Pharmacoeconomic analysis of selected antibiotics in lower respiratory tract infection.
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An interactive pharmacoeconomic model was designed to evaluate the effects of clinical response and adverse drug events on the comparative cost and cost-effectiveness of a relatively new antibiotic, clarithromycin, compared with those of six other antibiotics used to treat community-acquired lower respiratory tract infection. The cost and cost-effectiveness analyses were based don 12 randomized, double-blind, controlled clinical trials conducted between 1987 and 1992 in regionally distributed outpatient clinics in the United States. The trials enrolled a total of 2377 patients. Of the 2377, 1102 patients were treated for acute exacerbation of chronic bronchitis, 591 for pneumonia, and 201 for either of the two conditions. Safety data for one of the antibiotics was obtained from a trial of patients with sinusitis (N = 483). The antibiotics included in the analysis were amoxicillin/clavulanate, ampicillin, cefaclor, cefixime, cefuroxime, clarithromycin, and erythromycin. The main outcome measures were the costs of resources to achieve a clinical response, costs related to managing adverse drug events, and costs of antibiotic treatment from the perspective of managed care. The mean total cost per episode ranged from approximately $137 to $267. The drug acquisition cost typically contributed a small amount to the overall cost. For the cost-effectiveness analysis, in which complication-free cure was used as a proxy for patient satisfaction, the range of mean cost per complication-free cure varied from approximately $307 for clarithromycin to $612 for cefaclor. When ranked from most to least cost-effective, the order was as follows: clarithromycin, cefixime, amoxicillin/clavulanate, erythromycin, cefuroxime, ampicillin, and cefaclor. The costs associated with clinical management (including treatment failure) and managing adverse drug events significantly contribute to the total cost and cost-effectiveness of antibiotics in the outpatient setting. Cost-effectiveness analyses are valuable in analyzing the various costs associated with the treatment of lower respiratory tract infection (acute exacerbation of chronic bronchitis or pneumonia) and may be useful tools for physicians managing patients, members of pharmacy and therapeutics committees developing formularies, and medical staff implementing practice guidelines. (+info)
Why is evaluation of the cost effectiveness of audit so difficult? The example of thrombolysis for suspected acute myocardial infarction.
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BACKGROUND: Cost effectiveness analysis is an established technique for evaluation of delivery of health care, but its use to evaluate clinical audit is rarely reported. Thrombolysis for suspected acute myocardial infarction is a commonly used therapy of established effectiveness and an appropriate subject for audit in many healthcare settings. OBJECTIVE: To measure the cost effectiveness of audit of thrombolysis in some district general hospitals. MAIN OUTCOME MEASURE: Cost of audit per extra patient treated with thrombolysis (incremental cost effectiveness ratio). DESIGN: Prospective agreement with physicians to undertake repeated audits of a specific aspect of the management of patients with acute myocardial infarction. Baseline measurement of the proportion of these patients given thrombolysis in each hospital were made, as were three subsequent retrospective audits, giving time series of measurements. Costs were estimated from records of staff time and other resources used in each hospital; effectiveness was estimated by fitting the results to a model which assumed a uniform rate of increase over time in the proportion of eligible patients given thrombolysis which might be accelerated by regular audit. Upper and lower limits for main outcome measure were derived from sensitivity analysis of costs and logistic regression of time series data. SETTING: Five district general hospitals in North West Thames Regional Health Authority including one control hospital were used, starting in April 1991 when widespread medical audit was first introduced. RESULTS: Between the first and last audits, the proportion of patients with suspected acute myocardial infarctions receiving thrombolysis rose in three of the hospitals undertaking audit by 20% to 37% and fell by 6% in the fourth (although this hospital started with a rate in excess of 90%). The corresponding change in the control hospital was an increase of 15%. The differences between each of the auditing hospitals and control hospital were not significant, except in one case, where 51 extra treatments per year were attributable to audit (95% confidence intervals (95% CIs) 0.5 to 61 cases per year). Estimated overall costs in each hospital ranged from 3700 Pounds to 5200 Pounds for data collection, a series of four audit meetings, and subsequent actions. The central estimate of cost effectiveness in the three responsive hospitals ranged from 101 Pounds to 392 Pounds per extra case given thrombolysis, with very wide 95% CIs. In the fourth hospital audit had zero effectiveness as defined in this study. CONCLUSIONS: Methodological difficulties were encountered which need to be considered in future economic evaluations of clinical audit and related activities. These were: (a) adequate control for other factors influencing clinical behaviour; (b) uncertainties about the sustainability of changes in behaviour associated with audit; and (c) the relative infrequency in a single hospital of specific clinical events leading to small numbers for analysis. These difficulties constitute major challenges for the economic evaluation of clinical audit. They are most likely to be overcome in a large study which compares clinical audit with other interventions aiming for the same quality improvement, such as patient specific reminders or educational programmes. (+info)
A critical review of priority setting in the health sector: the methodology of the 1993 World Development Report.
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The 1993 World Development Report, Investing in Health, suggests policies to assist governments of developing countries in improving the health of their populations. A new methodology to improve government spending is introduced. Epidemiological and economic analyses from the basis for a global priority setting exercise, leading to a recommended essential public health and clinical services package for low- and middle-income countries. Ministries of Health in many countries have expressed an interest in designing a national package of essential health services, using the methodology. Given the apparent importance attached to the study and its far reaching potential consequences, this article provides an overview of the method, the main issues and problems in estimating the burden of disease as well as the cost-effectiveness of interventions. Strengths and weaknesses in the databases, value judgements and assumptions are identified, leading to a critical analysis of the validity of the priority setting exercise on the global level. (+info)
A cost comparison of approaches to sexually transmitted disease treatment in Malawi.
(52/8073)
Since syndromic management of STDs requires treatment with at least two antibiotics per patient, one of the concerns raised by adoption of the syndromic approach is the cost of drugs, especially for developing countries with limited drug budgets. The objective of the current study is to compare the cost-effectiveness of syndromic management to current national practice for the management of STDs in Malawi. The actual cost of observed antibiotic treatment for 144 patients receiving same day treatment for two STD syndromes in Malawi was determined using prices from the Malawi government supply catalogue. This was then compared to the calculated cost of treatment had the same patients been managed syndromically according to national guidelines. The cost of drug treatment under current practice was similar to the cost of syndromic treatment. However, at least one-third of observed patients did not receive effective treatment for either likely cause of their STD syndrome and wastage accounted for 54% of total observed drug cost. Overall, syndromic management of STDs in Malawi would result in more effective treatment of STDs at no additional cost. Since the indirect costs of low treatment efficacy were not taken into account in this analysis, a net saving is likely to be realized with the adoption of syndromic management. (+info)
Evolving therapy for Helicobacter pylori infection: efficacy and economic impact in the treatment of patients with duodenal ulcer disease.
(53/8073)
Helicobacter pylori infection is present in most patients with duodenal ulcer disease, and cure of H pylori infection has been shown to dramatically reduce ulcer recurrence. Therapeutic strategies for duodenal ulcer disease have rapidly evolved over the past several years in an effort to consistently cure H pylori infection in a safe, cost-efficient manner. This paper reviews the effectiveness of treatments for H pylori infection in patients assessed with duodenal ulcer disease. The impact of clinical success on economic effectiveness has been determined in a recent prospective outcomes trial. Treatments with clarithromycin plus omeprazole or clarithromycin plus ranitidine-bismuth-citrate (RBC) provide consistent cure of H pylori infection, with eradication rates of 70% to 80%. Recent studies suggest that higher rates of eradication are possible with triple combination therapy (e.g., clarithromycin plus a second antibiotic and a proton pump inhibitor or RBC), but the optimal triple therapy regimen (including the combination of drugs, dosage, and duration of treatment) has not yet been defined. A recent 1-year prospective outcomes trial has demonstrated that eradication therapy with clarithromycin and omeprazole, compared with standard antisecretory therapy, provides measurable savings in utilization of ulcer-related health-care resources. Combination therapy with clarithromycin plus omeprazole, clarithromycin plus RBC, or clarithromycin plus lansoprazole and amoxicillin have been approved for the treatment of H pylori infection in patients with duodenal ulcer disease. Economic analysis has confirmed that cure of H pylori infection not only contributes to the clinical resolution of duodenal ulcer disease, but also provides economic advantages by reducing costs associated with recurrence. (+info)
Antiviral therapy for neonatal herpes simplex virus: a cost-effectiveness analysis.
(54/8073)
Each year, about 1,600 infants in the United States are infected with neonatal herpes simplex virus. We conducted a cost-effectiveness analysis of antiviral drug therapy (acyclovir) for three forms of herpes simplex virus infection: skin, ear, and mouth (SEM), central nervous system (CNS), and disseminated multiorgan (DIS) disease. Five levels of patient outcomes were examined (normal, mild, moderate, severe, dead). We obtained information on disease occurrence and survival from clinical trials and historical reviews of untreated newborns. We considered approaches for treating all or any of the forms of the disease and compared them with no use of antiviral drugs. The main measure of effectiveness was lives saved, including those of descendants of survivors. Costs were measured from a societal perspective and included direct medical costs, institutional care, and special education. We used a discount rate of 3% and valued dollars at 1995 levels. We also considered the perspective of a managed care organization. From a societal viewpoint relative to no treatment, antiviral therapy for SEM resulted in a gain of 0.8 lives and a cost reduction of $78,601 per case. For the treatment of CNS and DIS disease, antiviral therapy saved more lives but at increased cost, with respective marginal costs per additional life saved of $75,125 and $46,619. From a managed care perspective, antiviral therapy is more cost-effective than from a societal viewpoint because costs of institutional care and special education are not the responsibility of managed care organizations. Development of at-home therapies will further improve the cost-effectiveness of antiviral therapy for neonatal herpes simplex virus infection. (+info)
When is a cost-effectiveness claim valid? How much should the FDA care?
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Federal law requires the Food and Drug Administration (FDA) to regulate the promotional claims of prescription drugs and certain devices. Standards of evidence for claims of safety and therapeutic efficacy are rigorous because inappropriate product use may place human life at risk. However, equally demanding criteria for claims of cost-effectiveness of marketed technologies seem to be unnecessary because the consequence of error is principally a bad buy rather than patient harm. Concern exists about the validity of cost-effectiveness studies, the potential for bias, standards for the conduct of cost-effectiveness research, and the needs of managed care. The FDA should moderate its role in regulating cost-effectiveness claims of drugs and devices. This would foster information flow to healthcare providers and insurers and protect the FDA concern regarding false or misleading claims of effectiveness. Although the issues are applicable to both devices and drugs, we draw mainly from the field of pharmacoeconomics because this is where most of the policy has developed. (+info)
Incorporating quality of life data into managed care formulary decisions: a case study with salmeterol.
(56/8073)
Pharmacy and Therapeutics committees of managed care organizations have traditionally developed formularies by limiting the numbers and kinds of pharmaceuticals they purchase, with the goal of cutting costs. These attempts to manage pharmaceutical costs do not take into account the interrelationship of the costs of various components of care; thus, drug costs may decrease, but expenditures for utilization of other resources may increase. Cost-minimization and basic cost-effectiveness studies, on which many prior- authorization and formulary programs are based, only evaluate only the cost of the drug and its effectiveness. However, with the heightened competition in the healthcare market, emphasis is increasingly being laid on patient satisfaction and outcomes. Cost-utility analysis is a potentially superior pharmacoeconomic tool because it evaluate the effect of drug therapy on quality of life; however, data from such analyses are seldom readily available to the committees that evaluate a drug's potential effects on the entire healthcare system. The purpose of this review is to stress the importance of approaching formulary management from a wider perspective and to emphasize that the results of cost-utility studies should be proactively evaluated and incorporated into decisions regarding formularies. This is especially important for symptom-intensive diseases, such as asthma, in which the quality of life can be notably impaired. Cost-utility analyses should be conducted for all newer therapies, such as salmeterol, which are highly effective and which have a positive impact on quality of life, to determine the overall effect on the managed care plan's budget. (+info)