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PubMed2004

[Comparison of the cost of treatment of premature labor with atosiban or beta-sympathomimetics from the perspective of the health care payer--a pharmacoeconomic model].

OBJECTIVE: To evaluate the cost of treating premature delivery with atosiban or beta-sympatomimetic drugs (fenoterol and hexoprenalin) from the perspective of health care payer--the medical insurance company. DESIGN: A pharmaco-economic model based on the results of randomized, controlled clinical study. SETTING: Hospital Pharmacy at Vitkovice Hospital of Blessed Mary Antonia, Ostrava. METHODS: The study is based on the application of clinical decision-making analysis, which includes results of a randomized controlled clinical study as well as data on the cost of clinical interventions and cost of drug therapy. The pharmaco-economic model was created from the perspective of the payer of health care--the insurance company. This model presumes the administration of atosiban or beta-sympatomimetic drugs (fenoterol and hexoprenalin) for the period of 18 and 48 h and the therapy of possible untoward effects for the next 72 h after the administration of the drugs. The analysis of sensitivity of pharmacokinetic model also employs so called low and high estimate of supplementary cost for the treatment of untoward effects. RESULTS: After the administration of the drugs for the period of 18 h the total cost of the payer of medical care was in the range of 21,914.5-21,974.4 CKr in atosiban, 19,878.7-22,661.4 CKr in fenoterol and 19,942.9-21,974.4 CKr in hexoprenalin. In the administration of the drugs for 48 h, the overall cost of the payer of medical care was in the range of 43,082.5-43,142.4 CKr in atosiban, 19,960.3-23,150.7 CKr in fenoterol and 20,131.3-23,574.0 in hexoprenalin. CONCLUSIONS: This study compared overall cost associated with hospitalization of a premature delivery from the perspective of the medical care payer, i.e. the health insurance company. The authors applied a pharmaco-economic model evaluating hospitalization for the period of 48 h and subsequent therapy of possible untoward effects for the period of up to 72 h. In case of a shorter administration of atosiban (up to 18 h) the overall cost of hospitalization for premature delivery for the period of 48 h from the point of view of medical insurance company is basically comparable with the administration of beta-sympatomimetic drugs. If atosiban is administered for more than 18 h, the overall cost of hospitalization is higher than with beta-sympatomimetic drugs, and the cost increases in relation to the duration of atosiban administration.

Czech Republic↗
PubMedDate not supplied

Health and economic outcomes modeling practices: a suggested framework.

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.

Journal Article↗
PubMed2006

Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial).

OBJECTIVES: To establish the cost-effectiveness of surgery and sclerotherapy for the treatment of varicose veins. DESIGN: Randomised controlled trials (RCTs) were carried out for conservative treatment, sclerotherapy and surgery for varicose veins. An economic analysis was carried out alongside the randomised trial. Economic modelling was undertaken based on the primary data collection and a literature review (database searches undertaken in April 2000 and updated in March 2001). SETTING: Primary data collection was from a large district general hospital and a teaching hospital both in England over a 2-year period from January 1999. Cost-effectiveness analysis and economic modelling were carried out using an NHS perspective. PARTICIPANTS: A total of 1009 patients were recruited. INTERVENTIONS: Thirty-four patents were randomised in Group 1 (minor varicose veins with no reflux, randomised between conservative treatment and sclerotherapy), 77 in Group 2 (moderate varicose veins with reflux, randomised between surgery and sclerotherapy) and 246 in Group 3 (severe varicose veins with reflux, randomised between conservative treatment and surgery). The remaining 652 patients formed the observational part of the study. MAIN OUTCOME MEASURES: The cost-effectiveness analysis was based on NHS treatment costs for the 2002--3 financial year, and utilities based on the Short Form 6D (SF-6D) preference-based health measure. For the clinical trial, the outcome measures were health-related quality of life (HRQoL) [Short Form with 36 Items (SF-36), EuroQol quality of life questionnaire (EQ-5D), visual analogue scale (VAS) and standard gamble], symptomatic relief, anatomical extent (for which a new classification was developed and validated), patient satisfaction and the incidence of complications. RESULTS: Of the RCTs, only the Group 3 trial was large enough to provide clear results. This showed that surgical treatment produced better results than conservative treatment in terms of HRQoL, symptomatic relief, anatomical extent and patient satisfaction. Clinical outcomes of surgery and sclerotherapy showed significant improvement in the extent of varicose veins, symptomatic and HRQoL parameters. Cost-effectiveness analysis based on the Group 3 trial showed that the surgery produced an estimated discounted benefit of 0.054 quality-adjusted life-year (QALY) over a 2-year period, with an additional discounted cost of pound 387.45, giving an incremental cost-effectiveness ratio (ICER) of pound 7175 per QALY. Economic modelling suggested that surgery produced a still greater benefit when considered with a 10-year time horizon, with an ICER of pound 1936 per QALY. Injection sclerotherapy produced an incremental benefit of approximately 0.044 QALY at a cost of pound 155 when compared with conservative treatment, giving an ICER of pound 3500 per QALY. When surgery was compared with sclerotherapy, surgery produced greater benefit with a lower ICER (showing extended dominance). CONCLUSIONS: Standard surgical treatment of varicose veins by saphenofemoral ligation, stripping and multiple phlebectomies is a clinically effective and cost-effective treatment for varicose veins, with an ICER well below the threshold normally considered appropriate for the funding of treatments within the NHS. Injection sclerotherapy also appears to be cost-effective, but produces less overall benefit, with a higher ICER than surgery for patients with superficial venous reflux. In minor varicose veins without reflux, sclerotherapy is likely to provide a small average benefit with acceptable cost-effectiveness. Research is needed into methods for accurate and acceptable utility evaluations for conditions with relatively minor effect on HRQoL and also for a validated and standardised method of classification for varicose veins.

Adolescent↗
PubMed1996

Role of decision analysis in relation to clinical trials and a US perspective of the Battelle model.

Economic assessment of evolving technologies is assuming increasing importance worldwide. One form of economic assessment uses decision analysis, a simulation technique, to determine whether performing a clinical trial is worthwhile. This type of assessment may streamline data collection within a clinical trial, and can aid in the interpretation of a trial result with substantial benefits and toxicities. Although second-line chemotherapy for patients with metastatic breast cancer is in common use, its benefit is unclear and it is associated with substantial cost. A database search of currently active or recently closed randomised phase III comparative trials for metastatic breast cancer found only 6 trials involving a comparison of chemotherapies. Only 1 trial allowed prior chemotherapy for metastatic disease. Given the paucity of forthcoming clinical data, decision analysis is an appropriate tool for estimating the effectiveness of potential treatments with second-line agents for metastatic breast cancer. The findings of the Battelle decision analysis model, described in this issue, identified response rates and 1-year mortality as the key areas of focus for comparative trials. Decision analysis can improve the design and efficacy of prospective, comparative trials but cannot replace them.

Breast Neoplasms↗
PubMed1990

European women's employment and fertility again.

The author examines questions concerning women's employment and fertility in Europe and considers the implications of relevant economic models "for differences in fertility and labour supply patterns between women and for econometric analysis....I review the main economic models...and explore what extensions to these models may be required. The review of models is limited to those which consider both fertility and employment decisions."

Behavior↗
PubMed1986

How often should a preventive procedure be repeated? An economic analytic model applied to dentistry.

Operation research techniques have successfully been applied to economical order situations. An Economical Recall System (ERS) model, based on this theory, is proposed for curative and preventive dental care. The ERS model assumes a preventive procedure with no lead time between application and initiation of effect, an immediate decline in morbidity level once the effect is initiated, and linear increasing rate of morbidity. The model also assumes a positive net present value of the prevention program and therefore the question approached is the optimal time sequence at minimal cost. The model supplies a valuable tool for analyzing the effect of the curative, preventive and administrative components of a program and how changes in each, or any combination, of these variables will affect the end results.

Dental Care↗
PubMed2003

Economic evaluation of oral valdecoxib versus diclofenac in the treatment of patients with rheumatoid arthritis in a randomized clinical trial.

In contrast to economic models that provide probabilistic estimates of economic impact, data extracted from clinical trials may be used to evaluate and compare actual resource utilization and costs. Health-care resource utilization and the costs of these resources were compared from the perspective of the UK National Health Service using data obtained in a 6-month clinical trial of oral valdecoxib 20 mg once daily and diclofenac 75 mg twice daily for the symptomatic treatment of rheumatoid arthritis. However, calculated health-care costs were exclusive of drug acquisition costs because the price of valdecoxib was not available at the time of analysis. While the efficacy of the two treatments was similar, use of valdecoxib was associated with a reduction in total health-care costs amounting to approximately 200 British pounds per patient. This lower cost was associated with reduced use of health-care resources for gastrointestinal serious adverse events (gastrointestinal SAEs). In particular, the incidence of hospitalization and number of hospital days for gastrointestinal SAEs was lower in the valdecoxib group. Analysis of cost per gastrointestinal SAE favoured valdecoxib (cost savings of 742 British pounds), suggesting that even when these events did occur they were less severe. When costs of gastrointestinal SAEs were averaged over the entire population, valdecoxib was suggested to have lower total costs per patient compared with diclofenac (cost savings of 115 British pounds per patient), mainly resulting from significant savings in hospitalization costs (76.49 British pounds per patient). These data are consistent with economic models and suggest that the favourable gastrointestinal profile of valdecoxib observed in clinical trials will be of economic benefit.

Administration, Oral↗
PubMed2004

Modeling the economic net benefit of a potential vaccination program against ocular infection with Chlamydia trachomatis.

Trachoma is an ocular infection caused by Chlamydia trachomatis that carries a huge public health burden as a leading cause of preventable blindness globally. We developed a model of the economic benefits of a potential vaccine. Factors that impact the efficacy of a vaccination program (such as the sensitivity and specificity of algorithms to identify high-risk individuals), and personal and environmental risk factors for trachoma affect the maximum vaccination and screening costs at which a vaccination program can achieve a positive net benefit. This model is useful for planning vaccine programs in areas with varying trachoma risk factors and endemicity.

Algorithms↗
PubMed1997

Modelling the economic benefits of tuberculosis preventive therapy for people with HIV: the example of Zambia.

OBJECTIVE: To assess the economic benefits and costs of providing isoniazid preventive therapy for tuberculosis (TB) in HIV-infected persons in Zambia. DESIGN: A spreadsheet model incorporating variables drawn from published studies and unpublished data. SUBJECTS: Data drawn from a number of different studies and published literature involving a range of subjects. SETTING: Zambia. RESULTS: Using data primarily from Zambia we have modelled the costs and benefits of a TB preventive therapy programme using daily isoniazid for 6 months. The basecase scenario assumes recruitment at a voluntary testing and counselling site where HIV seroprevalence is 30%; persons with HIV have a 25% probability of developing active TB during their lifetime; two additional cases of TB would be prevented per person completing a course of preventive therapy; compliance would be 63%, and the efficacy of the isoniazid in preventing active TB of 60%. The costs under this scenario would exceed the benefits by a factor of 1.16 [benefit: cost ratio (BCR) of 0.86]. However, if preventing one case of TB prevented an additional five cases, the benefits would exceed the costs by a significant margin (BCR of 1.71). Other scenarios indicate that the targeted preventive therapy of persons with HIV whose occupation or living situation places them in contact with a large number of others (teachers and students, health personnel, military and police, miners, prisoners, etc.) would yield significant net benefit. The operational challenge for TB preventive therapy is thus to identify and target large numbers of such persons.

AIDS-Related Opportunistic Infections↗
PubMed2006

Assessing generalisability in model-based economic evaluation studies: a structured review in osteoporosis.

To support decision making, many countries have now introduced some formal assessment process to evaluate whether health technologies represent good 'value for money'. These often take the form of decision models that can be used to explore elements of importance to generalisability of study results across clinical settings and jurisdictions. The objective of this review was to assess whether articles reporting decision-analytic models in the area of osteoporosis provided enough information to enable decision makers in different countries/jurisdictions to fully appreciate the variability of results according to location and be able to apply the evaluation to their own setting. Of the 18 articles included in the review, only three explicitly stated the decision-making audience. It was not possible to infer a decision-making audience in eight studies. The target population was well reported, as were resource and cost data, and clinical data used for estimates of relative risk reduction. However, baseline risk was rarely adapted to the relevant jurisdiction, and when no decision maker was explicit it was difficult to assess whether the reported cost and resource use data were in fact relevant. A few studies used sensitivity analysis to explore elements of generalisability, such as compliance rates and baseline fracture risk rates, although such analyses were generally restricted to evaluating parameter uncertainty. This review found that variability in cost effectiveness across locations is addressed to a varying extent in modelling studies in the field of osteoporosis, limiting their use for decision makers across different locations. Transparency of reporting is expected to increase as methodology develops and decision makers publish 'reference case' type guidance.

Costs and Cost Analysis↗
PubMed2004

Linking economic activities to the distribution of exotic plants.

The human enterprise is flooding Earth's ecosystems with exotic species. Human population size is often correlated with species introductions, whereas more proximate mechanisms, such as economic activities, are frequently overlooked. Here we present a hypothesis that links ecology and economics to provide a causal framework for the distribution of exotic plants in the United States. We test two competing hypotheses (the population-only and population-economic models) using a national data set of exotic plants, employing a statistical framework to simultaneously model direct and indirect effects of human population and ecological and economic variables. The population-only model included direct effects of human population and ecological factors as predictors of exotics. In contrast, the population-economic model included the direct effects of economic and ecological factors and the indirect effects of human population as predictors of exotics. The explicit addition of economic activity in the population-economic model provided a better explanation for the distribution of exotics than did the population-only model. The population-economic model explained 75% of the variation in the number of exotic plants in the 50 states and provided a good description of the observed number of exotic plants in the Canadian provinces and in other nations in 85% of the cases. A specific economic activity, real estate gross state product, had the strongest positive effect on the number of exotics. The strong influence of economics on exotics demonstrates that economics matter for resolving the exotic-species problem because the underlying causes, and some of the solutions, may lie in human-economic behaviors.

Ecosystem↗
PubMedDate not supplied

Cost-effectiveness models of clinical trials of new pharmaceuticals for AIDS-related Pneumocystis carinii pneumonia: are they helpful to policy makers?

BACKGROUND: Pneumocystis carinii pneumonia (PCP) has been the most common and most costly complication of acquired immunodeficiency syndrome (AIDS). Because of concern over the high costs of care for persons with AIDS, policy makers have instituted a number of new measures to encourage cost-effectiveness. Although the clinical efficacy of new pharmaceutical agents is evaluated extensively before approval, comparative trials of a new agent with its major competitor are sometimes not carried out, and estimates of cost-effectiveness are therefore difficult to obtain. METHODS: We describe methodologic issues associated with the development of economic models of new pharmaceutical agents and illustrate these issues with an analysis of second-line therapeutic options for PCP. RESULTS: A new drug, trimetrexate, and the standard second-line therapy, pentamidine, are both inferior to the standard first-line therapy, trimethoprim/sulfamethoxazole, as initial therapy for moderate to severe PCP. However, as many as half of the patients with PCP are either intolerant or refractory to trimethoprim/sulfamethoxazole therapy for PCP. Economic models suggest that, if the two drugs have identical survival rates, then trimetrexate, despite a higher acquisition cost, is both less expensive and more effective in achieving toxicity-free survival than pentamidine in patients who require second-line therapy for PCP. Sensitivity analyses indicate that trimetrexate is less expensive than pentamidine over a wide range of estimates of costs and effectiveness. CONCLUSIONS: To make well-informed therapeutic decisions, policy makers and physicians require head-to-head studies of a new pharmaceutical agent with its major competitor. However, economic models can be used to derive estimates of cost-effectiveness of new pharmaceutical agents when such data are lacking. The interpretation of these models raises general issues related to the perspective of the investigators, study design, estimation of costs of care, rates of response, toxicity, and survival, and generalizability of the results to other settings as well as methodologic issues that are unique to human immunodeficiency virus (HIV) disease. If a comparative trial found better survival rates, then cost-effectiveness models would be of limited usefulness; almost all physicians would use the drug with the higher survival rate.

AIDS-Related Opportunistic Infections↗
PubMed1999

Cost-effectiveness model of a phase II clinical trial of a new pharmaceutical for essential thrombocythemia: is it helpful to policy makers?

Essential thrombocythemia (ET) is a rare, chronic myeloproliferative disorder of unknown origin characterized by thrombocytosis, excessive megakaryocytes, hemorrhages, and thrombotic complications. Because of the high costs of care for persons with rare diseases, policymakers are concerned with both clinical effectiveness and cost-effectiveness of new treatments. Although the clinical efficacy of all new pharmaceutical agents for rare diseases is evaluated extensively in clinical trial settings before approval by the Food and Drug Administration (FDA), comparative phase III trials of a new agent with its major competitor are sometimes not possible to carry out, and estimates of cost-effectiveness are therefore difficult to obtain. We describe methodologic issues associated with the development of economic models of new pharmaceutical agents for rare diseases and illustrate these issues with an analysis of a new therapy for ET. Anagrelide is a newly approved platelet aggregation inhibitor that can be used as primary therapy for ET. The agent reduces platelet counts by 50% in more than 70% of ET patients. Economic models suggest that, over the first year of anagrelide therapy, monthly costs for therapy and complications decreased from $775 to $490, the effectiveness improved to 98%, and the cost-effectiveness improved to $1,505 per major complication (gastrointestinal bleed, transient ischemic attack or stroke, or preinfarction angina or myocardial infarction) prevented. Sensitivity analyses indicate that, after the first 3 months of treatment, total costs of anagrelide treatment were in the range of $1,505 to $1,615 per major complication prevented. To make well-informed therapeutic decisions, policymakers and physicians require head-to-head studies of a new pharmaceutical agent with its major competitor. However, economic models can be used to derive estimates of cost-effectiveness of new pharmaceutical agents when such data are lacking. The interpretation of these models raises general issues related to the perspective of the investigator, study design, estimation of costs of care, rates of response, toxicity, survival, and the ability to generalize the results to other settings, as well as methodologic issues that are unique to rare diseases. If a comparative study found better therapeutic outcomes, then cost-effectiveness models would be of limited usefulness. Almost all physicians would use the drug with the better therapeutic profile.

Clinical Trials, Phase II as Topic↗
PubMed2003

A cost analysis of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion.

An economic model was developed to compare costs of stand-alone anterior lumbar interbody fusion with recombinant human bone morphogenetic protein 2 on an absorbable collagen sponge versus autogenous iliac crest bone graft in a tapered cylindrical cage or a threaded cortical bone dowel. The economic model was developed from clinical trial data, peer-reviewed literature, and clinical expert opinion. The upfront price of bone morphogenetic protein (3380 dollars) is likely to be offset to a significant extent by reductions in the use of other medical resources, particularly if costs incurred during the 2 year period following the index hospitalization are taken into account.

Bone Morphogenetic Protein 2↗
PubMed1996

The cost of treating genital warts.

BACKGROUND: Genital warts is a common sexually transmitted disease treated by a variety of medical specialists. Standard therapies offer symptomatic relief but cannot ensure lasting remission. Using the clinical literature, claims databases, and a panel of experienced practitioners, the relative efficacy, cost, and cost effectiveness of five common treatments for genital warts were assessed in this study. METHODS: We reviewed the clinical literature for the following genital wart therapies: podofilox, podophyllin, trichloroacetic acid, cryotherapy, and laser therapy, focusing on their relative efficacy. Physicians experienced in treating genital warts defined standard treatment protocols for men and women patients with moderate wart burdens. Using national claims data and protocols developed by physicians, we derived three economic models based on provider charges, third-party payments, and a resource-based relative value scale, respectively. RESULTS: The literature review demonstrated highly variable success and recurrence rates among treatment methods and failed to show that one treatment provides consistently superior efficacy. In the economic models, treating women generally proved more costly than treating men per episode of care. This was due to the need for more extensive follow-up visits in the treatment of women. Total costs were highest for cryotherapy and lowest for a patient-applied therapy that reduced the need for follow-up visits. CONCLUSIONS: Clinicians should consider both clinical and cost issues when choosing the appropriate treatment for patients with genital warts.

Clinical Protocols↗
PubMed1998

An epidemiological and economic simulation model to evaluate the spread and control of infectious bovine rhinotracheitis in The Netherlands.

Bovine herpesvirus type I (BHV1), causing infectious bovine rhinotracheitis (IBR), was introduced in the Netherlands in 1971. In 1993, about 42% of the dairy cows had antibodies against BHV1. In the future, stricter requirements are anticipated regarding the health status of exported breeding cows and material. To support policymakers in their decisions on IBR eradication, a simulation model was developed in which the epidemiological and economic consequences of various control strategies were evaluated. This paper describes the model and provides an overview of some important outcomes. In the model, dairy herds were classified into different disease states based on (1) the reproduction ratio of the disease (R, defined as the number of secondary cases caused by one infectious animal) (2) the within-herd prevalence, within each value of R and (3) the expected number of infectious animals in an infectious herd within each prevalence range. The dynamic transition probability of a herd going from one state to another per week depends on direct contacts between animals, and other contacts such as transmission through fomites, indirect transmission through other species, airborne transmission and minor disease-specific routes such as venereal or iatrogenic transmission. Five control strategies, including both a voluntary vaccination program and a compulsory vaccination program for all dairy herds were evaluated. A voluntary vaccination program with 50% participation is not expected to lead to eradication of IBR. It appears that compulsory vaccination would be necessary to reach an IBR-free status.

Animals↗
PubMed2006

Recent developments in decision-analytic modelling for economic evaluation.

The past few years have seen rapid changes in the methods of decision-analytic modelling of healthcare programmes for the purposes of economic evaluation. This paper focuses on four developments in modelling that have emerged over the past few years or have become more widely used. First, no one optimal method for extrapolating outcomes from clinical trials has yet been established. Modellers may draw from a set of varied assumptions about survival extrapolation that encompass a range of possibilities from highly optimistic to extremely cautious. Secondly, the practicality and appeal of microsimulation as a method for analysing healthcare decision problems has increased dramatically with the speed of computing technology. Individual instantiations of a system are generated by using a random process to draw from probability distributions a large number of times (also known as Monte Carlo or probabilistic simulation). Microsimulation is moving in new directions, such as discrete-event simulations that simulate sequences of events by drawing directly from probability distributions of event times; this approach is now being broadly applied to model situations where populations of patients interact with healthcare delivery systems. Microsimulation modelling of transmission systems at the population level is also rapidly developing. Thirdly, model calibration is emerging as a new tool that may offer health scientists a means of generating important fundamental knowledge about disease processes. Model calibration allows evidence synthesis in which observations on observable quantities are used to draw inferences about unobservable quantities. The methodology of model calibration has advanced considerably, drawing on theories of numerical analysis and mathematical programming such as gradient methods, intelligent grid search algorithms, and many more. As a fourth issue, an area of extraordinary activity is in the use of transmission models to analyse interventions for infectious diseases, including population-wide effects of vaccination. Transmission models use differential equations to simulate, deterministically for the most part, transitions among infection-related health states. Only recently have modelling methodologies been combined so that cost-effectiveness analyses can consider explicitly not only the patient-level benefits of interventions but also the secondary benefits through transmission dynamics. Advances in technology allow more realistic and complex healthcare models to be simulated more rapidly. However, decision makers will not readily accept results from models unless they can understand them intuitively and explain them to others in relatively simple terms. The challenge for the next generation of modellers is not only to harness the power available from these newly accessible methods, but also to extract from the new generation of models the insights that will have the power to influence decision makers.

Clinical Trials as Topic↗