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Monday, May 20, 2002 |
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7:00-8:00 AM |
Early
Bird Forum |
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"AMCP FORMAT
FOR FORMULARY SUBMISSIONS: WHO IS USING THEM, WHO WILL BE EVALUATING THEM, AND
WHAT REGULATORY CONCERNS DO THEY RAISE"
Since AMCP published its guidance, "A Format for Submission of Clinical and
Economic Data in Support of Formulary Consideration by Managed Health Care
Systems in the United States", a number of health plans and PBMs have adopted
it. This session will focus on how this guidance is being used, who will be
evaluating it, and possible regulatory concerns about its use. |
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7:00-7:10 AM |
Moderator: Dell
Mather PharmD, Senior Director, Pharmacotherapy Assessment & Policy, Prime
Therapeuti |
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7:10-7:20 AM |
Who Is Using Them
Speaker: Peter M. Penna PharmD, President, PM
Penna LLC, Seattle, Washington, USA and AMCP Officer |
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7:20-7:30 AM |
Regulatory Concerns
Speaker: Laurie Beth Burke RPh, MPH, Chief,
Regulatory Review Branch, FDA, CDER, DDMAC, Rockville, MD, USA |
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7:30-8:00 AM |
Panel Discussion and Audience
Participation
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8:00-8:30 AM |
Welcome
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Peter Neumann ScD, ISPOR Annual Meeting Program
Chair and Assistant Professor of Policy & Decision Sciences, Harvard School of
Public Health, Boston, MA, USA
Presidential Address
Eva Lydick PhD, ISPOR 2001-2002 President and Director of Epidemiology,
AstraZeneca, Wilmington, DE, USA
Presentation: ISPOR Avedis Donabedian Outcomes
Research Lifetime Achievement Award & ISPOR Research Excellence Awards
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8:30-10:00 AM |
First Plenary Session |
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“Uses and Users of Outcomes Research: Meeting the
Critical Needs?”
This session will consider the different needs of users of outcomes research
(clinicians, payors, policymakers, patients, and study sponsors) and how
outcomes research studies are used. Case studies will illustrate helpful and
less helpful examples of these analyses and their applications. Particular
attention will be paid to the perspective of the clinician in reading and
acting on the results of outcomes research in making prescribing decisions.
Discussants will address the particular role of (1) government in making
coverage decisions, supporting and disseminating pharmaceutical outcomes
research and (2) patients in making decisions to pay or not to pay for
prescribed therapy.
Moderator: Sandy Schwartz MD, Professor of
Medicine and Health Management and Economics, University of Pennsylvania,
School of Medicine and Wharton School, Philadelphia, PA, USA
Outcomes Research and the Clinician’s Perspective
Speaker: Jerry Avorn MD, Associate
Professor, Harvard Medical School, Boston, MA, USA
The Role of Government
Discussant: Deborah Zarin MD, Director,
Technology Assessment Program, Agency for Healthcare Research and Quality, US
Department of Health & Human Services, Rockville, MD, USA
The Role of Patients
Discussant: Edwin Hedblom PharmD, Chief
Pharmacy Officer – AARP Pharmacy Division, UnitedHealth Group, Minnetonka, MN,
USA
Questions and Audience Participation
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10:00-10:30 AM |
Exhibits &
Poster Presentations - Session I |
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Coffee Breaks Sponsored by
JeSTARx |
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10:30-12:00 PM |
Concurrent Podium Sessions (4 Sessions)
Pharmacoeconomic/health economic, quality-of-life and outcomes research study
results for the following diseases will be presented
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CARDIOVASCULAR
DISEASE/DISORDERS I |
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Moderator: Gregory Hess MD, MBA, Consultant, Wayne,
PA, USA |
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CV1 |
NONCOMPLIANCE WITH STATIN THERAPY: LOST CLINICAL BENEFITS AND IMPLICATIONS
FOR COST-EFFECTIVENESS
Benner JS1, Ganz DA1, Weinstein MC2, Neumann PJ2, Glynn RJ1, Avorn J1,
1Brigham and Women's Hospital / Harvard Medical School, Boston, MA, USA;
2Harvard School of Public Health, Boston, MA, USA |
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CV2 |
OUTCOMES AND
COSTS OF ISCHEMIC COMPLICATIONS AND BLEEDING IN PATIENTS UNDERGOING
PERCUTANEOUS CORONARY INTERVENTIONS
Delea TE1, Plent S2, Edelsberg JS1, Oster G1, 1PAI, Brookline, MA, USA;
2The Medicines Company, Cambridge, MA, USA |
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CV3 |
LONG-TERM
COSTS AND CLINICAL CONSEQUENCES OF DIFFERENT LEVELS OF 2-HOUR POST
PRANDIAL BLOOD GLUCOSE IN NON-DIABETES PATIENTS
Palmer AJ, Roze S, Foos V, Lurati FM, Hirini S, CORE Center for Outcomes
Research, Basel, Switzerland |
CV4 |
CORRELATION
BETWEEN NEW YORK HEART ASSOCIATION CLASSIFICATION AND PATIENT-REPORTED
OUTCOMES
Yokoyama KK1, Blumenschein K2, Johannesson M3, Gause D4, Frech F4,
1Novartis Pharmaceuticals Corporation/Scott & White Health Plan/University
of Texas at Austin, East Hanover, NJ, USA; 2University of Kentucky College
of Pharmacy and Martin School of Public Policy and Administration,
Lexington, KY, USA; 3Stockholm School of Economics, Stockholm, Sweden;
4Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA |
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MENTAL HEALTH
(Including
Dementia) |
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Moderator: David
Miller PhD, Head,
Health Outcomes, GlaxoSmithKline, Greenford, Middlesex, United Kingdom |
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MH1 |
A ROBUST GLOBAL TREATMENT RESPONSE AVAILABLE TO
OLANZAPINE-TREATED PATIENTS IS ASSOCIATED WITH MEANINGFUL IMPROVEMENT IN
NEGATIVE SYMPTOMS AND QUALITY OF LIFE
Kinon BJ1, Zhao Z2, 1Lilly Research Laboratories, Indianapolis, IN, USA;
2Eli Lilly and Company, Indianapolis, IN, USA |
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MH2 |
COMPARISON OF TREATMENT COST FOR DEPRESSION BETWEEN
FLUOXETINE, PAROXETINE, SERTRALINE AND VENLAFAXINE USING MANAGED CARE
CLAIMS DATA
Curkendall SM1, Goehring EL1, She D1, Pezzullo JC2, Jones JK1, 1The Degge
Group, Ltd, Arlington, VA, USA; 2Georgetown University, Washington, DC,
USA |
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MH3 |
DEPRESSION IN PRIMARY CARE: TREATMENT AND RESPONSE
Corey-Lisle PK1, Nash R2, Stang P3, Swindle R1, 1Eli Lilly & Company,
Indianapolis, IN, USA; 2Florida A&M University, Tallahassee, FL, USA;
3Primary Care Network, Blue Bell, PA, USA |
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MH4 |
THE BURDEN OF
DEPRESSION IN CANADA
Desjardins B1, Laurier C2, 1University of Montreal, Faculty of
Pharmacy, Merck Frosst Canada Ltd, Kirkland, QC, Canada; 2University of
Montreal, Montreal, QC, Canada |
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DIABETES |
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Moderator:
Joseph Menzin PhD,
President, Boston Health Economics, Inc., Waltham, MA, USA |
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DB1 |
THE VALUE OF MULTIPLE YEARS HISTORY IN IDENTIFYING
COMORBID CONDITIONS IN A RETROSPECTIVE DATA ANALYSIS
Morris L, Henderson SC, von Allmen H, Margolis J, IMS Health, Plymouth
Meeting, PA, USA |
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DB2 |
QOL INDICATORS OF SATISFACTION AND IMPACT ASSOCIATED
WITH WEB-ENABLED DIABETES SELF-MANAGEMENT TOOLS
Atherton M1, Becker MA2, 1George Mason University, Fairfax, VA, USA;
2PDHI, INC, Bernardsville, NJ, USA |
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DB3 |
DIABETIC FOOT ULCERS: THE ECONOMIC CONSEQUENCES OF
INPATIENT ADMISSIONS OVER FIVE YEARS
O'Brien J, Patrick A, Caro JJ, Caro Research Institute, Concord, MA, USA |
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DB4 |
A SYSTEMATIC ANALYSIS OF CONCOMITANT MORBIDITY AND
MORTALITY IN DIABETES
Farquhar I1, Summers KH2, Sorkin A3, Weir E4,
1Health Services Solutions P.A., Columbia, MD, USA; 2Eli Lilly & Company, Indianapolis, IN, USA;
3University of Maryland Baltimore County, Baltimore, MD, USA; 4Analytical
Computing, Baltimore, MD, USA |
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INFECTION |
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Moderator:
John Hornberger MD, MS,
Partner, Acumen LLC and Clinical
Professor of Medicine, Stanford University School of Medicine, Burlingame,
CA, USA |
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IN1 |
META-ANALYSIS OF UTILITY ESTIMATES: HIV/AIDS AND STROKE
Tengs TO, Lin TH, Health Priorities Research Group, University of
California, Irvine, CA, USA |
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IN2 |
VALUE OF
INFORMATION ANALYSIS OF THE DECISION BETWEEN CIPROFLOXACIN VS TRIMETHOPRIM
SULPHAMETHOXAZOLE FOR EMPIRICAL TREATMENT OF WOMEN WITH PYELONEPHRITIS
Fenwick E1, Claxton K1, Wang J2, Sculpher M1, Kubin M3, Davey P4,
1University of York, York, UK; 2University of Dundee, Dundee, Scotland,
UK; 3Bayer AG, Wuppertal, Germany; 4MEMO, University of Dundee, Dundee,
Scotland, UK |
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IN3 |
COST-EFFECTIVENESS OF NEW RAPID SCREENING TECHNOLOGIES FOR GONORRHEA IN
URBAN EMERGENCY ROOM DEPARTMENTS
Aledort JE, Goldie SJ, Harvard University, Boston, MA, USA |
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IN4 |
THE COST OF
ANTIRETROVIRAL THERAPY IN THREE CENTRAL AMERICAN COUNTRIES
Becker R, Zaccagnini P, Rattana S, Ovation Research Group, Highland Park,
IL, USA |
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12:00-1:30 PM |
Exhibits, Poster Presentations –
Session I and Lunch |
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Lunch Sponsored by GlaxoSmithKline |
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1:30-2:30 PM |
Concurrent Issues Panels (4 Sessions)
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| How Does
Genomics Change Portfolio Management? |
Genomics technologies offer substantial promise in the area of clinical
development. However, decision-making in an era of a 10-fold increase in
targets and limited budgets will require additional discipline and
methodologies. We present an options strategy for assessing the
potential of new candidate molecules, and then test the concepts with an
industry expert.
Chair:
Kevin
Schulman MD, MBA, Director, Center for Clinical & Genetic Economics,
Duke University, Durham, NC, USA
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Standards of Evidence: What is
Appropriate? |
This panel will address the question: What should
the standards of evidence be for promotional claims by the pharmaceutical and
possibly the medical device industries regarding cost effectiveness to assist
health care decision-making?
Chair: Bryan Luce
PhD, MBA, Senior Research Leader & CEO, MEDTAP International, Bethesda, MD,
USA
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| Should
Meta-Analysis Only Include Clinical Trial Data? |
This
session debates Cochrane collaboration approaches to meta-analysis that
excludes all non-RCT data and Bayesian approaches that include
uncontrolled trials and observational studies.
Chair: Adrian Towse MA, Mphil, Director,
Office of Health Economics, London, United Kingdom
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Who Will Develop New Drugs for Tuberculosis or Malaria? |
Recent scientific advances offer new promise that
breakthrough therapies for the treatment of tuberculosis and malaria could
soon be discovered. An increasing focus on global health issues in the public
sector and in industry provides a framework for the business case and the
partnerships to move these discoveries out of the lab and into the market.
Chair: Doris Rouse PhD, Director, Global Health,
RTI International, Research Triangle Park, NC, USA |
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2:30-2:45 PM |
Break |
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2:45-3:45 PM |
Concurrent Contributed Workshop
Presentations (9 sessions) |
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Methodology Issues |
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WW1 |
USE AND MISUSE OF DIAGNOSIS RELATED GROUPS (DRGS) IN
ESTIMATING COSTS
O'Brien J, Caro Research Institute, Concord, MA, USA |
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WW2 |
INCIDENCE OR PREVALENCE: IMPLICATIONS FOR FORMULARY
DECISION-MAKING
Shaya FT1, Mullins CD1, Wong W2, 1University of Maryland, Baltimore, MD,
USA; 2CareFirst BlueCross BlueShield, Baltimore, MD, USA |
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WW3 |
PROBABILISTIC COST-EFFECTIVENESS MODELING: OVERVIEW
OF METHODS AND CHALLENGES WITH AN INTERACTIVE ILLUSTRATION
Briggs AH1, Gagnon YM2, Levy AR3, 1University of Oxford, Oxford, UK;
2OCCAM Research & Consulting Inc, Vancouver, BC, Canada; 3University of
British Columbia, Vancouver, BC, Canada |
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WW4 |
MEASURING PATIENT-REPORTED OUTCOMES IN CANCER
STUDIES: PRELIMINARY FINDINGS FROM THE CANCER OUTCOMES MEASUREMENT WORKING
GROUP
Lipscomb J1, Gotay CC2, Snyder C1, 1National Cancer Institute, Bethesda,
MD, USA; 2University of Hawaii, Honolulu, HI, USA |
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Health Policy |
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WW5 |
THE ROLE OF ECONOMIC EVALUATION OF PHARMACEUTICALS
IN HEALTH DEVELOPMENT ASSISTANCE
Rovira J, Preker AS, Musgrove PA, The World Bank, Washington, DC, USA
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Quality of Life |
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WW6 |
IMPUTATION OF MISSING QOL DATA: METHODS AND
INTERPRETATION
Crawford B1, Massaro J2, 1Mapi Values, Boston, MA, USA; 2Boston
University, Boston, MA, USA |
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Design and Implementation |
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WW7 |
USING HEALTHCARE CLAIMS DATA TO DEVELOP DISEASE RISK
PREDICTION MODELS
Russell MW1, Huse DM2, 1ICSL Healthcare Research, Waltham, MA, USA;
2PharMetrics, Inc, Watertown, MA, USA |
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WW8 |
COMPARISON OF "TOP-DOWN" VS "BOTTOM-UP" BUDGET
IMPACT MODELS
Kleinstiver PW, Katalyst Health Technology Assessments, London, ON, Canada |
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Practical Issues |
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WW9 |
INCORPORATING ECONOMIC OUTCOMES INTO FORMULARY
DECISIONS
Mauskopf J1, Wright A2, Hocker S3, 1MEDTAP
International, Durham, NC, USA; 2Advance PCS, Hunt Valley, MD, USA; 3PAREXEL, Baltimore, MD, USA |
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3:45-4:00 PM |
Break |
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4:00-5:00 PM |
Concurrent Contributed Workshop Presentations (9 sessions) |
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Methodology Issues |
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WW10 |
NUMBER
NEEDED TO TREAT (NNT): IS IT A USEFUL BENCHMARK FOR THE EFFICIENCY OF
THERAPIES?
Caro J1, Huybrechts K1, Kamae I2, 1Caro Research Institute, Concord, MA,
USA; 2Kobe University, Chuou-ku, Kobe, Japan |
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WW11 |
THE
APPLICATION OF EXPERT OPINION IN PHARMACOECONOMIC STUDIES
Evans C, Crawford B, Mapi Values, Boston, MA, USA |
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WW12 |
THE USE OF
PATIENT SELF-REPORTED HUMANISTIC OUTCOMES INFORMATION TO IMPROVE QUALITY
OF CARE
Schmeichel CJ, LeVine P, Netherton D, InfoMedics, Inc, Woburn, MA, USA |
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WW13 |
THE
SEER-MEDICARE DATABASE: A UNIQUE RESOURCE FOR PHARMACOECONOMIC RESEARCH IN
ONCOLOGY
de Lissovoy G1, Warren JL2, 1MEDTAP International, Bethesda, MD, USA;
2National Cancer Institute, Bethesda, MD, USA |
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Design and Implementation |
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WW14 |
INCORPORATING FUTURE EVENTS INTO COST-EFFECTIVENESS MODELS
Mauskopf JA1, Bala MV2, 1MEDTAP International, Durham, NC, USA; 2Centocor, Inc, Malvern, PA,
USA |
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WW15 |
METHODOLOGICaL AND PRACTICAL ISSUES IN DEVELOPING AND ANALYZING ONCOLOGY
MODELS
Shih YCT1, Sorensen S1, Nuijten M2, 1MEDTAP International Inc, Bethesda,
MD, USA; 2MEDTAP International, Jisp, Netherlands |
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WW16 |
BENEFITS OF
A SIMPLE DECISION ANALYTIC APPROACH TO CLINICAL DRUG DEVELOPMENT
Richter A, RTI Health Solutions, Research Triangle Park, NC, USA |
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WW17 |
DECISION
ANALYSIS IN THE DRUG DEVELOPMENT PROCESS: USE OF PHARMACOECONOMICS TO
INFORM "GO/NO-GO" DECISION MAKING
Thompson D1, Bird A2, Weinstein MC2, 1Innovus Research, Inc, Medford, MA,
USA; 2Harvard School of Public Health, Boston,
MA, USA |
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Practical Issues |
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WW18 |
EVIDENCE OF
THERAPEUTIC EQUIVALENCE: IMPLICATIONS FOR ECONOMIC ANALYSES
Ortiz MS, Neighbors DM, Irish W, RTI Health Solutions, Durham, NC, USA |
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5:10-6:00 PM |
ISPOR Health
Science Forum |
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Moderator: John Hutton BSc, Bphil, Chair, ISPOR
Health Science Committee & Vice President, European Operations, MEDTAP
International, London, UK
ISPOR Health Science Committee Task Force Chairs will provide an update on the
"Good Research Practices" initiatives, code of ethics, and use of
pharmacoeconomic/health economic information in healthcare decision-making
- Good Modeling Research Practices
- Good Research Practices in Prospective Studies
- Good Research Practices in Retrospective Database Studies
- Good Research Practices in Quality of Life and Performance-based Measurement Studies
- Good Research Practices in the Use of Pharmacoeconomic/Health Economic Information in Healthcare Decision-Making
- Good Research Practices in Code of Ethics
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5:10-6:00 PM |
ISPOR
Student Forum |
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Introduction and Student Network Report
Speaker: C. Denise Clemmons,
ISPOR Student Network Chair & Graduate Student, University of Illinois,
Chicago, IL, USA
"Careers in Academia, Consulting, Government and Industry: A View From
the Ivory Towers"
Pharmacoeconomics and outcomes research (POR) spans a broad spectrum of
issues from studies evaluating the costs and effectiveness of a
particular pharmaceutical intervention to the impact of reimbursement
policies on the outcomes of care. It also ranges from the development
and use of tools to perform patient-based assessments to analyses of the
best way to disseminate the results to consumers, providers and payers.
Persons with training in POR have a variety of opportunities within
academia, consulting, government (as a payor or regulator) and industry.
Within each of these environments there are aspects of conducting,
evaluating, monitoring and communicating research – with the proportion
of effort and viewpoint varying among the alternatives. We will discuss
the major activities and expectations within each environment and the
importance of finding a place that fits with ones interests and skills,
which may vary over a career path. This will be an informal session with
time for questions and discussion.
Speakers:
C. Daniel Mullins PhD, Associate Professor,
School of Pharmacy, University of Maryland, Baltimore, MD, USA and
Dean G. Smith PhD, Professor, University of
Michigan, Ann Arbor, MI, USA
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6:00-8:00 PM |
Exhibitors’ Open House, Poster
Presentations – Session I and Reception |
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Reception Sponsored by
MEDTAP International |
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