOR Determinants of Compliance & Persistence Working Group Chair & Assistant Professor, University of Western Ontario & Mc Master University, Director CCR-Net & Director Health Informatics Lawson Health Research  Institute, London, ON, Canada

Prospective Assessment of Medication Compliance & Persistence
Compliance research requires an understanding about the best methodology to conduct trials including, randomized controlled clinical trials setting, observational cohort, and quasi- experimental.  Key considerations for researchers regarding the design, analysis and reporting of results of such trials will be reviewed.

Speaker: Femida Gwadry-Sridhar PhD, RPh, MSc on behalf of the ISPOR Analyses Standards Leadership Group & Assistant Professor, University of Western Ontario & Mc Master University, Director CCR-Net & Director Health Informatics – Lawson , London, ON, Canada

The Costs of Non-compliance
Medication non-compliance and failure to persist with treatments have substantial economic consequences.  A systematic review of the literature will aim to provide the basis for a cost of ‘illness’ study for selected diseases.

Speaker: Judith Shinogle MSc, PhD, ISPOR Economics of Compliance & Persistence Working Group Chair & Assistant Professor, Department of Health Services Administration, University of Maryland College Park School of Public Health

Determinants of Compliance & Persistence
A systematic review is complete. We  assessed the effectiveness of compliance-enhancing interventions, founded on key "determinants" of non-compliance.  The results for selected disease areas will be presented.

Speaker: Femida Gwadry-Sridhar PhD, RPh, MSc, ISPOR Determinants of Compliance & Persistence Working Group Chair & Assistant Professor, University of Western Ontario & McMaster University, Director CCR-Net & Director Health Informatics- Lawson-, London, ON, Canada

Discussion

ISPOR Good Research Practices for ISPOR Retrospective Database Analysis Task Force Forum

Design and Analysis of Non-Randomized Studies of Treatment Effects using Secondary Databases

This forum will present the major issues of design, analysis, and interpretation of findings from therapeutic effectiveness studies using secondary databases. Your comments and input are invited.

Moderator: Michael Johnson PhD, Co-Chair, Good Research Practices for Retrospective Database Analysis Task Force and Associate Professor, University of Houston, College of Pharmacy, Houston, TX USA

Speakers:
Marc Berger, MD, Vice President, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA
Muhammad Mamdani, PharmD, MA, MPH, Director, Applied Health Research Centre (AHRC), Li Ka Shing Knowledge, Institute of St. Michael's Hospital, Canada and Associate Professor, Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Canada
Colin Dormuth, ScD, Assistant Professor, Dept. of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia; Chair of Pharmacoepidemiology Group, Therapeutics Initiative, British Columbia, Canada
William Crown, PhD, President, i3Innovus, Waltham, MA, USA
Bradley Martin PhD, RPh, PharmD, Assoc. Prof. and Division Chair, College of Pharmacy, University of Arkansas for Medical Sciences, Department of Pharmacy Practice, Little Rock, AR USA
Emily Cox, PhD, Senior Director of Research, Express Scripts, Saint Louis, MO, USA

ISPOR Good Research Practices On Economic Data Transferability Task Force Forum

Good Research Practices On Economic Data Transferability

The draft final report and recommendations on best practices in transferability of economic data in health economic evaluations will be discussed.  Several factors may limit the generalizability of economic (i.e. resource, cost and utility) data, including differences in relative prices, practice patterns, availability of health care resources and community values of health states. This session will focus on issues identified by ISPOR members concerning the draft Task Force Report now at the ISPOR website. These issues include defining key variable economic data, guidelines for acceptance of data from outside a country while considering existing national guidelines, and directions for future research.

Speakers:
Michael Drummond PhD, Professor of Health Economics, University of York, Centre for Health Economics, Heslington, York, UK
Shelby Reed PhD, RPh, Assistant Research Professor, Duke Clinical Research Institute, Durham, NC, USA
Mark Sculpher PhD, Professor of Health Economics, Centre for Health Economics, University of York, York, UK

ISPOR Quality Improvement in Cost-Effectiveness Research (QICER) Task Force Forum

Quality Improvement in Cost-Effectiveness Research & Use

This session will focus on facilitating the improvement of health care economic evaluation research and its use in making health care policy.  Updates on the present and future of global guidelines, statistical problems in cost effectiveness research and ideas for improving the science, the prevalence and scope of quality guidelines in journals & publications, and barriers to use of cost effectiveness data by decision-makers and patients will be presented by the ISPOR QICER Task Force.

Speaker: William McGhan PhD, PharmD, Professor of Pharmacy & Health Policy, University of the Sciences, Philadelphia, PA USA

ISPOR Student Network Educational Forum

Overview of Decision Analysis and its Application

A decision tree analysis is one of the most systematic tools of decision making in the health care practice setting. This ISPOR Student Educational Forum will provide a basic overview of the key terminology in decision analysis. During this forum, students will bridge the gap between understanding pharmacoeconomics concepts and the application of decision analysis.

Moderators: Zeba Khan, PhD, Executive Director, Pricing, General Medicines, Novartis Pharmaceuticals, East Hanover, NJ USA, ISPOR Student Network Faculty Advisor; Seina P Lee, PharmD, MS, Outcomes Research Fellow, Ortho-McNeil Janssen Scientific Affairs,LLC/Department of Health Policy, Thomas Jefferson University, ISPOR Student Network Chair 2007-2008

Speaker: Grant H. Skrepnek PhD, Assistant Professor, Pharmacy Practice and Science University of Arizona College of Pharmacy

12:00PM-1:00PM   ISSUE PANEL - SESSION II (5 concurrent session)
   


CLINICAL OUTCOMES RESEARCH ISSUES

IP6: ARE GOOD PRACTICE PRINCIPLES FOR OBSERVATIONAL COMPARATIVE EFFECTIVENESS RESEARCH NEEDED?
Moderator: Nancy A. Dreyer PhD, Chief of Scientific Affairs, Outcome, Cambridge, MA, USA.
Panelist(s): Marc L. Berger MD, Vice President, Eli Lilly, Global Health Outcomes, West Point, PA, USA; Sean D Sullivan PhD, RPh, Professor of Pharmacy and Public Health and Director, University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA; Jacques Lelorier PhD, Professor, Université de Montreal, Montreal, QC, Canada.

HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH ISSUES

IP7: WHAT DID THE MEDICARE REPLACEMENT DRUG DEMONSTRATION TEACH US ABOUT THE ROLE OF COST-EFFECTIVENESS ANALYSES IN PUBLIC POLICY?
Moderator: Penny E Mohr MA, Director, Division of Research on Health Plans and Drugs, Centers for Medicare and Medicaid Services, Office of Research, Development and Information, Baltimore, MD, USA.
Panelist(s): William Lawrence MD, MS, Research Fellow, Agency for Healthcare Research and Quality, Center for Outcomes and Effectiveness Research, Rockville, MD, USA; Allan Wailoo BSc, MA, PhD, Senior Lecturer in Health Economics, The University of Sheffield, Health Economics and Decision Science, School of Health and Related Research, Sheffield, UK; Martin Zagari MD, Global Health Economics Head, Amgen, Thousand Oaks, CA, USA.

IP8: QUANTITATIVE APPROACHES TO REGULATORY RISK-BENEFIT ASSESSMENT FOR FDA DECISION-MAKING: WHAT WOULD WORK?
Moderator: James T. Cross MS, Graduate Student, University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA.
Panelist(s): F. Reed Johnson PhD, Senior Fellow and Principal Economist, RTI International, Research Triangle Park, NC, USA; Larry D. Lynd PhD, Assistant Professor, University of British Columbia, Faculty of Pharmaceutical Sciences, Vancouver, BC, Canada; Louis P. Garrison PhD, Professor of Pharmacy, University of Washington, Department of Pharmacy, Seattle, WA, USA.

IP9: PRACTICAL CONSIDERATIONS ON COVERAGE WITH EVIDENCE DEVELOPMENT: HOW WILL THE PIPER BE PAID?
Moderator: Stuart MacLeod MD, PhD, FRCPC, Executive Director, Children's & Women's Health Centre of British Columbia, Vancouver, BC, Canada.
Panelist(s): Mike F Drummond PhD, Professor of Health Economics, Centre for Health Economics, University of York, York, Heslington, UK; Sean Tunis MD, MSc, Executive Director, Center for Medical Technolgy Policy, Baltimore, MD, USA; Pierre Philippe Sagnier MD, Vice President Global Health Economics, Bayer Schering Pharma, Outcomes and Reimbursement, Wuppertal, Germany.

PATIENT-REPORTED OUTCOMES RESEARCH ISSUES

IP10: QALYS GONE WILD?
Moderator: Peter I. Juhn MD, MPH, Vice President, Evidence and Regulatory Policy, Johnson & Johnson, New Brunswick, NJ, USA.
Panelist(s): Adrian Griffin MsC, Vice President, Strategic Affairs, LifeScan, Inc, High Wycombe, Buckinghamshire, UK; Peter J. Neumann ScD, Professor, Tufts-New England Medical Center, Institute for Clinical Research and Health Policy Studies, Boston, MA, USA; Michael Schlander, MD, MBA, Professor, Institute for Innovation & Valuation in Health Care (InnoVal-HC), University of Heidelberg, Eschborn, Germany.

1:00PM-2:30PM   LUNCH, EXHIBITS, POSTER PRESENTATIONS VIEWING - SESSION II
     
1:30PM-2:00PM   GUIDED TOUR OF THE HEALTH CARE DECISIONS USING OUTCOMES RESEARCH INFORMATION POSTER SESSION
     
1:30PM-2:30PM   EDUCATIONAL SYMPOSIUM Sponsored by RTI Health Solutions
    Obtaining a PRO Label Claim: What Evidence Do you Need?

The Symposium is free and open to all ISPOR delegates, no pre-registration required.

Sponsored by

In February 2006, FDA published the draft Guidance for Industry on Patient-Reported Measures: Use in Medical Product Development to Support Labeling Claims.  In order to obtain a Product Label Claim for a Patient-Reported Outcome (PRO), industry sponsors need to provide evidence that the outcome was measured using a validated instrument in a clinical trial that was properly designed for that purpose.

To meet this objective, it’s important to understand label claim wording and structure.  Industry Representatives from PhRMA Health Outcomes Technical Group have been working with FDA to further describe the evidence needed to support labeling claims and the level of documentation required for PRO briefing documents submitted to FDA for review.  One piece of that evidence is the Conceptual Framework for Instruments and Endpoint Models for Study Protocols.   This workshop will review what is a label claim, what evidence is needed to support the claim, and how to design a conceptual framework and endpoint model for a PRO Evidence Dossier.

1:30 - 1:35 
OPENING REMARKS
The speakers will briefly address PRO Label Claims for FDA and the supporting evidence needed to obtain a PRO Product Label Claim.  In addition, one of the speakers will describe developing conceptual frameworks and endpoint models for PRO Evidence Dossiers.
Moderator: Sheri Fehnel PhD Global Head, Patient-Reported Outcomes, RTI Health Solutions, Research Triangle Park, NC, USA

1:35 - 1:50
WHAT IS A PRO LABEL CLAIM AND WHAT EVIDENCE DO YOU NEED?
The speaker will discuss PRO label claims and provide examples. The evidence needed to support obtaining a PRO label claim will also be described.
Speaker: Kati Copley-Merriman MS, MBA, Global Head, Outcomes Research and Regulatory Strategy, RTI Health Solutions, Ann Arbor, MI, USA

1:50 – 2:05
PRO EVIDENCE TO SUPPORT LABEL CLAIMS

The speaker will discuss the outline of a PRO Evidence Dossier to support Label Claims and describe the section contents.
Speaker: Julie Chandler PhD, Senior Director, Epidemiology, Merck Research Laboratories, Blue Bell, PA, USA

2:05 – 2:20
CONCEPTUAL FRAMEWORK AND ENDPOINT MODELS TO SUPPORT LABEL CLAIMS

The speaker will discuss the structure and process for developing conceptual frameworks and endpoint models for PRO Evidence Dossiers and provide examples.
Speaker: Diane Wild MS, Director, Patient-Reported Outcomes, Oxford Outcomes, Oxford, UK

2:20 - 2:30
DISCUSSION / Q&A

2:30PM-3:30PM   WORKSHOPS -SESSION I (5 concurrent sessions)
   

ECONOMIC OUTCOMES RESEARCH

W1: PRESENTING UNCERTAINTY IN COST-EFFECTIVENESS RESEARCH
Discussion Leaders: Katia Noyes PhD, MPH, Associate Professor, University of Rochester School of Medicine, Community and Preventive Medicine, Rochester, NY, USA; Elisabeth Fenwick PhD, Lecturer, University of Glasgow, Public Health and Health Policy, Division of Community Based Medicine, Glasgow, UK

HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH

W2: PAYING FOR PILLS BY RESULT: PERFORMANCE-BASED REWARDS FOR INNOVATION
Discussion Leaders: Louis P. Garrison PhD, Professor of Pharmacy, University of Washington, Department of Pharmacy, Seattle, WA, USA; Sean D Sullivan PhD, RPh, Professor of Pharmacy and Public Health and Director, University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA; Peter J. Neumann ScD, Professor, Tufts-New England Medical Center, Institute for Clinical Research and Health Policy Studies, Boston, MA, USA; Adrian Towse MPhil, Director, Office of Health Economics, London, UK

PATIENT-REPORTED OUTCOMES RESEARCH

W3: GOOD RESEARCH PRACTICES FOR THE APPLICATION OF CONJOINT ANALYSIS IN HEALTH – A CHECKLIST FOR PUBLISHING IN OUTCOMES RESEARCH
Discussion Leaders: John FP Bridges PhD, Assistant Professor, Johns Hopkins University, Bloomberg School of Public Health, Health Policy and Management, Baltimore, MD, USA; F. Reed Johnson PhD, Senior Fellow and Principal Economist, RTI Health Solutions, Health Preference Assessment, Research Triangle Park, NC, USA; A. Brett Hauber PhD, Senior Economist and Head, RTI Health Solutions, Health Preference Assessment, Research Triangle Park, NC, USA

W4: DEVELOPMENT AND USE OF DECISION BOARDS FOR DETERMINATION OF THE GENERAL PUBLIC'S PREFERENCE IN WILINGNESS-TO-PAY ANALYSIS
Discussion Leaders: Michael Iskedjian BPharm, MSc, President, PharmIdeas, Buffalo, NY, USA; Olivier Desjardins BSc, Senior Research Analyst, PharmIdeas Research and Consulting Inc, Ottawa, ON, Canada; Thomas Einarson PhD, VP Scientific Affairs, PharmIdeas Research and Consulting Inc, Oakville, ON, Canada

USE OF REAL WORLD DATA

W5: RECOMMENDATIONS FOR THE USE OF PATIENT REGISTRY DATA AS A COMPLEMENT FOR RANDOMIZED CLINICAL TRIALS
Discussion Leaders: Steven K Takemoto PhD, Associate Professor, Saint Louis University, Center for Outcomes Research, Saint Louis, MO, USA; Nancy A. Dreyer PhD, Chief of Scientific Affairs, Outcome, Cambridge, MA, USA; Claudio Faria PharmD, MPH, Associate Director of Clinical Research, UMass Medical School, Charlestown, MA, USA; Fang Wang MD, PhD, Director, GlaxoSmithKline, Global Health Outcomes, King of Prussia, PA, USA

3:30PM-3:45PM   BREAK, EXHIBITS & POSTER PRESENTATIONS VIEWING - SESSION II
   
3:45PM-5:00PM   THIRD PLENARY SESSION:
    Patient Reported Outcomes: Implementing Good Research Practices
Patient reported outcomes (PROs) are sometimes viewed as inherently subjective because they are derived from patients. There are objective ways to gather and analyze PROs, which must be explored amidst the mounting evidence of international and cultural differences in health-related quality of life that reinforce the subjectivity of responses. This session will review the FDA Guidance on PROs and recommendations from the ISPOR Task Force and explore improvements in methodology and application of PROs.
Moderator/Speaker:
Stephen Joel Coons PhD Stephen Joel Coons PhD
Professor, Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, AZ, USA

Speakers:
Ron Hays PhD Ron Hays PhD
Professor of Medicine, UCLA Department of Medicine, Division of General Internal Medicine & Health Services Research, Los Angeles, CA, USA
Nancy E. Mayo BSc, MSc, PhD Nancy E. Mayo BSc, MSc, PhD
James McGill Professor, Department of Medicine, School of Physical and Occupational Therapy, McGill University Division of Clinical Epidemiology, Division of Geriatrics, McGill University Health Center, Montreal, QC, Canada
Margaret Rothman PhD Margaret Rothman PhD
Senior Director, WW PRO Center of Excellence, Johnson & Johnson Pharmaceutical Services, LLC, Raritan, NJ, USA

     
5:00PM-5:15PM   ISPOR RESEARCH AWARDS
     
5:15PM-6:15PM   AUTHOR PRESENTATION HOUR - POSTER
     
5:15PM-7:00PM   EXHIBITORS' WINE & CHEESE RECEPTION & CONTRIBUTED POSTER PRESENTATIONS VIEWING - SESSION II
     
7:30PM-11:00PM   ISPOR SOCIAL EVENT - AN EVENING ON LAKE ONTARIO!!
    Don’t miss the opportunity to network with ISPOR members during a night of dinner and dancing at Atlantis.
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