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CATEGORY: Clinical Outcomes
Monday, May 17th, 11:30AM-12:30PM
TITLE: EFFECT OF SECTION 1013
"RESEARCH ON OUTCOMES
OF HEALTH CARE ITEMS AND SERVICES" OF THE US MEDICARE MODERNIZATION ACT ON
OUTCOMES RESEARCH
MODERATOR: Jean Paul Gagnon PhD,
Director Public Policy, Aventis Pharmaceuticals Inc., Bridgewater, NJ, USA
PANELISTS: Jean R. Slutsky, PA, MSPH,
Acting Director, Center for Outcomes and Evidence, Agency for Healthcare
Research and Quality (AHRQ), Rockville, MD, USA, Kathleen Lohr PhD,
Co-Director, RTI-UNC Evidence-based Practice Center, Research Triangle Park,
NC, USA; John Santa MD, Former Administrator, Office of Oregon Health
Policy and Research, Portland, OR, USA
PURPOSE: Three perspectives (AHRQ, Evidence-based Practice Center [EPC] ,
and a health policy analyst) will be presented to address issues relating to
Section 1013 (Research on Outcomes of Health Care Items and Services) of the
US Medicare Prescription Drug, Improvement and Modernization bill and
outcomes research. Panelists will address questions that include what AHRQ
will do to address its new Medicare program charge, how the EPCs will be
involved, how successful have they been, how the EPCs relate to the
discipline of health outcomes research, what impact they will have on the
process of assessing health care technology, and how have they been used in
decision-making.
OVERVIEW: Evidence-based practice and
outcomes research have gained broad acceptance among academics, health care
providers, policy makers, and patients alike over the past few years. With
the passage of the new Medicare bill with Section 1013 (Research on Outcomes
of Health Care Items and Services) it is reasonable to consider the
potential changes in store for the pharmaceutical industry, patients, payers
and decisionmakers. Since 1997 AHRQ has supported EPCs to conduct systematic
reviews of a wide range of clinical and health policy topics. Health care
decisionmakers use these reports to construct clinical practice guidelines
and quality measures, to make coverage decisions, and to design future
research agendas. The new Medicare bill calls for AHRQ to conduct and
support research to meet the priorities and requests for scientific evidence
and information that will improve the quality, effectiveness, and efficiency
of health care delivered to the elderly. Specifically, the bill calls for
AHRQ to determine the outcomes, comparative clinical effectiveness, and
appropriateness of health care items and services including prescription
drugs. This session looks at ways that AHRQ generally, its EPC program
specifically, and related entities might respond to the Section 1013
charges.
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CATEGORY: Health Policy
Monday, May 17th, 11:30AM-12:30PM
TITLE: STRATIFIED COST-EFFECTIVENESS ANALYSIS: THE
RISKS AND REWARD OF LOOKING AT SUB-GROUPS
MODERATOR: Henry Glick PhD,
Health Economist, University of Pennsylvania, Division of Internal Medicine,
Philadelphia, PA, USA
PANELISTS:
Jeffrey Hoch PhD,
Assistant Professor, University of Western Ontario, Department of
Epidemiology and Biostatistics, London, ON, Canada; Andrew Willan PhD,
Professor, Department of Public Health Sciences, University of Toronto,
Toronto, ON, Canada; Joseph Heyse PhD, Executive Director, Merck
Research Laboratories, Biostatistics and Research Data Systems, West Point,
PA, USA; John Cook PhD, Health Economics, Merck Research
Laboratories, Blue Bell, PA, USA
PURPOSE:
The most common result from
an economic evaluation is a pooled analysis for a potentially heterogeneous
population (e.g., one that includes people of different ages, genders,
levels of disease severity, one that includes people who may be treated in
different health care settings, and one that includes people who may be
treated in different parts of the world). This panel will explore the
strengths and weaknesses of three analytic approaches for the evaluation of
whether such pooled economic results in trials are applicable to subgroups
in the trial.
OVERVIEW:
The speakers will outline
three approaches to the evaluation of the representativeness of pooled
economic results in the analysis of patient-level data: net monetary benefit
regression (Hoch); empirical Bayes shrinkage estimation (Willan); and the
assessment of qualitative and quantitative interaction (Cook/Heyse). The
interactive discussion between the audience and participants will focus on
synergies between the methods as well as their differences.
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Tuesday, May 18, 9:15AM-10:15AM
TITLE: THE IMPACT OF MEDICARE’S PRESCRIPTION DRUG LEGISLATION ON PHARMACOECONOMICS AND OUTCOMES RESEARCH
MODERATOR: Peter Neumann ScD, Associate Professor of Policy and Decision
Sciences, Harvard School of Public Health, Boston, MA, USA
PANELISTS: Diane Simison PhD, Principal, PharmAnalysis Group, Inc.,
Alexandria, VA, USA; Ronald J. Ozminkowski PhD, Director, Health and
Productivity Management Research, Medstat, Ann Arbor, MI, USA
PURPOSE: To explore how the
recently enacted Medicare Modernization Act
(MMA) will impact the funding and performance of pharmacoeconomics and
outcomes research
OVERVIEW: Panelists will examine the
impact and relevance of MMA provisions on pharmacoeconomic and health
outcomes research. Key discussion topics will include: existing Medicare
data and data needs for the future; how to analyze the inpatient,
outpatient, and pharmaceutical experience for beneficiaries with a selected
number of high-cost medical conditions; the financial impact of the "donut
hole"
in coverage, and the laws impact on self-administered Part B drugs, use of
formularies, the Medication Management Program, competitive bidding for
drugs and biologics, and new technologies for hospitals
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CATEGORY: Risk
Monday, May 17th, 11:30AM-12:30PM
TITLE: RISK SHARING DEALS IN THE REAL WORLD: CAN WE
AFFORD THEM AND DO THEY WORK?
MODERATOR: Charles Petrie PhD,
Sr. Director/Team Leader, Outcomes Research Group, Pfizer Inc, Groton, CT,
USA
PANELISTS: Adrian Towse MA,
Director, Office of Health Economics, London, UK;
Maureen Mangotich MD,
MPH, Medical Director, State Initiatives, Pfizer Health Solutions,
Santa Monica, CA
PURPOSE:
To illustrate and discuss basic components of two
current, real world examples of risk sharing arrangements involving a
pharmaceutical manufacturer and a health care payer.
OVERVIEW:
For a variety of reasons, healthcare delivery
systems and payers of health care are increasingly reluctant to carry all
the risk for the medicines, procedures, and services they offer given
that pricing and utilization can be unpredictable and difficult to control.
Consequently, health care financing arrangements designed to share the risk,
manage budgetary volatility, and align payer and provider incentives are
finding application. Panelists will present and discuss two risk share
arrangements: the Pfizer-Florida Medicaid Program and the NHS Multiple
Sclerosis Program.
CATEGORY: Cost
Monday, May 17th, 11:30AM-12:30PM
TITLE: COST ATTRIBUTION IN ECONOMIC EVALUATION: WHAT IS SIGNAL AND WHAT IS
NOISE?
MODERATORS: Teresa Kauf PhD,
Research Assistant Professor, Center
for Clinical and Genetic Economics, Duke Clinical Research Institute,
Durham, NC, USA
PANELISTS: Gerry Oster PhD, Vice
President, Policy Analysis Inc. (PAI), Brookline, MA, USA; Daniel
Polsky, PhD, Research Associate Professor, General Internal Medicine,
University of Pennsylvania, Philadelphia, PA, USA
PURPOSE: The intent of this Issues Panel
is to discuss the pros and cons
of studying total medical costs versus disease- or intervention-related
costs in economic evaluations.
OVERVIEW:
Limiting the inclusion of costs in economic evaluation to disease- or
intervention-specific components increases the opportunity for analysts to
detect important treatment differences (increased signal through decreased
noise). On the other hand, others argue that difficulties with classifying
costs as 'related' and 'unrelated' require consideration of all costs in
economic evaluations at the expense of increased variance (decreased ability
to detect signal through increased noise). The panelists in this session
will present contrasting views on cost attribution in economic evaluation.
An interactive discussion between the audience and participants will focus
on valid and reliable methods of cost attribution in the context of the
'noise versus signal' debate.
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Tuesday, May 18, 9:15AM-10:15AM
TITLE: COST INFORMATION TREATMENT IN STATED PREFERENCE EXPERIMENTS – WHAT IS
THE GOLD STANDARD?
MODERATOR: Deborah Marshall, PhD, Assistant Professor, McMaster University
and Innovus Research Inc, Burlington, ON, Canada
PANELISTS: Reed Johnson, PhD, Senior Fellow, Research Triangle Institute,
Research Triangle Park, NC, USA; Kathryn Phillips, PhD, Associate Professor,
University of California, San Francisco, CA, USA
PURPOSE: To examine controversies in alternative approaches to information
treatment in stated preference experiments and propose ‘best practice’
criteria.
OVERVIEW: In the real world, we observe actual behaviours that are based on
individuals’ preferences. In stated preference studies (either contingent
valuation or conjoint analysis), we can control and standardize the
information provided to respondents, but this naively assumes that our
description will prevent individuals from ‘recoding’ the information and
interpreting it based on their own experiences. On the other hand, it has
been shown in examining the value of mortality risks that people can be
trained to appropriately interpret changes in small fractions, but this
jeopardizes the generalizability of the results to any representative sample
of the population.
Similarly, stated preference studies are often used to estimate the marginal
utility of money and measure benefits using willingness-to-pay. However,
estimates of the marginal utility of income are only valid if respondents
accept cost levels as income-constrained, out-of-pocket expenses of
obtaining the desired scenario. Do respondents interpret stated preference
questions in this way? There is currently little empirical evidence on how
cost information is perceived and thus no gold standard on how stated
preference studies should present such information.
This debate will centre on how much preparation and information should be
provided to respondents so that the responses represent the preferences of
the individuals in the sample, but also represent a response within some
standardized context that is generalizable. The panelists will elucidate the
pros and cons of alternative approaches, including options for presenting
cost information, and propose ‘best practice’ criteria.
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CATEGORY: Quality of Life/Patient-Reported Outcomes
Monday, May 17th, 11:30AM-12:30PM
TITLE: INDUSTRY AND REGULATORY PERSPECTIVES ON TRANSLATING PATIENT REPORTED
OUTCOME MEASURES
MODERATOR:
Joyce Cramer BS, Yale University, New Haven, CT, USA
PANELISTS: Laurie Burke RPh, Director,
Study Endpoints and Label Division, U.S. Food and Drug Administration,
Rockville, MD, USA; Richard J. Willke PhD, Senior Director/Group
Leader, Worldwide Outcomes Research, Pfizer Inc., Peapack, NJ, USA; Diane
Wild MSc, Director, Oxford Outcomes, Cassington, Oxford, UK
PURPOSE: During this session an industry perspective and a regulatory
perspective will be presented to compare different approaches to translation
and cultural validation of patient reported outcomes measures (PROs)
instruments prior to their use in clinical trials, as well as consideration
of the costs and potential benefits of these approaches, including their
implications for bias and precision of results.
OVERVIEW: Various methods for translation and cultural adaptation have been
proposed recently to ensure that the meaning of the original PRO instrument
will be the same in all translations. While setting standards for producing
translations, encouraging homogeneity of translation processes, and
facilitating use existing translations, these procedures have the potential
to impede trial implementation by increasing the time and budget required
for including PRO endpoints. The panelists and audience will discuss what
degree of stringency in the proposed methodology adds to the quality of the
instrument.
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Tuesday, May 18, 9:15AM-10:15AM
TITLE: CAN WE BRIDGE TOO FAR? ISSUES IN MAPPING BETWEEN QUALITY-OF-LIFE
INSTRUMENTS AND UTILITY
MODERATOR: Michael
B.
Nichol PhD, Associate Professor & Chair, University of
Southern California, Los Angeles, CA, USA
PANELISTS:
Robert Kaplan PhD,
Chair/Professor, University of California, San Diego, San Diego, CA, USA;
Christopher McCabe PhD, Depute Director, NICE Decision Support Unit,
University of Sheffield, UK
PURPOSE:
This issues panel will
explore the use of mapping methods for deriving utility scores for
cost-effectiveness research.
OVERVIEW: Researchers have been
increasingly interested in the use of mapping methods to expand the
availability of utility scores for CEA.
Panelists will address such issues as: Reliability and validity of mapping
procedures; Sensitivity to change of mapping procedures; Comparison to gold
standards, such as direct elicitation; and, the importance of differences in
the utility estimating procedure from a CEA perspective.
CATEGORY: Reimbursement
Tuesday, May 18, 9:15AM-10:15AM
TITLE: THE VALUE OF POST-LAUNCH STUDIES – WHAT IS DESIRABLE VS. WHAT IS
FEASIBLE?
MODERATOR: Adrian Towse, Director, Office of Health Economics, London, UK
PANELISTS: Michael Drummond DPhil, Director, Centre for Health Economics,
York, UK (Research perspective); Andreas Laupacis MD, MSc, FRCPC, President
& CEO, Institute for Clinical Evaluative Sciences, Toronto, ON, Canada
(Agency perspective); Pete Fullerton PhD, Professor (Affiliate) University
of Washington, WA, USA (Managed care perspective)
PURPOSE: During this issue panel, 3
perspectives (managed care, health technology assessment, and researcher)
will be presented to compare and contrast what is desirable versus what is
feasible for post-launch pharmacoeconomics and outcomes studies.
OVERVIEW: Although the main emphasis of pharmacoeconomics and outcomes
research is likely to remain on the pre-launch phase, there is increasing
interest in conducting studies post-launch. Many payers are interested in
the cost-effectiveness of the drug in regular clinical practice and there
are examples of research partnerships between manufacturers and managed care
groups. Also, agencies determining guidelines for the reimbursement or use
of drugs (e.g. NICE in the UK) are increasingly specifying the types of
further research that will help them when they come to revise their guidance
in the future. These include additional clinical studies, observational
studies and research into the impact of new drugs on quality of life. The
panel will discuss the types of study requirements that are currently being
specified by agencies and the practical and methodological problems in
carrying them out.
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