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Value in Health
The Official Journal Of The International Society For Pharmacoeconomics And Outcomes Research


Abstracts

Volume 1 Number 2

Atherosclerosis, Acute Coronary Events, and Cholesterol-Lowering: A New Paradigm
Daniel J. Rader MD, University of Pennsylvania

Our current understanding of some mechanisms involved with the occurrence of acute coronary events indicates that coronary atherosclerotic plaques need not develop to the point of stenosis before resulting in an acute event. Recent studies show that the majority of myocardial infarctions result from lesions that are 30-60% stenotic, many of which are not associated with any overt clinical symptoms. In view of the fact that every year in the United States, 200,000 persons with no previous history of coronary disease die from their first myocardial infarction, a major issue becomes identifying persons at risk for coronary disease. Risk assessment for coronary events is a critical area in terms of moving forward with decision-making for lipid-lowering therapies and developing strategies to reduce acute coronary events, and the morbidity and mortality related to them.

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Lipoproteins and Cardiovascular Disease: Biological Basis and Epidemiological Studies
William Castelli MD, Framingham Cardiovascular Institute

There is a long history to our understanding of the biological basis of lipoproteins in cardiovascular disease and to the key epidemiological studies in this field. Building on a wealth of laboratory evidence explaining the role of cholesterol and lipoproteins in the pathogenesis of atherosclerosis, epidemiological studies have characterized associations between serum lipid abnormalities and the risk of myocardial infarction. While elevation in total cholesterol has been associated with an increased risk of myocardial infarction, this information alone is not sufficient. To adequately predict cardiac risk, blood cholesterol must be further characterized by the high density lipoprotein (HDL) cholesterol present and the ratio of total cholesterol to HDL cholesterol. Several other factors, including such clinical syndromes as the "deadly quartet" of insulin resistance, central obesity, high triglycerides, and hypertension, are also associated with a markedly increased cardiac risk and should be identified; these may require unique therapeutic approaches. In addition to the costs of tertiary prevention and therapy after infarct, the impact of long-term morbidity and the economic consequences of this disease further emphasize the importance of optimizing current therapies and actual practice.

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Landmark Trials in Lipid Reduction
W. Virgil Brown MD, Emory University

Since the first epidemiological evidence on the benefit of lipid reduction in coronary heart disease (CHD) was gathered, a number of questions have emerged in this field of research. Consistent findings across a number of landmark trials have shown that lipid-lowering therapies significantly reduced major subsequent cardiovascular events in coronary patients with high and moderate low density lipoprotein (LDL) blood cholesterol levels. Although there has been some confusion on the effect of lipid intervention on mortality, recently, definite answers have come from several major trials that establish a clear decrease in coronary death for patients after reduction of plasma cholesterol levels. Primary prevention in individuals with high LDL cholesterol levels was shown to be beneficial in terms of cardiovascular event reduction; more data are needed to address this issue for subjects with moderate LDL cholesterol levels. Reduction of LDL cholesterol below normal levels appeared to be beneficial for coronary patients, but again, further research is needed to elucidate this point. To date, major trials have answered some of the many questions pertaining to lipid-lowering therapies; further research will continue to provide information and allow patients to benefit maximally from lipid interventions.

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Prevention of Heart Disease: Is LDL Reduction the Outcome of Choice? ABSOLUTELY YES
Evan A. Stein MD, PhD

There is only one well-established relationship between blood cholesterol lipid fractions and coronary artery disease (CAD) that meets all the Heiss and Tyroler criteria of causality. While there are a number of blood lipid fractions, only LDL cholesterol satisfies these criteria. We review the effect of reducing low density lipoprotein (LDL) cholesterol levels on CAD in the landmark lipid intervention trials performed since 1972. Lowering of LDL cholesterol consistently and systematically resulted in a reduction of cardiovascular events, irrespective of the therapy applied or the changes in high density lipoprotein (HDL) cholesterol or triglyceride levels. Findings accumulated over many studies and many years provided sufficient evidence to satisfy all the criteria required to establish a causative relationship between LDL cholesterol and CAD. Consistent interventional benefit demonstrated that reduction of LDL cholesterol is currently the treatment of choice in prevention of heart disease.

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Prevention of Heart Disease: Is LDL Reduction the Outcome of Choice?: NO, THERE IS MORE
Jim Shepherd MD and J.S. Park, PhD

The West of Scotland Coronary Prevention Study (WOSCOPS), a placebo-controlled 5-year cohort study, demonstrated that the use of pravastatin decreased low density lipoprotein (LDL) levels and associated risk of myocardial infarction. The rate of occurrence of coronary events however, was similar across the four lowest quintiles of LDL reduction (23-41% reductions in mean LDL levels). The relationship between reduction of LDL and the reduction of risk was not linear. Further analysis indicated that even in overlap groups where patients exhibited equivalent mean LDL levels on treatment, pravastatin treatment was associated with less risk of occurrence of coronary events than placebo treatment. These results suggest that while LDL level does serve as a predictor of the risk of coronary events, other factors exist that should be considered and investigated further.

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Halpern Abstract

In the field of outcomes research, modeling is increasingly being used to assess costs and outcomes associated with healthcare interventions. However, there is little standardization with regard to modeling practices, and the quality and usefulness of economic and health outcomes models may vary. We propose the following set of recommendations for good modeling practices to be used in both the development and review of models. These recommendations are divided into three sections: criteria to be addressed before model development or initial review; criteria used during model development or evaluation; and criteria used following model development. These recommendations also include examples regarding different modeling techniques and practices as well as a checklist (see appendix) to assess model correspondence with the recommendations. We hope that the use of good practice recommendations for modeling will not only improve the development and review of models but also lead to greater acceptance of this methodology.

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Volume 1 Number 3

The Economics of Hypercholesterolemia and Lipid-Lowering Therapy: A Brief Historical Tour
Gerry Oster PhD

The first formal economic evaluation of a lipid-lowering intervention was conducted almost 20 years ago. The field exploded in the mid-1980s following the publication of findings from the Lipid Research Clinics Coronary Primary Prevention Trial (LRC-CPPT), in which the bile-acid sequestrant, cholestyramine, was reported to reduce the incidence of coronary artery disease in adults with significant elevations in cholesterol. Almost all of the early pharmacoeconomic studies that followed focused on this agent. Later in the decade, the introduction of lovastatin, the first 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (or "statin"), revolutionized the treatment of hypercholesterolemia, as it was significantly more effective than earlier agents (as were the other statins that followed it). Pharmacoeconomic studies of the statins generally have reported that, despite their higher cost, they are significantly more cost-effective than bile acid sequestrants. Recent long-term clinical trials, such as the West of Scotland Coronary Prevention Study (WOSCOPS) and the Scandinavian Simvastatin Survival Study (4S), have provided firm evidence of the benefits of the statins in both the primary and secondary prevention of coronary artery disease. Formal economic evaluations were incorporated into most of these end-point studies—in contrast to morbidity and mortality trials of earlier lipid-lowering agents—and results from these evaluations are just now becoming available. The availability of primary economic data derived directly from large-scale, long-term clinical trials raises important questions about the future role of modeling in this area.

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Compliance and the Real World
Susan Andrade ScD

Until 1994, rates of noncompliance for lipid-lowering therapies were largely drawn from clinical trials and showed favorable risks for drug discontinuation, ranging from 4-15% for 1-year risk to 11-30% for 5-year risk. Although cross-study comparisons are difficult to make because of variations in study design and measures collected, when evaluating compliance to antihyperlipidemic drugs in primary care settings, results in general show substantially higher rates of discontinuation than those reported from randomized clinical trials. Recent studies from the United States, Australia, and Canada support the conclusion that adherence to lipid-lowering drugs is very poor in primary care settings.
Multivariate sensitivity analysis can also be used to present results in a consistent and meaningful way that will facilitate comparisons across the PE literature. Using these methods, broader acceptance and application of PE results by policy-makers would become possible. To reduce the uncertainty about what is being accomplished with PE studies, it is recommended that these guidelines become requirements of both scientific journals and healthcare plan decision-makers. The standardization of economic modeling in this manner will increase the acceptability of pharmacoeconomics as a practical, real-world science.

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Use of Surrogate Measures and Efficiency Frontier Analysis
Thomas Delea, MSIA

Use of surrogate measures of effectiveness in cost-effectiveness analyses requires the assumption that a constant and monotonic relationship exists between the surrogate measure and the clinical outcome of interest. Results from epidemiologic studies and randomized controlled trials provide considerable support for the use of changes in lipids as a surrogate measure of effectiveness for changes in coronary heart disease risk and mortality in cost-effectiveness analyses of lipid-lowering therapies. Accordingly, the cost-effectiveness of lipid-lowering therapies is examined using efficiency-frontier analysis and a variety of surrogate measures, including the percent change in low density lipoprotein cholesterol (LDL-C) and the ratio of LDL-C to high density lipoprotein cholesterol (HDL-C), and the percentage of patients attaining goal LDL-C levels. These analyses suggest that niacin, fluvastatin (20 and 40 mg), simvastatin (5 mg), pravastatin (20 mg), and atorvastatin (10-80 mg) are cost-effective therapies; simvastatin (10, 20, and 40 mg), pravastatin (10 and 40 mg), all dosages of lovastatin, and the bile acid sequestrants are not. Advantages and limitations of this methodology are discussed.

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Clinical Trials and External Validity
Bruce Kinosian MD and Henry Glick

Although a number of clinical trials are available estimating the benefits of lipid-lowering therapies that include economic end-points, development of modeling methodologies are essential to extend results of those trials over time and to other populations. We reviewed the key issues to be considered when extending trial data to real-world situations. The availability of recent randomized controlled trials of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors in primary and secondary prevention has demonstrated the limitations of earlier modeling efforts to project benefits of lipid modification. The importance of risk stratification is demonstrated, particularly the importance of both LDL and HDL cholesterol either together or as a ratio measure. The selection of modeling methodology to extend benefits of a treatment beyond the end of a trial and over a lifetime is discussed. The relationship between benefits from lipid reduction and risk difference is described, demonstrating that for individuals with established coronary heart disease (CHD) and those older than age 58, benefits from lipid reduction are greater than those predicted from baseline lipid-related risk differences alone. The implications of these data for primary prevention of CHD in the elderly are discussed.

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Pharmacoeconomic Modeling & Sensitivity Analysis
Joel W. Hay PhD

The field of pharmacoeconomics (PE) faces serious concerns of research credibility and bias. The failure of researchers to reproduce similar results in similar settings, the inappropriate use of clinical data in economic models, the lack of transparency, and the inability of readers to make meaningful comparisons across published studies have greatly contributed to skepticism about the validity, reliability, and relevance of these studies to healthcare decision-makers. Using a case study in the field of lipid PE, two suggestions are presented for generally applicable reporting standards that will improve the credibility of PE. Health economists and researchers should be expected to provide either the software used to create their PE model or a multivariate sensitivity analysis of their PE model. Software distribution would allow other users to validate the assumptions and calculations of a particular model and apply it to their own circumstances.

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Volume 1 Number 4

What is Happening in the Real World in Lipid Therapy and Is It Appropriate? The Need for a Paradigm Shift
Sidney C. Smith, Jr. MD

Cardiovascular disease is now the leading cause of death and disability in our society. Current strategies in the United States have been very effective in treating the symptomatic manifestations of severe obstructions but have done little to alter the long-term outcome of cardiovascular disease. Although lipid-lowering therapies have proven beneficial in secondary prevention for patients with cardiovascular disease, they are not as widely employed in contemporary practice as they should be. Better implementation of lipid-lowering therapies, including such major issues as clear treatment guidelines, physician and patient compliance, and delivery of healthcare and quality of care, must be addressed to shift thinking about the treatment of cardiovascular disease as we advance into the next century.

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Criteria for the Economic Evaluation of Lipid Studies in Health Systems
Paul C. Langley PhD

From the perspective of a health system as a drug purchaser, it is becoming increasingly obvious that the traditional pharmacoeconomic cost-outcomes techniques of comparator drug evaluation are of limited application. The reason is that such approaches fail to address the information needs of drug purchasers. The key question that these evaluations should address is: If a new product is introduced to formulary, what will be the net impact on the costs of treatment of that disease or therapy area and on the outcomes profile of the treating population? It is on these criteria that claims made for lipid therapies should be judged. Issues that the traditional approach fails to address include: 1) the impact of budget constraints, 2) the determinants and impact of therapy switching, 3) the impact of poor compliance on claims for cost-effectiveness, and 4) the way in which more integrative approaches to treatment delivery might reinforce claims made for particular products. Guidelines are important in this process because they set out the informational requirements and analytical standards required of drug manufacturers making a submission to pharmacy and therapeutics committees. This paper identifies what may be considered to be the minimum informational requirements and suggests how a systems approach to drug evaluation could apply in the area of lipid therapy and the claims for competing products.

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Patient Education and Compliance: How to Make it Cost-Effective
James M. McKenney PharmD

The current level of noncompliance with prescription medications exerts a tremendous burden on the healthcare system in terms of both cost and poor health. The process of developing a program to improve compliance for lipid therapy is twofold. First, patients must be met at their specific level of need. This involves enabling, reinforcing, prompting, and problem solving. Second, the delivery of treatment must be addressed. Large centers and groups should refer lipid patients to a central team of professionals specializing in lipid therapy; or groups of physicians should contract extra patient support out to other groups, such as pharmacies. The implementation of a compliance program will not be immediately cost-effective but will have the long-term benefit of reduced costs through improved health.

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A Canadian Perspective
Nicolaas Otten

Although the healthcare program in Canada is in many ways universal, there are several differences between the provinces. Two key federal bodies (the Health Protection Branch of Health Canada and the Patented Medicine Prices Review Board) are involved in the drug review process. In addition, the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), an organization funded jointly by provinces and the federal government, reviews new or existing drugs at the request of provinces. Each province or territory and the federal government has its own drug plan or plans. The 10 Canadian provinces require a notice of compliance, information on pricing, and clinical and comparative information for submission of a new drug. Over the last 3 years, 8 of the 10 provinces have required pharmacoeconomic analyses to be added to the submissions. Four of the eight provinces requiring pharmacoeconomic evaluations have specified that these evaluations should be made according to the Canadian Coordinating Office for Health Technology Assessment guidelines. A review of the utilization patterns of lipid-lowering therapies is presented in this Canadian context. Statins comprised 80% of the lipid-lowering drug market in 1995. Prescribers use statins available in Canada interchangeably for all approved and nonapproved indications. The newest statin, atorvastatin, has attained a market share for new prescriptions equivalent to simvastatin and pravastatin, despite the lack of clinical outcome studies. CCOHTA reviewed the evidence of efficacy and effectiveness of statins, evaluated whether significant differences existed between statins, and analyzed published economic evaluations. It found that treatment of higher-risk patients with statins is more cost-effective than that of lower-risk subjects. The evaluation also concluded that the statins, as a class, probably act in reducing LDL and raising HDL, resulting in beneficial clinical outcomes.

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A UK Perspective
Peter Davey

Making decisions on lipid-lowering treatment varies across Europe. Legislation differs from country to country, so it is difficult to generalize about European policy. From the perspective of the United Kingdom, this paper addresses the impact of rationing, cost containment, information feedback, fund-holding and drug expenses. Primary versus secondary prevention for cardiovascular disease is also discussed, including current recommendations for prescribing statins and other interventions.

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A US Military Perspective
Daniel D Remund, Ernest L Sutton

This paper discusses lipid therapy decision-making at the population level within the United States (US) Military Health Services System. The US Military Health Services System serves approximately 8.2 million beneficiaries fairly representative of the general population. Of its $680 million annual pharmacy expenditure, $45-$50 million is spent on lipid-lowering drugs. The military Medical Treatment Facilities (MTF) carry a Tri-Service Drug Formulary list, which serves as a bare minimum to which individual facilities may add other agents. The Department of Defense Pharmacoeconomic Center (PEC) performs cost-effectiveness analyses, establishes the Tri-Service Drug Formulary list and the National Mail Order Pharmacy formulary list, and provides drug treatment guidelines. Hyperlipidemia treatment guidelines published by the Pharmacoeconomic Center in 1995, which recommend the use of niacin, colestipol, and pravastatin, are currently under revision to take into consideration new drugs and new information in the field of lipid-lowering therapies. Future changes to the MTF outpatient formulary management may include the introduction of a Basic Core List of essential agents and a Master Pharmaceutical Agent List comprising the only drugs from which facilities may choose to add to their Basic Core List. These changes are designed to standardize drug availability across military facilities and to leverage market share for lower drug prices.

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A Managed Care Perspective
James Bonnette

This paper highlights some of the problems associated with lipid therapy in the primary and secondary prevention of cardiovascular disorders and to make some potentially useful suggestions in the context of managed care. For managed care organizations, financial and logistical issues create obstacles to the provision of primary prevention of cardiovascular disease. These current obstacles necessitate the generation of external forces, perhaps regulatory or standards agencies, that may help increase accountability in managed care organizations for midterm and distant outcomes. In contrast, the provision of secondary prevention by managed care organizations has fewer limitations. One of the major challenges in secondary prevention, however, is the low rate of physician compliance with national treatment guidelines and standards. Among possible explanations for this observation are limitations in health data collection and integration. Improvements in data management are vital to the achievement of treatment goal optimization in secondary prevention.

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A Pharmacy Benefit Manager Perspective
J. Russell Teagarden, Robert S Epstein

Lipid-lowering therapy can account for 7% of per patient per month drug costs. Because this can be a significant proportion of a payer's drug expenditure, this class of drugs attracts payers' attention and thus becomes a focus of efforts designed to control drug expenditures. Pharmacy benefit managers (PBMs) use several techniques and capabilities to affect the use of these drugs to improve overall medical care and to capture financial opportunities. There is a gap between the marketplace needs for lipid therapy value information and current pharmacoeconomic evaluations of lipid therapy. The measurement units that current pharmacoeconomic analyses tend to use are not necessarily intuitive and do not easily conform to the existing conceptual framework of policy makers. The successful evaluation of PBM activities will be contingent on a recognizable and widely accepted quantitative measurement framework.

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Employer and Consumer Perspectives
William F McGhan

This paper reviews various published reports from surveys on employer opinion, perception of needs, and trends with regard to healthcare benefits; the consumer perspective regarding healthcare is also discussed. Surveys indicate that businesses want continuous evidence that high-quality healthcare can positively impact company profits. Employers and labor unions are demanding more cost-effective healthcare. At both employer and consumer levels, greater patient education is needed, as well as traditional educational media. Direct-to-consumer advertising and use of the World Wide Web are increasingly important in enabling consumers to participate more fully in their own lipid-related decision-making. Finally, the transition of lipid-lowering drugs to over-the-counter accessibility has great implications with respect to issues of patient preferences and willingness to pay in the evolving healthcare environment. Groups in the United States, such as the National Committee on Quality Assurance and the Foundation for Accountability, are setting standards and beginning to assess both process and outcomes in patient care. Further collaborative efforts are needed that raise standards of care and stimulate more cost-effective healthcare. The pharmacoeconomics and outcomes data gathered will, one hopes, also demonstrate to global businesses the positive financial impact of high-quality healthcare and appropriate lipid therapy.

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Prevalence-Based Economic Evaluation
Josephine Mauskopf

Objective: Researchers have often stated that economic evaluations of new drugs have rarely been used to inform healthcare decisions, despite the large volume of published studies. In this paper, a new categorization for economic evaluations of new drugs is proposed: incidence-based and prevalence-based. This categorization is designed to increase the likelihood that decision-makers are given more complete and useable economic information about new treatments. Results: Incidence-based evaluations (such as cost-effectiveness analysis) focus on the impact of a new treatment on a health condition from onset until cure or death. Prevalence-based evaluations focus on the impact of a new treatment on a health condition during a 1-year period. An incidence-based evaluation may focus either on a representative individual or on a specific disease cohort. A prevalence-based evaluation generally focuses on a specific population. Incidence-based evaluations measure the value of the new treatment compared to alternative treatments for the same health conditions and compared to commonly used treatments for other health conditions. Prevalence-based evaluations measure the impact of introducing the new treatment on annual healthcare budgets and population health.
Conclusion: Both types of evaluation provide important information when a new treatment is introduced to a population.

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Volume 2 Number 4

The Role of SSRI Antidepressants for Treating Depressed Patients in the California Medicaid (Medi-Cal) Program
Jeffrey S McCombs, PhD, Michael B Nichol, PhD, Glen L Stimmel, PharmD

This research used paid claims data to investigate the likelihood that patients achieved an adequate course of antidepressant drug therapy and the impact of completed therapy on health care costs. Completed therapy was defined was defined as six or more months of uninterrupted therapy at an adequate dose as determined by AHCPR treatment guidelines. Apparent average daily dose for each prescription filled was calculated from data on the prescription paid claim and allowances were made for titration of dose to therapeutic levels and changes in antidepressant therapy. A total of 1648 new episodes of antidepressant therapy were identified for analysis. The likelihood of achieving an adequate course of antidepressant therapy was 22%. Completion rates varied significantly across antidepressants with fluoxetine achieving the highest completion rate at nearly 51%. Total health care costs were significantly lower for patients who completed therapy (- $1487; P = .0487) due primarily to lower ambulatory care costs (- $1296; P = .0110). Fluoxetine was the only antidepressant therapy which exhibited significantly lower total health care cost per patient relative to the older tricyclic antidepressants (- $3524; P = .0024). The total costs of treating depression in the ambulatory setting were found to vary widely across alternative antidepressants. Most of the cost-savings associated with fluoxetine use were associated with the increased likelihood of completed therapy. Further research is needed to verify if fluoxetine achieves better rates of completed therapy relative to other SSRI antidepressants using data from other settings.

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Towards a European Consensus on Conducting and Reporting Health Economic Evaluations—A Report from the ISPOR Inaugural European Conference
Mireille M. Goetghebeur, PhD, Donna Rindress, PhD

This report is a summary of key issues in consensus development regarding the conduct and reporting of health economic research in the European context, presented and discussed at the ISPOR Inaugural European Conference in Cologne, Germany, December 1998. Recommendations of the Harmonization by Consensus of the Methodology for Economic Evaluation of Health Care Technologies in the European Union (HARMET) project were presented, as well as two instruments under development: software for Reporting Economic Evaluation Results (REER) and software for collecting and managing cost data called the Health Cost Database Software (HCDS). Working independently, but interrelated with the objectives of the HARMET initiative, preliminary results from the ongoing European Network on Methodology and Application of Economic Evaluation Techniques (EUROMET) project were presented. Each presentation was followed by an expert discussion panel with audience participation. Issues raised included the development of standards and related topics such as usefulness to European decision-makers, and education and training in health economics in Europe.

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Cost-Effectiveness of Prolonged Administration of a Low Molecular Weight Heparin for the Prevention of Deep Venous Thrombosis Following Total Hip Replacement
David Bergqvist, MD, PhD, Bengt Jönsson, PhD

Recently there has been discussion on the value of prolonged thromboprophylaxis after elective hip surgery to prevent thromboembolic complications up to one month. Continuing low molecular weight heparin for one month can significantly reduce the frequency of venographically-proven deep vein thrombosis (DVT). How this will influence health economics has hitherto not been evaluated. Data on costs and effect from a randomized comparison between around 10 and 30 days once daily low molecular weight heparin (enoxaparin) were used in a cost effectiveness study. Data on treatment costs were based on patients actually treated for DVT within the randomized study. Various sensitivity analyses were performed. In the study both phlebographically detected and clinically manifested venous thromboembolism were registered. By using costs from the health care system in Sweden it could be shown that the cost was 6,075 Swedish Krona (SEK) per phlebographic DVT avoided and 13,184 Swedish Krona (SEK) per clinical DVT avoided. If more than 50% of the patients managed to self-administer the low molecular weight heparin injections, the use of prolonged prophylaxis is cost-effective. Prolonged prophylaxis with the low molecular weight heparin enoxaparin after elective hip arthroplasty is cost-effective provided that at least 50% of the patients can administer the subcutaneous injections themselves.

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Postmarketing Studies: Benefits and Risks
Frances B. Garfield, PhD, J. Jaime Caro, MDCM

The objective was to consider the benefits and risks of large postmarketing outcomes studies, as demonstrated by studies of the statin drugs, using literature review. The statin studies had a strong coat tail effect. Each new study was beneficial to all statins as well as the one studied. Economic analyses based on the results of the postmarketing studies concluded that the drugs were not cost-effective. Long-term postmarketing studies were slow to be put into perspective and did not immediately influence other researchers or clinicians. During that time, the sponsoring companies shouldered opportunity costs as well as the actual costs of the studies. The risk that one drug company would use another company's results instead of investing in their own research did not materialize. The studies definitively showed that the drugs and the lowering of lipids were safe and efficacious. The studies also expanded the indications for the drugs, generated goodwill in the medical and research communities for the sponsors, allowed sponsors to include specific claims in their advertisements, generated follow-up studies, spawned economic analyses that sparked interest in the medical and lay press, and had a major impact on clinicians' use of the drug. The risks and benefits of postmarketing studies may depend on the company's time perspective. In the short term, the risks may outweigh the benefits. Only companies that have a longer perspective may find it beneficial to undertake large postmarketing studies.

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Assessment of Quality of Care for Managed Care and Fee-For-Service Patients Based on Analysis of Avoidable Hospitalizations
L. Clark Paramore, MSPH, Anne Elixhauser, PhD

As managed care has grown to dominate the US health care delivery system, questions have been raised about the impact on the quality of care provided to its enrollees. Two important aspects of health care quality are access to care and the appropriateness of care. This analysis evaluated the occurrence of preventable hospitalizations among managed care (MCO) versus fee for service (FFS) populations to compare access to and appropriateness of preventive, primary, and surgical health care services. Rates of preventable hospitalizations associated with ambulatory sensitive conditions (ASCs) were calculated based on all discharges from Massachusetts hospitals in 1995, and categorized by population characteristics including: age, sex, ethnicity, and insurance status. Multivariate logistic regression models were employed to explain the likelihood of having a preventable hospitalization. Rates of preventable hospitalizations for two of the conditions evaluated (perforated appendix and diabetes complications) were lower for MCO enrollees. For two additional indicators (immunization preventable pneumonia and low birth weight), MCO rates were no different from FFS rates. Results for pediatric asthma were inconclusive. For four out of five quality indicators evaluated, individuals in Massachusetts MCOs are doing better or no worse than their counterparts in FFS plans. Until population-based data on managed care enrollees becomes available, and until such data can be linked to utilization and health outcomes information, investigations into the quality of services provided by MCOs compared to FFS plans cannot be definitive.

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An Analysis of the Impact of Demographic, Clinical, and Social Factors on Health-Related Quality of Life
George J Wan, PhD, MPH, Michael A Counte, PhD, David F Cella, PhD, Lesbia Hernandez, PharmD, MPH, Shirley Deasy, MA, Gail Shiomoto, MD

This study investigated the impact of demographic, social, and clinical factors on cancer patients' self-ratings of health-related quality of life (HRQL). The sample consisted of 1342 ethnically diverse individuals in treatment at four member institutions of the Eastern Cooperative Oncology Group (ECOG). Multivariable regression analyses were employed to determine the relationship between demographic variables (age, gender, race/ethnicity, socio-economic status (SES), living arrangement), clinical factors (performance status rating (PSR), disease type, disease stage), and social characteristics (spiritual beliefs, religious affiliation, relationship with physician) and five outcome measures of HRQL. The dependent variables, four dimensions of HRQL and overall HRQL, were measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Quality of Life Measurement System. The results indicated that the full set of predictor variables accounted for 45% of the variance in patients' reporting of overall HRQL, 25% of the variance in physical well-being, 27% of the variance in social well-being, 30% of the variance in emotional well-being, and 41% of the variance in the area of functional well-being. The findings suggest that there are multiple factors that influence an individual's assessment of their HRQL and that these factors need to be considered in the management and treatment of culturally diverse cancer patients.

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The Influence of Case Mix, Site Selection, and Methods Biases on Costs of Hospitalization For Acute Exacerbations of Chronic Obstructive Airways Disease and Lower Respiratory Tract Infections
Peter G. Davey et al.

Objective: To compare costs of hospitalization for lower respiratory tract infection (LRTI) in patients who received antibiotics before admission to those who did not, and in patients with and without underlying chronic obstructive airways disease (COAD) or diabetes mellitus.
Methods: All hospitalizations in a population of 366,849 residents in Tayside Scotland from 1993 to 1994 were analyzed. Three groups of patients were identified by primary discharge diagnosis in 1993/94 and previous admissions from 1980 to 1992: 1) acute exacerbation of COAD; 2) LRTI plus a secondary diagnosis of COAD or previous admission with COAD; 3) LRTI but no secondary COAD or previous admission with COAD. Setting specific costs were applied (e.g., general medicine, intensive care, geriatrics). Dispensed antibiotic prescribing in the 28 days before admission was identified from all community pharmacies. Nonparametric statistical tests were used.
Results: Patients with COAD were more likely to have received antibiotics before admission: COAD (n = 893) 49%; COAD + LRTI (n = 316) 43%; LRTI only (n = 822) 33%. Patients who received antibiotics before admission had lower hospital costs than patients who did not. Mean total costs per admission: COAD £1604 versus £1625 (p = .5); COAD + LRTI £2281 versus £2297 (p = .5); LRTI only £2365 versus £3233; (p = .009). Increasing age and diabetes mellitus were associated with higher hospital costs in all three groups.
Conclusion: Economic models of the value of preventing hospital admissions for COAD or LRTI will be subject to case mix bias unless they adjust for age, community antibiotic use, and comorbidity.

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The Norwegian Version of the Psoriasis Disability Index— A Validation and Reliability Study
A.K Wahl et al

Objective: The aim of this study was to translate the Psoriasis Disability Index (PDI) into Norwegian and validate it in a Norwegian setting. The PDI is a measure that was developed to assess the impact of psoriasis on the patient's life.
Methods: Two hundred and eighty-two patients with psoriasis were included in the study (80% outpatients, and 20% hospitalized).
Results: Face and content validity were assessed as satisfactory. The PDI seems to capture issues of importance to patients. The results indicate that the PDI does not capture a unidimensional concept. A factor analysis (principal component with orthogonal rotation) resulted in three factors (physical, social, and hygienic) that were substantially different. All three factors had satisfactory internal consistency. Altogether they explained 58% of the variance. In addition, there were differing patterns of correlation with external criteria, such as dimensions of SF-36, as well as with sex, age, and education.
Conclusions: The PDI has been found to have acceptable reliability in this study. However, further validation is necessary to estimate the sensitivity to change.

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