Invited Presentations
Scientific Presentations - Original
Research
Applications Workshops
Decision-making for Coverage and Adoption of Medical Technologies
Abstract #: FS2
Decision Making for Health Care Technology: The Real World
William T. McGivney, Ph.D
Technology Assessment increasingly has become the foundation for a significant
amount of decision making in health care. Technology assessments have become the
clinical policy guiding the utilization of drugs, devices, procedures and
techniques. Technology assessments are translated directly into coverage policy
and to patient selection criteria for use in precertification or utilization
management programs in managed care. Technology assessments constitute the
building blocks of clinical guidelines for the overall management of disease
states.
Many definitions of technology assessment exist with the most common one being:
"Technology assessment is the evaluation of the safety, effectiveness, and
cost-effectiveness of the drugs, devices, procedures, and techniques used in the
practice of medicine and of the settings under which such care is developed."
This presentation will examine the application of the evaluation of safety and
effectiveness and of the evaluation of costs and cost-effectiveness in
decision-making in the health care system, with particular emphasis on managed
care.
Clearly, the focus of coverage decision-making in managed care companies for
devices, procedures, techniques and even for drugs has been on the evaluation of
safety and effectiveness. Consideration of costs and cost-effectiveness in what
even indirectly might be construed as coverage policy has been limited to the
development of drug formularies in HMOs. In stating this, it is important to
recognize that managed care is not synonymous with the term HMO, but rather
encompasses products from managed indemnity to preferred provider organizations
to point of service to health maintenance organizations. In national managed
care companies, coverage policy tends to be established based on the evaluation
of safety and effectiveness and extended consistently across all products.
Trends in methods of reimbursement increasingly will shift the responsibility
for establishing clinical and coverage policies away from managed care companies
back to the provider communities. Assumption of reimbursement through capitation
and global case rates forces providers to better understand the cost
implications of the utilization of individual technologies for the overall
management of a disease.
The presentation will examine reasons for the limited practical application of
cost-effectiveness analysis heretofore in the managed care world and explore the
potential for the increasing use of cost analysis and cost-effectiveness
analysis under more global methods of reimbursement. Among the issues that will
be explored in this context are:
mechanisms for decision-making in managed care companies (i.e. coverage vs.
medical necessity);
locus of decision-making authority in the United States vs. other countries;
importance of data derived from controlled trials vs. General practice;
acceptance by society of CEA in decision-making;
CEA analysis in prevention; CEA is okay when we are not really sick;
the complexity of and uncertainty in CEA;
CEA as phase II in the era of accountability in medicine.
William T. McGivney, Ph.D. Biosketch
Bill McGivney recently accepted the position of Chief Executive Officer of the
National Comprehensive Cancer Network in Philadelphia. Prior to joining the
National Comprehensive Cancer Network, he was Vice President of clinical and
Coverage Policy, Aetna U.S. Healthcare where he was responsible for coverage
policy across all products (drugs, devices, procedures, and techniques,
technology assessment activities, and direct clinical decision support
development)
Prior to joining Aetna in June of 1991, Bill spent 10 years with the American
Medical Association, most recently serving as Director of the Division of Health
Care Technology.
Bill received his Ph.D. in Pharmacology from the University of North Carolina
Medical School and then completed a post-doctoral fellowship in the Department
of Psychiatry at Harvard Medical School. Bill is a nationally recognized expert
in the area of drug and device regulation and coverage and reimbursement policy.
In 1989, he was recognized for this expertise and his contributions to drug and
device policy development with the FDA Commissioner's Medal of Appreciation.
Bill has served on numerous national committees including The Board of Directors
of the United Network for Organ Transplantation, the nation's transplant policy
board.
Abstract #: FS2
Decision-Making in a Managed Care Formulary
Robert Martin, R.Ph
Foundation Health Corporation and Integrated Pharmaceutical Services adopted
a policy in January 1997 to require all pharmaceutical manufacturers and others
who wish products to be considered for Formulary acceptance to meet evidentiary
and analytical standards in their submission documentation. This presentation
will introduce the details of these standards and describe the methodological
basis of the guideline evaluation. Submissions will be required to take a
systems impact perspective. This will be important in predicting patterns of
drug substitution and the cost and outcomes consequences of shifts in therapy.
This approach is quite unique in its focus on evidentiary and analytical terms
in developing clinical and economic models of a managed health care system,
compared to standards required by other health systems in other countries and
economic evaluations of pharmaceuticals by expert groups in the United States.
Robert Martin, R.Ph. Biosketch
Robert Martin received his Bachelor of Science in Pharmacy from Purdue
University in 1973. He continued his pharmacy training at Purdue and received a
Master of Science in Clinical Pharmacy in 1975, including a one year residency
in Internal Medicine at Indiana University Hospital in Indianapolis, Indiana. He
served as Clinical Instructor and Assistant Professor at the University of
Arizona College of Pharmacy for five years. Bob then held Operations Director
responsibilities with a large national chain for nine years, and moved into the
managed care environment in the last five years with Foundation Health and
Integrated Pharmaceutical Services in Rancho Cordova, California, where he was
Vice President of Pharmacy Operations. His responsibilities included all aspects
of pharmacy operations, as well as Clinical Pharmacy operations and Disease
Management Program development. These programs were used to evaluate, educate,
and improve the quality and cost-effectiveness of pharmaceutical care
management, and promote targeted changes in prescribing behavior impacting long
term medical outcomes. Currently, he is Vice President, West Coast Operations,
for ProMedex, Inc. a health informatics company that provides electronic data
interchange tools for Health Risk Assessments and Clinical Outcomes measurement
and monitoring. These tools are available for several disease areas through an
electronic health booth and Internet format.
Decision-making in Health
Care: Theory
Abstract #: SS1
Methodologic Issues in Cost-Effectiveness Analysis of
Health Care Technologies
Milton C. Weinstein, Ph.D.
Cost-effectiveness analysis (CEA) has roots in a variety of disciplines,
including economics, operations research, statistics, psychology, and ethics.
These perspectives have merged with those of clinical medicine, epidemiology,
and pharmacy to produce a vibrant field of research and practice. This diversity
of backgrounds is both a blessing and a curse for the field of CEA. It is a
blessing because CEA is more widely used than it might be if it were the
exclusive property of a single profession. It is a curse because each discipline
exacts different, and often conflicting, demands on the methodology.
Controversies exist regarding acceptable sources of outcome data for use in CEAs,
valuation of health outcomes, appropriate costs to include, and many others. The
result has been a lack of consistency in the application of CEA, which
undermines its usefulness as a tool for comparing the cost-effectiveness of
diverse health interventions.
The Panel on Cost-Effectiveness in Health and Medicine was convened by the U.S.
Public Health Service to provide some consistency in the practice of CEA. By
appealing to theoretical principles in each of the contributing disciplines, the
Panel derived a set of recommendations of the practice of CEA that should make
it more broadly applicable. Nonetheless, remaining methodologic issues deserve
further attention.
The outstanding issues in CEA encompass four categories: issues relating to the
legitimate sources of outcome estimates and the roles of clinical data and
modeling; issues relating to the measurement and valuation of health-related
quality of life; issues relating to the scope of costs included and the role of
the analytic perspective; and issues relating to the ethical underpinnings of
CEA.
Both primary data from clinical trials and modeling based on secondary data are
valid and essential inputs to CEA. Clinical trials alone have limitations of
design and purpose that make them incomplete and often inappropriate sources of
data for CEA. Models alone are limited by their validity and perceived validity
and are subject to manipulation. Both are needed in order to produce valid and
useful CEAs.
There is an emerging consensus that health outcomes in CEA should be measured in
terms of quality-adjusted life years (QALYs) and that the quality weights should
be based on the preferences of affected persons regarding health states. One
question is whether these preferences should be those of the general community
or those of the patients affected by the condition being evaluated. The Panel on
Cost-Effectiveness in Health and Medicine recommends the use of community
preferences, but this leaves open a number of methodologic issues. Is it
acceptable that different CEAs use different health-status classification
systems and different sets of preference weights, provided that the weights are
properly scaled? Should the preference weights be obtained from the general
community, or from individuals familiar with particular health impairments
(providers, relatives of patients)? Should preference information be collected
within clinical trials, or in free-standing community surveys? Do simple rating
scales provide valid reflections of preferences, or must choice-based stimuli
such as time tradeoff or standard gamble be used? It is encouraging that
research is underway to develop a variety of preference-weightable health status
instruments, both generic and disease-specific. More research is needed to
compare these measures, and to assess under what conditions the choice of
instrument and weighting method materially affects the results of CEAs.
The varying roles of CEA for different decision makers have led some to suggest
that the societal perspective may not be useful for decisions in managed care
organizations or other settings. Economic theory suggests that fully informed
consumers who wish to maximize health subject to a budget constraint will select
health plans which allocate resources cost-effectively, but numerous market
imperfections undermine this model. People switch health plans, which dilutes
the incentive of their current plan to adopt a lifecycle perspective on either
costs or health outcomes. Cost borne by third parties, such as government, are
likewise not reflected in the resource allocation decisions of private agents,
which also leads to misallocations of resources. The Panel on Cost-Effectiveness
in Health and Medicine recommends the use of a "Reference Case" analysis from
the societal perspective, in addition to analyses done from more narrow
perspectives.
The ethical foundations of CEA may not seem relevant to health care managers,
but they speak to some of the most fundamental issues in health care delivery.
Should persons of different ages be given equal priority? Should gains in life
expectancy for persons in immediate need of rescue from imminent death be valued
the same as gains due to prevention? Should a health benefit for 100 people be
considered equal to a benefit 100 times as great for one individual? The
calculus of QALYs leads to answers that are sometimes unsettling, but on further
reflection may well reflect the views of the community.
The pharmaceutical industry uses CEA as a yardstick to evaluate its products.
The health-care industry has been slow to incorporate CEA into their decision
making, but there are signs that this is changing. Industry and academia need to
work together so that CEA can fulfill its promise.
Milton C. Weinstein, Ph.D. Biosketch
Milton C. Weinstein is an internationally known authority on the methods of
cost-effectiveness analysis in health care. He is the Henry J. Kaiser Professor
of Health Policy and Management at the Harvard School of Public Health and
Professor in the Department of Medicine at Harvard Medical School. He earned his
A.B. (1970) and A.M. (1970) in Applied Mathematics, and his M.P.P. (1972) and
Ph.D. (1973) in Public Policy at Harvard University. Professor Weinstein's
research and teaching focuses on the cost-effectiveness of health practices and
technologies, with particular application to heart disease, cancer, and AIDS. He
co-chaired the Panel on Cost-Effectiveness in Health and Medicine for the U.S.
Public Health Service. He is a member of the Institute of Medicine of the
National Academy of Sciences, and a past president of the Society for Medical
Decision Making. He is principal author of Hypertension: A Policy Perspective
(with William B. Stason, Harvard University Press, 1976) and Clinical Decision
Analysis (with Harvey V. Fineberg, W.B. Saunders, 1980). He consults with
numerous pharmaceutical companies, managed care organizations, and government
agencies.
Abstract #: SS2
Psychology of Judgment and Decision Making
Thomas R. Stewart, Ph.D.
After four decades of research on judgment and decision
making, what do we know? We know that people can make remarkably bad judgments
in onesituation and remarkably good ones in another. We know that behavior
appears "rational" some of the time and wildly "irrational" at other times. We
know that human ability to make complex inferences exceeds that of the most
powerful computer in some situations, yet cannot match a simple hand calculator
in others. In other words, human cognitive ability varies from person to person,
from time to time, and from situation to situation.
Despite thousands of studies, research on judgment and decision making has had
little impact on how judgments and decisions are actually made. This is not
because little of value has been discovered, but rather because of a) the
difficulty of making sense of a bewildering variety of seemingly contradictory
results and b) the lack of a clear prescription for applying the research to
real decisions.
Two developments, one new and one old but often ignored, offer promise both for
resolving the apparent inconsistencies in the research and for understanding how
to apply it to real decisions. The new development is the observation by Kenneth
Hammond that there are two groups of judgment and decision researchers who
implicitly use quite different standards for "good judgment." One group applies
a coherence standard (Are judgments logically consistent?) while another applied
a correspondence standard (Are judgments correct, according to some objective
criterion?). Of course, this distinction is important in all of science as well
as in everyday life. The older development, originating with Egon Brunswik and
refined and extended by Kenneth Hammond, is that one cannot understand internal
judgment processes without understanding the external environment that creates
the need for judgment. With an understanding of the coherence/correspondence
distinction and the importance of the environment for judgment and decision
making, it is possible to derive some important lessons that can be applied to
understanding and improving real decisions.
Thomas R. Stewart, Ph.D. Biosketch
Thomas R. Stewart, Ph.D. is Director for Research at the Center for Policy
Research, University at Albany, State University of New York. He received his
Ph.D. in quantitative psychology from the University of Illinois and was
formerly with the Graduate School of Public Affairs and the Center for Research
on Judgment and Policy at the University of Colorado. He specializes in
theoretical, methodological and applied studies of judgment and decision making,
and is particularly interested in expert judgment and medical decision making.
His specific interests include methods of judgment analysis and the
decomposition of judgmental skill; studies of judgment in medicine, weather
forecasting, and global environmental change; and the role of scientific
uncertainty and disagreement in policy formation.
Decision-making in Health Care: Bayesian Applications of Preventive Medicine
Abstract TS2
Analyzing Clinical and Pharmacoeconomic Data for Resource Allocation
Using Bayesian Analysis
Dennis G. Fryback, Ph.D
The decision to include a new agent or not in a formulary depend on many things
and among these are the incremental magnitude of benefit to patients, and the
likely incremental costs of securing this benefit, compared to currently
employed treatments. The purpose of this presentation is to illustrate in a
tutorial fashion elementary Bayesian analysis of data from clinical trials to
compute probability distributions over quantities such as these that are
critical for decision making.
Bayesian analyses require two ingredients, a prior distribution over the
quantity of interest and observed data. These are combined by standard
probability calculations into a posterior probability distribution over the
quantity of interest. The posterior distribution quantifies the likelihood of
all possible magnitudes of benefit (or cost) given both what was known before
the trial and the observed data from the trial. An approximation for this
calculation will be demonstrated using simple, spreadsheet based computations
without specialized software, for the common case of trials with binomial
outcome data bearing on a proportion of interest (e.g., a 1-year mortality
probability), and for the case of continuous data relevant to inferences about a
quantity with a Normal distribution.
The prior distribution reflects the beliefs of the decision maker before the
experimental data are observed. Perhaps the most controversial point of Bayesian
analysis is use of information other than the directly observed experimental
data in statistical calculations. In this talk we will demonstrate how to
systematically elicit a Beta prior distribution for a binomial proportion and
the circumstances under which this prior distribution does or does not have
negligible effect will be illustrated.
The simple Bayesian analyses illustrated here can serve in many circumstances,
and the critical concepts of Bayesian analyses will be demonstrated by them. We
will conclude with a brief survey of more advanced applications and frontiers
Bayesian calculations for pharmacoeconomic data.
Dennis G. Fryback, Ph.D. Biosketch
Dennis Fryback received his BS degree from UCLA (Psychology-Mathematics;1969),
and MA (Mathematics, 1973) and PhD (Psychology, 1974) from the University of
Michigan. He joined the faculty of the University of Wisconsin-Madison in 1974
with appointments in the Department of Preventive Medicine and in the Department
of Industrial Engineering. He has been Professor of Preventive Medicine and
Industrial Engineering since 1984. Active as a teacher and researcher in medical
decision making and technology assessment, he is a founding member, and fourth
President, of the Society for Medical Decision Making. He was the second
Editor-in-Chief of the society's journal, Medical Decision Making, and and in
1994 he was one of three people who received that society's EL Saenger Career
Service Award in the first year the award was given. In July 1996 he was elected
Fellow of the Association for Health Services Research. Dr. Fryback's research
and consulting interests include medical technology assessment, health care
cost-effectiveness analysis, measurement of health status and health-related
quality of life assessment, and clinical decision analysis. He chaired the Board
of Scientific Counselors of the National Library of Medicine from 1992-94, and
the Health Care Technology Study Section for the Agency for Health Care Policy
and Research from 1992-96. He was one of 10 members of the United States
Preventive Services Task Force, appointed in 1990 by the Assistant Secretary for
Health to prepare the second edition of the Guide to Clinical Preventive
Services for publication in January 1996, and served from 1993-96 as a member of
the Panel on Cost Effectiveness in Health and Medicine convened by the Office of
Disease Prevention and Health Promotion of the US DHHS to prepare the definitive
text on cost-effectiveness analysis methods for the Public Health Service
(Cost-Effectiveness in Health and Medicine. New York: Oxford University Press,
July 1996). Dr. Fryback regularly provides consulting services to private
companies, and academic, state, and federal research programs to assist in
designing and analyzing studies of medical decision making and medical
technology assessment.
Abstract TS3
Estimating the Loss Function in a Bayesian Analysis
Josephine A. Mauskopf, Ph.D., M.H.A., M.A.
A hospital or managed care organization bases their decision as to whether or
not to include a new drug on the formulary on estimates of the magnitude and
uncertainty of the health and cost outcomes with the new drug compared to
current treatments. The estimates of uncertainty may be expressed as probability
distributions using a Bayesian analysis. Whether or not the decision maker
includes the new drug on the formulary will also depend on their 'loss'
function. This loss function is a representation of the decision maker's utility
or value for each possible combination of health and cost outcomes based on
their risk preferences. The decision maker will include the new drug on the
formulary if there is a gain in expected utility or value from using the new
drug rather than remaining with the current treatment. The parameters defining
the 'loss' function will depend on factors such as the seriousness of the
disease to be treated and the competitiveness of the market.
There are two standard economic approaches that have been used to estimate loss
functions for consumers of durable goods such as automobiles and home heating
systems. The first method is the standard gamble estimation approach which
requires the decision maker to choose between a product with values of the
outcomes that they can achieve with certainty or a second product where there is
a chance of experiencing either the better or worse values of the outcomes. The
second method is a random utility approach where the decision maker is asked to
choose between products with different attributes including expected outcomes
and their uncertainty. The data from either of these approaches can be used to
estimate a 'loss' function.
Before these approaches can be applied to health care decision making, we need a
better understanding of the role that different drug attributes play in hospital
and managed care decision making. Such an understanding can be obtained from
structured interviews with the decision makers.
Once loss functions have been estimated they can be combined with the Bayesian
estimates of the probability distributions for the outcomes to determine the
expected utility when adopting the new drug compared to staying with the current
treatment. Estimates of the loss function can also be used to determine the
probability of the decision maker choosing to adopt a new drug under different
pricing scenarios and under different levels of uncertainty about the outcomes
compared to current treatment.
Josephine A. Mauskopf, Ph.D., M.H.A., M.A. Biosketch
Dr. Mauskopf is Senior Director of the Pharmacoeconomics Program in Research
Triangle Institute's Center for Economics Research. She has extensive experience
both as a consultant and within the pharmaceutical industry designing and
implementing pharmacoeconomics research strategies. She has estimated the
cost-effectiveness of anti-retroviral drugs, as well as drugs for treating
herpes zoster, epilepsy, neonatal respiratory distress syndrome, digoxin
toxicity, and primary pulmonary hypertension. She has also managed projects to
develop or culturally adapt psychometrically valid quality-of-life measures for
migraine, genital herpes, and epilepsy. She has estimated the impact of an
antidepressant on work and social disability. She has developed Markov models of
disease progression for lung cancer and HIV infection and has developed a
simulation model of time spent in the operating and recovery rooms. Dr. Mauskopf
was previously Department Head of Economics Research at Burroughs Wellcome Co.
and Director of Pharmacoeconomics Research for Anti-Virals and Anti-Infectives
at Glaxo Wellcome Inc. She has published extensively in journals including The
Journal of the American Medical Association, Journal of Pediatrics,
Pharmacoeconomics, Medical Care, The American Journal of Public Health, Health
Services Research, and American Journal of Cardiology.
Future
Directions of Economic Evaluations in Healthcare
Abstract LS1
Making Economic Evaluations Respectable
Uwe E. Reinhardt, Ph.D.
Cost-effectiveness and cost-benefit analysis incorporate numerous assumptions
and judgments by the analyst. These assumptions and judgment may reflect the
analyst's own personal inclinations or perhaps that of the sponsor's. Whatever
the drive, for these economic evaluations in health care to be taken seriously
by the health care decision maker, the authors must be held accountable for the
quality of their work.
A useful model in this respect is the accounting profession. The trust in and
respect for the accountant's work rests on three major pillars.
1. STANDARDS: The accounting profession has developed a standard body of account
techniques that are shared world-wide. Example: "the ledger"
2. CODE OF ETHICS: A widely shared set of principles guide the valuation of the
asset and liabilities.
3. WILLINGNESS FOR AUDIT: The accounting profession is willing to subject their
work to deeply probing outside audit at a moment's notice.
Road To "Respectability" For Pharmacoeconomics:
1. STANDARDIZATION: The first step in attaining "respectability" is to seek a
much greater standardization of pharmacoeconomic evaluations. The product of
this standardization must take on the force of binding rules.
2. CODE OF ETHICS: The second step is to develop a set of principles of conduct
for analysts to follow. Empower professional health economic organizations to
enforce the principles.
3. AUDITS: Establish an audit process.
In the next century, decisions in health care increasing will be driven by
sophisticated information systems available to both sides of the market. Health
care research, in general, and pharmacoeconomic analyses, may be able to play a
significant role if the studies can overcome certain obstacles and reach a new
level of :respectability.
Uwe E. Reinhardt, Ph.D. Biosketch
Uwe E. Reinhardt, a native of Germany, has taught at Princeton University since
1968, rising through the ranks from assistant professor of economics to his
current position. He has taught courses in both micro- and macro-economic theory
and policy, accounting for commercial, private non-profit and governmental
enterprises, financial management for commercial and non-profit enterprises, and
health economics and policy. Professor Reinhardt received the Bachelor of
Commerce degree from the University of Saskatchewan, Canada in 1964, when he was
also awarded the Governor General's Gold Medal as Most Distinguished Graduate of
his graduating class. He received his Ph.D. in economics from Yale University in
1970. His doctoral dissertation was entitled Physician Productivity and the
Demand for Health Manpower. He has received honorary degrees of Doctor of
Science from the Medical College of Pennsylvania and from Mount Sinai School of
medicine, City University of New York.
Although Professor Reinhardt's research interests since that time have centered
mainly on health economics and policy, his work has also included topics in
corporation finance, including benefit-cost analyses of the Lockheed L-1011 Tri
Star and the Space Shuttle. In 1978, Professor Reinhardt was elected to the
Institute of Medicine of the National Academy of Sciences, on whose Governing
Council he served from 1979 to 1982. At the institute, he has served on a number
of study panels, among them the Committee on the implications of for-profit
medicine. He currently serves on the Institute's Committee on Technical
Innovation in Medicine and on the Committee on the Implications of a Physician
Surplus.
During 1987-90, Professor Reinhardt was a member of the National Leadership
Commission on Health Care, a private sector initiative established to develop
options for health-care reform and he continues to serve on that body's
successor, the National Leadership Coalition of Health Care, co-chaired by
former Presidents Carter and Ford. He is past president of the Association of
Health Services Research on whose board he still serves. From 1978 to 1993, he
has served on the Board of Trustees of the Teachers Insurance and Annuity
Association where he has been a member of its Mortgage Finance Committee during
the same period. Professor Reinhardt has served on a number of government
committees and commissions, among them the National Council on Health Care
Technology of the then U.S. Department of Health and Welfare (1979-82) and the
Special Medical Advisory Group of the then Veterans Administration (1981-85).
From 1986 to 1995 he served three consecutive three-year terms as a Commissioner
on the Physician Payment Review Commission (PPRC), established in 1986 by the
Congress to advise it on issues related to the payment of physicians. During
1996, he served as a member of the Committee on the U.S. Physician Supply of the
Institute of Medicine (IDM) of the National Academy of Sciences,. He currently
is a member of the Council on the Economic Impact of Health Reform, a privately
funded group of health experts established to track the economic impact of the
current revolution in health-care delivery and cost control. In 1996, he was
appointed to the Board of Health Care Services of the Institute of Medicine,
National Academy of Sciences. Professor Reinhardt was or is a member of numerous
editorial boards, among them the Journal of Health Economics, the Milbank
Memorial Bank Quarterly, Health Affairs, The New England Journal of Medicine and
The Journal of the American Medical Association.
Abstract LS2
Harmonization of Pharmacoeconomic Guidelines in the EU
Wolfgang Greiner, Ph.D.
Until a few years ago, economic evaluations on medical services and
pharmaceuticals were seldom conducted in Europe of Germany. Most of the
publications on economic evaluation studies came from the US, followed by the
United Kingdom, Canada and Scandinavia. Other EU countries were not particularly
active in this field. However, this has changed. Although most of the studies
are still done in the US, health economic studies are now also conducted in
European countries for all major new pharmaceutical innovations. In some
European health systems economic evaluations are even needed for price
negotiations (e.g.. France and Sweden), or to negotiate the co-payment level
(e.g. Italy, Netherlands of Switzerland), or to get drugs listed on a positive
list of in treatment guidelines (e.g. Germany and France).
In Germany all the institutions in medical care are preparing for a time when
the power of the sickness funds and supplier associations will decline and
competition increase. Economic evaluations will then play a much bigger role,
because economic considerations will have a larger impact on the decisions
concerning resource allocation in medical care. In addition, health policies in
the Eu countries are influencing each other. Therefore, drug companies employ an
international price (Euro-Pricing) and research strategy.
Most of the EU countries are still "developing countries" with regard to
economic evaluation. These studies are often criticized for being biased and, in
many cases, not solidly conducted. The scientific quality of economic
evaluations is often questioned, and in some cases the critics are right. Many
commercial consultants do not meet minimum scientific standards. A precondition
for economic evaluation studies to be accepted by decision makers in Europe in
the future is for those studies to be of high quality.
The Hannover group published the Hannover Guidelines in January 1995, which have
been translated into and published in English and Japanese. Recently, a
consensus group published the German Recommendations of Economic Evaluation
Studies, which are accepted by most relevant groups. However these
recommendations are only a first step and need periodic revision to meet
scientific developments and new standards in this field.
Guidelines have also been published in other EU countries (e.g.. Great Britain
and Italy). A project financed by the European Commission was started some
months ago to harmonize the recommendations as far as possible with respect to
questions such as using quality of life measures, discounting rate or measuring
indirect costs. Whether guidelines should guide those who commission economic
evaluations, those who conduct these studies or those who use them in decision
making is an open question. In any case they will guarantee minimum standards
and will also make it easier to transfer study methods and study results to
other countries, as the different European guidelines take into account the
standards already developed overseas (e.g.. in Australia and the US).
Wolfgang Greiner, Ph.D. Biosketch
Wolfgang Greiner is currently senior research fellow at the Centre for Health
Economics and Health System Research. He has published a number of articles in
scholarly journals of health economics. He has worked in particular on health
insurance issues and methodological questions concerning economic evaluations of
health services and quality of life measurement. Wolfgang Greiner has been a
member of the EuroQol group since 1995 and has led several major health economic
projects (on asthma, cystic fibrosis, immunsuppression, liver and kidney
transplantation). Before graduating in insurance economics he worked in the
international department of a German bank.
The North German Center for Health Services Research (HSR), directed by Prof.
Dr. J. -Matthias Graf von der Schulenburg, University of Hannover, is a
university-based research institute specializing in economic evaluation of
health services and the economics of health insurance. The centre currently has
a staff of 24 researchers. It has worked on many projects in this field financed
by the State of Lower Saxony, the Federal Research and the Federal Health
Departments, health insurers, physicians' organizations and industry.
Abstract LS3
Developing A.P.O.R GAPP (Generally Agreed upon Pharmacoeconomic Principles)
Steven Finder, M.D., M.B.A., M.P.H.
Based upon the membership survey, APOR members believe that current
pharmacoeconomic guidelines fail to meet their needs and that APOR should
develop agreed upon criteria for the conduct and reporting of pharmacoeconomic
analyses.
Pharmacoeconomics lies at a cross-road. Without a clear set of principles that
define acceptable standards, pharmacoeconomic research loses validity among its
users, yet as an emerging science it needs the freedom to be innovative and
creative in developing new methods and approaches. To address this need, A.P.O.R
is developing GAPP (Generally Accepted Pharmacoeconomic Principles). GAPP will
be a constantly evolving set of principles that will define an acceptable level
of standards for pharmacoeconomic research while providing a framework that
fosters innovation.
This presentation will present the work of the Consensus Development Committee
and A.P.OR.'s road map to GAPP. This presentation will address the following
points.
1. Why the need for GAPP.
2. Are previous initiatives enough
3. Why one approach is not enough.
4. The perspectives and methodologies that GAPP must address.
5. The framework for GAPP. How APOR proposes developing GAPP.
6. How everyone can participate.
7. Where are we.
8. What is next.
Steven Finder, M.D., M.B.A., M.P.H. Biosketch
Steven Finder, MD, MBA, MPH, is President of MedAnalysis, a Pharmacoeconomic
Research Organization bringing pharmacoeconomics and formulary management
support to managed care organizations. Prior to MedAnalysis he was Deputy
Director of the Department of Defense Pharmacoeconomic Center (PEC) at San
Antonio, Texas, where he was primarily responsible for the development and
oversight of cutting edge cost-effective evaluations of specific disease state
pharmacotherapy. He developed the Functional Cost Based method for applied
pharmacoeconomics being used by the PEC in its current disease state models and
Best Value procurement process. While at the PEC he developed a number of
disease states evaluations to include diabetes, BPH, osteoporosis, migraine
prophylaxis, typhoid and hepatitis A vaccination, PCP infection in HIV, GERD,
and candida vaginalis among others, and recently completed an analysis and model
of major depression. Many of these evaluations have been presented at national
conferences or are being published. In addition, Dr. Finder was elected to the
Executive Board of the Association of Pharmacoeconomics and Outcomes Research
and is the chairman of the Consensus Development Committee, which is developing
standards and guidelines for the conduct and presentation of pharmacoeconomic
evaluations. Dr. Finder received his BS in 1976 from the United States Military
Academy at West Point. After a short stint as a military officer, he entered
medical school at the University of Texas at Houston, where he graduated in
1982. He completed his internship at Walter Reed Army Medical Center, and was
assigned duties as a Brigade Surgeon and Commander of a medical company (a
mini-MASH), a rare honor in peacetime. Dr. Finder's experience during his two
years of command led to his interest in management. He completed a full time MBA
at the University of Texas in Austin Graduate School of Business in 1990, where
he was recognized as a Sord Scholar. In 1991, he completed an MPH at the
University of Texas School of Public Health in San Antonio and in 1992 a
residency in Public Health and Preventive Medicine at Madigan Army Medical
Center. He subsequently completed several economic evaluations of preventive
medical services which led to his recruitment to the PEC in 1994, in an effort
to bring management, business and epidemiological expertise to the new field of
applied pharmacoeconomics.
Economic and Outcomes
Issues in Mental Health
Abstract #: MH1
COST EFFECTIVENESS OF DRUGS VS
PSYCHOTHERAPY FOR MODERATE DEPRESSION IN THE PRIMARY CARE SETTING
Russo, L, Curley, C, Yuan, Z, Singer, M
Case Western Reserve University,
Cleveland, OH. US
BACKGROUND: Depression may be the most
prevalent clinical problem presenting to primary care physicians (PCPs). Common
treatment options are selective serotonin reuptake inhibitors (SSRI), tricyclic
antidepressants (TCA), and psychotherapy. OBJECTIVE: Assess the
cost-effectiveness of 4 treatment protocols for moderate depression; (1) TCA,
followed by SSRI if unsuccessful (2) SSRI, followed by TCA (3) Psychotherapy,
followed by SSRI (4) Psychotherapy, followed by TCA. METHODS: A decision
analytic model, with Markov processes, was developed with 5 treatment arms
representing the 4 treatment protocols and no treatment. The states for the
Markov processes were: (1) death from suicide (2) death from other causes (3)
better on treatment (4) depressed on treatment (5) better off treatment (6)
depressed off treatment. The time horizon was 16 six-week cycles. Drug,
consultation costs were obtained from hospital and pharmacy sources. Utilities
of health states were obtained from a survey of PCPs. Other data were obtained
from literature review.. The reference case was a 30 year old white female. A
discount rate of 3% was used. Incremental cost-effectiveness (C/E) analysis was
performed. The perspective is the health care system ( indirect costs were not
available at this time). RESULTS: The incremental C/E ratios for TCA/SSRI and
psychotherapy/TCA were $ 9,617.38/QALY and $ 56,637.40/QALY. TCA achieved
virtually identical effectiveness as SSRI but at 20% less cost. Results were
sensitive to the cost of psychotherapy and the utility of being better on
psychotherapy. CONCLUSION: If an incremental C/E ratio of $ 56,637.40 is deemed
cost-effective, then psychotherapy followed by TCA is the protocol of choice.
Otherwise, TCA followed by SSRI is the best alternative.
Abstract #: MH2
COST-EFFECTIVENESS ANALYSIS OF
FLUOXETINE VERSUS AMITRIPTYLINE AS INITIAL TREATMENT OF A MAJOR DEPRESSIVE
DISORDER EPISODE IN PRIMARY CARE
Venturini F, Hay JW, University of
Southern California, Los Angeles, CA, USA
Depression has been cited as the most
common clinical problem that primary care physicians are called upon to diagnose
and treat. Medication have been shown to be effective in all forms of major
depressive disorder (MDD) OBJECTIVE: The purpose of this analysis was to
evaluate the incremental cost-effectiveness of fluoxetine in comparison with
amitriptyline as initial treatment of a MDD episode in primary care, from the
perspective of a health maintenance organization (HMO). METHOD: A simulation
model based on the theory of clinical decision analysis was constructed. The
duration of the analysis was nine months, the average length of a MDD episode.
Patients included were those without history of depression. The direct costs
included in the model were: drug acquisition cost, outpatient medical care,
laboratory tests and procedures, and hospital care. Costs were obtained from
public sources and were expressed using 1996 dollars. Two different measures of
effectiveness were utilized: years of life saved suicide related, and rate of
treatment success. Treatment was considered successful if there was no need of
withdrawal or switch to the alternative treatment, and no need to refer the
patient to a psychiatrist. The efficacy and safety data, and the suicide figures
were derived from published literature. Univariate sensitivity analyses were
performed. RESULTS: The estimated incremental cost per year of life saved with
fluoxetine treatment was $128. The estimated incremental cost per successful
event was $1,446. The results were mainly stable when a sensitivity analysis was
applied to the variables employed in the model. CONCLUSIONS: Despite its higher
acquisition cost, fluoxetine was found to be a cost-effective treatment for MDD.
These results are consistent with most of the available literature, and they
should be taken into account by HMOs administrators in the formulary process and
in the development of treatment guidelines.
Abstract #: MH3
ACCESS TO TREATMENT FOR DEPRESSION
IN A MEDICAID POPULATION
Melfi, CA, Croghan, TW
Lilly Research Laboratories, and
Indiana University School of Medicine, Indianapolis, IN.
Mentally ill Medicaid recipients
represent a population which may be particularly vulnerable to limited access to
adequate treatment their mental illness. OBJECTIVE: The purpose of this study is
to compare depressed Medicaid recipients to those with private medical
insurance, and to examine racial differences in the treatment of depression in
the Medicaid recipients. METHODS: Data for the privately insured are derived
from a database of claims for enrollees in a variety of employer-provided health
plans. The Medicaid data are from a single state plan. We divide each dataset
into people who have a claim indicating a depression diagnosis, but no
prescription for an antidepressant; and people who have a diagnosis of
depression and at the same time fill a prescription for an antidepressant.
Comparisons are made using t- tests and chi-square tests of significance. We
compare groups based on treatment received as well as patterns of use of
antidepressants. RESULTS: The privately insured patients who are treated with
antidepressants are much more likely to receive the newer selective serotonin
reuptake inhibitors (SSRIs) rather than the older tricyclic antidepressants
(TCAs) relative to Medicaid patients. Within the Medicaid group, African
Americans are more likely to receive TCAs than are white Medicaid patients.
Depressed privately insured patients are more likely to receive psychotherapy
than are depressed Medicaid patients. There is also a much higher rate of
continuous therapy on initial antidepressant in the privately insured group.
CONCLUSIONS: Our results indicate that access to quality mental health care is
significantly restricted among depressed Medicaid recipients. In addition,
within depressed Medicaid patients, there are racial differences with regard to
care and treatment access.
Abstract #: MH4
USE OF AN AUTOMATED SCREENING
PROCEDURE (THE SHEDLER QPD PANEL) TO IDENTIFY PSYCHIATRIC DISORDERS IN A GROUP
MODEL HMO
Wiener, MB, Kearney, K, Beck, A,
Shedler, J, Kaiser-Permanente, Denver, CO, USA
The costs of psychiatric disorders are
significant. It is estimated that depression costs Americans $44 billion in
treatment costs, decreased productivity, lost income, and suicide. Depression
and anxiety are among the most commonly seen disorders in primary care, but
often go undiagnosed and untreated. It is estimated that 60 percent of patients
with diagnosable psychiatric disorders are seen in primary care settings, termed
the de facto mental health care system. There is a need for effective screening
of depression and other psychiatric disorders in primary care settings. As of
now, no psychiatric screening tool has gained real acceptance among primary care
providers. METHOD: A protocol was developed which utilizes an automated,
computerized screening procedure to diagnose depression and anxiety disorders in
a large group HMO. The screening procedure made use of a computerized quality of
life questionnaire (the SF-12), which included basic depression and anxiety
screening items. When patients gave responses that indicated possible problems,
the test branched automatically to the Shedler Quick PsychoDiagnostics Panel
(QPD Panel), an automated test designed to diagnose a range of psychiatric
disorders. The QPD panel provides physicians with a specific DSM-IV diagnosis, a
numerical "severity score" indicating the patient's current level of distress,
and a listing of the symptoms that gave rise to the diagnosis. Patients who met
diagnostic criteria for a psychiatric disorder were treated according to the
existing practice guidelines for the HMO. CONCLUSION: Of 200 patients screened,
less than 1% indicated that the tool was inappropriate or declined to
participate due to the confidential nature of the questions. Patient and
physician satisfaction with the QPD Panel was near 100%.
Abstract #: MH5
Schizophrenic Patients' Views of
Antipsychotic Medication
Conner TM, Rascati KL. The University
of Texas at Austin, USA
Drug therapy for schizophrenia is
costly and often produces bothersome side effects. However, noncompliance to
therapy often results in rehospitalization, further increasing the cost to treat
the illness. Several newer antipsychotic medications recently have become
available which report lower incidence of side effects, and thus greater
compliance. The need for outcomes research, including quality of life
measurement and pharmacoeconomic analyses, to compare the drugs available is
therefore evident but often challenging. OBJECTIVES & METHODS: As part of a
larger study examining a quality of life questionnaire, we sought to assess
treatment at an outpatient clinic from the patients' perspective. Forty- eight
patients agreed to be interviewed or to self-complete a questionnaire. Of these
patients, thirty-nine could provide coherent responses to questions. RESULTS:
Patients reported they almost always took their antipsychotic medication as
prescribed. Generally, patients reported their symptoms were somewhat to much
better since starting medication. While on average, patients reported they felt
happy, compared to how they felt before they began taking medication, 25% said
they were unhappy. Surprisingly, over half the patients reported they
experienced no side effects from medication. Thirty-five (almost 90%) patients
correctly reported that they took medication and of these, most could name the
drugs they were taking. However, six (15%) patients reported there were no
benefits to taking their medicine. Several patients expressed a desire to stop
taking or to decrease their medication, even if they knew of benefits for taking
it. CONCLUSION: Most patients who were surveyed were knowledgeable about their
medication and understood that it was important to continue antipsychotic
treatment. The implications of these findings will be discussed.
Abstract #: MH6
ECONOMIC EVALUATION OF
PHARMACEUTICALS IN ISRAEL: RISPERIDONE - A TEST CASE
Shani S., Haran B., Lev B.
Ministry of Health, Jerusalem, Israel.
The national Health Insurance Las was
implemented in Israel in 1995. The law states that each citizen is entitled to
receive health care treatments of established quality. Pharmaceuticals included
in the list of health care treatments are reimbursed by the Sick Funds (HMOs).
When the law came into effect, the list of reimbursed pharmaceuticals was
defined as the 1994 formulary of Israel's largest Sick Fund. Since 1994, this
list has not been updated although numerous new molecules have been registered.
The Pharmaceutical Administration in the Ministry of Health set up a mechanism
for updating the national list of reimbursed pharmaceuticals using
pharmacoeconomic analysis as a tool for decision making. OBJECTIVE: Risperidone,
a new antipsychotic drug indicated for schizophrenia was chosen as a test case
for the proposed mechanism. METHODS: Data collected from a review of the
literature and local data were used to perform a cost effectiveness analysis
comparing risperidone with neuroleptics and clozapine. RESULTS: Both risperidone
and clozapine are more effective than neuroleptics. The cost of treating a
schizophrenic patient per year in Israel (in 1996 US dollars) is 200$ for
neuroleptics, 1850$ for clozapine (including blood sampling) and 2550$ for
risperidone. Risperidone is not more cost-effective than neuroleptics when used
as a first line treatment for schizophrenia. Hence, risperidone should not be
reimbursed for this use. Risperidone is cost-effective when used for treating
schizophrenics non responsive to neuroleptics, though less than clozapine. Due
to quality of life considerations, risperidone should be used before clozapine
for treating these patients. CONCLUSIONS: The cost-effectiveness analysis let to
a suggested clinical treatment guideline for reimbursing risperidone. This test
case contributed to the establishment of a mechanism for reimbursing new
pharmaceuticals.
Desease State Management: Episodes, Outcomes, and Cost of Care
Abstract #: CC1
DEVELOPMENT AND APPLICATION OF COMBINED EPISODES OF CARE AND PERFORMANCE
MEASURES METHODOLOGIES
Diamond LH, Gibson TB, Houchens RL, The MEDSTAT Group
OBJECTIVES: This presentation describes the development of a computerized
inpatient/outpatient severity-adjusted episode of care grouper based upon the
Disease Staging severity of illness system. This episode grouper extends the
unit of analysis for cost and utilization reporting beyond the inpatient
admission and outpatient claim level to link together all recorded services
delivered for treatment of a specific disease in all settings (i.e., inpatient,
outpatient) by all types of providers. METHODS: Episode creation requires
classification of diseases into homogeneous units to identify claims that are
clinically related to each other, and logic to link together related services.
Disease Staging, a clinically-based disease classification system, serves as a
framework by defining each condition and its severity levels. To link together
related services, different approaches were used to construct episodes for acute
and chronic conditions. While episodes for chronic conditions are well-defined,
episodes for chronic conditions can be continuous or recurring, and the disease
progression and underlying maintenance aspects of chronic conditions are
reflected in the episode construct. In addition to clinical input, a national
database of private pay medical claims was utilized to develop, test and verify
episode logic. Episodes for each disease were developed separately, making
certain to balance clinical rigor with feasibility of implementation. RESULTS:
Using 1993 and 1994 data from the national database of medical claims described
above, a comparison of treatment patterns and episode measures (cost, and use)
for one chronic and one acute disease, diabetes and bacterial pneumonia, are
presented. In addition, risk-adjusted, episode-based comparisons of populations
and patients in different geographic regions are included. The application of
these episodes for evaluating clinical performance measures will also be
presented.
Abstract #: CC2
ECONOMIC OUTCOMES OF A DIABETES DISEASE MANAGEMENT PROGRAM
Fox, KM, Epstein, R, Suppapanya, N, Sutphin, M, Merck-Medco Managed Care, L.L.C.,
a subsidiary of Merck & Co., Inc. Montvale, NJ, US
Diabetes mellitus affects 16 million Americans and leads to long-term
complications of retinopathy, neuropathy and nephropathy. Programs of patient
education and self- management should achieve better glucose control thereby
improving short and long-term outcomes. OBJECTIVE: The purpose of this study was
to determine the economic outcomes of a patient-centered disease management
program for diabetes. METHOD: A pre versus post comparison was conducted to
examine the differences in health care utilization and associated costs between
the year prior to the disease management program and the year during the program
intervention. Subjects were insulin-taking diabetics who were identified through
drug claims. 1,635 patients from one health care plan were continuously enrolled
in the program from September 1994 through August 1995 and included in the
analysis. Key components of the program included a personalized letter,
quarterly newsletters, a risk assessment survey, and a toll-free support line.
Medical claims data were used to track resource utilization and costs. RESULTS:
All-cause hospitalizations were reduced by 14% (p<0.05) during program
participation leading to a to $522,786 cost savings per 1,000 patients. All-
cause emergency room visits increased by 9.5% while outpatient and physician
office visits did not change significantly. A $457,396 per 1,000 patients cost
reduction was found overall. For diabetes-specific resource utilization, a 10%
decrease in hospitalization, 20% decrease in emergency room visits, 56% decrease
in outpatient visits and 8% decrease in physician office visits was
demonstrated. The diabetes- specific utilization reduction lead to an overall
cost savings of $214,968 per 1,000 patients in diabetes costs. Drug therapy
utilization did not change from pre to post program. CONCLUSION: These findings
indicate that patient education targeted to improving self- management of
diabetes lowers the cost of care by $458 per diabetic patient per year.
Abstract #: CC3
COST BURDEN OF NEWLY-TREATED, NON- INSULIN-DEPENDANT DIABETES MELLITUS.
Zbrozek AS, Whalen E, Smith ME, Bayer Corporation, West Haven, CT.
Non-insulin-dependant diabetes mellitus (NIDDM) is known as a costly disease.
The cost effect of initial drug therapy has not been previously reported.
OBJECTIVE: We wanted to understand the marginal effect of early diabetes
treatment on direct medical costs. METHOD: An integrated pharmacy and medical
claims data base was used to extract cohorts. Patients having a NIDDM ICD-9-CM
code and an NDC code for any oral antidiabetic or insulin prescription were
initially captured. Index year 1992 was used for all initial prescriptions and
all patients were continuously enrolled in non-fee-for-service health plans.
Patients had continuous eligibility for 24 months after the prescription index
date. Patients had 6 months of continuous eligibility prior to index date
without receipt of any antidiabetic drug during this period. Mean costs per
month were tabulated during pre and post index periods in both cohorts. RESULTS:
Patients aged 45-64 years (N=634) at end of post-index period averaged total
costs (and diabetes-related costs) of $7692 ($2538)/year and $6360 ($1200)/year
in the first and second post- index years, respectively. Patients 65 years and
older (N=723) at pre-index averaged total (and diabetes-related) costs of $6408
($984)/year and $6354 ($1074)/year during the first and second years since
index, respectively. Mean annual total costs during the pre-index period were
estimated at $3072/patient and $4248/patient in the respective cohorts.
CONCLUSIONS: Patients with NIDDM incurred high mean direct medical costs prior
to drug therapy onset. Mean direct medical costs after drug therapy onset were
elevated in both cohorts. These elevations were explained in part by costs coded
for NIDDM therapy or outcomes. During each post-index period, mean
diabetes-attributed costs were proportionately lower than aggregate costs
attributed to non-diabetes conditions.
Abstract #: CC4
ANNUAL COSTS OF ASTHMA TREATMENT IN MANAGED CARE: THE ASTHMA OUTCOMES REGISTRY
Huse, DM, Richner, RE, Piercey, G, Hartz, SC, Medical Research International,
Burlington, MA, USA, and SmithKline Beecham Pharmaceuticals, Philadelphia, PA,
USA.
OBJECTIVE: To monitor asthma treatment, outcomes, and costs in managed care.
METHOD: The Asthma Outcomes Registry is a longitudinal study of more than 2,500
patients aged 5-77 years who had received medical treatment for asthma within 18
months prior to identification at three U.S. managed-care organizations.
Symptoms of asthma are assessed at baseline and then at six-month intervals,
using mailed questionnaires. Questionnaires are completed by a parent or
guardian for subjects under 12 years of age, and otherwise are
self-administered. Prescribed therapy, test results, and the occurrence of acute
exacerbations are documented through medical chart review. Data on health-care
utilization, including prescriptions dispensed, are obtained from health
insurance claims or similar administrative databases. To date, utilization and
cost data have been collected and analyzed for 1,145 subjects at two sites,
covering the 365-day period prior to each subject's date of enrollment. RESULTS:
Mean annual costs of asthma treatment, including inpatient and outpatient
medical care and prescription drugs were $623 per patient, including $68 for
hospitalization, $228 for outpatient medical care, and $327 for prescription
drugs. Total annual costs increased with age from $442 in asthmatics aged 5-15
years to $930 in those >50 years of age. Costs were also somewhat higher in
females ($691) than males ($522). These results are higher than previously
reported estimates of the annual cost of medical care for asthma. CONCLUSION:
Experience to date shows the Registry to be a valuable tool for studying the
both the epidemiology and economics of asthma in managed care.
Abstract #: CC5
IS ERYTHROPOIETIN COVERAGE COST- EFFECTIVE FOR MEDICARE?
Shih, Y-CT and Kauf, TL
UNC School of Pharmacy, Chapel Hill, NC, USA
OBJECTIVE: This study examines the impact of EPO coverage in terms of health
care utilization and expenditures. Medicare expenditures for ESRD beneficiaries
are decomposed into three parts. "EPO-direct" is the Medicare reimbursement for
EPO administration. "EPO-indirect" is additional expenditure due to
complications or savings from improved health conditions. "EPO-unrelated" is for
covered care unrelated to EPO. If EPO coverage is cost-effective for Medicare,
then "indirect" savings should outweight "direct" and "indirect" cost, and
utilization due to anemia and related conditions should be reduced. METHODS:
Several HCFA data sets providing claims information for Medicare beneficiaries
are used. Claims made during the two year period before and after coverage of
EPO were examined for dialysis-dependent ESRD beneficiaries. Using the pre-EPO
beneficiaries as the control group, we use multivariate regression and share
equations to study the variation in program expenditures as a result of EPO
coverage. We also use logit to estimate changes in the probability of hospital
admission and a count data model to investigate utilization variations. Powe et
al (1993) showed an increase in per capita expenditures of ESRD patients over
the 5 year post-EPO coverage period, though the magnitude of that increase was
less than estimated previously. However, our estimation from expenditure
decomposition shows that indirect savings outweigh the direct and indirect cost
of EPO, and the expenditure increase observed above is mainly from "EPO-unrelated"
expenditures. Moreover, medical complications as a result of anemia decrease
after EPO coverage. CONCLUSION: This study provides claims-based evidence that
EPO coverage has been cost-saving for Medicare. Our results also underscore the
importance of distinguishing between variation caused by general trends vs. the
policy under investigation. This is possible only with the use of claims-based
data.
Abstract #: CC6
A MARKOV PROCESS TO ESTIMATE THE LIFETIME TREATMENT PATTERNS OF PATIENTS WITH
AIDS-RELATED CYTOMEGALOVIUS RETINITIS
Dooley, JA, Dooley, GJ, Langley, PC, University of Arizona, Tucson, AZ, US
Cytomegalovirus (CMV) retinitis currently affects 30-40% of patients with end
stage AIDS. Constantly evolving treatment approaches and limited long-term
clinical data indicate a modeling approach to produce estimates of lifetime
treatment patterns suitable for pharmacoeconomic evaluation. Markov modeling
techniques are widely used to model disease prognosis and outcomes of therapy
and clinical data is usually abstracted to a fixed probability for transitions
between model states. OBJECTIVE: The purpose of this study was to develop
disease models for the alternative therapeutic approaches for CMV retinitis and
to evaluate the effect of using variable probability transitions based on all
available clinical data rather than fixed probabilities. METHOD: A seven stage
Markov model was developed representing all possible treatment states.
Probabilities were assigned to the transitions between states using standard
methods to convert clinical data to fixed probabilities. The model was evaluated
using Monte Carlo techniques for the three primary therapies (IV Ganciclovir, IV
Foscarnet and Oral Ganciclovir). Some transitions were recalculated as
time-dependent probabilities to more accurately reflect the available clinical
data and the models were reevaluated. RESULTS: The Markov models produced
clinically plausible estimates of the average lifetime treatment state duration.
Using time-dependent probabilities significantly changed the time spent in
different treatment phases, the overall survival duration was reduced by an
average of 41%. CONCLUSION: Markov models can be used as the basis for
evaluation of CMV retinitis therapies and the approach is sufficiently flexible
to accommodate new therapeutic developments. The significantly changed time in
state estimates resulting from the use of time-varying probabilities indicates
that caution should be exercised when clinical data is reduced to fixed
probabilities to simplify the modeling process
Economic and
Outcome: Issues in Pharmaceutical Care
Abstract #: PC1
PHARMACEUTICAL CARE AND PATIENT
OUTCOMES IN HYPERTENSION AND COPD PATIENTS AT VA MEDICAL CENTERS
Portner, TS, Gourley, DR, Gourley, GA,
Solomon, DK, Bass, GE,
University of Tennessee College of Pharmacy, Memphis, TN,
US
A multicenter outcomes study was
conducted in 10 VA medical centers and 1 academic medical center across the
United States. OBJECTIVE: The purpose of the study was to evaluate the impact of
pharmaceutical care on select clinical, economic, and humanistic patient
outcomes in COPD and HTN patients in ambulatory care environments. METHOD:
Clinic patients treated for a diagnosis of HTN or COPD were randomly assigned to
a treatment group which received pharmaceutical care or a control group which
received standard care over a four month study period. Clinical pharmacists and
pharmacy residents worked together to conduct the protocols, focusing on the
management of COPD and HTN relative to physiologic measures, patient adherence
to therapy, drug knowledge, utilization of resources, and functional status.
RESULTS: For the HTN study arm, there were 153 evaluable patients (76, treatment
and 77, control) and 115 evaluable patients in the COPD study arm (54, treatment
and 61, control). For the hypertension study arm, treatment group patients made
greater improvements over the 4 month study period than did control group
patients on measures of systolic blood pressure, knowledge of disease and
treatment, satisfaction with care, and self assessed adherence to medication
regimens (p < 0.05). For the COPD study arm, treatment group patients made
greater improvements over the 4 month study period than did control group
patients on patient ratings of symptom interference with activities and dyspnea
measures, ratings of bodily pain, satisfaction with care, and self assessed
adherence to medication regimens (p < 0.05). CONCLUSION: Findings indicate
considerable contribution of pharmacists to patients' improvement in
hypertension and COPD disease states.
Abstract #: PC2
EVALUATION OF A LIPID MANAGEMENT
PROGRAM IN THE COMMUNITY PHARMACY SETTING
McMillan, KS, Gourley, DR, Portner, TS,
Gourley, GK, Solomon, DK,
University of Tennessee College of Pharmacy, Memphis,
TN. US
OBJECTIVE: The purpose of this
pretest–posttest control group study was to evaluate clinical and humanistic
outcomes in patients enrolled in a pharmacist–directed lipid management program
in the community pharmacy setting. Outcome measures included total cholesterol,
LDL–cholesterol, HDL–cholesterol, and triglyceride levels; patient satisfaction
with pharmaceutical care; patient knowledge of hyperlipidemia; and patient
willingness to pay for the service. METHODS: Patients at risk for coronary heart
disease (CHD) or with known CHD identified from a search of the pharmacy
prescription database and walk–in patients were invited to participate in a
wellness and cholesterol screening. Patients found to have elevated
LDL–cholesterol or triglyceride levels and at least one risk factor according to
National Cholesterol Education Program (NCEP) guidelines were asked to
participate in the study. Fifty–two subjects were randomized to a treatment
(n=26) or control (n=26) group. The treatment group was followed in a 6 month
pharmacist–directed lipid management program and the control group referred to
their healthcare provider for care. The intervention was pharmacist provision of
disease management and monitoring and education to patients with hyperlipidemia.
Education involved instruction in lifestyle modification including diet and
exercise therapy, the role of cholesterol in the development of CHD, and
counseling on drug therapy. The pharmacist worked in collaboration with
treatment patients' physicians to design an appropriate therapeutic regimen
based on NCEP guidelines. RESULTS: The study will be completed by the end of
February with final results available in April 1997. CONCLUSION: This project
will serve as a model for community pharmacies for the establishment of lipid
disease management programs.
Abstract #: PC3
An Application of the Time-Dependent
Cox Regression Model in the KAISER/USC Pharmacists' Consultation Intervention
Study
Yuan, Yong,1 Hay, Joel,1 Groshen,
Susan2
1Department of Pharmaceutical Economics
& Policy , and 2Preventive Medicine, University of Southern California
OBJECTIVE: The Kaiser Permanente/USC
Patient Consultation (PC) study aims to analyze the impact of the three
different models of pharmaceutical care on patient outcomes and quality of life.
To evaluate whether pharmacist consultation has a favorable impact on drug
therapy that improves patient survival, we consider a model for survival
analysis that include multiple time-dependent indicator variables to predict the
effect of pharmacy intervention on mortality rate. However, in the PC
intervention sites, many patients switched within the model after initial
randomization. We needed a strategy which takes account of intervention actually
received. METHODS:The number of new prescriptions filled at PC intervention
sites was introduced into Cox Models as intervention variables in order to
measure the extent to which the patient was exposed to each model of
pharmaceutical care. The baseline of comparison is the Control Group, which was
not exposed to any formal PC intervention. Selection bias is then a potentially
serious problem. The Adjusted Wu- test was used to test the model for
endogeneity, if there is endogeneity and the Two-Stage method will be then
performed. RESULTS: The "As treated " analysis didn't outperform the "Intent to
treat" analysis (ITT). It is not surprising that "As treated " and ITT analysis
defined totally different target population which showed the statistically
significant intervention effects. However, the ITT analysis alone is not
appropriate to answer the explanatory questions; it must be supplemented by
analyses taking into account the treatments actually received. CONCLUSION: In
such settings, one can use the Cox model for inference about the relative risk
in such cases by using multiple time-dependent covariate structure to specify a
continuous functional form for the relative hazard as a function of time since
switch. We conclude that the time dependent model predicts better than our
previous time-fixed model.
Abstract #: PC4
ECONOMIC EVALUATION OF DISEASE
MANAGEMENT IN A COMMUNITY PHARMACY SETTING
Munroe, WP, Kunz, K, Dalmady-Israel, C,
Potter, L, Schonfeld, WH, MedOutcomes, Inc., Richmond, VA, US, and Technology
Assessment Group, San Francisco, CA, US
To improve both health and economic
outcomes for patients, an intervention program was started at three retail
pharmacies. The interventions performed by specially trained pharmacists
included targeted patient education, systematic patient monitoring and feedback,
behavior modification, and regular communication with patients' physicians to
allow early intervention for drug related problems. OBJECTIVE: The study was
conducted to assess the economic impact of these patient-focused pharmacy
interventions in the community retail setting among patients with hypertension,
diabetes, asthma and/or hypercholesterolemia. METHOD: Prescription drug costs
and total medical costs were analyzed by comparing claims data from 188 patients
enrolled in the intervention program at the three participating pharmacies to
data from 400 matched control patients at five non- participating pharmacies.
All of the pharmacies were part of the same retail chain, and all patients used
the same health care insurer. RESULTS: For all disease states, the average cost
per prescription was significantly higher in the intervention group than in the
control group (p<.001 for hypertension, asthma, and hypercholesterolemia;
p=0.045 for asthma). However, differences in monthly prescription costs were
only significant for patients with asthma, with monthly costs being higher in
the intervention group. With regard to total monthly medical costs, substantial
savings were demonstrated in the intervention group across all cost analyses.
Savings ranged from conservative estimates of $144 per patient per month to $294
per patient per month when accounting for the possible influence of age,
comorbid conditions and disease severity. CONCLUSION: Pharmacist interventions
in this community pharmacy-based disease management program were associated with
substantial reductions in monthly health care costs to patients with
hypertension, hypercholesterolemia, diabetes and/or asthma.
Abstract #: PC5
AN EVALUATION OF THE ECONOMIC IMPACT
OF THE PHARMACY BENEFIT FOR EMPLOYER GROUPS
Nol-Hiering L, Gause DO, Nathewitch A,
Menz JM, Smith WP Novartis Pharmceuticals, Summit, NJ, Geisinger Health Plans,
Danville, PA, USA
To contain healthcare expenditures,
employer groups are placing presure on insurance carriers to minimize costs. Due
to the misconception of the pharmacy benefit asa non-essential component of the
healthcare delivery system, these programs are often targeted for cost
containment. OBJECTIVE: The purpose of this study was to compare medical
utilization between MCO members with or without pharmacy benefit. METHOD: A
retropsective analysis of medical claims during the period July 1, 1995-June 30,
1996 was conducted utilizing data from Geisinger Health Plans (GHP), an MCO with
approximately 180,000 members. Of these members, approximately 150,000 members
have pharmacy benefits while approximately 30,000 do not. A random sample of
patients from each group who had at least one medical claim during the 12 month
period was obtained. The regression analysis was performed adjusting for age
group, sex, and select illnesses as indicated by associated diagnostic codes
(ICD-9-CM classification scheme). RESULTS: Patients without benfit expended
annually an adjusted mean of $7034 while patients with benefit expended an
adjested mean of $4778 on medical utilization. The number of medical claims also
differed with an adjusted mean of 49.7 claims for paitents without benefit
compared to an adjusted mean of 39.1 claims for patients with benefit. The
potential annual savings for patients with pharmacy benefit unadusted by
employer costs in sponsoring the program is $2256 per patient. CONCLUSION:
Preliminary results demonstrate the value and potential savingss to employers
providing pharmacy benefits. Further anlysis will adjust for income and
incorporate employer sponsored program costs.
Abstract #: PC6
A NATIONAL STUDY ON FACTORS
PREDICTING MEDICATION UTILIZATION BY EPILEPSY PATIENTS
Rahman, A, Dighe, MS, Rappaport, HM.
School of Pharmacy, Northeast Louisiana University, Monroe, LA.
Epilepsy is a disease state associated
with severe disability, and limitations. The incidence of epilepsy in United
States is less than 1%. However it represents a severe socioeconomic burden on
the society. Drug therapy is the major method of controlling this condition, and
is also the most costly category of service. In this era of cost containment and
formulary restrictions, it is important to identify the factors associated with
medication utilization for condition such as epilepsy. The data for the purpose
of this study were obtained from the 1992 National Ambulatory Medical Care
Survey (NAMCS). Data on eighty- two patients with a diagnosis of epilepsy
(ICD-9- CM 345 to 345.91) were extracted using SETS version 1.22 and analyzed
using Statistix version 4.1. Of these, the majority of patients received health
coverage through either an HMO(17%), Medicaid(18%), Medicare(19%), or Commercial
Insurance (36.6%). An ordinary least squares (OLS) regression model was
developed to identify the role of demographic, comorbid, diagnostic, patient
disposition and insurance coverage factors on medication utilization. The
results of the statistical model suggest a significant positive slope in
medication utilization. However it is further observed that there were a fewer
number of medications prescribed to patients with Commercial Insurance (p=0.02).
None of the other demographic, comorbid, diagnostic, and patient disposition
factors were significant. The regression model explained 24.97% of the variance
among the hypothesized relationships. The results of this study may hold
important policy implications on the role of insurance status and drug
prescribing. It suggests that Commercial Insurers may have better administrative
control on drug prescribing. More studies of this type should be done in the
future using large commercial health insurance databases.
Patient Preferences &
Analytical Methods
Abstract #: AM1
ASSESSING THE COMPARATIVE ECONOMIC VALUE OF
OSTOMY POUCHES: A WILLINGNESS TO PAY APPROACH
Poon, AW, Gaylin, DS, Shapiro, JR, Mendelson, DN,
Rubin, RJ, The Lewin Group, Fairfax, VA, US.
OBJECTIVE: We developed novel WTP methodology to
assess the comparative costs and benefits of ostomy pouches; closed-end pouches
have advantages in convenience, security, and comfort but can be more expensive
than drainable pouches. METHOD: Through a survey of 90 colostomates and 100
Enterostomal Therapy Nurses, we analyzed the importance of 20 fundamental pouch
attributes. The most important attributes were grouped into five categories
based on physical or practical differences between closed-end and drainable
pouches. 55 colostomates were surveyed about their willingness to pay for each
of these benefits. The average WTP values for the five categories and retail
pouch costs were inputs into a cost-benefit model, which calculates net benefit,
accounting for individual differences in pouch use. RESULTS: The typical
colostomate had a WTP of $34/month for the benefits that result from switching
to closed-end pouches from drainable; the typical costs of switching were
$24/month, yielding an average net benefit of $10/month. CONCLUSIONS: Relative
to monthly pouch costs of approximately $60/month, a net benefit of $10/month is
substantial. Closed-end pouches, therefore, should be the preferred product
under most circumstances, even after considering differences in cost. WTP
surveys are a theoretically preferred method of measuring the benefit of medical
interventions, but have posed problems in application because of the difficulty
many individuals have in valuing abstract health benefits, such as a risk
reduction in mortality. This analysis demonstrates the applicability of WTP
methods for evaluating benefits of a medical device that causes concrete,
tangible changes in QoL.
Abstract #: AM2
THE IMPACT OF PATIENT ATTITUDES ON THE DEMAND
FOR DRUGS
Mucha, LM, Foreman, SE, Penn State University,
Department of Health Policy and Administration, University Park, PA. US.
Estimating the demand for prescription drugs is a
complex issue. While insurance coverage for prescribed medicines is important,
it is not the only factor that impacts demand. OBJECTIVE: The purpose of this
study was to build on prior drug demand studies by adding another piece of the
puzzle: patient attitudes. We tested to see how patients' attitudes towards
their physician and medicine impacts the decision to fill prescriptions. METHOD:
Data from the 1987 National Medical Expenditure Survey were used to estimate a
two part model of demand. The first part used logistic regression to estimate
probability of use of drugs (N=25599). The second part used OLS regression on a
semilog model to estimate level of drug use conditional on use (N=15185). The
two attitudinal measures of interest were: (i) respondent agrees home remedies
are better than prescribed medicines, and (ii) respondent agrees s/he can get
well without the aid of the physician. The drug measure indicates how a patient
perceives the effectiveness of drugs. The physician measure indicates the effect
of the level of trust a patient has in the physician on the decision to fill a
prescription. RESULTS: Results showed that, ceteris paribus, respondents who had
favorable attitudes towards physician and drugs had a significantly higher
probability and level of use of drugs than respondents who did not . Odds ratios
from part one for both the drug (0.85) and physician measure (0.85) were
significant (p.<.001). The same held true for the coefficients in part two (9%
and 12% significantly [p.<.001] less drug use, respectively). CONCLUSION:
Attitudes are as important predictors of drug demand as health status and
insurance coverage are.
Abstract #: AM3
LINKING Patient's preferences and TREATMENT
OUTCOMES in allergy:
an EMPIRICAL INVESTIGATION.
Ricard, N. Health Economics Department Hoechst
Marion Roussel Canada Research Inc, Laval, Quebec, Canada
Kind, P. Centre for Health Economics University
of York, York, England.
Empirical evidence indicates that involving
patients in decision making about their care improves their compliance with
treatment, their perceptions of quality, and their outcomes. Such involvement
can be achieved by explicitly monitoring patient's preferences particularly in
regard to symptoms that impact on their quality of life. Methods of measuring
patient-centered preferences do exist but no gold standard has been identified
in this area. OBJECTIVE: To investigate the relationship between patient's
preferences for relief of symptoms in allergy and efficacy/outcome following
treatment. METHOD: In a clinical study of a new therapy, 400 patients rated
their preferences for the relief of allergy symptoms prior to treatment. Patient
recorded on a 10-point rating scale the level of desirability associated with
the relief of sneezing, rhinorrhea, itchy nose, palate and/or throat, and of
itchy, watery, red eyes. A preference scaling factor relating patient's
impairment to each allergy symptom was recorded on a 10 centimeter feeling
thermometer. Treatment outcome was determined by the change in allergy symptom
score over a 7-day period. Treatment outcome was analyzed with respect to
patient's preferences, and the functional equation linking these variables was
used to determine an adjusted symptoms severity score. RESULTS: Patient's
preferences will be presented and discussed with respect to the derived
functional equation. CONCLUSION: Patient's preferences for symptomatic relief in
allergy are important elements in determining outcomes to treatment, and can
provide new information to assist decision making in selecting treatment of
allergy.
Abstract #: AM4
Validation of the full and reduced batterY of
scaleS for measuring the qol of patients ON ANTI-HYPERTENSIVE THERAPY
Nelsen, LM., Himmelberger, DU, Budd DW, Liss, CL.
Markson, LE. Merck & Co., Inc., West Point, OA and Health Outcomes Group, Palo
Alto, CA
Objectives: To examine the performance
characteristics of a full and reduced battery of scales (BOS) designed to
measure treatment- related QoL in hypertensive patients.
Methods: The BOS consists of 43 questions
representing 6 domains (psychological general well-being, sleep disturbance,
sexual function and cognitive function). Data included baseline and three one
month timepoints following for 53 "stable" patients (blood pressures well-
controlled with anti-hypertensive medication), 90 patients "changing"
medications due to treatment-related side effects, and 84 "newly treated"
patients. Performance characteristics examined included test/re-test reliability
in "stable" patients, construct validity and responsiveness in "changing" and
"newly treated" patients, and internal consistency in the "stable" and
"changing" patients. Items to delete were identified using "Merit", developed to
quantify the ability of a question to identify meaningful change in QoL over
time.
Results: The performance characteristics of the
full BOS indicated high levels of internal consistency (.74-.95); and acceptable
reliability (ICC of .46 to .85). At 3 months compared to baseline, all domains
demonstrated significant responsiveness. At 3 months, the change in all domains,
except for sexual function, were significantly correlated with change in global
QoL. Using the Merit Method, the full BOS was reduced from 43 to 21 questions.
The performance characteristics of the reduced BOS did not differ significantly
from the full BOS. External validation of the reduced questionnaire using data
from two Phase III trials provided results similar to those from the full BOS.
Conclusions: The data from this study confirm
that the performance characteristics of full and reduced batteries of scale are
satisfactory for measuring QoL in hypertensive patients.
Abstract #: AM5
ASSESSING THE QUALITY OF LIFE OF CAREGIVERS
FOR PERSONS WITH PROBABLE ALZHEIMER'S DISEASE
Berzon RA, Reilly M, Whalen E, Graham E, Smith
ME. Bayer Pharmaceutical Division, West Haven, CT and Reilly Associates,
Waccabuc, NY
Dementia is a chronic syndrome that is manifest
by a progressive deterioration of cognition, function and behavior. Alzheimer's
disease is the most common form of dementia in the United States. It and related
dementias affect approximately four million U.S. residents.
It is widely recognized that Alzheimer's disease
has a profound effect on families and close friends who devote time to caring
for the patients. These dementia caregivers are burdened by emotional stress and
anxiety that can be long-term and severe. We hypothesized that by intervening in
the treatment of patients with probable Alzheimer's disease that these and other
detriments to caregiver health-related quality of life (HRQoL) and time
allocation could be moderated.
Objective: To investigate the effects of
metrifonate, an acetylcholinesterase inhibitor, on caregiver HRQoL and time
allocation.
Methods: This was a 26-week, randomized,
double-blind, parallel group, placebo-controlled safety and efficacy study
conducted at 25 sites by the Bayer Pharmaceutical Division. A total of 408
patients between 45 and 90 years of age with probable Alzheimer's disease of
mild to moderate severity entered the study. A total of 357 caregivers completed
HRQoL and time allocation surveys. Caregiver burden was assessed via the Screen
for Caregiver Burden (SCB), the cognitive subscale of Poulshock and Deimling
(1984), and the 17-item Mental Health Index (MHI-17) of the Medical Outcomes
Study. Caregiver time use was measured with the Caregiver Activity Time Survey
(CATS).
Discussion: The methodology by which HRQoL and
time allocation data are collected and managed for caregivers for those persons
with probable Alzheimer's Disease of mild to moderate severity is presented.
Practical issues regarding questionnaire administration to subject surrogates
are reviewed, as are modes of questionnaire delivery.
Abstract #: AM6
AN OBSERVATIONAL ASSESSMENT OF CLINICAL
OUTCOMES ASSOCIATED WITH THE USE OF ANTIEMETICS BY HOSPITALIZED CANCER
CHEMOTHERAPY PATIENTS
Vermeulen , LC, Windisch, PA, Vlasses, PH,
Matuszewski, KA, University HealthSystem Consortium, Oak Brook, IL. US
OBJECTIVE: The study objectives were to assess
the comparative effectiveness of granisetron, ondansetron, and other antiemetics
by evaluating the functional health status; the degree of nausea and emesis
rates; and use patterns in patients receiving cancer chemotherapy, in U.S.
academic health centers. METHODS: A prospective, observational study was
conducted in 14 hospitals. This study evaluated the use of antiemetics in
hospitalized cancer chemotherapy patients. The primary clinical outcomes of
interest measured were the impact of adverse effects to chemotherapy on the
functional status of patients, using a validated instrument (MFLIE), and the
occurence of post-treatment vomiting. RESULTS: Data was collected on 439 adult
patients. The most common types of cancer chemotherapy regimens used consisted
of cisplatin, paclitaxel, etoposide, and cyclophosphamide. Common antiemetics
used for treatment of chemotherapy-induced emesis were ondansetron,
dexamethasone, lorazepam, and granisetron. A total of 323 (74%) patients
reported no episodes of emesis, and 35 (8%) patients reported one episode of
emesis. Granisetron and ondansetron were associated with better overall outcomes
(e.g., no vomiting, functional health status) for high and moderate emetogenic
chemotherapy than standard antiemetics or no antiemetic therapy. In contrast,
standard or no antiemetic therapy produced comparable outcomes to granisetron
and ondansetron for low emetogenic chemotherapy. CONCLUSION: Both granisetron
and ondansetron appear to be comparable in achieving positive antiemetic
functional and clinical outcomes. The study data also suggests that 5-HT3
antagonist antiemetics be used in high emetogenic chemotherapy because of the
benefit of positive outcomes. Non-5-HT3 antagonist antiemetic therapy or no
antiemetic therapy achieved positive outcomes in patients receiving low
emetogenic chemotherapy.
Comparative
Outcomes and Cost-effectiveness Analysis
Abstract #: EA1
COST-BENEFIT ANALYSIS OF CALCIUM
SUPPLEMENTATION TO REDUCE THE RISK OF OSTEOPOROTIC HIP FRACTURES AMONG AGED
WOMEN
Mallick R, Pracon, Reston, VA. USA
OBJECTIVE: To examine the costs and
benefits of universal calcium supplementation to prevent osteoporotic hip
fractures. METHODS: The perspective is that of Medicare since 75% of hip
fractures occur among aged enrollees. Data sources included the 1992 National
Hospital Discharge Survey, and 1995 Medicare data on volume and payments for DRGs 210, 211, and 236. A MEDLINE search identified published studies of
relative risk estimates of the association between calcium intake and hip
fractures and surveys of daily calcium intake among aged US women. We calculated
the percent of aged enrollees who have suboptimal calcium intake and projected
the potentially preventable percent of hospitalizations and payments for
treating hip fractures if the at risk population received optimal calcium
supplementation for over one year. Potential dollar savings were discounted by
3%. Retail prices for calcium supplements in suburban Washington were used. Per
capita net benefits of calcium supplementation were calculated by subtracting
the cost of supplements and dividing by the size of the target population.
RESULTS: In 1995, over 164,000 hip fractures occurred among aged Medicare
enrollees. Medicare paid hospitals $1.2 billion for these fractures. Only 5% of
aged American women met the US RDA of 1000 mg of calcium per day. If all aged
women met this requirement, 38% to 41.7% of annual hip fracture hospitalizations
could be prevented at an aggregate annual savings of $449-493 million. Net per
capita savings from calcium supplementation for women over age 75 are between
$15.50 and $19.40. CONCLUSIONS: Calcium supplementation for women over age 75 is
cost effective if supplements cost Medicare less than $40 per beneficiary
annually. These savings are conservative since related costs for surgeons,
nursing homes and home care are excluded.
Abstract #: EA2
INFLUENCE OF ANESTHETIC MANAGEMENT
ON RESOURCE USE IN MAJOR JOINT REPLACEMENT
Orkin FK, Dartmouth-Hitchcock Medical
Center, Lebanon, NH, USA
In tandem with concern for escalation
of health care costs has been desire for greater value. Strategies in anesthesia
care have focused on choosing anesthetic regimens (drugs, techniques) with lower
pharmaceutical acquisition costs, ignoring the possibility that anesthetic
management may influence resource use beyond the operating room (OR) and
postanesthetic care unit (PACU). OBJECTIVE: This study explored the influence of
anesthetic management on resource use in major joint replacement throughout the
hospital stay. METHOD: Within an institution-wide, multidisciplinary quality
improvement initiative, a data base was established, containing administrative,
financial, patient, surgical, and anesthetic information, covering all patients
having total hip or knee replacement in a university hospital during the period
1/94-7/96. Summary statistics were obtained for variables of interest, with
P<0.05 considered statistically significant. RESULTS: The data base contains 832
patients: 437 received general anesthesia, the remainder received alternative
techniques. Patients receiving general anesthesia were younger (mean 65.6 vs.
68.7 years, P<0.001). Use of general anesthesia vs. alternative had no influence
on anesthesia, operating room, PACU, or intensive care unit (if any) time,
number of blood transfusions, physical therapy hours, and charted adverse
events. Alternative techniques were associated with shorter ward (6.2 vs. 6.9
days, P<0.003) and hospital (6.3 vs. 7.0, P<0.008) stay, with the greatest
differences associated with adjuvants enhancing postoperative pain control.
CONCLUSION: Efforts to control anesthesia expenditures should not be limited to
acquisition costs of anesthetic drugs and supplies. Rather, a broader
perspective must be taken to explore ways in which anesthetic management may
influence 'downstream' resource use beyond the OR and PACU. That alternative
anesthetic techniques were associated with shorter hospital stay prompts
continuing analysis of the data set to identify pharmaceutical components of
'best practice'.
Abstract #: EA3
MEDICAL AND ECONOMIC RELEVANCE OF
INPATIENT TREATMENT OF PNEUMONIA WITH CEFTRIAXONE IN COMPARISON TO
CIPROFLOXACINE, MEROPENEM AND PIPERACILLIN/TAZOBACTAM
Kilburg, A, Bachinger, A, Rychlik, R
Institute of Empirical Health
Economics, Altenberger-Dom-Strasse 16, D-51519 Odenthal, Germany
Ceftriaxone, Ciprofloxacin, Meropenem
and Piperacillin-Tazobactam are some of the most preferred antibiotics to treat
pneumonia. In a retrospective analysis the cost structure of above different
antibiotic treatments was established. OBJECTIVE: This analysis centred around
the question which of these alternative therapies incurs the best
cost-effectiveness ratio. The comparison of costs and benefits was made on the
basis of a cost-effectiveness analysis. METHOD: A decision tree with four
endpoints was constructed: (1) successful therapy with adverse drug reaction (2)
successful therapy without adverse drug reaction (3) failed therapy (4) death.
Data regarding efficacy, duration of treatment and casualities underlying were
taken from clinical studies. Health care costs included in the model were all
medical costs (hospitalization, drug costs etc.) and indirect costs (absence
from workplace, burial allowance). The benefit was defined as the cure rate of
pneumonia. The following benefit rates were revealed in clinical studies:
Ceftriaxone 0.6136, Ciprofloxacin 0.6939, Meropenem 0.8750,
Piperacillin/Tazobactam 0.9549. For a better comprehension of the results a
sensitivity analysis was conducted to determine the influence of the efficacy on
the effectiveness adjusted costs and the effects of the frequency of adverse
drug reactions using Piperacillin/Tazobactam. RESULTS: Therapy with Ceftriaxone
resulted in total costs of 11,942.47 DM per successfully treated patient.
Therapy with Ciprofloxacine incurred total costs of 13,352.41 DM, and therapy
with Meropenem caused total costs of 7,720.39 DM. Concerning the therapy of
pneumonia with Piperacillin/Tazobactam, total costs of 6,538.28 DM per
successfully treated patient were calculated. CONCLUSION: This decision tree
analysis reveals that therapy with Piperacillin/Tazobactam has the best cost-
effectiveness ratio.
Abstract #: EA4
AN META-ANALYSIS OF CLINICAL TRIALS
OF INTERFERON-BETA FOR MULTIPLE SCLEROSIS.
Dedhiya, SD, Kong, SX, Salmon JW,
Crawford, SY. The University of Illinois at Chicago, Chicago, IL, US.
Multiple sclerosis (MS) is crippling
neurological disorder that manifests itself in varied forms of disability and
functional impairment, affecting young adults. Interferon- beta (IFNB) therapy
was approved for treatment of relapsing remitting (RR) type MS. However,
clinical trials using IFNB prior to its approval did not convincingly establish
its effectiveness in reducing exacerbation rates. OBJECTIVE: To assess published
clinical trial data and determine if IFNB therapy is effective in reducing
exacerbation rates in RR-MS and to examine the strengths and limitations of
carrying out a meta-analysis. METHOD: A meta-analysis of published clinical
trials using IFNB therapy for MS was carried out. The results were summarized
for-reduction in exacerbation rates, number of exacerbation-free subjects in
treatment and control groups, and difference in disability status using the
Expanded Disability Status Scale (EDSS) score. RESULTS: Six studies were
identified based upon predecided inclusion-exclusion criteria. The summarized
results revealed that there was a significant reduction in the exacerbation rate
in the group treated by IFNB (p<0.001); no difference was observed in the number
of exacerbation-free subjects between the treatment and control group. However,
the change in EDSS score could not be estimated conclusively because of lack of
information. CONCLUSIONS: IFNB therapy reduces exacerbation rates in MS, but
issues such as identification of clinical end points for MS, reporting of
results, etc., need to be addressed before conducting clinical trials for MS and
for successful integration of information in future meta-analyses. As a
statistically rigorous method, meta-analysis portends as a valuable tool to
provide a comprehensive summary of efficacy and safety estimates--the critical
elements, for cost-effectiveness analyses, necessary to establish the impact of
drug therapy on patient outcomes.
Abstract #: EA5
COMPARISON OF THE COST-EFFECTIVENESS
OF DYNAMIC SUSCEPTIBILITY CONTRAST MRI [DSC MRI] VERSUS BRAIN SPECT IN THE
DIAGNOSIS OF ALZHEIMER'S DISEASE USING A BAYESIAN ANALYTIC MODEL.
Smith MD1, McGhan WF2, LaFrance ND3,
Weaver M3, Harris GJ4, Renshaw PF5.
1Health Decision Strategies,
2Philadelphia College of Pharmacy and Science, 3Bracco Diagnostics, 4New England
Medical Center, 5McLean Hospital
PURPOSE: The purpose of this study was
to compare the cost-effectiveness of several functional neuroimaging modalities
for the diagnosis of Alzheimer's disease (AD). METHODS: For the cost-effective
analysis of DSC MRI and clinically-evaluated brain SPECT [cSPECT], 23 patients
with probable AD and 18 age and gender matched elderly comparison subjects
underwent a structural MRI scan and functional DSC MRI scan and cSPECT scan. For
the cost-effective analysis of a quantitatively-evaluated SPECT [qSPECT], 20
patients with probable AD and 8 age and gender matched elderly comparison
subjects underwent a structural MRI scan and a functional qSPECT scan. A Bayes'
revision decision tree was constructed using the sensitivity, specificity, and
disease prevalence from the clinical assessment studies. Out-patient direct
medical, non- medical, and indirect costs were determined from survey,
observational study and published literature. Cost-effectiveness ratios were
evaluated from the perspective of a hospital and society. Sensitivity analysis
was conducted to establish relationships of costs, disease prevalence, and
neuroimaging modality sensitivity and specificity. RESULTS: Direct medical costs
to the hospital for structural MRI+DSC MRI and structural MRI+SPECT were $586
and $865 and to society were $773 and $1159. Cost- effectiveness ratios were
$650, $1040, and $967 for MRI+DSC, MRI+cSPECT, and MRI+qSPECT per accurate
evaluation from a hospital perspective and $858, $1393, and $1296 from a
societal perspective. CONCLUSIONS: Based on a Bayesian analytic model, MRI + DSC
MRI was the more cost-effective imaging modality in evaluating patients for
Alzheimer's disease both from the perspective of a hospital and from society.
Abstract #: EA6
LONGITUDINAL ACE INHIBITOR AND
CALCIUM CHANNEL BLOCKER ANTIHYPERTENSIVE UTILIZATION FOR SELECT PATIENTS IN THE
DEPARTMENT OF DEFENSE PRESCRIPTION DATABASE.
Okano, GJ, Rascati, KL, Wilson, JP,
Smeeding, JE, The University of Texas College of Pharmacy, Austin, TX. USA,
Grabenstein, JD, Remund, D, The Pharmacoeconomic Center, Ft. Sam Houston, TX.
USA
The Department of Defense has recently
constructed a prescription database through the Uniformed Services Prescription
Database Project. OBJECTIVES: For patients initiated on an ACE Inhibitor or
Calcium Channel Blocker (CCB), the objectives of this study were to
retrospectively: 1) determine those patients experiencing ONE change in therapy
from initiation in therapy; and 2) estimate the marginal medication costs
associated with the change. METHODS: Patient antihypertensive therapy was
examined from February 1, 1994 through July 31, 1995. The unit of analysis was
the patient. If patients were continuously enrolled for the 18 months of the
study; had no antihypertensive medications from February 1, 1994 to July 31,
1994; but began therapy with an ACE Inhibitor or CCB in August 1994, their
therapy was followed for one year. Marginal costs were estimated using Average
Wholesale Price (AWP) and Average Manufacturers Price (AMP). RESULTS: Based on
the criteria, 183 patients were identified as newly treated hypertensive
patients. Of the 183 patients, 42 (23%) experienced one change in therapy.
Specifically: 14 (8%) increased dose; 2 (1%) decreased dose; 17 (9%) changed
medications; and 9 (5%) had another medication added. The estimated increase in
marginal cost per patient above the cost of continuing on the same therapy for
the year was calculated at $53.83 (AWP) and $38.79 (AMP). CONCLUSION: This
results of this study provide insight into the utilization of antihypertensive
therapy and the associated marginal costs as a result of the change. Analysis of
data for a larger sample of patients is currently being conducted.
Hypertension:
Identification of Patients and Costs
Abstract #: HY1
Utility and Validation of
Administrative Data for Identifying a Hypertensive Cohort in a Managed Care
Population.
James F. Murray, James B. Roehm,
Charles A. Alexander, Nicholas A. Hanchak, Stephen J. Boccuzzi, U.S. Quality
Algorithms, Inc.Ø, Blue Bell, PA, and Merck & Co. Inc., West Point, PA.
Retrospective analysis of
administrative data has proven to be an effective method for the
characterization of provider practice patterns. A limitation in the use of this
type of data is the ability to accurately identify the target population. To
develop and validate a selection algorithm for the identification of
hypertensive patients a retrospective study in a 2 million member independent
practice HMO with an open formulary was conducted. Newly diagnosed members with
hypertension were identified on the date of their first claim/encounter with
hypertension-specific ICD-9 criteria, preceded by at least a 12 month interval
without hypertension criteria. Additional claims or pharmacy records, if
available, were used as corroborating evidence for hypertension (i.e., drug
claim within +/- 6 months or a second ICD-9 encounter/claim within +12 months).
Diagnostic validation of the selection algorithm was accomplished by auditing a
5% random sample of 174 patients through medical chart audit. The hypertension
diagnosis was confirmed if it was recorded on the problem list or 2 recorded
blood pressure readings exceeding 140 mm Hg systolic or 90 mm Hg diastolic were
found. 157 of the 174 members were confirmed hypertensive for a positive
predictive value (PPV) of 90.2%. The PPV was improved to 95.4% when
corroborating evidence of the diagnosis was utilized. The algorithm was highly
accurate for identifying a hypertensive cohort for describing the practice
patterns in the pre and post JNC V time frames to include 1) the distribution of
anti-hypertension agents in new starts, 2) discontinuation rate, 3) persistence
and 4) compliance.
Abstract #: HY2
PHARMACY BENEFIT MANAGEMENT
DATABASES CAN BE USED AS A TOOL TO IDENTIFY PATIENTS AT RISK FOR ADVERSE DRUG
REACTIONS
Hudson TJ, Gardner SF, Smith KF, Davis
DA. University of Arkansas for Medical Sciences, Little Rock, Arkansas and
Pharmacy Associates, Inc., Little Rock, Arkansas
Thiazide diuretics, although widely
prescribed, are associated with a relatively flat dose response curve and a
significant increase in metabolic disturbances at doses 25mg/day. OBJECTIVE: The
purpose of this study was to determine the prevalence of prescriptions for
hydrochlorothiazide (HCTZ) 50mg/day in a paid claims database. We also
identified prescription profiles with concomitant medications to treat metabolic
disturbances potentially worsened by thiazide diuretics. METHODS: We queried the
database of a PBM using RxFocusØ software (Argus Health Systems, Inc.). The
database contained paid claims for prescriptions for 145,000 patients from
Arkansas and Louisiana. Patient profiles with prescriptions for HCTZ 50mg/day
from March 1, 1997 to May 31, 1997 were identified. Letters were mailed to
prescribing physicians outlining the ceiling effect and metabolic disturbances
associated with high doses of thiazide diuretics. Each profile was evaluated for
the presence of medications used to treat metabolic disorders. RESULTS: Three
hundred seventy-six patient profiles with paid prescription claims for HCTZ
50mg/day were identified. Thirty-six profiles were excluded secondary to
incomplete data. The profiles (n=340) reflected patients aged 27 to 84 years
(37% male). One hundred four (31%) profiles included at least one medication for
treatment of a metabolic disorder. Medications included anti-diabetic agents
(n=23), hypolipidemic medications (n=12), potassium supplements (n=46) and
medications for gout (n=5). Eighteen patients were receiving medications from
more than one category. CONCLUSIONS: Despite published data regarding the flat
dose response curve of HCTZ and increased side-effects at higher doses, 340
patient profiles in this database contained paid claims for HCTZ 50mg/day.
Nearly one-third (31%) of the profiles indicated the patient was being treated
for at least one metabolic disorder potentially worsened by high-dose HCTZ.
Although some individuals may respond favorably to HCTZ 50mg/day, patients
should be closely monitored for the presence of new metabolic disturbances or
worsening of known disorders.
Abstract #: HY3
COST OF TREATMENT OF HYPERTENSION IN
CANADA
Tasch, RF, Marentette, MA, West, R,
Technology Assessment Group, Montreal, QC; Memorial University of Newfoundland,
St. John's, NF, Canada
OBJECTIVE: To estimate the incremental
cost of treating hypertensive patients in Canada. METHODS: Using the
Saskatchewan Health databases, we measured the direct medical cost of treatment,
in terms of physician visits (MD), prescription medications (Rx), and
hospitalizations, of a case group and an age- and gender-matched control group.
Rx were categorized as cardiovascular and non- cardiovascular drugs. We
performed univariate and multivariate regression analyses using variables such
as age, gender, and common comorbid conditions to predict the cost of MD, Rx,
hospitalizations, and total treatment. Finally, we extrapolated the results from
Saskatchewan to a national level, using Canadian population prevalence figures,
in order to estimate the total annual cost of treating hypertension in Canada.
RESULTS: For hypertensive patients, the annual cost of treatment per patient was
$2,040, comprised of $500 for MD, $599 for Rx, and $940 for hospitalizations.
For control group patients, the annual cost of treatment per patient was $1,360,
comprised of $347 for MD, $256 for Rx, and $756 for hospitalizations. All these
differences were highly statistically significant. In addition, we found that
patients in the hypertension group had more comorbid conditions than control
group patients. Controlling for the presence of comorbid conditions, as well as
age and gender, reduces the difference per patient from $680 (unadjusted) to
$603 (adjusted). CONCLUSIONS: Applying the adjusted cost difference to a
national level yields an annual incremental cost of treating hypertension in
Canada of $1.3 billion to $2.8 billion, depending on assumptions concerning
prevalence. These figures may be conservative given that certain medical costs,
such as laboratory tests and procedures, as well as indirect costs to society
such as lost productivity, were not included.
Abstract #: HY4
AN ECONOMIC MODEL OF CARDIOVASCULAR
DISEASE IN HYPERTENSIVES RECEIVING PHARMACOLOGIC TREATMENT
Russell, MW, Huse, DM, Drowns S, Hartz,
SC, Medical Research International, Burlington, MA. US
Huse, DM, Sytkowski, PA, D'Agostino,
RB, Drowns, S, Hamel,EC, Hartz, SC, Medical Research International, Burlington,
MA. US and Boston University, Boston, MA US
Many persons taking antihypertensive
drugs continue to have elevated blood pressure relative to current guidelines.
OBJECTIVE: To estimate the clinical and economic benefits of more rigorous
adherence to current treatment guidelines. METHOD: We developed an economic
model of cardiovascular disease (CVD, including coronary heart disease [CHD].
Stroke, and congestive heart failure [CHF]) and its relationship to blood
pressure and antihypertensive treatment in the U.S. adult population (aged 40-79
years). This model forecasts CVD incidence and direct medical-care costs
(discounted at 5% per annum) for demographic groups using national risk factor
profiles. Principal data sources included the Framingham Heart Study, major
national health surveys, and healthcare cost database. RESULTS: We estimate that
18% of US men and women aged 40-79 who ae currently free of CVD receive
antihypertensive therapy and that 17% of treated persons continue to have
diastolic bloood pressure of 90 mm Hg or higher. Among those receiving
antihypertensive therapy, incidence of CHD, stroke, and CHF increase by 23%,
15%, and 65%, repsectively, with each 10-point rise in diastolic blood pressure.
Expected per capita costs of CVD over five years among treated hypertensives
range from $1,470 at DBP <80 mm Hg to $1,746 at DBP of 80-89 mm Hg to $2,270 at
DBP> 90 mm Hg. CONCLUSION: More aggressive treatment of hypertension can
be expected to yield substantial economic benefits in addition to reducing the
risk of cardiovascular diasease and mortality.
Abstract #: HY5
META-ANALYSIS, MARKOV DECISION TREE,
AND COST-EFFECTIVENESS ANALYSIS ON THE TREATMENT OF ESSENTIAL HYPERTENSION IN
THE ELDERLY.
Ricci JF, Oh S, Martin B., College of
Pharmacy, Pharmacy Care Administration, University of Georgia, Athens, Ga. US
The purpose of this study was to
determine the marginal cost-effectiveness of the pharmacological treatment of
hypertension in the elderly. METHOD: A decision tree modeling the prognosis of
hypertensive elderly patient between 60 and 75-years old was constructed. The
model was run over 15 years in one-year increments. It included one decision
node with two emanating branches (pharmacological treatment and no treatment of
hypertension), each modeled with a Markov process. Transition probabilities were
estimated using the Mantel-Haenzel pooled estimates for event rates for seven
morbid and fatal clinical endpoints obtained from nine published randomized
clinical trials on the treatment of hypertension for patients 60 years of age
and older. Cardiovascular clinical endpoints were stratified in three categories
- cerebrovascular, major coronary, and all other cardiovascular events. Cost
data were obtained from a two-year retrospective study of the administrative
claims of the Medicaid Program in Georgia. RESULTS: The average annual
anti-hypertensive prescription expenditures was $428 per patient. Average annual
hospital expenditures for patients without any prior diagnosis in one of the
three cardiovascular categories was $2,150 vs. $4,030 for patients with at least
one prior cardiovascular endpoint diagnosis. Over a 15-year time horizon, the
non-discounted life expectancy in the treatment group was 11.79 years, a 3%
discounted life-years gain of 0.37 compared to the no treatment group. The
average marginal cost- effectiveness ratio indicated that pharmacological
therapy increased life expectancy at a cost of $2,047 per life-year gained with
a 95% confidence interval going from a cost-saving scenario to $7,197.
CONCLUSION: Pharmacological treatment of hypertension in the elderly is cost-
effective in comparison to many other medical interventions
Abstract #: HY6
COMPARISON OF TWO ONCE-DAILY
DIHYDROPYRIDINE CCBs IN THE MANAGEMENT OF HYPERTENSION IN PA MEDICAID PATIENTS
Linde-Zwirble,W, Newbold,RC, Lidicker,
J Health Process Management, Doylestown, PA. US
Hypertension affects almost 10% of the
PA Medicaid population. Given the wide variety of hypertension agents available,
prescribers must understand the efficacy, safety, and cost of each agent.
OBJECTIVE: This study compared two once-daily, dihydropyridine Calcium Channel
Blockers (CCBs) for number of healthcare encounters, use of healthcare
resources, total and drug charges. METHOD: The 1994-96 comprehensive PA Medicaid
claims database was reviewed for all adult patients ages 18-64 with a diagnosis
of hypertension. All patients were retained for study with: at least one
prescription for either Norvasc or Adalat CC, no other CCBs in the 8 months
preceding the earliest prescription (REFERENCE) and no other CCBs in the 9
months following the earliest prescription (MONITORING), and continuous
eligibility. RESULTS: The demographic characteristics and compliance of the two
groups were similar. Adverse outcomes as well as resource use were largely
similar. However, the Norvasc group had a higher rate of CV conditions (N=419,
14.6%) than Adalat CC (N=176, 7.4%) and a higher rate (23.4%) of
hospitalizations than Adalat CC (15.9%). Interestingly, Adalat CC had a
significantly lower average number of classes of concurrent antihypertensive
agents (0.38 vs. 0.52); this correlated with lower cost of medications for
treatment with Adalat CC. After controlling for pre-existing CV conditions, this
effect remained. CONCLUSION: A direct cost benefit for Adalat CC was observed
because of less use of concomitant drugs for hypertension. Differences in other
kinds of resource use between the two groups were either rare (like
hospitalizations), or unvarying (like physician visits). We believe that there
may be an opportunity for cost savings with Adalat CC in managing hypertension
because of lower acquisition cost and lower concomitant drug therapy.
Costs,
Resources, and Utilities in Cardiovascular Disease
Abstract #: CD1
THE DIRECT MEDICAL COSTS OF CORONARY ARTERY
DISEASE (CAD) IN THE U.S.
Russell, MW, Huse, DM, Drowns, S, Hamel, EC,
Hartz, SC, Medical Research International, Burlington, MA. US
Despite significant reductions in CAD incidence
and prevalence in the U.S. in recent years, the costs of treating CAD remain of
great concern. New interventions that reduce CAD risk continue to be developed
and may offset some of these costs. However, they compete with existing
interventions for limited healthcare resources. These resource allocation
decisions require quantification of the expected costs of treating CAD.
OBJECTIVE: To develop current incidence- based estimates of the direct medical
costs of CAD in the U.S. METHODS: A Markov model of the costs of CAD-related
medical care among persons with and without prior history of CAD was developed.
Risks of initial and subsequent CAD events were estimated using recently updated
Framingham Heart Study coronary risk equations and national data on CAD risk
factors. Costs reflected treatment of CAD events ("event-related") and surgical/nonsurgical
follow-on care ("non event-related"), and were derived from national public-use
databases and medical literature. RESULTS: First-year event- related costs are
estimated to be $17,532 (fatal MI), $15,540 (nonfatal MI), $2,569 (angina),
$12,058 (unstable angina), and $713 (sudden CAD death). Non event- related costs
are estimated to be $1,051 annually. Five- and ten-year cumulative costs (1995
dollars) for persons initially free of CAD are estimated at $9.3 billion and
$12.6 billion respectively; for all persons with CAD, these costs are estimated
to be $71.5 billion and $126.6 billion respectively. CONCLUSION: The direct
medical costs of CAD are substantial, and as new interventions that reduce the
risk of CAD are introduced to the marketplace, healthcare providers and payers
need to consider their net effect on the costs of managing this disease.
Abstract #: CD2
COST-EFFECTIVENESS OF A STEPPED TREATMENT
REGIMEN OF IBUTILIDE FOLLOWED BY ELECTRICAL CARDIOVERSION IN THE TREATMENT OF
ATRIAL FIBRILLATION AND FLUTTER
Zarkin, GA, Bala, MV, Calingaert, B, VanderLugt,
JT, Research Triangle Institute, Research Triangle Park, NC, US
Pharmacological agents used in treating atrial
fibrillation (AF) and atrial flutter (AFL) act much more slowly and are less
effective than electrical cardioversion (EC). Recently, ibutilide fumerate, a
new intravenous rapid- acting Class III antiarrhythmic agent, was approved by
FDA for treating AF and AFL. OBJECTIVE: To compare the cost- effectiveness of a
stepped treatment regimen of ibutilide first-line followed by EC second-line, to
treatment with EC first-line, for AF and AFL. METHODS AND DATA: We developed a
decision-tree model of the treatment of AF and AFL using outcome probabilities
from a Phase III clinical trial. The resource use was based on the literature
and physician clinical judgment. The resource costs were based on Medicare and
hospital charge data adjusted by Medicare cost-to-charge ratios. RESULTS: For
AF, a stepped treatment regimen of ibutilide followed by EC second-line is
cheaper by $260 (95% CI: -$658, $27) and has a higher conversion rate (0.92 vs
0.78) than treatment with EC first-line. For AFL, the stepped treatment regimen
results in a cost reduction of $395 (95% CI: -$685,-$206) and an increase in
conversion rate (0.98 vs 0.86). Monte Carlo simulation showed that the stepped
therapy was cheaper for 96 percent of AF patients and 100 percent of AFL
patients. CONCLUSIONS: A stepped treatment regimen of ibutilide followed by EC
second-line is both less expensive and more effective than treatment with EC
first-line for AF and AFL. Our study illustrates cost- effectiveness analysis of
a stepped therapy and provides guidelines for performing Monte Carlo simulations
and presenting sensitivity results for such analyses.
Abstract #: CD3
COMPARISON OF CANADIAN AND UNITED STATES COSTS
AND OUTCOMES IN THE TREATMENT OF ANEURYSMAL SUBARACHNOID HEMORRHAGE
Glick, H, Polsky, D., Willke, R, Schulman, K,
University of Pennsylvania, Philadelphia, PA, Pharmacia and Upjohn Inc.
Kalamazoo, MI
Objective: Using data from a randomized trial of
tirilazad mesylate we assess the differences between Canada and the U.S. in
resource utilization and outcome in the treatment of aneurysmal subarachnoid
hemorrhage during both initial hospitalization and post-discharge periods.
Methods: Of the 877 patients randomly assigned to one of three treatment groups,
194 were enrolled in Canada and 683 were enrolled in the U.S. We analyze the
difference between countries in patient characteristics, resource utilization,
costs, and outcomes by comparing means and the 95% confidence interval around
the difference in means. We also predicted utilization with multivariate
regression analysis. Results: Average hospital stay was 4.7 days (95% CI,
1.1-8.2) longer in Canada. In general, however, hospital stays in Canada were
substantially less intensive. Patients treated in Canada spent 4.1 days (95% CI,
-6.5 to -1.7) fewer in nursing homes and rehabilitation centers than did those
in the U.S in the 90 days post- randomization. The average cost of care in the
U.S., using U.S. unit costs, was $11,234 more than in Canada (95% CI, $5,204 to
$17,046). Using Canadian unit costs for Canada the cost difference increased to
$15,328 (95% CI, $9,759 to $20,898). There were no statistically significant
differences among the outcomes of Glasgow Outcome Score, death, and occurrence
of vasospasm. When controlling for differences in the severity of illness at
randomization, the results remained qualitatively the same. Conclusion: We found
that the apparent difference in length of stay between the countries was due to
a shift in the sites of formal care rather than in the number of days of this
care. We found no significant difference in outcomes to justify the additional
costs of care in the U.S. We also found that costs for the initial
hospitalization in the U.S. were substantially higher than those in Canada
despite the shorter lengths of stay.
Abstract #: CD4
CHANGES IN UTILIZATION OF A RETROSPECTIVE
COMPARISON OF ACE INHIBITORS IN PATIENTS WITH HEART FAILURE AFTER DISSEMINATION
OF GUIDELINES
Nguyen, M.H.1, Patterson, H.K. 1, Dlutowski, M.J.
1, Duong, P.T. 2, Johnson, N.E. 1, Stang, P.E. 2
1Office of Health Policy and Clinical Outcomes,
Thomas Jefferson University, Philadelphia, PA, USA. Hospital, 2SmithKline
Beecham Pharmaceuticals, Collegeville, PA, USA. Office of Health Policy and
Clinical Outcomes
Despite its proven efficacy in congestive heart
failure (CHF), there is some evidence which suggests an underutilization of ACE
inhibitor therapy in patients with CHF. In June of 1994, AHCPR CHF Gguidelines
for the management of patients with heart failure were published by the Agency
for Health Care Policy and Research (AHCPR) in 1994 were established to to
assist clinicians physicians in the management of patients with left left heart
failure. and as a means of reducing unexplained variation in clinical practice.
Guideline implementations can produce better patients outcomes. Despite the
proven efficacy of ACE Inhibitor (ACEI) therapy in patients with left heart
failure, there is evidence suggesting that ACEI therapy has been underutilized
in these patients.
OBJECTIVE: The purpose of this study wasisto
evaluatecompare the use trends of ACEIInhibitor usage for and treatment outcomes
of patients hospitalized with exacerbations of for heart failure CHFafter over a
one year period following the AHCPR publication of the AHCPR guidelines were
disseminated. METHODS: Patients admitted to the hospital with congestive heart
failure between 1994 and 1995 were identified from our clinical and financial
accounting database using ICD-9-CM codes for CHF (428.0) and with DRG code 127
DRG codes for heart failure and shock (127)and ICD-9-CM code 428.0 for CHF were
identified from our clinical and financial accounting database. We randomly
selected and conducted a retrospective chart review of a sample of 50 patients'
charts from each year to determine eligibility and use ACEIInhibitortherapy.
eligibility and usage in 1995 and compared to the utilization reported in the
previous year. Additional data were collected for all identified
encountersextracted which including ed disease severity of illness, length of
hospital stayLOS, resource utilization and re-admission rates. RESULTS:
LOS
(days)Re-admission RateDischarged Alive
1994 (n=208)6.713%96.2%
1995 (n=198)7.710.1%94.5%The use of ACEI for
eligible patients increased in the year after the AHCPR guidelines were
published. In 1995, 85% of eligible patients were discharged on ACEI Inhibitor
therapy compared with onlyto 61% of patients in 1994. The LOS remained
consistent for the two period. CONCLUSION: There appearsseems to be a trends
towards increased utilization of ACEIInhibitorsamong eligible patients with no
difference in LOS (excluding outliers) with decreased re-admission rates at our
hospital., as recommended by the guidelines among eligible patients at our
University Hospital
Abstract #: CD5
UTILITY VALUES FOR HEALTH STATES ASSOCIATED
WITH CARDIOVASCULAR DISEASE: A COMPARISON OF VISUAL ANALOG SCALE, TIME TRADEOFF
AND STANDARD GAMBLE TECHNIQUES.
Bagchi, I, Taylor, TN, University of Iowa, Iowa
City, IA, USA
OBJECTIVE: The objective of this study was to
evaluate the use of the New York Heart Association (NYHA) functional
classification for measuring utilities for health states associated with
cardiovascular diseases. METHOD: The subjects for this study were 41 students
from the College of Pharmacy who were presented with a simplified, four-state
scenario for cardio-vascular diseases, based on the NYHA functional
classification. Utility assessments were conducted by two interviewers using a
computer program and a standardized protocol. Test-retest reliability was
determined by correlation analysis. Regression analysis was used to identify
factors explaining variation in utility scores. RESULTS: The utility scores were
as follows:
No
LimitationSlight limitationModerate
LimitationMarked Limitation
Visual Analog Scale88.6 (+7.5)65.9 (+10.0) 42.6
(+12.0)21.1 (+10.9)
Time Tradeoff89.5 (+12.3)78.7 (+17.0) 64.0
(+23.5)39.5 (+27.0)
Standard Gamble93.7 (+7.2)85.7 (+11.0) 72.2
(+16.4)47.3 (+26.0)For each health state, the mean utility values obtained by
the three instruments were in the following order: SG>TTO>VAS, consistent with
the literature. For each instrument, progressively better health states were
associated with higher mean utility scores. The VAS exhibited higher test-retest
reliability than TTO or SG though the number of subjects completing a second
interview was small (n=12). Neither age nor gender were found to affect the
scores. Interviewer effects were found to exist for TTO and SG, but not for the
VAS scores. CONCLUSION: It is concluded that a simplified four-state scenario
based on the NYHA classification, is useful for measuring utilities for health
states associated with cardiovascular diseases.
Abstract #: CD6
THE SOCIOECONOMICAL EFFICIENCY OF THE
TREATMENT OF CHRONIC VENOUS INSUFFICIENCY USING AN ASCIN CONTAINING DRUG
COMPARED WITH COMPRESSION THERAPY
Rappenhoner, B, Bachinger, A, Pfeil, T, Rychlik,
R. Institute of Empirical Health Economics, Altenberger-Dom-Strasse 16, D-51519
Odenthal, Germany
OBJECTIVE: Both direct and indirect costs
incurred by treatment of chronic venous insufficiency including qualitiy of life
in Germany were illustrated on the basis of a cost utility analysis comparing
compression therapy to an ascin containing drug.
By means of a decision tree analysis these two
alternative clinical treatments were compared. METHODS: First a period of one
year was considered, then the results were projected for a period of 10 years.
The analysis is based on a simple blind, placebo-controlled, randomized clinical
study. The benefit of these clinical treatments was defined as improvement of
quality of life compared to placebo and measured in quality-adjusted life-years
(QALY). RESULTS: For drug application both direct and indirect costs amount to
DM 1,.370.45. The direct and indirect costs of compression therapy amount to DM
1,512.12. The enhanced quality of life compared with placebo for drug therapy
revealed 0.1074 QALY and for compression therapy 0.0278 QALY. To enhance
qualitiy of life by one QALY, the following costs are incurred: drug DM
14,079.32, compression therapy DM 433,126.62. Projected for 10 years, costs for
drug application have been calculated at DM 123.702,51 for compression therapy
at DM 433,126.62. A sensitivity analysis reveals that even if compression
therapy is successful, costs of drug application per QALY will be lower than
those of compression therapy at any presumption. CONCLUSION: Considering the
implementation of quality of life (QALY) costs incurred by treatment of chronic
venous insufficiency with drug compared to those for compression therapy will be
lower, although the individual evaluation of direct and indirect costs revealed
cost reduction more for compression therapy.
Economic and Outcomes Issues in Managed Care, Pharmacy Benefit Management, and
Government
Abstract #: EO01
ECONOMIC ANALYSIS: CARBOPLATIN
VERSUS CISPLATIN IN LUNG AND OVARIAN CANCER
Khan, ZM, Rascati, KL, Smeeding, J,
Koeller, J, The University of Texas, Austin, TX, US
The purpose of this study was to
conduct a resource utilization and an economic analysis on the use of
carboplatin versus cisplatin over multiple cycles in lung and ovarian cancer.
OBJECTIVE: The objective was to measure and compare direct medical resource
utilization and costs associated with carboplatin and cisplatin administration
over three to six courses of treatment. METHOD: The perspective of this one-year
prospective, multi-center, cost-minimization evaluation was that of the
provider. A convenience sample of 16 sites representing a mix of cancer centers,
outpatient clinics, medical centers, and managed care sites participated.
Individuals involved with data collection at all sites were trained via on-site
and/or teleconference training. Site visits were made to assure reliability of
at least 0.80. Data were collected and compiled via a fax transmission process
that scans directly through optical mark and character recognition into a
computer data base. Outcome measures included costs of: medications, emergency
room visits, physician/clinic visits, home health care visits, transfusions,
special procedures, consultations, hospitalizations, and other/miscellaneous
costs. RESULTS: Of 220 patients, 164 met the study criteria (response rate=75%)
with 95 patients in the carboplatin group and 69 in the cisplatin group (average
numbers of courses were 4.5 for both groups). The average number of visits per
patient were as follows for carboplatin and cisplatin respectively:
hospitalizations - 0.25 vs. 0.28; clinic visits - 0.95 vs. 1.67; ER visits -
0.11 vs. 0.09; and lab visits - 5.70 vs. 5.20. All outcome variables and their
costs will be presented. CONCLUSION: When evaluating the costs of different drug
therapies, it is important to evaluate other relevant costs associated with the
treatment.
Abstract #: EO02
Costs and antihyperglycemic drug use
over 8 years among HMO members newly diagnosed with type 2 diabetes (DM2) Brown
JB1, Glauber HS1, Nichols GA1, Bakst AW2, 1Kaiser Permanente Center for Health
Research (KPCHR) Portland, OR, US and 2SmithKline Beecham Pharmaceuticals,
Collegeville, PA, US
Brown JB1, Glauber HS1, Nichols GA1,
Bakst AW2, 1Kaiser Permanente Center for Health Research (KPCHR) Portland, OR,
US and 2SmithKline Beecham Pharmaceuticals, Collegeville, PA, US
There is a lack of information about
long-term patterns of antidiabetic drug use. Objective:
To describe patterns of antidiabetic
drug use over an eight year period and evaluate costs of antidiabetic drug
utilization in a large diabetic population. Method: In 1987, KPCHR began a
registry of all members with diabetes, identified primarily from hospital
discharge diagnoses and purchases of drugs and testing supplies. For the
purposes of this study, decision rules were established to identify DM2 registry
patients. Drug utilization data was obtained from records of drugs dispensed
from Kaiser pharmacies during the first quarter (Q1) of each eight calendar
years (1988-1995). Results: Of 1014 HMO members newly identified as DM2 in Q1
1988, 10% used no antidiabetic drug (NRX), 79% used sulfonylureas (SU) only, 9%
used insulin (I) only, and 2% used both I and SU. Over the 8 year period the
percentage of HMO members from the initial cohort transitioning to I therapy and
SU + I had doubled. By 1995, 29% of the original cohort had died, 19% used NRX,
31% used SU only, 19% used I only, and 3% used SU + I. There was also a trend
towards increasing SU dosage over time. In a separate analysis of all DM
patients in 1995, the average annual antidiabetic drug/supply costs for patients
receiving SU was $207 compared to $439 for I only patients and $511 for SU + I
patients. Conclusions: Improved glycemic control of patients would reduce the
rate of transition to insulin therapy in DM2 patients and may reduce diabetic
drug and supply costs.
Abstract #: EO03
ANTIDIABETIC DRUG USE AND COSTS OVER
8 YEARS AMONG HMO MEMBERS NEWLY DIAGNOSED WITH TYPE 2 DIABETES (DM2)
Brown, JB1, Glauber HS1, Nichols GA1,
Bakst AW2, Kaiser Permanente Center for Health Research (KPCHR), Portland,OR, US
and SmithKline Beecham Pharmaceuticals, Collegeville, PA, US
There is a lack of information about
long-term patterns of antidiabetic drug use. OBJECTIVE: To describe patterns of
antidiabetic drug use over an eight year period and evaluate costs of
antidiabetic drug utilization in a large diabetic population. METHOD: In 1987,
KPCHR began a registry of all members with diabetes, identified primarily from
hospital discharge diagnoses and purchase of drugs and testing supplies. For the
purposes of this study, decision rules were established to identify DM2 registry
patients. Drug utilization data was obtained from records of drugs dispensed
from Kaiser pharmacies during the first quarter (Q1) of each eight calendar
years (1988-1995). Results: Of 1014 HMO members newly identified as DM2 in 1Q
1988, 10% used no antidiabetic drug (NRX), 79% used sulfonylureas (SU) only, 9%
used insulin (I) only, and 2% used both I and SU. Over the 8 year period, the
percentage of HMO members from the initial cohort transitioning to I therapy and
SU+I had doubled. By 1995, 29% of the initial cohort had died, 19% used NRX, 31%
used SU only, 19% used I only and 3% used SU+I. There was also a trend towards
increasing SU dosage over time, In a separate analysis of all DM patients in
1995, the average annual antidiabetic drug/supply costs for patients receiving
SU was $207 compared to $439 for I only patients and $511 for SU+I patients.
Conclusions: Improved glycemic control of patients would reduce the rate of
transition to insulin therapy in DM2 patients and may reduce diabetic drug and
supply treatment costs.
Abstract #: EO04
Antidepressant Therapy in a Mental
Health Managed Care Setting
Conner TM1, Trott J2, Rascati KL1 The
University of Texas at Austin, USA1 The University of Texas at San Antonio, USA2
The newer antidepressant drugs
available today are reported to be highly efficacious in reducing depressive
symptoms and cause few side effects to the patient. However, few studies have
been conducted on these newer drugs in "real-world" settings. OBJECTIVES &
METHODS: In a retrospective review of medical records, we examined drug
treatment for major depression at a mental healthcare organization.
Specifically, we sought to describe 1) which antidepressant drugs were most
frequently prescribed at initial outpatient visit; 2) how often dose (other than
initial titration) or drug changes were made within six months of initial
treatment; 3) how often these therapy changes were made because of side effects;
and 4) how often adjunct therapy was prescribed for reported side effects from
the antidepressant therapy. We identified 335 new patients with major depression
who began treatment between September 1, 1995 and August 31, 1996. RESULTS: One
hundred forty-four (43%) medical records have been reviewed. Of these,
forty-seven met study criteria and have been analyzed. Preliminary results show
that approximately 62% of patients were prescribed either fluoxetine (14 of 47)
or sertraline (15 of 47) as first-line therapy; each patient averaged 1.4 (s.d.
1.10) dose or drug changes over a six- month period; approximately 40% of
therapy changes were made because of reported side effects; and adjunct therapy
was documented to have been prescribed for one patient specifically for a side
effect from antidepressant therapy. CONCLUSION: Further analysis on a larger
sample size is currently being conducted. Preliminary findings suggest that
adjunct therapy for side effects of antidepressants is not common in this
setting. Implications for future research, including cost analysis, will be
discussed.
Abstract #: EO05
HEALTH-RELATED QUALITY OF LIFE OF
ADULT ASTHMATIC PATIENTS: A SURVEY OF ENROLLEES OF A MCO IN A LARGE METROPOLITAN
AREA.
Kong, SX, Dedhiya, SD, G.D. Searle &
Co. Skokie, IL, US.
Each year 9 to 12 million people suffer
from asthma in the US. Asthma remains a chronic condition that has a significant
effect on patients' personal and social life. OBJECTIVE: To evaluate the general
and disease specific health-related quality of life (HQL) of asthmatic patients
and to examine the major factors that may have a significant impact on the HQL.
METHODS: Adult asthmatic patients (N=480; age Ņ 17) living in a large
metropolitan area were identified from the computerized claims database of a
large HMO. A mail questionnaire survey which included the SF-36 Health Survey to
measure generic HQL and the Asthma Quality of Life Questionnaire (AQLQ) for the
asthma-specific HQL, was developed. Other variables included perceived asthma
severity, impact on sleep, support from family members and friends, health care
resource utilization (e.g., ER visits, hospitalization), work days lost and
demographic variables. Regression analysis was used to identify the significant
predictors of different domains of generic and asthma disease-specific HQL.
RESULTS: A 42% response rate was achieved. The average age of the respondents
was 39.4 (SD, 12.6) years. About 76% were female; 49% were black, and 33% were
white; 27% were smokers, 27% were ex-smokers, and 46% had never smoked. Female
patients reported lower scores on several domains of the SF-36 and AQLQ although
there were no significant gender-related differences with respect to other
variables measured. Patients with lower HQL scores reported significantly
greater health care resource utilization and had incurred more loss in work
days. CONCLUSIONS: Asthma can significantly reduce patient HQL measured by both
generic and disease-specific instruments. There is a strong correlation between
the HQL scores measured by the two instruments. Patients with lower HQL scores
consumed more health care resource and had more work days lost.
Abstract #: EO06
INCIDENCE OF FRACTURES IN MEN AND
WOMEN FIFTY PLUS YEARS OF AGE
Wisner, C, Abbott, T. Fischer, L,
Berger, M,
HealthPartners, Minneapolis, MN, US,
Merck & Co., Inc. West Point, PA, US
This study determined the incidence of
fractures, pulmonary embolism and pneumonia in health plan enrollees over fifty
years old. STUDY DESIGN: Enrollees were assessed for incidence of one of ten
fracture types categorized into central (hip and pelvis) and appendage (femur,
patella, ankle, tibia/fibula, proximal humerus, other humerus, distal forearm,
and radius/ulna) fractures, pulmonary embolus, and pneumonia. Comparisons were
made between men and women, fifty to sixty-four years and sixty-five plus years.
RESULTS: In both age groups, women were twice as likely to experience fractures
as men (.009 vs. .005 and .02 vs. .01, respectively). For both sexes, the
incidence of fractures doubled in the older group. Complications of pulmonary
embolus were experienced by six in the older female group (n=694) compared to
one in the comparison group (drawn from a population with no fractures). Males
had one incidence of pulmonary pneumonia compared to four in the comparison
group. Males in the older group (n=217) had eleven cases of pneumonia after the
fracture. CONCLUSION: Women are much more likely than men to experience
fractures of all kinds in all age groups. Women also appear more likely to
experience complications related to the fracture, particularly older women.
This study determined the incidence of
fractures, pulmonary embolism and pneumonia in health plan enrollees over fifty
years old. STUDY DESIGN: Enrollees were assessed for incidence of one of ten
fracture types categorized into central (hip and pelvis) and appendage (femur,
patella, ankle, tibia/fibula, proximal humerus, other humerus, distal forearm,
and radius/ulna) fractures, pulmonary embolus, and pneumonia. Comparisons were
made between men and women, fifty to sixty-four years and sixty-five plus years.
RESULTS: In both age groups, women were twice as likely to experience fractures
as men (.009 vs. .005 and .02 vs. .01, respectively). For both sexes, the
incidence of fractures doubled in the older group. Complications of pulmonary
embolus were experienced by six in the older female group (n=694) compared to
one in the comparison group (drawn from a population with no fractures). Males
had one incidence of pulmonary pneumonia compared to four in the comparison
group. Males in the older group (n=217) had eleven cases of pneumonia after the
fracture. CONCLUSION: Women are much more likely than men to experience
fractures of all kinds in all age groups. Women also appear more likely to
experience complications related to the fracture, particularly older women. This
study determined the incidence of fractures, pulmonary embolism and pneumonia in
health plan enrollees over fifty years old. STUDY DESIGN: Enrollees were
assessed for incidence of one of ten fracture types categorized into central
(hip and pelvis) and appendage (femur, patella, ankle, tibia/fibula, proximal
humerus, other humerus, distal forearm, and radius/ulna) fractures, pulmonary
embolus, and pneumonia. Comparisons were made between men and women, fifty to
sixty-four years and sixty-five plus years. RESULTS: In both age groups, women
were twice as likely to experience fractures as men (.009 vs. .005 and .02 vs.
.01, respectively). For both sexes, the incidence of fractures doubled in the
older group. Complications of pulmonary embolus were experienced by six in the
older female group (n=694) compared to one in the comparison group (drawn from a
population with no fractures). Males had one incidence of pulmonary pneumonia
compared to four in the comparison group. Males in the older group (n=217) had
eleven cases of pneumonia after the fracture. CONCLUSION: Women are much more
likely than men to experience fractures of all kinds in all age groups. Women
also appear more likely to experience complications related to the fracture,
particularly older women.
Abstract #: EO07
THE COST OF OSTEOPOROSIS RELATED
FRACTURES IN WOMEN AGED 50-64Abbott, T, Wisner, C, Rizzo, J, Fischer, LR,.
Amundson, G, Hedblom B, and Berger, M, Merck and Company, Inc. West Point, PA,
USA and Health Partners, Minneapolis, MN, USA
Abbott, T, Wisner, C, Rizzo, J,
Fischer, LR,. Amundson, G, Hedblom B, and Berger, M, Merck and Company, Inc.
West Point, PA, USA and Health Partners, Minneapolis, MN, USA
Osteoporosis is a chronic condition
characterized by increased risk of fracture. Each year an estimated 1.3 million
fractures can be associated with osteoporosis. Estimates of the direct medical
cost of these fractures exceed $10 billion. OBJECTIVE: To assess the time
pattern of health care expenditures associated with osteoporotic fracture and
determine if there are important long term impacts. METHODS: Women between ages
50 and 64 continuously enrolled in a large Midwestern MCO from 1/93 to 12/95
were studied for osteoporosis related fractures. Cases were identified as
incident fracture of the hip, pelvis, femur, patella, ankle, tibia, proximal
humerus, other humerus, forearm, or ulna. Cases were matched like aged control.
All charges for cases and controls were collected for a total of 18 months
beginning 6 months prior to fracture. These charges were subsequently divided
into three time periods: baseline (6 months prior), acute (first 3 months), and
chronic (remaining 9 months). RESULTS: During the baseline period, those women
who subsequently fractured had substantially higher health care utilization
($330 per month compared to $190). During the acute phase, costs increased
dramatically for cases ($1719 per month). During the chronic phase, women who
fractured continued to have increased health care utilization compared to
baseline ($427 per month). CONCLUSIONS: First, women who fracture tend to have
higher utilization of health care resources than women who did not fracture.
Second, there is an increase in utilization even after accounting for acute
care. Third, current estimates of the total burden of illness which focus on
acute care may dramatically underestimate the true costs.
Abstract #: EO08
OLDER WOMEN AND THE RISK OF
FRACTURES
Fischer, L, Wisner, C., Abbott, T.,
Amundson, G., HealthPartners, Minneapolis, MN, US, Merck & Co., Inc. West Point,
PA, US
OBJECTIVE: This paper addresses two
questions: Are older women who experience fractures sicker and more impaired
than an age-matched sample of women without fractures? What is the impact of
fractures on health outcomes for older women? STUDY DESIGN: Samples were drawn
of women age 65+ enrolled in a Social HMO which was part of a large HMO in the
Twin Cities, Minnesota. Women who experienced fractures were compared to a
sample of women without fractures, matched by age. Data were drawn from health
status surveys before and after the date of fracture (fracture N = 42; matched N
= 126). Four variables were examined: health status, ADLs, IADLs, and falls. The
analyses compared age-matched samples and: (1) a general fracture sample, (2) a
central fracture sample (hip and pelvis), and (3) an appendage fracture sample
(non-hip femur, patella, ankle, tibia/fibula, proximal humerus, other humerus,
distal forearm, radius/ulna). RESULTS: Preliminary analyses indicate older women
with central fractures, compared to the matched sample without fractures, were
significantly more likely to report health and functional problems both before
and after the fracture. No differences in health or functional status were found
in any of the comparisons of the appendage fracture group. Women with fractures
were more likely to have had falls. Both the fracture and matched samples tended
to have more functional deficits in the later time period. CONCLUSION: Older
women and health and functional impairments are especially at risk for central
fractures (hip and pelvis). There is also an aging effect. In this small sample,
we were not able to detect an impact of fractures on health outcomes.
Abstract #: EO09
Academic detailing to affect market
share of hmg-coa reductase inhibitors
Benson, SR, Torborg, SA, Boreen, DM,
Magda, JJ, Burns, KD, Waltermire, RD, Pharmacy Gold INC., St. Paul, MN, US.
OBJECTIVES: To determine if academic
detailing could influence physician prescribing patterns for HMG-CoA reductase
inhibitors in the setting of a 1.5 million patient BlueCross BlueShield plan.
Methods: This product strategy was the second phase of our Prime TherapeuticsØ
program. We targeted top prescribers as well as top clinics throughout the
state. The focus of the strategy was to shift patients from Mevacor and Zocor to
Lescol, our preferred agent, or Pravachol as a cost effective alternative. The
clinics were contacted by a clinical pharmacist and a presentation was given
which detailed the benefits of the program and cost effectiveness of the
preferred products. Quarterly reports of clinic and individual physician
prescribing patterns were presented to the group. Follow-up material included
patient lists of those taking the targeted agents. Results: We report on the
results of 16 clinics which included 216 physicians who were given the
presentation before the end of 3rd quarter 1996. The market share for Lescol
changed from 16.9% to 20.1% (19% relative increase) from 2nd quarter to 3rd
quarter. Pravachol market share rose by 0.6%, while Mevacor and Zocor had
decreases in market share of 3.5% and 0.2% respectively. This market share shift
corresponded to a projected annual savings of $70,000 for these 16 clinics. When
extrapolating to the remainder of our targeted clinics, the total cost savings
to the plan would be approximately $300,000 annually. Conclusion: Academic
detailing is an effective technique to influence physician prescribing patterns
and shift market share. This method has high physician acceptance and is cost
effective to the PBM.
Abstract #: EO10
EFFECTS OF ACADEMIC DETAILING ON
THERAPEUTIC SELECTION AND UTILIZATION OF ACE INHIBITORS
Torborg SA*, Benson SR , Juge D and
Waltermire RD, Pharmacy Gold Inc., St. Paul , MN, U.S.A.
OBJECTIVE: To explore the utility of
academic detailing for lowering drug expenditures in the angiotensin converting
enzyme (ACE) inhibitors class and addressing under-utilization of this class for
appropriate therapeutic indications. METHODS: ACE inhibitor prescribing
represented the initial focus of a multi-step academic detailing program
designed to influence physician prescribing within a 1.5 million member
BlueCross BlueShield Plan. Physicians and Clinics in the top 20% for ACE
inhibitor costs were targeted. The strategy was to shift prescribing from
Vasotec and Capoten to a less costly alternative such as Zestril. Information
about ACE inhibitor use for patients with congestive heart failure, post
myocardial infarction and diabetic nephropathy was presented along with the cost
information to stimulate appropriate utilization for these indications. Clinic
and individual prescribing data were presented at all meetings. Each physician
received an individual report and patient list following the meeting. Physicians
that were not part of a targeted clinic were contacted directly. RESULTS: By the
end of 3rd quarter 1996 we had presented to 70/379 (18.5%) of the clinics in the
HMO network. Of the top 20% of targeted physicians, we had contacted
approximately 80%. Overall market share for Zestril improved from 28.2% to 35.3%
with a decrease for Vasotec of 36.6% to 30.5%. Capoten decreased from 11.1% to
1.8%. Overall ACE inhibitor utilization for the plan increased by 10% in this
same period. CONCLUSION: Academic Detailing is an effective and well received
method for affecting physician prescribing patterns in the ACE inhibitor class.
Significant market share changes and cost savings were realized while
utilization of the class increased through the first three quarters of 1996.
Abstract #: EO11
COST EFFECTIVENESS OF RETROSPECTIVE
DRUG UTILIZATION REVIEW
Benson, SR, Burns, KD, Waltermire, RD,
Pharmacy Gold, INC., St. Paul, MN, US.
OBJECTIVES: To determine if operation
of our retrospective drug utilization program called Gold Advantageń could
result in direct cost savings for a 5,000 member employer group. METHODS:
Pharmacy and medical claims data for all patients in the employer group were
analyzed on a monthly basis. Five areas for intervention are examined: 1)
drug-disease interactions, 2) drug-drug interactions, 3) over and
under-utilization, 4) duplication and 5) duration. Each case is assigned a risk
priority score (RPS) which estimates the likelihood of the patient being
hospitalized due to the alert. The top 10% of cases are then reviewed by a
clinical pharmacist. If the alert is deemed clinically significant, a letter is
mailed to the prescribing physician and the pharmacist. This letter includes an
explanation of the program, the patient's drug profile and an evaluation form to
be returned to Pharmacy Gold, Inc. Using the evaluation forms, we can estimate
the cost savings based on therapeutic intervention by the provider. RESULTS: As
of 10/1/96, we had analyzed approximately 117,000 claims at a cost of $18,720.00
to the employer group. We mailed out 249 alert letters to providers with 164
(65%) returning the evaluation forms. Of these 164, 29.9% responded that they
would change or stop the patient's therapy. The total potential cost savings for
all 249 letters was $157,500.00. Therefore, the cost savings can be estimated as
follows: $157,500 X 164/249 X 0.299 = $31,017.00. The direct benefit to the
employer group is then $31,017.00 - $18,720.00 = $12,297.00. CONCLUSION: The use
of Gold Advantageń as a retrospective drug utilization program can result in
substantial direct cost savings for the client.
Abstract #: EO12
ELECTRONIC CASE IDENTIFICATION FOR
MANAGED CARE OUTCOMES STUDIES: ASSESSING THE RELIABILITY OF PHARMACEUTICAL
CLAIMS DATA, DIAGNOSIS CODES AND PROCEDURE CODESDuChane, J, Grebosky, B, Gunter,
M, Brixner, D, Von Worley, A, Lovelace Clinic Foundation, Albuquerque, NM,
Novartis Pharmaceutical Corporation, Summit, NJ, US
DuChane, J, Grebosky, B, Gunter, M,
Brixner, D, Von Worley, A, Lovelace Clinic Foundation, Albuquerque, NM, Novartis
Pharmaceutical Corporation, Summit, NJ, US
OBJECTIVE: The purpose of the study was
to select and evaluate the reliability of an indicator or group of indicators
that can be used to electronically identify managed care patients for inclusion
in an epilepsy outcomes study. METHOD: Patients were identified electronically
whose records over an 18-month period included: 1) use of an antiepileptic
medication and/or, 2) a diagnosis pertaining to epilepsy or convulsions, and/or
3) a procedure relating to epilepsy. The selected patients were then grouped
into 12 subcategories such as, those using one antiepileptic medication alone,
those using one medication combined with the presence of one diagnosis code,
those with the presence of one diagnosis code alone, etc. A predictive value was
assigned to each of the 12 subcategories. Verification of a patient's seizure
disorder was provided by correspondence with the patient's physician and through
manual chart reviews. RESULTS: A total of 2,756 patients were identified
electronically as potentially having seizure disorders. Preliminary results
indicate that the most reliable indicator was the combination of all three
electronic indicators. Diagnosis codes alone yield greater predictability than
do medications alone; procedure codes alone are highly unpredictable.
CONCLUSIONS: Patients with seizure disorders can be identified electronically by
combining information relating to three primary indicators with physician
verification and chart reviews. The use of medication alone was not found to be
a reliable method for identifying persons with seizure disorders.
Abstract #: EO13
METHODOLOGY FOR CALCULATING DOSING
RATIOS BETWEEN TARGETED DRUGS
BETWEEN TARGETED DRUGS
Bull, S, Shoheiber, O, Novartis
Pharmaceuticals, Summit, New Jersey, US.
Therapeutic interchange can be
associated with costly physician visits and patient dissatisfaction while
titrating to an effective dose. To help minimize these cost, enormous amounts of
money are often invested to determine therapeutically equivalent doses between
target drugs. Although randomized, double-blind, controlled clinical trials are
considered by many as the gold standard in establishing equivalent dosing
efficacy between drugs, they are extremely time consuming and expensive to
conduct. OBJECTIVE: The goal of this study is to test a retrospective
methodology for determining effective dosing ratios between drugs. METHODS: The
methodology uses retrospective longitudinal analysis of a large pharmacy claims
database. The analysis involves the following steps: 1) Identify patients who
switched between the two targeted medications; 2) Include patients with
longitudinal data that indicate "pre" and "post" switch dose stabilization; 3)
Calculate the preswitch-postswitch dose ratios. The following criteria can
affect the interpretation of the switch ratio: 1) Long gaps between refills. 2)
Unstable doses before and after the switch. 3) Titration of other medications
during the switch. 4) Overall integrity of claims data. RESULTS: From a sample
of 38 patients switched between Lotensin and Vasotec, approximately 20% of the
data was of value in determining a dosing ratio. From this data, the milligram
to milligram dose ratio between Lotensin and Enalapril was found to be 1.12:1.
This finding trends well with conversion ratios that were found to be effective
in other conversion protocols. DISCUSSION: This methodology can provide
organizations with an easy systematic way to establish dose switching
guidelines. Shortcomings associated with this approach are the lack of clinical
efficacy indicators, and the need of a large database to identify a significant
number of patients switched between the target medications.
Abstract #: EO14
Economic Outcomes Associated with
Initial Treatment Choice in Depression: A retrospective Database Analysis
Edgell, ET, Hylan, TR, Eli Lilly and
Company, Indianapolis, IN. US
Objective: The purpose of this study
was to examine the economic outcomes associated with initial treatment choice
faced by the physician and patient after a diagnosis of depression. Method: A
database containing 1990-93 patient-level clinical and financial information was
used to classify patients into one of four treatment cohorts: diagnosis-only,
psychotherapy, drug therapy, and combination therapy. Sample selection bias was
accounted for using a two-stage process where treatment choice was estimated
using a multinomial logistic regression model in the first stage. From this
model, a decreasing function of the probability of receiving treatment, the
Inverse Mills Ratio (IMR), was calculated. The IMR was then included as a
covariate in second stage regression equations estimating total costs. Log
predicted costs from the second stage were compared across all observations and
in observations whose initial provider was a non-mental health physician to
determine the relative costs associated with each cohort. REsults: Significant
differences (p < 0.008) in total costs were found between the combination
therapy and psychotherapy cohorts in the analysis that included all observations
(n = 9,110). In the analysis that included patients who initiated therapy with a
non-mental health physician (n = 2,673) the drug therapy cohort was found to be
significantly more costly as compared to the diagnosis-only cohort. Conclusions:
There is not a significant difference in total health costs between depressed
patients who initiate treatment with psychotherapy and depressed patients who
initiate treatment with drug therapy.
Abstract #: EO15
COST AND USE FOR SELECTED DISEASES
AND CONDITIONS: OPPORTUNITIES FOR DISEASE MANAGEMENT?
Holzer S, Marder W, Ozminkowski RJ,
Peters J. The MEDSTAT Group
OBJECTIVE: The purpose of this research
was to analyze the prevalence, utilization, and expenditures for patients with
12 different diseases and conditions thought to be common and costly to private
payers in the United States: asthma, coronary artery disease,
cholecystitis/cholelithiasis, depression, diabetes, hypertension, low back pain,
otitis media, pneumonia, sinusitis, upper respiratory infection, and urinary
tract infection. We sought evidence that might identify opportunities for
minimizing variation in healthcare costs. METHOD: We used the linked Medical-Rx
MarketScanØ database from 1992 through 1994. We identified study patients based
on their having been diagnosed with each disease or condition under study, using
a detailed clinical algorithm. Disease-specific and general medical and drug
claims data were aggregated for each patient. We compared patients within each
disease or condition group to other persons without the disease who submitted
claims to MarketScanØ clients. RESULTS: Prevalence of these conditions ranged
from a low of 7 per 1,000 for cholecystitis and cholelithiasis, to a high of 195
per 1,000 for upper respiratory infection. Combined, these conditions represent
more than 330,000 total cases. The disease-specific costs of these conditions
totalled more than $164 million in 1994, or nearly 22 percent of the total
healthcare expenditures for MarketScan enrollees. The total healthcare payments
for the patients with each disease or condition were 1.5 -2 times higher than
the payments for patients without each disease or condition. Variation in
prevalence and expenditures over time and evaluation of the proportion of
patients contributing to the proportion of healthcare dollars will be presented.
CONCLUSIONS: The prevalence, utilization, and expenditure variation among
patients with these disease leads to differential opportunities for disease
management approaches.
Abstract #: EO16
PROBLEMS IN PHARMACOECONOMIC STUDY
SAMPLE SELECTION
Strauss, BM, Smith, ME, Schwartz, L,
Linde-Zwirble,W, Newbold,RC, Lidicker, J
Bayer Corporation, West Haven, CT,
Health Process Management, Doylestown, PA. US
Controlled trials have strict selection
criteria to limit case-mix differences in order to evaluate specific
interventions. However, this may result in study populations that are
systematically different from 'real world' patients, treated in clinical
practice. The utility of pharmacoeconomic information from such prospective
studies is at best suspect. Retrospective studies using billing claims data sets
can illuminate this situation. OBJECTIVE: To examine differences in demographic
characteristics of hypertensive patients in PA Medicaid when applying a set of
prospectively designed exclusion criteria in a retrospective cost study. METHOD:
15-months of 1994-96 PA Medicaid claims data were reviewed for hypertensive
patients receiving at least one prescription for a Calcium Channel Blocker
(CCB). A subset of patients were selected for inclusion in a cost study. Entry
was restricted by age, eligibility, choice of CCB, a CCB-free period, and change
in CCB. Patient demographics were examined for five subgroups.
RESULTS:
Set Number % Female % Black Me an Ag e
(ye ars )
1-Starting 44,997 70.9% 29. 9% 61. 6
2-All criteria but age 1,058 69.8% 22.
0% 60. 3
3-All criteria 595 60.7% 27. 2% 49. 8
4-Adalat CC 176 60.2% 33. 0% 48. 5
5-Norvasc 419 60.8% 24. 8% 50. 4
Selecting age results in a large
decrease in percent Female. Selecting all criteria but age shows a significant
decrease in percent Black. CONCLUSION: This study reveals how prospectively
designed retrospective studies relying on claims data can be used to evaluate
patient exclusion criteria and selection biases inherent to controlled clinical
trials. Our selection process did produce a homogeneous sample representative of
the overall population.
Abstract #: EO17
PHARMACOECONOMIC ANALYSIS OF
VENLAFAXINE IN DEPRESSION
Einarson TR, Addis a, Iskedjian M,
Shane L. Faculty of Pharmacy, University of Toronto
OBJECTIVES. Cost effectiveness analysis
of drug groups in treating adults for acute major depressive disorder including
SNRIs (venlafaxine), SSRIs (fluoxetine, fluvoxamine, sertraline, paroxetine),
and TCAs (amitriptyline, imipramine, desipramine, nortriptyline). METHOD:
Decision tree model over six months was constructed using an expert panel. The
analytic viewpoint was for the Ontario Ministry of Health as payer for all
direct costs, derived from standard lists, including cost of drug, medical care,
laboratory costs, and treating adverse events (ADRs). Rates of success and
dropouts were determined from a meta-analysis of published ramdomized controlled
trials. Medine, Embase, and IPA were searched from 1984-1996, and references
from retrieved articles and reviews. Outpatients and inpatients were analyzed
separately. For SNRIs and TCAs, the backup drug was SSRIs; for SSRIs, it was
SNRIs. Expected cost and incremental cost per success were calculated. Threshold
analysis and Monte Carlo simulations tested sensitivity. RESULTS: Meta-analysis
identified 56 treatment arms from 36 randomized controlled trials on 2953
patients (2380 outpatients and 573 inpatients). SNRIs had highest success rates
and lowest dropout rates. For outpatients, expected costs were $4774, $5072, and
$6181 for SNRis, SSRIs, and TCAs, respectively. Cost per success was $6044,
$6633, and $9035, respectively. For inpatients, expected costs were $12,537, for
SNRIs, $12,914 for SSRIs, and $13,400 for TCAs; cost per success was $16,702;
$17,642; and $19,423, respectively. SNRIs were dominant for all incremental cost
effectiveness analyses. Sensitivity analyses confirmed the robustness for
outpatients, but sensitivity for outpatients on success rates. CONCLUSIONS:
Venlafazine is a cost effective drug for the treatment of major depressive
disorder in both outpatients and inpatients in Ontario.
Abstract #EO18
THE COST OF BEHAVIORAL DISTURBANCES
IN DEMENTIA TO LONG TERM CARE
O'Brien JA, Shomphe LA, Caro JJ, Caro
Research, Boston, MA. USA
Objectives. To examine the role
behavioral disturbances (BD) play in transitioning a resident with dementia to a
category of higher resource intensity. Methods. The Massachusetts (MA) Medicaid
Nursing Home Case-Mix system determines ten per diem reimbursement rates based
on a management minutes score that covers need for assistance with activities of
daily living and allows special attention categories, such as BD. After
assigning a score on admission, it is reassessed quarterly. Data from 1995 were
examined to identify the prevalence of BD in each of the ten rate levels and
those patients who transitioned to that level solely due to BD. Physician
consultation data were also explored as the cost of visits is not included in
the per diem rate. Results.. Of the 13,130 patients with dementia, 20% had
documented BD. The prevalence of BD in this population ranged from 0.9% in the
lowest rate level to 17.2% in the highest one. Of those with BD, 70% were in a
higher care level solely due to BD. This represents an additional annual cost of
1995 US$667,243 to Medicaid. Patients with BD required 12.5% more medical
consultations than those with dementia without BD. Conclusion. Although
institutionalization itself is often considered to be the final major cost
threshold for patients with dementia, it is clear that differential care costs
can be quantified relating to specific disease elements, such as BD. BD is an
identifiable cost factor in long term residential care. Controlling BD in a
institutionalized dementia population could lower the cost of that care.
Abstract #: EO18
THE COST OF BEHAVIORAL DISTURBANCES
IN DEMENTIA TO LONG TERM CARE
O'Brien JA, Shomphe LA, Caro JJ, Caro
Research, Boston, MA. USA
Objectives. To examine the role
behavioral disturbances (BD) play in transitioning a resident with dementia to a
category of higher resource intensity. Methods. The Massachusetts (MA) Medicaid
Nursing Home Case-Mix system determines ten per diem reimbursement rates based
on a management minutes score that covers need for assistance with activities of
daily living and allows special attention categories, such as BD. After
assigning a score on admission, it is reassessed quarterly. Data from 1995 were
examined to identify the prevalence of BD in each of the ten rate levels and
those patients who transitioned to that level solely due to BD. Physician
consultation data were also explored as the cost of visits is not included in
the per diem rate. Results.. Of the 13,130 patients with dementia, 20% had
documented BD. The prevalence of BD in this population ranged from 0.9% in the
lowest rate level to 17.2% in the highest one. Of those with BD, 70% were in a
higher care level solely due to BD. This represents an additional annual cost of
1995 US$667,243 to Medicaid. Patients with BD required 12.5% more medical
consultations than those with dementia without BD. Conclusion. Although
institutionalization itself is often considered to be the final major cost
threshold for patients with dementia, it is clear that differential care costs
can be quantified relating to specific disease elements, such as BD. BD is an
identifiable cost factor in long term residential care. Controlling BD in a
institutionalized dementia population could lower the cost of that care.
Abstract #: EO19
PHARMACOECONOMIC EVALUATION IN
JAPANESE PHARMACEUTICAL COMPANIES AND ITS USAGE IN GOVERNMENT POLICY DECISIONS
Ikeda, S, Inoue, S, Oliver, AJ,
Ikegami, N, Department of Health Policy and Management and Department of
Pharmacy, School of Medicine, Keio University, Tokyo, Japan
In Japan, as from August 1992, the
submission of materials derived from pharmacoeconomic evaluation have been
accepted at the time of new drug price negotiation. The pharmaceutical companies
generally consider their submitted materials to be private information.
Moreover, it is not clear how the government use these materials in their policy
decisions. OBJECTIVE AND METHOD: In this paper, for the purpose of understanding
the present condition of pharmacoeconomic evaluation in Japanese pharmaceutical
companies, the results from an investigative interview of selected employees at
twenty-two pharmaceutical firms are outlined. Also, an analysis of how the
submitted economic data is reflected in drug prices is undertaken. RESULTS: Our
analyses clarifies that in recent years an economic evaluation has been
submitted for most new pharmaceutical products. However, a clear connection
between the submitted economic materials and the issuing of a supplement to
deserving new products was not found. For example, the prices of sixty-eight
drugs with similar effectiveness were singled out by using a comparative method.
Of these sixty-eight products, forty-eight (71%) had undergone a submitted
economic evaluation. Five of the sixty-eight drugs were reported to offer
advantages in terms of added innovation or added usefulness, but an economic
evaluation had been submitted for only two of these five drugs. CONCLUSION: We
conclude that there is an urgent need to construct a system in which the results
of pharmacoeconomic evaluation can be appropriately used in government pricing
decisions.
Abstract #: EO20
Cost-Effectiveness of Azithromycin
for the treatment of Acute Otitis Media in a rural Population
Sansgiry Sujit S, Sansgiry Shubhada S,
Cady Paul S, Weldezghi Bernardos K, College of Pharmacy, Idaho State University,
Pocatello, ID. US
Acute Otitis Media (AOM) characterized
by the presence of fluid in the middle ear affects almost 50% of children below
the age of three. Amoxicillin, used predominately as the first line therapy for
the treatment of AOM, could fail either due to bacterial resistance or poor
patient compliance. Azithromycin is effective against beta-lactamase producing
bacteria, has a short duration of treatment, and once a day dosing regimen.
Objective: The purpose of this study was to compare the cost-effectiveness of
azithromycin with amoxicillin, trimethoprim/sulfamethoxazole (tmp/smz), and
erythromycin/sulfisoxazole (ery/sulfa) respectively, in the treatment of AOM.
Method: A decision analysis approach was used to develop models using three
drugs as initial therapies for the treatment of AOM. Idaho Medicaid Database
(IMD), a retrospective antibiotic prescription data and information obtained
from literature were evaluated. Efficacy rates were calculated by two methods
using weighted means for cure rates reported in the literature and success rates
calculated from the IMD. Drug cost was calculated by averaging retail
prescription price obtained from four local pharmacies and average cost per
prescription calculated from the IMD. Cumulative cost for each therapy was
calculated by the 'folding back process' and a constant second line therapy
using amoxicillin/clavulanate. Results: The results from the IMD and literature
were consistent. Cost for the treatment of AOM using azithromycin was higher
($29.89 -- $34.03) compared to amoxicillin ($9.79 -- $20.00), tmp/smz ($10.73 --
$18.96), and ery/sulfa ($23.73 -- $26.20). Conclusion: The results indicated
that as a first line therapy, azithromycin may not be cost-effective when
compared with amoxicillin, tmp/smz, and ery/sulfa in the treatment of AOM.
Abstract #: EO21
MEDICAL CARE COSTS IN THE TWO YEARS
FOLLOWING A STROKE BY TYPE OF STROKE: AN ANALYSIS OF MEDICARE CLAIMS DATA
Taylor, TN, Meyer J. College of
Pharmacy, University of Iowa, Iowa City, Iowa.
OBJECTIVE: We sought to estimate costs
of treating stroke over a two year period for persons with subarachnoid
hemorrhage (SAH), intracerebral hemorrhage (ICH), and ischemic stroke (ISC).
METHODS: Medicare claims data from a 5% sample of Medicare beneficiaries were
used for this study. Persons aged 65 and older with a 1990 hospitalization with
a principal diagnosis of SAH (ICD-9-CM code 430), ICH (codes 431-432), or ISC
(codes 433- 434 or 436) were classified as stroke cases. We randomly selected
two percent of Medicare beneficiaries in the 5 percent sample to serve as a
control population. The first stroke hospitalization in 1990 served as the index
event and cases were followed for seven quarters beyond the quarter of the
initial hospitalization. Controls were also followed for two years. Cost of
hospital inpatient, outpatient, Part B, Skilled Nursing Facility, and home
health care services were estimated from the Medicare data. Medicare
cost-to-charge ratios were used to estimate inpatient hospital costs. RESULTS:
18,768 cases met our criteria for stroke (305 SAH, 1,905 ICH, and 16,558 ISC).
The mean first year total costs were $29,898 for SAH, $18,542 for ICH, $16,809
for ISC, and $3,134 for controls. The mean second year total costs were $2,962
for SAH, $3,710 for ICH, 5,796 for ISC, and 3,255 for controls. First year costs
varied significantly by type of stroke and survival status. Inpatient hospital
costs accounted for the majority of costs in each year for both cases and
controls. CONCLUSION: Medical care costs incurred in the two years following a
stroke are substantial and vary by type of type of stroke and survival.
Abstract #: EO22
Confidence in Cost of Illness
Analysis: Focus on Asthma
Malone, DM, Smith, DH, Lawson, KA,
University of Colorado Health Sciences Center, Denver, CO. USA, and University
of Washington, Seattle, WA. USA.
Cost of illness (COI) analyses are
often performed using multiple data sources, with numerous assumptions and
typically provide only point estimates. Estimates are often taken at face value
and may lead to improper public policy decisions. OBJECTIVE: The purpose of this
study is to contrast U.S. asthma- specific COI estimates from a single data
source, the 1987 National Medical Expenditure Survey (NMES), to those determined
by Weiss et al. METHODS: The NMES data were used to identify persons with asthma
using ICD-9 codes. Confidence intervals around point estimates were constructed
by using the NMES weighting and stratification variables with SUDAANØ
statistical software. Estimates from Weiss et al. and NMES were inflated to 1994
dollars. RESULTS: Using NMES data, we estimate the total cost of asthma to be
$5.8 billion (95% confidence interval(CI): $3.6 to $8.1 billion). The Weiss et.
al. estimate is $7.8 billion in 1994 dollars. While the two overall estimates
are similar, there are differences in the proportion of costs accounted for by
individual cost categories, particularly in estimates of indirect costs. The
NMES total indirect cost estimate is $674 million (95% CI $270 million to $1.0
billion) versus over $2.9 billion in Weiss et al. Some of this difference is
because Weiss et al. included a mortality cost and the NMES analysis did not.
Even after accounting for the mortality cost difference, the Weiss et al.
indirect costs are still greater by more than $1.3 billion. CONCLUSION: The
results demonstrate that estimates of the cost of asthma in the U.S. can varying
significantly depending upon the data source and assumptions.
Abstract #: EO23
COST OF MULTIPLE SCLEROSIS IN CANADA
Tretiak, R,* Grenier, J-F,† Rivi¸re M.*
*Quintiles Canada, Montreal, PQ, Canada; †Berlex Canada Inc., Lachine, PQ,
Canada
OBJECTIVE: Multiple sclerosis (MS) is a
common neurologic disease in young and middle-aged adults affecting
approximately 35,000 Canadians. The objectives of this study were to estimate
the cost of MS from the perspective of Canadian society, annually and over a
patient's lifetime and to determine how the cost of the disease evolves with
disease progression. METHODS: Patients were consecutively recruited by
neurologists in 14 MS outpatient clinics across Canada. They were classified by
the Expanded Disability Status Scale (EDSS) into three groups: mild (EDSS 2.5),
moderate (EDSS=3.0-6.0) and severe (EDSS 6.5). Sociodemographic, clinical and
resource utilization data were collected for the three months prior to patient
inclusion. Costing of resources consumed was performed from Ministry of Health,
private third party payers, patient and societal perspectives. Average Canadian
costs ($CDN 1995) were valued from available provincial data. Using published
Canadian epidemiological data on the evolution of the disease and the cost of MS
by severity group, a lifetime cost model was developed.
RESULTS: A total of 198 patients were
included in the analysis (mild: n=62, moderate: n=68 and severe: n=68). Costs
increased over time with increasing EDSS scores from all perspectives. Results
show that patients bear most of the economic burden of the disease. Indirect
costs, including lost daily activity/leisure time and lost productivity, were
the major societal cost drivers.
CONCLUSIONS: This burden of illness
study provides a basis for cost-effectiveness analyses of new therapeutic
interventions for MS. The importance of lost time as a cost driver suggests that
MS patients' quality of life may be increasingly affected with disability
progression.
Abstract #: EO24
USE OF COST-BENEFIT ANALYSIS AND
OUTCOMES MONITORING IN HOSPITAL FORMULARY DECISION-MAKING: REOPRO (Abcix
HOSPITAL FORMULARY DECISION-MAKING:
REOPRO (Abciximab)
Abernathy, GB, Kimberlin, K, Jaggers, R
Fairfax Hospital, Falls Church, VA. US
ISSUE: Several drugs coming onto the
market have potential financial impact of over a million dollars/institution in
2-3 years time. Traditional Pharmacy & Therapeutics Committee review is no
longer sufficient for these complex clinical/financial decisions. PROCESS:
Reopro blocks the final common pathway of platelet aggregation and is used to
prevent acute reclosure of coronary arteries in patients undergoing PTCA at a
cost of $1350/patient. Our institution performs 1,300 PTCA procedures/year. An
emerging drug therapies team (pharmacists, physicians, nurse specialists,
financial analysts, administrators, cardiac cath technicians) was formed to
decide whether to make Reopro available in the institution and for what
indications. Financial impact was estimated based on physician assessment of
usage, patient volume, and indications in clinical trials. Projected positive
and negative outcomes were derived from clinical trial information. DECISION:
After the initial analysis, the decision was made not to add Reopro to the
formulary in 1995. The availability of additional clinical trial results with
extension of positive outcomes and minimization of negative outcomes resulted in
the decision to add Reopro in October 1996. In addition, hospital cardiology
procedure-specific outcomes data became available in early 1996 improving our
ability to contextualize clinical trial results. The emerging drug therapies
team developed the structures needed to optimize outcomes (standard orders,
physician and staff education, changes in clinical practices) and an outcomes
monitoring plan to allow reassessment of cost-benefit every 3-6 months. The team
will be used to analyze expected additional indications for Reopro. This model
is being used for other emerging drugs with potentially large financial impact.
The model could be adapted for use in a broad spectrum of healthcare provider or
payer settings.
Abstract #: EO25
MEDICAL AND ECONOMIC RELEVANCE OF
INPATIENT TREATMENT OF PNEUMONIA WITH CEFTRIAXONE IN COMPARISON TO
CIPROFLOXACINE, MEROPENEM AND PIPERACILLIN/TAZOBACTAM
Kilburg, A, Bachinger, A, Rychlik, R
Institute of Empirical Health
Economics, Altenberger-Dom-Strasse 16, D-51519 Odenthal, Germany
Ceftriaxone, Ciprofloxacin, Meropenem
and Piperacillin-Tazobactam are some of the most preferred antibiotics to treat
pneumonia. In a retrospective analysis the cost structure of above different
antibiotic treatments was established. OBJECTIVE: This analysis centred around
the question which of these alternative therapies incurs the best
cost-effectiveness ratio. The comparison of costs and benefits was made on the
basis of a cost-effectiveness analysis. METHOD: A decision tree with four
endpoints was constructed: (1) successful therapy with adverse drug reaction (2)
successful therapy without adverse drug reaction (3) failed therapy (4) death.
Data regarding efficacy, duration of treatment and casualities underlying were
taken from clinical studies. Health care costs included in the model were all
medical costs (hospitalization, drug costs etc.) and indirect costs (absence
from workplace, burial allowance). The benefit was defined as the cure rate of
pneumonia. The following benefit rates were revealed in clinical studies:
Ceftriaxone 0.6136, Ciprofloxacin 0.6939, Meropenem 0.8750, Piperacillin/Tazobactam
0.9549. For a better comprehension of the results a sensitivity analysis was
conducted to determine the influence of the efficacy on the effectiveness
adjusted costs and the effects of the frequency of adverse drug reactions using
Piperacillin/Tazobactam. RESULTS: Therapy with Ceftriaxone resulted in total
costs of 11,942.47 DM per successfully treated patient. Therapy with
Ciprofloxacine incurred total costs of 13,352.41 DM, and therapy with Meropenem
caused total costs of 7,720.39 DM. Concerning the therapy of pneumonia with
Piperacillin/Tazobactam, total costs of 6,538.28 DM per successfully treated
patient were calculated. CONCLUSION: This decision tree analysis reveals that
therapy with Piperacillin/Tazobactam has the best cost- effectiveness ratio.
Economic and Outcomes Issues in Clinical Trials, Chart Reviews, Surveys, and
Long-term Care
Abstract #: LC01
ECONOMIC EVALUATION OF SUPREFACT
DEPOT AND OTHER LH-RH AGONISTS IN THE TREATMENT OF ADVANCED PROSTATIC CARCINOMA
Alloul, K, Lafortune, L. Health
Economics Department. Hoechst Marion Roussel Canada Research Inc, Laval, Que,
Canada.
Suprefact Depot is a new 8 week LH-RH
agonist formulation recently approved in Canada for advanced prostatic
carcinoma. Like other LH-RH agonists, it has demonstrated equal efficacy and
safety compared to orchidectomy. OBJECTIVE: The total direct medical cost of
LH-RH agonist therapy was evaluated from the perspective of canadian provincial
ministry of health and provincial drug formularies. METHOD: A cost-minimization
compared Suprefact Depot to Lupron 30 day and Zoladex 12 week depot formulation.
Drug acquisition cost, pharmacy mark-up on product, pharmacist dispensing fee,
urologist visit fee and physician administration fee were entered into the cost
equation. For each province, costs over a monthly, yearly and remaining life
(2.5 years) time horizon were computed. Sensitivity analyses were performed to
account for variations in practice patterns and in compliance to recommended
dosing intervals. RESULTS: Based on national average costs, the use of Suprefact
Depot compared to Zoladex and Lupron respectively results in monthly cost
savings to the provincial formularies of $26.31 and $34.81 per patient; in 1996
yearly maximum aggregate cost savings to the drug plan of $77 186 and $104 028,
based on current community pharmacy prescription numbers; and in annual
cost-savings to the ministry of health of $279 and $525 respectively. Only in
the unlikely situation of compliance to Suprefact 8 week dosing interval and
non- compliance to Zoladex 12 week dosing interval for all patients receiving
one of these two agents does Suprefact Depot become only slightly ($1.15 a
month) more expensive than Zoladex. CONCLUSION: Amongst LH-RH agonists,
Suprefact Depot remained a cost-saving treatment strategy for all provinces and
for all scenarios envisioned.
Abstract #: LC02
IDARUBICIN ORAL VERSUS INTRAVENOUS:
A COSTING MODEL IN AML PATIENTS.
Williamson, T.E.. Bence-Bruckler, I., &
Kearns, B., Pharmacia & Upjohn, Toronto, Ontario, Canada
Hospitals face challenges in shifting
treatments to outpatient settings to combat bed closures and reduced budgets.
Outpatient treatment of selected AML with idarubicin oral may introduce
institutional savings. OBJECTIVE: The study purpose was to examine costs of
using oral versus intravenous idarubicin in treatment of acute myelogenous
leukemia, assuming, for the purposes of this report, equal efficacy of oral and
intravenous idarubicin. METHODS: A review was conducted at the Ottawa General
Hospital to determine the number of cycles of AML chemotherapy administered over
one year, and what proportion of these cycles contained idarubicin. Resource
utilization and actual costs incurred by patients receiving idarubicin therapy
were determined from records as captured by the institutional on- line
case-costing system, and were utilized in the cost determinations. For the
propose of this study, the costs retrieved included nursing and pharmacy costs,
which had incorporated into them overhead costs for bed stay, building
maintenance, etc. The impact of switching to oral idarubicin was modeled based
on reductions in both nursing and pharmacy requirements. RESULTS: Intravenous
idarubicin had a per patient cost of $4,295 (nursing 22.2%; pharmacy 77.8%) in
an inpatient setting and $3,767 (nursing 10.0%; pharmacy 90.0%) in an outpatient
day car unit. The corresponding costs for oral idarubicin were $4,195 (nursing
22.8%; pharmacy 77.2%) and $3,574 (nursing 10.6%; pharmacy 89.4%), respectively.
CONCLUSIONS: This study demonstrates that there are potential savings in
switching eligible patients from intravenous idarubicin inhospital to oral
idarubicin in an outpatient day clinic of $721. Oral idarubicin may potentially
save money in those patients eligible for outpatient day care treatment of AML
(patients treated with curative intent would not qualify).
Abstract #: LC03
Cost-Effectiveness of
Cyclophosphamide, Doxorubicin, and 5-Fluorouracil in Pre- menopausal Women With
Lymph Node Positive, Early Stage Breast Cancer
SUng JCY,1 Hay J,1 Louie sG,1Popovian
R,2 1Department of Pharmaceutical Economics and Policy, School of Pharmacy,
University of Southern California, LOS ANgeles, CA. US.
2PFizer Inc., New York, NY. US.
Breast cancer is the most common female
malignancy in the United States. Systemic adjuvant chemotherapy has been proven
to prolong survival in breast cancer patients. One such regimen which combines
cyclophosphamide, doxorubicin, and 5- fluorouracil (CAF) is considered a
clinically effective adjuvant therapy. Objective: To evaluate cost-effectiveness
(CE) of CAF therapy in a hypothetical cohort of pre-menopausal women with
lymph-node positive, early-stage breast cancer. METHOD: A medical decision
algorithm modeling was developed in accordance to possible clinical outcomes.
Clinical probabilities used in this model were merged with medical cost data to
evaluate the cost-effectiveness of CAF therapy. The clinical outcomes and health
care utilization information were gathered using economic, epidemiological and
clinical data from published studies. The average length of follow-up was five
years. The primary measure of cost-effectiveness is incremental cost per life-
year saved. The perspective of the study was societal. However, indirect costs
were not included due to insufficient data. Medical costs were expressed in 1996
US dollars. A discount rate of 3% was incorporated to establish relative weights
on deferred outcomes as opposed to immediate impacts. Univariate sensitivity
analyses were performed on key parameters in the model. RESULTS: The average
total health-care costs in the five-year period associated with CAF treatment of
a breast cancer patient was $24,470. The baseline analysis found an average
life-year gained of 4 months from CAF therapy at a cost of $48,292 per life-year
saved. The results of the model were relatively insensitive to reasonable
changes in parameter assumptions. However, the life-year gained and costs have
non-linear impact upon the CE ratio. CONCLUSIONS: Although adjuvant CAF therapy
is unlikely to produce net savings in medical resources, there is a survival
benefit for adjuvant CAF chemotherapy. The cost-effectiveness ratio is high, but
within the range of commonly reimbursed medical interventions.
Abstract #: LC04
MEDICAL AND ECONOMIC RELEVANCE OF
TREATMENT OF FEBRILE NEUTROPENIC CANCER PATIENTS WITH PIPERACILLIN/TAZOBACTAM
COMPARED TO CEFTAZIDIME
Kilburg, A, Casser, U, Rychlik, R
Institute of Empirical Health
Economics, Altenberger-Dom-Strasse 16, D-51519 Odenthal, Germany
In a clinical study Cametta et al.
showed that the antibiotic Piperacillin/Tazobactam/Amikacin combination
treatment of Febrile Neutropenic Cancer Patients was more efficient than a
combination therapy with Ceftazidime/Amikacin. In a retrospective decision tree
analysis the cost structure of these alternative treatments was established.
OBJECTIVE: The purpose of this study was to analyse the medical and economic
relevance of above alternative antibiotic treatments based on the multicentre
clinical study. The comparison of costs and benefits was made on the basis of a
cost-effectiveness analysis. METHOD: First a one-patient model was considered,
subsequently the results were projected onto the total population of the Federal
Republic of Germany. In the one-patient model (Markov model) three states were
constructed: (1) successful therapy, (2) failed therapy, (3) death. Health care
costs included in the model were all medical costs (hospitalization, drug costs
etc.) and indirect costs (absence from workplace). The benefit was defined as
the reduction of fever, or the elimination of the pathogenic microorganisms. The
success rate of the therapy with Piperacillin/Tazobactam/Amikacin was 61.40 %,
the success rate of the therapy with Ceftazidime/Amikacin was 53.85 %. RESULTS:
Combination therapy with Piperacillin/Tazobactam/Amikacin resulted in total
costs of 16,616.37 DM per successfully treated patient. Therapy with
Ceftazidin/Amikacin caused 20,828.36 DM per successfully treated patient.
CONCLUSION: This cost-effectiveness analysis reveals that a combination therapy
with Piperacillin/Tazobactam incurs lower total costs per succsessfully treated
patient. This cost differences is caused by a considerably difference in
indirect costs which are reduced to the loss of human capital. The use of the
human capital approach in case of the treatment of febrile neutropenia is
discussed controversially.
Abstract #: LC05
MEASURING HEALTH RELATED QUALITY OF
LIFE OF HIV/AIDS: TESTING THE RELIABILITY AND SENSITIVITY OF EQ-5D
Kind, P, Nabulsi, A, Maurath, C,
Sarocco, P,
BACKGROUND: The measurement of health
outcomes is critical to the clinical and economic evaluation of innovative
therapies. It is increasingly recognized that such outcomes must take account of
both quality and quantity of life. Measures of health-related quality of life
that have the capability of capturing patient preferences for health states,
enable us to capture outcome data which would not otherwise be included in the
evaluation of new treatment. Generic measure of this type, such as the QWB, SIP
and SF-36, have been developed for use in a wide range of settings. OBJECTIVE:
To test the performance of EQ-5D as a measure of health status in the treatment
of patients with HIV/AIDS. METHOD: The EQ-5D is a generic measure that can be
used as a profile, and as an index. It defines health-related quality of life in
terms of a profile of 5 dimensions – mobility, self care, usual activity,
pain/discomfort and anxiety/depression. In two Phase III studies of Ritonavir,
EQ-5D was used weekly initially the monthly to monitor patient reported health
status. A total of 1434 patients took part in these studies. RESULTS: In a study
of symptomatic AIDS patient (CD4 </= 100 cells uL) after 6 weeks of treatment,
significant differences were found between experimental and control groups, with
patients who received Ritonavir demonstrating drug and observations on EQ-5D. In
a study of asymptotic, HIV-positive patients without AIDS-defining illness,
there was not a correlation between observations on EQ-5D and clinical
improvements in CD4 counts. CONCLUSIONS: Coefficients of reliability and
sensitivity indicate that EQ-5D behaves exceptionally well in terms of
conventional psychometric measures of performance.
Abstract #: LC06
ECONOMIC EVALUATIONS BASED ON DATA
COLLECTED RETROSPECTIVELY FOR PHASE III STUDY SUBJECTS
Russell, MW, Huse, DM, Drowns S, Hartz,
SC, Medical Research International, Burlington, MA. US
increasingly being incorporated into
late- stage clinical trials. Nevertheless, commercial pressures to streamline
drug development and speed up regulatory approval often hinder the
implementation of prospective pharmacoeconomic studies. OBJECTIVE: To conduct
retrospective economic evaluations of a new intravenous antibiotic based on
three pivotal clinical trials. METHODS: Data for economic evaluations were
collected for patients at U.S. study centers (hospitals). Resource use and
associated costs were not collected during the trials, so it was necessary to
collect the necessary data retrospectively through supplemental chart review and
follow-up investigation. Since patient follow-up was incomplete for economic
evaluation, data collected during the trials were supplemented by review of the
medical records of study patients encompassing the entire hospital stay and any
readmission within 30 days following discharge. Hospital costs were assigned to
trial patients using "rapid estimation" methods, involving models that predict
total hospital cost based on key variables, including length of stay, time spent
in special care units, number of surgeries, and in-hospital mortality. These
models were developed using regression methods and cost data from 66 U.S.
hospitals, then validated using data from 33 different institutions. Cost
estimates therefore reflected "usual" patterns of treatment in a large sample of
hospitals, rather than protocol-induced resource use. RESULTS: Retrospective
data collection was completed for 74% of the 711 patients at U.S. study centers.
Rapid estimation models proved to be highly accurate in predicting the total
costs of hospitalization. CONCLUSION: While theoretically less than ideal,
retrospective pharmacoeconomic study designs continue to prove valuable in drug
development.
Abstract #: LC07
CELIPROLOL DOMINATES ATENOLOL IN
PRIMARY PREVENTION OF CARDIOVASCULAR RISK
Milne, Richard J1, Vander Hoorn,
Stephen2; Adis International Ltd1; University of Auckland2, Auckland, New
Zealand
OBJECTIVES: To compare the
antihypertensive and lipid modifying effects and the lifetime effectiveness of
10 years' treatment of patients with mild to moderate hypertension with
celiprolol versus atenolol and to estimate the incremental cost effectiveness.
METHODS: Antihypertensive and lipid
effects were estimated from a pooled analysis of all published head-to-head
comparisons of celiprolol versus atenolol. The baseline 10-year risk of coronary
events, stroke events and cardiovascular death were computed from published
Framingham Weibull model regression equations. The absolute and relative risk
reduction for coronary and stroke events and cardiovascular death were estimated
from the same equations as functions of antihypertensive and lipid effects, age,
gender and smoking history. Direct medical costs included drug acquisition and
treatment of coronary and stroke events.
RESULTS: Celiprolol (285mg/day) and
atenolol (91mg/day) have equivalent effects on systolic and diastolic blood
pressure, however celiprolol reduces the ratio of total serum cholesterol to
HDL-cholesterol by 8.3% but atenolol increases this ratio by 10.3%. Celiprolol
is predicted to be equally effective in reducing stroke risk but to be >2-fold
more effective than atenolol against coronary risk and to confer a 1.2- to
3-fold greater survival advantage. Over 10 years, the cost of monotherapy with
celiprolol versus atenolol is >$400 per patient lower (1996 NZ discounted
dollars) despite a 19% higher tablet cost. These findings are sensitive to drug
prices and lipid effects but robust to age, gender, the costs of treating
coronary and stroke events and the lag time to treatment effect.
CONCLUSIONS: Compared with atenolol,
monotherapy with celiprolol is predicted to reduce the risk of coronary but not
stroke events, improve survival and cost substantially less over the 10-year
treatment period.
Abstract #: LC08
A COST-EFFECTIVENESS ANALYSIS
COMPARING TURBUHALERØ AND A PRESSURIZED METERED DOSE INHALER (pMDI)
Sthl E, Liljas B, Pauwels R1
Astra Draco AB, Lund, Sweden
1Afd. Pneumologie, University Hospital,
Ghent, Belgium
BACKGROUND: 1004 asthmatic patients
(mean age 44 years and mean PEF 102% pred. normal value) in seven countries were
randomised into an open, parallel-group study. For 52 weeks, they inhaled
2-agonists and/or corticosteroids either via Turbuhaler or a pMDI. All patients
were considered adequately treated with inhaled corticosteroids and/or
2-agonists before inclusion into the study. The clinical conclusion was that
budesonide and terbutaline in Turbuhaler offered a superior alternative to
corticosteroids and bronchodilators in pMDIs in maintenance treatment of asthma.
COST-EFFECTIVENESS ANALYSIS: Canadian
data from the study were used (440 patients being the largest subpopulation).
Costs and effectiveness (number of exacerbations and number of days with
exacerbation) were compared.
RESULTS: The total annual costs were,
on average, CAD 457 less for a patient using Turbuhaler than for one using pMDI
(p=0.057). The cost difference was mainly due to lower costs for hospitalization
and loss of production. The cost differences for inhaled steroids and 2-agonists
were both statistically significantly in favour of Turbuhaler (p<0.001). Both
effectiveness variables show that Turbuhaler was better than using pMDI for the
one year treatment.
CONCLUSION: Treatment using Turbuhaler
is a cost-effective strategy in asthmatic patients using inhaled steroids and
B2-agonists.
Abstract #: LC09
Comparison of octreotide and
vasopressin in the management of acute bleeding varices: A cost-effectiveness
study.
Hui RL, Louie GK, Wilson LS. Department
of Pharmaceutical Economics and Policy, University of Southern California, Los
Angeles, CA, US and Pharmaceutical Services, California Pacific Medical Center,
San Francisco, CA, US.
Octreotide is a therapeutic alternative
for the treatment of esophageal variceal bleeding and is reportedly less toxic
than treatment with vasopressin. Octreotide is up to three times more expensive
than vasopressin but has not been conclusively demonstrated to be clinically
superior. OBJECTIVE: The purpose of this study is to determine which agent,
octreotide or vasopressin, is more cost effective in the treatment of acute
esophageal variceal bleeding with standard practice in a single institution.
METHOD: Data were retrospectively collected from review of 21 patients who were
admitted for acute esophageal variceal bleeding during 1990 to 1995. Cost
analysis was done using length of stay in the intensive care unit, total drug
costs, amount of blood transfusions and number of diagnostic tests. The analysis
was done using the 1996 dollar figure. RESULT: There were no significant
difference between patients' age, sex, cause of variceal bleeding and the
overall Child's Grade among the two treatment groups. The vasopressin patient
group accumulated a per patient charge of $21,830 with an overall efficacy rate
of 60%. The octreotide patient group had a per patient charge of $13,128 with an
efficacy rate of 45%. Efficacy was defined as a combination of variables.
Vasopressin had an average cost- effectiveness ratio of $48,786 whereas the
cost-effectiveness ratio was $18,635 for octreotide. The incremental cost-
effectiveness ratio was $60,013, favoring octreotide. A small sample size and
potential treatment bias due to the historical sample are weaknesses of this
study. The study results were validated using simplified data comparisons of
published studies and a marginal cost-effectiveness ratio of these data and
showed similar results. CONCLUSION: The results of this study show that
octreotide is more cost-effective than vasopressin.
Abstract #: LC10
OUTPATIENT DVT TREATMENT WITH
FRAGMINØ CAN RESULT IN COST AND BED DAY SAVINGS.
Williamson, TE, Pharmacia & Upjohn,
Toronto, Ontario, Canada.
Hospitals face challenges in shifting
treatments to outpatient settings to combat bed closures and reduced budgets.
Outpatient DVT treatment with the Low Molecular Weight Heparin, FragminØ can
introduce savings. OBJECTIVE: The study purpose was to examine resource
utilization in the treatment of DVT in- hospital in a teaching and community
setting, and develop a software model demonstrating the impact of switching to
outpatient treatment with FragminØ. METHODS: Chart analyses were performed in
two hospitals in Canada, one teaching and one community. Chart abstraction
covered 6 months from January-June, 1996 and all patients treated for DVT in
that time. 126 charts were abstracted to examine medical treatment, length of
stay (LOS), and tests. A software model was developed where standard costs for
each hospital could be applied to each component of resource utilization.
RESULTS: 45% of patients in a community hospital were eligible for outpatient
DVT treatment vs. only 39% in a teaching hospital. Mean LOS was 9 days in a
community hospital vs. 5 in a teaching institute. Based on a cohort of 100 DVT
patients, the annual institute savings in dollars and bed days would be $143,910
and 360 days in a community hospital vs. $63,960 and 156 days in a teaching
hospital. With bed day cost reduced to zero, days saved remains constant in both
types of institutions with total annual savings of $1,560 for a teaching
hospital and a cost increase of only $90 for a community hospital. CONCLUSION:
This study demonstrates that the higher cost of FragminØ (vs. heparin) is more
than offset by the institution savings in tests and bed days. Savings are higher
in a community hospital, but could be implemented in many hospitals.
Abstract #: LC11
IVIG MULTICENTER DRUG SURVEILLANCE
STUDY IN US ACADEMIC HEALTH CENTERS
Chen, C, Danekas, L, Whiting, B, Ratko,
T, Vlasses, P, Matusewski, K, University HealthSystem Consortium, Oak Brook, IL.
US
OBJECTIVES: This multicenter drug
surveillance study was conducted to characterize the current use of intravenous
immunoglobulin (IVIG) at academic health centers. Evaluation of labeled and
off-labeled indications was based on guidelines established through literature
review and expert opinion distributed in May of 1995.
METHODS: Twelve US academic health
centers prospectively enrolled up to 50 patients between April and November of
1996. Patient were included if they were receiving IVIG for the first time as an
inpatient. Data collected included indications, outcomes, and adverse events
associated with IVIG use.
RESULTS: A total of 254 patients were
enrolled in the study (males 110, females 144). Non-labeled indications
comprised 29% to 100% of IVIG usage at each institution (average 65%). Forty-two
percent of patients received IVIG for labeled indications. Of those patients,
one-fourth had at least one positive outcome associated with IVIG
administration. Based on recommendations from UHC "model" guidelines, the
remaining patients (58%) could be categorized into one of three groups: 1)
patients who receive IVIG for unlabeled but acceptable indications (12%); 2)
unlabeled but possibly indicated if alternatives fail or in specific situations
(22%); 3) unlabeled and unacceptable indications (24%). Forty percent of
patients receiving IVIG for labeled indications received prophylactic medication
in order to prevent adverse events. Only 28% of patients receiving IVIG for
unlabeled indications received prophylactic medication. Eight percent of
patients in the labeled group reported adverse events, where as 14% of patients
in the unlabeled group reported adverse events.
CONCLUSIONS: Results showed that 58%
percent of patients were receiving IVIG for unlabeled indications. Forty-six
percent of patients received IVIG for indications that were not specifically
recommended by UHC "model" guidelines. Economic implications for institutions
include closer evaluation of IVIG usage for unlabeled indications to identify
areas of inappropriate prescribing of an expensive biological pharmaceutical.
Abstract #: LC12
AN ECONOMIC ANALYSIS OF IFOSFAMIDE
IN THE IN-PATIENT AND OUT-PATIENT SETTING
Authored by: John Doyle and Neeta Sinha
Background: In recent years,
chemotherapy is being administered increasingly in ambulatory settings. The
shift away from the in-patient setting has been fueled by the cost-minimization
goals, changing reimbursement patterns, and by rapid developments in the
medicine and technology arena. Hence, acceptability of a drug in today's medical
environment, depends on its ability to be administered effectively in an
ambulatory setting. Ifosfamide (Ifex, Mead Johnson, Bristol- Myers Squibb
Company), a synthetic analog of cyclophosphamide (Cytoxan, Mead Johnson,
Bristol-Myers Squibb Company), is one of the most important anticancer drugs
today. The adverse event profile of ifosfamide and the requirement of vigorous
hydration during the therapy had erroneously led to the general perception that
ifosfamide should always be administered in an in-patient facility. Since, it
has already been shown that the effectiveness of Ifosfamide based therapy is
independent of the setting it is administered in, we conducted an economic
analysis to investigate the potential advantage of administering Ifosfamide in
the out-patient setting. Methodology: Practice pattern analysis was conducted
with clinical data collected from sites where VIP (Vepesid+Ifosfamide+Platinum)
combination regimen was administered to Small Cell Lung Cancer patients, in the
in- patient and out-patient settings. Information on the treatment pathways,
resource utilization, and adverse events management was derived from the
practice pattern analysis. Next, activity-based costing methodology was employed
to assign appropriate financial values to the identified resources utilized.
Cost-Minimization analysis was performed to compare treatment costs among
comparators. Multi- Variate (Monte-Carlo simulation) sensitivity analysis was
performed to test the robustness of the models under various treatment settings.
Result: The treatment in the out-patient setting showed a cost advantage of
approximately 18.40%. High in-patient chemotherapy administration cost was the
major factor behind the cost difference. The reimbursement analysis showed that
the difference between the two settings was insignificant.
Abstract #: LC13
PROVIDING COST-EFFECTIVE CARE USING
ORAL 5-HT3 RECEPTOR ANTAGONISTS FOR PREVENTING CHEMOTHERAPY INDUCED NAUSEA AND
VOMITING.
Rough S, Carro G, The Evanston
Hospital, Evanston, IL USA
OBJECTIVE: This study was performed to
compare patient and cost outcomes of patients receiving oral and intravenous
serotonin type three (5-HT3) receptor antagonists for prevention of acute
chemotherapy induced nausea and vomiting (CINV). CINV, historically one of the
most feared side effects of chemotherapy, can be controlled with 5-HT3
antiemetic therapy. As a result of product availability and clinical practice,
5-HT3s traditionally have been administered intravenously. However, oral 5-HT3
therapy is as safe and effective as intravenous formulation; and tablets offer
advantages of convenience, and lower costs. This study describes the process of
implementing oral 5-HT3 antiemetic guidelines for CINV prevention. METHODS:
Patient and cost outcomes were evaluated in three phases: prior to implementing
IV 5-HT3 use guidelines, following IV 5-HT3 use guidelines, and following oral
5-HT3 use guidelines. A total of 162 patients were evaluated. Clinical data
collected included patient demographics, chemotherapeutic agent and emetogenic
potential, cancer site, acute emesis incidence and nausea severity, 5- HT3 dose
and route of administration. RESULTS: Following implementation of oral 5HT3 use
guidelines, 64 of 81 patients (80.0%) received 100% oral 5-HT3 prophylaxis.
Sixty-two, (97.0%) received granisetron and 2 (3.0%) received ondansetron. There
was no statistical difference in the incidence of acute nausea and vomiting in
patients receiving intravenous or oral 5-HT3 therapy, 14.1% and 7.8%,
respectively. 5-HT3 doses per outpatient visit decreased 31.9% from 1.7 to 1.2
and drug acquisition cost per visit decreased 27.2% from $113.66 to $82.79.
5-HT3 doses per inpatient day decreased 68.0% from 0.16 to 0.05 and cost per day
decreased 68.2% from $10.16 to $3.23. Annual drug cost savings to the
institution totaled $115,182. CONCLUSION: When compared to intravenous 5HT-3
therapy in the prevention of CINV, oral 5-HT3 therapy is cost-effective in most
patients.
Abstract #: LC14
COST-BENEFIT ANALYSIS OF MONITORING
SERUM VANCOMYCIN CONCENTRATION IN A TEACHING HOSPITAL.
OPARAOJI, EC, SIRAM, S, ANOSIKE, R,
PIPPALLA, RS, MEZGHEBE, H, HOWARD UNIVERSITY AND HOWARD UNIVERSITY HOSPITAL,
WASHINGTON, DC.
The purpose of this study was to
evaluate the economic benefits of routine monitoring of serum vancomycin
concentrations and recommend monitoring guidelines. METHOD: An IRB approval was
obtained, thereafter we conducted a 5-months retrospective chart review. Using a
computer generated list of patients on vancomycin from August to December 1995,
thirty-one patients charts were randomly retrieved from the medical record
department and reviewed.Twenty four of these patients met the inclusion
criteria. The data extracted from the charts were, serum vancomycin
concentrations and frequency of determination, dose and duration of vancomycin
treatment, and vancomycin untoward effects. Other data recorded were age,
weight, height, sex, status of renal function, and other concurrent nephrotoxic
or ototoxic drugs. Benefit-to-cost ratio and Return-on-investment for serum
vancomycin concentration was calculated . RESULTS:The Benefit-to-cost ratio was
0.696, and the Return-on-investment was -30.4%. A mean of 2.83 + 3.1 serum
vancomycin concentrations were obtained per patient during a mean therapy
duration of 10.2 +6.8 days. The mean daily dose ( 27.8+ 7.0 mg/kg), peak (21.7 +
6.54mcg/ml ) and trough (7.4 + 5.98mcg/ml ) were within recommended standards.
Also 2 (8.3%) patients experienced increased serum creatinine. CONCLUSION: Our
results showed that the routine monitoring of serum vancomycin concentration is
not cost beneficial. We recommend only one trough serum vancomycin concentration
for patients with normal or stable renal functions for a full course of
treatment. Patients with unstable renal function may require more than one
trough concentration determination and should be evaluated on a case by case
basis. Peak and trough concentrations should be reserved for patients with other
risk factors for ototoxicrty.
Abstract #: LC15
EVALUATING VISUAL ANALOG SCALING FOR
CANCER THERAPY: PERCEPTIONS OF ONCOLOGISTS.
McGhan WF,1 Corey R,2 Smith MD,3
Szeinbach S,4 and Oates M.1
1Philadelphia College of Pharmacy &
Science, 2Novartus, Inc., 3Health Decision Strategies, and 4Univ. of Mississippi
OBJECTIVE: The purpose of this study
was to develop and test an efficient instrument for gathering health state
preference scores that could be used in quality-of-life adjustments for patients
with breast cancer and multiple myeloma. METHOD: Alternative approaches were
considered including time trade off, standard gamble and conjoint analysis. The
assessment instrument chosen was a visual analog scale. Thirty-one health states
were included in the instrument. Non-cancer scenarios were included to allow
comparison with other published weights. A standard 100 point thermometer format
was used with "0 = Dead (Least Desirable)" to "100 = Healthy (Most Desirable)".
The visual analog scales were administered to two different groups of
oncologists. Group 1 (n =10) included national experts in breast cancer and
Group 2 (n =10) included national experts in multiple myeloma). RESULTS: Some of
the general states and their corresponding mean score included: severe headaches
(49.4 + 26.3), severe angina (31.3 + 14.0), general weakness (41.9 + 20.4), coma
( 4.7 + 3.3 ), chronic pain (38.3 + 15.8), hip fractures (30.8 + 21.7), and
depression (41.4 + 16.5). Some of the cancer related health states included:
chemotherapy (43.6 + 18.8), radiation for bone pain (49.6 +19.9), and cancer
with metastases (23.5 +16.9). Between the two groups of oncologists slight
differences in the perception of their patients' health state preferences
occurred with spinal cord compression (p=.032), restricted from strenuous
activity (p=.05), and ambulatory patient (p=.05). Further testing of preference
assessment alternatives will be done with cancer patients. CONCLUSIONS: This
study supports the use of visual analog scales as efficient ways to collect
health state preferences for quality-of-life adjustments in breast cancer and
multiple myeloma.
Abstract #: LC16
SELF REPORTED ASSESSMENT OF
FUNCTIONAL STATUS FOLLOWING 5-HYDROXYTRYPTAMINE 3 RECEPTOR ANTAGONIST THERAPY TO
CHEMOTHERAPY INDUCED NAUSEA AND VOMITING IN SIX CANCER CENTERS
Dempsey, CL, Farley, PA , Shillington,
AC, EPI-Q Inc, Oakbrook Terrace, IL
Cheff CM, The University of Illinois,
Chicago, School of Pharmacy, Chicago, IL
OBJECTIVE: The objective of this study
was to evaluate patient functional status with antiemetic prophylaxis for the
prevention of chemotherapy induced nausea and vomiting (CINV). Appropriate
documentation of functional status enables health care providers to evaluate a
patient's perception of well-being when comparing anti-emetic drug therapies.
METHODS: Functional status scores of patients who were administered a 5-
hydroxytryptamine 3 receptor antagonist (5- HT3)--either granisetron or
ondansetron--as prophylaxis for prevention of chemotherapy induced nausea and
vomiting were evaluated and compared using the Functional Living Index-Emesis
(FLIE) questionnaire. Pharmacists and nurses from six cancer centers
collaborated to administer 230 FLIE questionnaires to 115 outpatients who
received either highly, moderately high or moderately emetogenic
chemotherapeutic regimens. Patients completed the questionnaire immediately
prior to and 72 hours following chemotherapy. RESULTS: Results of the post-
chemotherapy FLIE scores showed that patients experiencing emesis documented a
much greater negative impact on functional status than those who had nausea
alone. The post- chemotherapy scores of patients who did not experience either
nausea or emesis were similar to the pre-chemotherapy FLIE scores, demonstrating
no impact on daily functioning. Mean pre- and post-chemotherapy FLIE scores were
124.2 and 110.4 for granisetron, and 124.9 and 111.9 for ondansetron,
respectively. CONCLUSION: These data suggest that there is no clinically
significant difference in the impact on functional status whether patients
received granisetron or ondansetron.
Abstract #: LC17
PSYCHOLOGICAL ADJUSTMENT AMONG NIDDM
PATIENTS IN TRANSITION FROM ORAL AGENTS TO INSULIN THERAPY
Welch GW1, Jacobson AM1, Bakst AW2,
Revicki D3, Marquis P4, 1Joslin Diabetes Clinic, Boston, MA, 2SmithKline Beecham
Pharmaceuticals, Collegeville, PA,3Medtap Int., Bethesda, MD, 4MAPI Institute,
Lyon, France.
Previous clinical reports have
described a complex process of emotional and psychological adjustment that
confronts the patient with Non-insulin dependent diabetes mellitus (NIDDM) for
whom diet and exercise prescriptions and oral hypoglycemic therapy are no longer
sufficient to control elevated blood glucose levels. Although up to 2/3 of NIDDM
patients transition to insulin therapy by the 10th year of treatment, little
empirical data is currently available on the measurement of psychological
aspects of this treatment transition. OBJECTIVES: Evaluate the psychological
aspects of treatment transition. METHODS: We compared diabetes-specific
psychological functioning of 132 NIDDM outpatients in an examination of the
transition to insulin therapy. In this cross-sectional study, patients treated
by oral agents only (O, n=40), oral agents plus insulin (O+I, n=16), and insulin
only (I, n=76) attending the Joslin Diabetes Clinic took part. Duration of
diabetes was 9.4±7.7, 11.5±10.1, and 15.5±9.1 years for the 3 groups
respectively. Psychological adjustment was measured by the 20-item Problem Areas
in Diabetes (PAID), a validated measure of diabetes-specific emotional
functioning. RESULTS: Multiple regression analysis results showed the mean PAID
score for the O+I group (38.6±22.9) was significantly worse (with a large effect
size) compared to the I group (24.9±21.1), adjusting for age and duration of
diabetes (T=2.69, p<.008). The O+I group scored non-significantly worse than the
O group (29.1±21.4), with a small to moderate effect size. CONCLUSION:
Psychological adjustment is poorer in NIDDM patients transitioning from oral
agents to insulin monotherapy. Improved glycemic control in NIDDM patients may
reduce the rate of transition to insulin therapy and improve patients'
psychological aspects of diabetes management.
Abstract #: LC18
OPTIMIZING SCREENING TOOL USE TO
DIAGNOSE OSTEOPOROSIS
Abbott III, TA and Mucha, LM, Merck &
Company, Inc., West Point, PA, USA
One challenge in the treatment of
osteoporosis is to determine the optimal use of technology to diagnose disease.
Currently the most preferred technique is hip DXA. However, cost and lack of
availability may make this test prohibitive for some patients. SCORE (Simple
Calculated Osteoporosis Risk Estimation) has been developed to triage candidates
for further evaluation including densitometry. SCORE is a six item survey which
identifies persons at high risk for osteoporosis. Although a screening tool can
reduce the number of unnecessary tests, it may also screen out viable candidates
for BMD testing. Thus, it is important to appropriately set the testing
threshold. Prior studies have calculated this based on an arbitrary standards,
such as 90% sensitivity. OBJECTIVE: This paper examines an alternative approach
to determining the testing threshold. Specifically, we use a social welfare
function to balance the costs of a false positive (FP), false negative (FN) and
testing . METHODS: This objective function can be written as:
max B*TP(T) - C1*FN(T) - C2*FP(T) -
C(T)(T)
where T is the testing threshold, B is
the benefit of treatment for a patient with osteoporosis, C1 is the cost of a
false negative, C2 is the cost of a false positive and C is the total costs of
screening. RESULTS: This maximand was tested using data obtained from 845
employees of the Bank of America. SCORE values were calculated and BMD was
performed for each study participant. We defined osteoporosis as being 2 or more
standard deviations below peak adult mean. CONCLUSIONS: Preliminary analysis
shows that use of SCORE as a screening tool would have lead to a reduction in
the number of unnecessary BMDs by 30-40%.
Abstract #: LC19
Quality Assessment of Economic
Evaluations Published in PharmacoEconomics, 1992-1995
Iskedjian M, Addis A, Bradley-Kennedy
C, Ilersich AL, Kruk D, Lanct™t K, Trakas K, and Einarson TR, University of
Toronto, Toronto, ON, Canada
OBJECTIVES: To assess the quality of
reporting of original economic research articles in PharmacoEconomics from its
1992 inception to the end of 1995, to identify strengths and weaknesses, and
analyze trends over time. METHODS: Each regular issue of PharmacoEconomicswas
examined for original economic evaluations. Accepted articles were categorized
by analytic type and publication year. We applied our previously developed
13-item quality scoring checklist that evaluated items on a scale of 0-4, 4
being correct, 3 acceptable, 2 doubtful, 1 not reported, 0 incorrect, and NA not
applicable. Items were weighted equally and averaged for each article to produce
an overall score (OS) having a maximum of 4.0. Quality scores were analyzed over
time and by study type. RESULTS: We identified 54 articles for analysis. OSs
ranged from 1.80 to 3.75, with a mean of 3.01 and SD = 0.47. The item
"definition of study aim" scored highest (OS = 3.46, SD = 0.69); "ethical
problems discussed and identified" scored lowest (OS = 1.44, SD = 0.92). Only
four items scored lower than 3.0. No significant time trend was apparent for OS
(R2 = 0.002). Cost-benefit (OS = 3.25, SD = 0.85, n = 5), cost-effectiveness (OS
= 3.11, SD = 0.97, n = 27), and cost- utility (OS = 3.29, SD = 0.93, n = 6)
analyses scored significantly higher than cost-analyses/cost-of-illness studies
(OS = 2.51, SD = 1.14, n = 8). The mean OS for 8 cost-minimization studies was
2.74 (SD = 0.49). CONCLUSION: Despite some weaknesses in particular aspects of
economic evaluations in PharmacoEconomics, it has published research papers with
acceptable overall quality and adequate methodology.
Abstract #: LC20
Cognitive Function and the Costs of
Alzheimer's Disease:
An Exploratory Pharmacoeconomic
Study
Ernst, Richard L., Hay, Joel W., Fenn,
Catharine, Tinklenberg, Jared,
Yesavage, Jerome A.
Objective: To estimate the dollar
savings in illness costs attainable from drug treatments for Alzheimer's disease
(AD) that stabilize or reverse patients' cognitive decline.
Methods: Medical and other
disease-related utilization data were collected from the caregivers of patients
diagnosed with probable AD. The quantities of utilization were priced at
national levels to generate measures of illness costs. Costs per patient were
then estimated as regression functions of scores on the Mini Mental State
Examination (MMSE), which was employed as an index of patient cognitive
function. Potential savings in illness costs were estimated by comparing
predicted costs at various baseline and intervention-level values of the
patient's MMSE score.
Results: The potential savings in
illness costs attainable from treatment appear to be small for both mildly and
very severely demented AD patients. However, for moderately to severely demented
home-dwelling patients having (say) MMSE = 7 at baseline, prevention of a
2-point decline in the score would save approximately $3,700 annually, and a
2-point increase in MMSE score rather than a 2-point decline would save
approximately $7,100.
Conclusions: Large savings in the costs
of caring for moderately to severely demented home-dwelling AD patients may be
achievable from disease interventions that have relatively minor impacts on
patients' cognitive status. The results indicated that, even when the treatment
effect is small, drugs that can impact the decline in cognitive function would
be able to produce numerically significant economic saving in this large
subgroup of AD patients.
Abstract #: LC21
OUTCOMES ASSESSMENT OF NSAID-INDUCED
GI COMPLICATIONS IN LONG-TERM CARE RESIDENTS
Baran, RW, Fastenau, JM, Doyle, JJ,
Erwin, WG
Institute for Pharmaceutical Economics,
Philadelphia College of Pharmacy and Science, Philadelphia, PA. USA
Osteoarthritis is one of the most
chronic conditions in persons 65 years of age and older. NSAIDs are the
predominate treatment for osteoarthritis. Although effective, NSAIDS are
associated with serious GI complications. The recently completed MUCOSA trial
identified 1) age greater than 75, 2) history of previous peptic ulcer, 3)
history of GI bleeding, and 4) history of cardiovascular disease as risks for
NSAID-induced GI complications. This risk profile is consistent with many LTC
residents in whom NSAID use has been identified to be greater than 13%.
OBJECTIVE: To determine a correlation between risk factors reported by the
MUCOSA trial and the following outcomes in LTC: 1) resource utilization, 2)
clinical/biological markers, 3) traditional clinical endpoints, 4) HRQol and 5)
resident satisfaction. METHODS: Outcomes associated with NSAID-induced GI
complications were identified. A retrospective chart review of 340 residents
prescribed NSAIDs was conducted with 800 to be completed. Outcomes according to
the five categories above were extracted from resident charts. Outcomes were
correlated to MUCOSA risk factors using SAS 6.11. RESULTS: Results show that at
least one risk factor was present in all residents, 74% had more than one risk
factor. Osteoarthritis comprised 56.8% of all NSAID indications. Perforated
duodenal ulcer developed in 21.2% of residents. Pathology/lab usage increased in
8.8% of residents and level of nursing care increased in 4.7% of residents.
These preliminary results will be further investigated in the larger population.
CONCLUSIONS: The risk factors for NSAID-induced GI complications identified by
the MUCOSA trial are predictive of negative outcomes in LTC. In addition,
multiple MUCOSA risk factors are common in this population.
Abstract #: LC22
DIAGNOSING OSTEOPOROSIS IN THE
NURSING HOME: EVIDENCE FROM THE RESIDENT'S CHART
Lemke, P, Joseph, D, LaPalio, L, Stahr,
P, Abbott T, Vitalink Pharmacy Services, Allentown, PA, USA and Merck & Company
Inc., West Point, PA, USA.
Osteoporosis can be defined as "a
disease characterized by low bone mass and microarchitechtural deterioration of
bone tissue, leading to enhanced bone fragility and a consequent increase in
fracture risk." Epidemiological studies suggest that a significant percentage of
women living in nursing homes have osteoporosis. Unfortunately, in many cases
these women are not diagnosed or treated. OBJECTIVE: This study evaluated the
extent residents could be diagnosed using information already listed on their
chart. One can operationally define a chart based diagnosis of osteoporosis as
either: an existing diagnosis, comments about osteoporosis on radiological
reports, or evidence of fracture. METHODS: A review of 110 female resident's
charts at a single home was conducted. The data collected included whether the
resident had a current diagnosis of osteoporosis, whether they had comments
concerning osteoporosis on radiological reports, and whether they have existing
fractures. RESULTS: Of the 110 patients examined, 59 (53%) could have been
diagnosed with osteoporosis based on the chart, of those only 16 (27%) had a
diagnosis listed, and only 5 were treated appropriately (Vitamin D, Calcium, and
antiresorptive agent). CONCLUSIONS: These findings suggest substantial under
diagnosis and treatment of osteoporosis in the nursing home and that a simple
case finding algorithm could increase the number of residents diagnosed at very
little cost.
Abstract #: LC23
OUTCOMES OF ANTIHYPERTENSIVE
THERAPY: INFLUENCE OF PATIENT BEHAVIOR
Garfield FB, Caro JJ, Caro Research,
Boston, MA. USA
Stafford JL, Bristol-Myers Squibb,
Princeton, NJ. USA
The outcome of treatment of
hypertension, an asymptomatic condition is heavily influenced by the patient's
compliance behavior. The health belief model attributes noncompliance to static
factors, such as the patients' beliefs about the disease or their inability to
pay for treatment. Another model views compliance to treatment as a process in
which individuals go through 5 recognized stages of behavior change. When
patients interact with their physicians, the patients may be in any one of the 5
stages or even have relapsed and interrupted treatment. Objectives. To determine
1) whether viewing compliance as a process of behavior change would conflict
with the more static health belief model 2) whether the behavior change approach
would provide measures that were applicable to compliance 3) whether using these
measures, researchers and clinicians could develop appropriate interventions to
increase compliance. Methods. Literature Review. Results. The review found that
the models describe different aspects of compliance with antihypertensive
therapy. Outcomes of therapy may be influenced by behavior change as much as by
beliefs or the barriers that prevent patients from taking their medication as
directed. Conclusion. In order to accurately measure compliance in hypertensive
patients, assessment instruments must incorporate elements from the process as
well as the static models of compliance behavior. More inclusive measures will
differentiate patients, which in turn will allow clinicians to more accurately
direct their interventions to each of their patients. Such focused interventions
have a greater probability of increasing compliance and improving the outcomes
of antihypertensive therapy.
Abstract #: LC24
MEASURING QOL IN A CHRONIC DISEASE:
THE EXAMPLE OF MULTIPLE SCLEROSIS IN CANADA
Tretiak, R,* Breton, M-C,* Grenier,
J-F,†Rivi¸re M.* *Quintiles Canada, Montreal, PQ, Canada; †Berlex Canada Inc.,
Lachine, PQ, Canada
OBJECTIVE: To measure quality of life
(QoL) in multiple sclerosis (MS) patients in Canada and to assess the QoL impact
of disease progression. METHODS: MS patients (198), were recruited on a
consecutive basis from 14 MS clinics in Canada and separated into three levels
of disease severity, based on their Expanded Disability Status Scale (EDSS)
score (mild, EDSS < 2.5; moderate, EDSS 3.0-6.0, and severe, EDSS > 6.5). QoL
was assessed cross-sectionally using the 36 Item Short-Form Health Survey
(SF-36), a validated generic QoL instrument. Statistical tests were used to
compare QoL scores between severity groups and to identify possible
relationships between QoL and patient parameters. RESULTS: QoL of MS patients
collapses early in the disease when physical disability is not yet a major
symptom (EDSS < 2.5). With disease progression, only physical functioning scales
show further decreases in QoL.
DISCUSSION: The results of the study
suggest that, either the SF-36 is insensitive to the evolution of patient QoL as
the disease progresses, that their is an adaptation of the patient to the
disease, or, that the immediate shock of diagnosis is so severe that patients do
not recover. A disease-specific instrument may provide additional information on
QoL. Cross- sectional observation was shown to be an interesting and effective
approach to estimating QoL in a chronic disease.
Abstract #: LC25
ECONOMIC MODELING OF CHOLESTEROL-
LOWERING USING INTERVENTION DATA
Strauss, BM, Glick, H*, Smith, ME,
Kinosian, B*, Bayer Corporation, West Haven, CT., *University of Pennsylvania,
Philadelphia, PA. US
Economic modeling of health care
intervention is a framework in which the effect of the intervention on the
target disease, in terms of health outcomes is made explicit. This approach
provides a tool to answer research questions regarding the effectiveness of
health care strategies and also determine efficient allocation of health care
resources. Decision analytic models have been used to estimate the costs and
effects of therapy for many years and their use is increasing. OBJECTIVE: This
paper describes and illustrates the use of decision analytic modeling to
evaluate the efficacy and effectiveness of a cholesterol- lowering agent for the
primary prevention of coronary heart disease (CHD). The model construct is based
on intervention study data from the Lipid Research Clinic Coronary Primary
Prevention Trial (LRC-CPPT). Previous CHD models have been based on observations
from epidemiological studies, such as the Framingham Heart Study, plus
intervention assumptions regarding efficacy and effectiveness. This approach was
adopted because information regarding the intervention, patient demographics,
and the relationship between changes in cholesterol and patient risk for CHD,
which are critical to the model, were not always available. METHOD: The model is
based on CHD risk equations, which are directly estimated from the experiences
of the LRC-CPPT participants. RESULTS: Concepts such as time delay, maximum
benefit, and the cost- effectiveness of the test therapy are estimated.
CONCLUSION: Previous work which based the probabilities and risk assessments on
assumptions questions the reliability and credibility of the results and
therefore confidence in the model. Using intervention data produces a model
which is robust and thus allows health care decision makers to base theirdecisions on actual experience.
