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Background: Motor neurone disease (MND) is a devastating condition which greatly diminishes patients' quality of life and limits life expectancy. Health technology appraisals of future interventions in MND need robust data on costs and utilities. Existing economic evaluations have been noted to be limited and fraught with challenges.Objective: The aim of this study was to identify and critique methodological aspects of all published economic evaluations, cost studies, and utility studies in MND.Methods: We systematically reviewed all relevant published studies in English from 1946 until January 2016, searching the databases of Medline, EMBASE, Econlit, NHS Economic Evaluation Database (NHS EED) and the Health Economics Evaluation Database (HEED). Key data were extracted and synthesised narratively.Results: A total of 1830 articles were identified, of which 15 economic evaluations, 23 cost and 3 utility studies were included. Most economic studies focused on riluzole (n = 9). Six studies modelled the progressive decline in motor function using a Markov design but did not include mutually exclusive health states. Cost estimates for a number of evaluations were based on expert opinion and were hampered by high variability and location-specific characteristics. Few cost studies reported disease-stage-specific costs (n = 3) or fully captured indirect costs. Utilities in three studies of MND patients used the EuroQol EQ-5D questionnaire or standard gamble, but included potentially unrepresentative cohorts and did not consider any health impacts on caregivers.Conclusion: Economic evaluations in MND suffer from significant methodological issues such as a lack of data, uncertainty with the disease course and use of inappropriate modelling framework. Limitations may be addressed through the collection of detailed and representative data from large cohorts of patients. [ABSTRACT FROM AUTHOR]

Introduction: Until recently, treatment options for damage to cartilage in the knee were limited to the use of microfracture or, occasionally, mosaicplasty. The developments of autologous and characterised chondrocyte implantation have provided new treatment options but have large upfront costs. The objective of this study was to estimate the cost effectiveness of characterised chondrocyte implantation in the UK National Health Service.Methods: An economic model was constructed in Microsoft Excel®, with patients undergoing either microfracture or chondrocyte implantation. Following treatment failure, patients can undergo a series of interventions, ultimately ending in knee replacement. Effectiveness and utility were modelled using clinical trial data, which were supplemented with synthesised registry data, and costs were taken from published sources. Results were expressed in clinical events, quality-adjusted life-years (QALYs) and British pounds. Both costs and outcomes were discounted at 3.5 % per year.Results: Chondrocyte implantation is estimated to reduce the lifetime probability of knee replacement by 50 % in comparison with microfracture, and to increase QALYs by 0.72 (16.57 vs. 15.85). Costs were estimated to be £23,307 for chondrocyte implantation, and £8008 for microfracture, with the incremental cost of £15,299 for chondrocyte implantation reflecting reduced resource use offsetting some of the procedure cost. These values gave a cost per QALY gained of £21,245.Conclusion: Chondrocyte implantation is estimated to provide substantial patient benefits over a lifetime horizon, with a considerable increase in QALYs. Despite the increase in costs, the procedure is cost effective at standard thresholds used in the UK. [ABSTRACT FROM AUTHOR]

The HIV pandemic continues to be one of our greatest contemporary public health threats. Policy makers in many middle- and low-income countries are in the process of scaling up HIV prevention, treatment and care services in the context of a reduction in international HIV funding due to the global economic downturn. In order to scale up services that are sustainable in the long term, policy makers and implementers need to have access to robust and contemporary strategic information, including financial information on expenditure and cost, in order to be able to plan, implement, monitor and evaluate HIV services. A major problem in middle- and low-income countries continues to be a lack of basic information on the use of services, their cost, outcome and impact, while those few costing studies that have been performed were often not done in a standardized fashion. Some researchers handle this by transposing information from one country to another, developing mathematical or statistical models that rest on assumptions or information that may not be applicable, or using top-down costing methods that only provide global financial costs rather than using bottom-up ingredients-based costing. [ABSTRACT FROM AUTHOR]

Bortezomib, thalidomide and lenalidomide can be aimed at treating patients with newly diagnosed multiple myeloma (both eligible and ineligible for transplantation) as well as those with relapsed or refractory disease. This review analysed the available clinical and economic data on these three drugs. Irrespective of which of the three agents is considered, the magnitude of the benefit in newly diagnosed cases (transplanted or non-transplanted) tends to be between 10 and 20 months per patient in terms of progression-free survival or survival; the survival benefit is smaller in relapsed or refractory disease. In addition, a single-institution observational analysis evaluated the outcomes in nearly 3000 consecutive patients examined between 1971 and 2006. The survival in patients diagnosed between 2001 and 2006 was longer than that observed in patients diagnosed between 1994 and 2000. This finding supports the conclusion that novel agents provide a survival improvement compared with traditional therapy. Formal cost-effectiveness studies on these three agents are still lacking. A MEDLINE search retrieved only four short papers or letters and no fulllength analysis. Hence, the cost effectiveness of these agents needs further investigation, with separate assessments of the different therapeutic settings. In a simplified analysis, we tried to contrast the average cost of treatment for each of the novel agents versus their respective benefit, expressed in quality-adjusted survival. Despite its preliminary nature, our assessment indicates that the cost effectiveness of these three agents is likely to be within commonly accepted pharmacoeconomic thresholds. [ABSTRACT FROM AUTHOR]

BACKGROUND: Sepsis has a high prevalence within intensive care units, with elevated rates of morbidity and mortality, and high costs. Data on sepsis costs are scarce in the literature, and in developing countries such as Brazil these data are largely unavailable. Enrolled patients were assessed daily in terms of cost-related expenditures such as hospital fees, operating room fees, gas therapy, physiotherapy, blood components transfusion, medications, renal replacement therapy, laboratory analysis and imaging. Standard unit costs (year 2006 values) were based on the Brazilian Medical Association (AMB) price index for medical procedures and the BRASINDICE price index for medications, solutions and hospital consumables. Medical resource utilization was also assessed daily using the Therapeutic Intervention Scoring System (TISS-28). Indirect costs were not included. The median total cost of sepsis was $US9632 (interquartile range [IQR] 4583–18 387; 95% CI 8657, 10 672) per patient, while the median daily ICU cost per patient was $US934 (IQR 735–1170; 95% CI 897, 963). The median daily ICU cost per patient was significantly higher in non-survivors than in survivors, i.e. $US1094 (IQR 888–1341; 95% CI 1058, 1157) and $US826 (IQR 668–982; 95% CI 786, 854), respectively (p < 0.001). For patients admitted to public and private hospitals, we found a median SOFA score at ICU admission of 7.5 and 7.1, respectively (p = 0.02), and the mortality rate was 49.1% and 36.7%, respectively (p = 0.006). Patients admitted to public and private hospitals had a similar length of stay of 10 (IQR 5–19) days versus 9 (IQR 4–16) days (p = 0.091), and the median total direct costs for public ($US9773; IQR 4643–19 221; 95% CI 8503, 10 818) versus private ($US9490; IQR 4305–17 034; 95% CI 7610, 11 292) hospitals did not differ significantly (p = 0.37). OBJECTIVES: To assess the standard direct costs of sepsis management in Brazilian intensive care units (ICUs) and to disclose factors that could affect those costs. Enrolled patients were assessed daily in terms of cost-related expenditures such as hospital fees, operating room fees, gas therapy, physiotherapy, blood components transfusion, medications, renal replacement therapy, laboratory analysis and imaging. Standard unit costs (year 2006 values) were based on the Brazilian Medical Association (AMB) price index for medical procedures and the BRASINDICE price index for medications, solutions and hospital consumables. Medical resource utilization was also assessed daily using the Therapeutic Intervention Scoring System (TISS-28). Indirect costs were not included. The median total cost of sepsis was $US9632 (interquartile range [IQR] 4583–18 387; 95% CI 8657, 10 672) per patient, while the median daily ICU cost per patient was $US934 (IQR 735–1170; 95% CI 897, 963). The median daily ICU cost per patient was significantly higher in non-survivors than in survivors, i.e. $US1094 (IQR 888–1341; 95% CI 1058, 1157) and $US826 (IQR 668–982; 95% CI 786, 854), respectively (p < 0.001). For patients admitted to public and private hospitals, we found a median SOFA score at ICU admission of 7.5 and 7.1, respectively (p = 0.02), and the mortality rate was 49.1% and 36.7%, respectively (p = 0.006). Patients admitted to public and private hospitals had a similar length of stay of 10 (IQR 5–19) days versus 9 (IQR 4–16) days (p = 0.091), and the median total direct costs for public ($US9773; IQR 4643–19 221; 95% CI 8503, 10 818) versus private ($US9490; IQR 4305–17 034; 95% CI 7610, 11 292) hospitals did not differ significantly (p = 0.37).… [ABSTRACT FROM AUTHOR]

Background: Palivizumab is one of the most costly paediatric medications for Medicaid and other health plans. It is uncertain whether the costs of palivizumab administration are justified in specific risk groups. Ongoing investigations of palivizumab require identification of reliable data sources.Objective: To estimate the reliability between Medicaid paid claims data and medical records documentation in a cost analysis of palivizumab.Study Design: A cross-sectional study of data reliability was performed within a cost analysis study of palivizumab in a cohort of at-risk patients during the US 2002/3 respiratory syncytial virus season. Exposure classification (to palivizumab prophylaxis) was compared using Medicaid claims and medical records data.Methods: The study was performed in 28 widely dispersed paediatric medical practices serving North Carolina, USA Medicaid patients within the AccessCare/Community Care of North Carolina (CCNC) Program, an enhanced primary care case management programme. Patients were eligible if they were born between 1 March 2002 and 28 February 2003 at 32-35 weeks estimated gestational age, were enrolled in the North Carolina primary care case management Medicaid programme during the study period and were patients of the participating practices. Medicaid healthcare claims were obtained in December 2003 for services provided between October 2002 and May 2003. Medical records were abstracted by community-based case managers. Primary variables included frequency, dates and dose of palivizumab injections. The main outcomes measures were agreement in the number of palivizumab injections, dates of administration and doses of palivizumab between Medicaid paid claims and medical record data.Results: Injection frequencies matched between medical record and Medicaid claims data for only 46.2% of study participants. Congruence in injection service dates occurred between data sources for only 1% of injections. Doses were similar between data sources for 81.9% of injections.Conclusions: In Medicaid recipients receiving palivizumab injection, Medicaid claims data were inconsistent with medical records data. Use of multiple data sources and validation are recommended to identify temporal relationships between drug administration and endpoints of interest. [ABSTRACT FROM AUTHOR]

The diffusion of protease inhibitors and non-nucleoside reverse transcriptase inhibitors in the US in 1996 and 1997 reduced the number of deaths attributable to HIV disease and changed the way we think about the illness. Today, HIV disease may be deemed a fairly expensive chronic condition rather than an intolerably expensive fatal illness. Although most studies have found that patients receiving new drug therapies are hospitalised less frequently than patients who received early drug therapies, it is unclear whether the diffusion of new drug therapies has increased or decreased the annual cost of care. However, it is evident that the diffusion of new drug therapies has increased the lifetime cost of care. Analysts rely on models to simulate the course and cost of HIV disease. This study reviews the evolution of these models, paying particular attention to how these models estimate the cost of care. The primary findings of this review are that the economic data used in these models are often too imprecise to accurately identify the cost of each disease stage and are almost always outdated. Moreover, it was found that estimates of drug costs in these models may not accurately reflect actual expenditures. [ABSTRACT FROM AUTHOR]

Aromatase inhibitors (AIs) have been evaluated clinically in a wide range of breast cancer treatment settings. Although these agents appear to have clinical superiority, they are more expensive than the therapies (primarily tamoxifen) they have been compared with, thus economic evaluation is required to consider their incremental value to the payer. This paper reviews published economic evaluations of AIs as first-line therapy for advanced cancer, and as adjuvant therapy for early breast cancer. The evaluations in the advanced setting demonstrate a range of different modelling techniques and consider the payer's perspective in three healthcare systems. There is broad similarity in the application of standard cohort Markov modelling techniques to evaluate AIs in the early breast cancer setting, covering four separate health system perspectives. AIs appear cost effective compared with current practice. An analysis in the advanced setting suggests that letrozole may be the more cost-effective AI. No direct comparisons of alternative AIs in the adjuvant setting are reported, although indirect comparisons may be feasible. Future evaluations of treatment strategies over the entire course of the disease may also be needed. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to evaluate the cost effectiveness of glaucoma treatment with bimatoprost compared with other intraocular pressure (IOP)-lowering medications in adult patients with chronic glaucoma or ocular hypertension (IOP of between 22 mm Hg and 34 mm Hg), from a US healthcare payers' perspective.Methods: Estimated yearly costs and cost per treatment success for 0.03% bimatoprost once daily (Lumigan) were compared with 0.5% timolol twice daily (generic), 0.005% latanoprost once daily (Xalatan) and the fixed combination of 0.5% timolol and 2.0% dorzolamide twice daily (Cosopt). The model was based on year 2003 medical resource costs (physician visits and drug acquisition costs) and treatment success rates from published clinical trials. The clinical measure utilised was the percentage of patients achieving target IOPs.Results: A higher percentage of patients achieved target IOPs with bimatoprost than with each of the other medications. At most target pressures, the cost per treatment success for patients starting treatment on bimatoprost was less than that for patients started on other drugs. This was true despite that, when looking at costs alone, the estimated yearly costs for bimatoprost (averaged over both patient success and patient failures) were similar to or greater than those for the other drugs. The greatest differences in cost per treatment success were seen at target pressures < or =15 mm Hg. For example, at a target pressure of 13 mm Hg, the cost per treatment success based on the model was 9238-10,229 US dollars for bimatoprost, 23,218 US dollars for timolol, 21,943 US dollars for latanoprost and 16,034 US dollars for timolol/dorzolamide. The incremental cost of achieving additional clinical success for bimatoprost ranged from 800 US dollars to 1,700 US dollars versus generic timolol, and from 300 US dollars to 3,100 US dollars versus timolol/dorzolamide. Bimatoprost was more effective and less costly than latanoprost.Conclusion: In our simplified model of cost per treatment success based on responder rates at varying IOPs, the greater efficacy of bimatoprost resulted in a cost per treatment success that was generally lower for bimatoprost than for timolol, latanoprost or timolol/dorzolamide. This was most pronounced at target pressures <15 mm Hg. [ABSTRACT FROM AUTHOR]

Introduction: Excellent treatment outcomes with long-term durability and few adverse effects are expectations of treatments for chronic conditions. The long-term cost effectiveness of newer treatments for benign prostatic hyperplasia (BPH), including high-energy transurethral microwave thermotherapy (TUMT) and combination pharmaceutical therapy, has not been sufficiently studied against existing alternatives. The objective of this study was to estimate the incremental cost effectiveness of BPH treatment alternatives.Methods: We employed a Markov model over a 20-year time horizon and the payer's perspective to evaluate the cost effectiveness of watchful waiting (WW), pharmaceuticals (alpha-adrenoceptor antagonists [alpha-blockers], 5-alpha-reductase inhibitors [5-ARIs], combination therapy), TUMT and transurethral resection of the prostate (TURP) in treating BPH. Markov states included improvement in symptoms, no improvement in symptoms, adverse effects and death. We used data from the published literature for outcomes, including systematic reviews whenever possible. Costs were estimated using a managed-care claims database and Medicare fee schedules, and were reported in Dollars US, 2004 values. Costs and effectiveness outcomes were discounted at a rate of 3% per year. Men (aged > or =45 years) with moderate to severe lower urinary tract symptoms and uncomplicated BPH were included in the analysis, and results were stratified by age and BPH symptom levels. Outcomes included costs, QALYs, incremental cost-utility ratios and cost-effectiveness acceptability curves. Sensitivity analysis was performed on important parameters, with an emphasis on probabilistic sensitivity analysis.Results: alpha-Blockers and TUMT were cost effective for treating moderate symptoms using the threshold of Dollars US 50,000 per QALY. For example, at 65 years of age, the cost per QALY was Dollars US 16,018 for alpha-blockers compared with WW and Dollars US 30,204 for TUMT versus alpha-blockers. TURP was the most cost-effective treatment for severe symptoms (Dollars US 5824 per QALY ) versus WW. Model results were robust to changes in costs and sensitive to the assumed probabilities, utility weights, extent of improvement and life expectancy. Nevertheless, acceptability curves consistently demonstrated the same alternatives as most likely to be cost effective.Conclusions: Our model suggests that alpha-blockers and TURP appear to be the most cost-effective alternatives, from a US payer perspective, for BPH patients with moderate and severe symptoms, respectively. TUMT was promising for patients with moderate symptoms and the oldest patients with severe symptoms, but otherwise was dominated. Value of information analysis could be used to determine the net benefit of additional research. [ABSTRACT FROM AUTHOR]

Overactive bladder is a common condition, with recent findings estimating the prevalence in adults at about 15%. Symptoms, including urinary urgency, high voiding frequency and urge incontinence, have been shown to decrease patients' quality of life. Given its high prevalence, the economic burden of overactive bladder is also substantial, with a recent estimate placing the annual cost in the US at 9.1 billion US dollars (year 2000 values). The objective of this review is to provide a critical appraisal of published economic evaluations of pharmacological and non-pharmacological treatments for overactive bladder. Published economic evaluations of treatments for overactive bladder have focused entirely on pharmacological treatments -- mainly on the two most commonly used drugs, oxybutynin and tolterodine, each of which is available in immediate- and extended-release formulations. Ten economic evaluations (more than half are cost-effectiveness studies) have been published. Modelling with decision trees or Markov models has been the predominant method. Evaluations comparing drug therapy with no treatment have concluded that drug therapy is cost effective. Analyses comparing the formulations of oxybutynin and tolterodine have produced highly inconsistent results, largely due to the sources of data employed for effectiveness and treatment discontinuation rates. There are no evaluations of drugs relative to non-pharmacological treatment, and there are other significant gaps in the economic evaluations of treatment to date. These include gaps resulting from a lack of reliable data on the performance of these drugs in real-world settings, particularly data on long-term persistence with treatment. A more definitive pharmacoeconomic comparison of oxybutynin and tolterodine formulations, incorporating all available clinical data, and other treatment options would help direct treatment. [ABSTRACT FROM AUTHOR]

Objective: To develop a Markov model that allows the cost effectiveness of interventions in patients with chronic obstructive pulmonary disease (COPD) to be estimated, and to apply the model to investigate the cost effectiveness of an inhaled corticosteroid/long-acting beta(2)-adrenoceptor agonist (beta(2)-agonist) combination (salmeterol/fluticasone propionate) versus usual care.Methods: A Markov model consisting of four mutually exclusive disease states was constructed (mild, moderate and severe disease, and death). The transition probabilities of disease progression (for smokers and ex-smokers) and death were derived from the published medical literature. The model outputs were costs, exacerbations, survival, QALYs and cost effectiveness. The model was made fully probabilistic to reflect the joint uncertainty in the model parameters. Efficacy data for the combination of inhaled salmeterol/fluticasone propionate 50/500microg twice daily in poorly reversible COPD patients with a history of exacerbations were obtained from the 1-year TRISTAN (TRial of Inhaled STeroids ANd long-acting beta-agonists) study and applied to the model, based on patient profiles representative of COPD clinical trials.Results: According to the model, the mean life expectancy with usual care alone (placebo group) was 8.95 years, which decreased to 4.08 QALYs once adjusted for quality and discounted, at a lifetime discounted cost of Can 16,415 dollars per patient (year 2002 values). Assuming that salmeterol/fluticasone propionate reduced exacerbation frequency only (base case analysis), the estimated mean survival time remained unchanged but there was an increase in the number of QALYs (4.21) for an estimated lifetime cost of Can 25,780 dollars, resulting in a cost-effectiveness ratio of Can 74,887 dollars per QALY (95% CI 21,985, 128,671) versus usual care. If a survival benefit was assumed for salmeterol/fluticasone propionate, the incremental cost per QALY was Can11,125 dollars (95% CI 8710, dominated) versus usual care. If the combination achieved around a 10% improvement in forced expiratory volume in 1 second, leading to delayed progression to more severe disease states, the benefits translated into an incremental cost per QALY of Can 49,928 dollars (95% CI 37 269, 66,006) versus usual care.Conclusions: This Markov model allows, for the first time, a means of estimating the long-term cost effectiveness and cost utility of interventions for COPD. Initial evidence suggests that for patients with poorly reversible COPD and a documented history of frequent COPD exacerbations, the addition of salmeterol (a long-acting beta(2)-agonist) to fluticasone propionate (an inhaled corticosteroid) is potentially cost effective from the Canadian healthcare payer's perspective. However, the precision of this estimate will be improved when additional data are available from clinical trials such as the ongoing TORCH (TOwards a Revolution in COPD Health) study. [ABSTRACT FROM AUTHOR]

Recent years have witnessed substantial progress in understanding the cost implications of rheumatoid arthritis (RA). To assess the divergent methodologies and their impact on the resulting cost analyses in RA, we conducted a systematic literature review to summarise the scientific evidence of RA-induced costs. Sixty-five reviews, models or cost analyses on the burden of illness and general costs associated with RA were identified. They covered the US, Canada, Sweden, the UK, The Netherlands, Germany and Finland. Twenty-four cost analyses provided appropriate data about direct and/or indirect costs. Each study was summarised separately. Costs were discounted to 2003 and converted to US dollars. The costs per RA-year ranged from $US1503 to $US16 514. However, each study has to be interpreted individually, with consideration given to the study population, indication, age of the study, database used, type of therapy, setting, level of cost differentiation and data derivation. Health technology assessment reports offer sufficient space to adequately describe the composite parts and restrictive elements of different methodological approaches and analyses. [ABSTRACT FROM AUTHOR]

Background: A low serum level of high-density lipoprotein (HDL)-cholesterol is an independent risk factor for coronary heart disease (CHD). Fibrates, particularly gemfibrozil, have been shown to raise HDL-cholesterol levels and reduce the incidence of CHD. The literature on fibrate cost effectiveness is quite limited.Objective: The objective of this analysis is to determine the cost effectiveness of the fibrates gemfibrozil and fenofibrate in the primary prevention of CHD. The target population includes patients with low levels of HDL-cholesterol, but without pre-existing CHD or other CHD risk factors sufficiently elevated to indicate drug therapy.Study Design and Methods: From a societal perspective, a lifetime incremental cost-effectiveness model was developed to calculate baseline and treatment costs, life-years gained and QALYs gained. Model parameter values were taken from existing literature. In this 'backward induction' model, the expected costs and outcomes for each 5-year time-interval are utilised in subsequent 5-year time period calculations over the patient's entire lifetime. The study population consisted of a hypothetical cohort of males and females in the US aged 45-74 years, with low levels of HDL-cholesterol and no prior history of CHD. The base-case CHD risk factors for this population were obtained from the VA-HIT (Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial) population baseline characteristics, but assuming no prior CHD history. Estimates for the reduction in CHD risk associated with fibrate therapy reduction are also taken from the VA-HIT study.Results: Using a societal cost-effectiveness threshold of US$50, 000 per QALY, primary prevention of CHD in patients with low HDL-cholesterol levels using generic gemfibrozil therapy is cost effective for all age and sex categories, in contrast to fenofibrate therapy, which is cost effective for males, but not for females at baseline risks levels. In the base-case scenario, because of their higher CHD lifetime risk, it is more cost effective to treat males than females with either gemfibrozil or fenofibrate. For males and females the cost per QALY decreases with age for most age intervals. Gemfibrozil is more cost effective than fenofibrate for all age-sex categories because of the assumed equal efficacy and the higher fenofibrate drug cost. In the comparison scenario, generic lovastatin was more cost effective than gemfibrozil for men except at age 45 years and women at all ages, and more cost effective than fenofibrate for both men and women.Conclusions: This analysis suggests that fibrate therapy, particularly with generic gemfibrozil, is cost effective in the primary prevention of CHD in individuals with low HDL-cholesterol levels, with or without elevated triglyceride levels. Certain patient subgroups, such as those with elevated triglyceride levels, smokers and those with diabetes mellitus are likely to achieve both CHD risk reduction and overall savings in net expected medical care costs. Comparable cost-effectiveness results are also shown for lovastatin therapy in the target patient population. Gemfibrozil dominates fenofibrate because of the lower cost of therapy (direct and indirect costs). These conclusions are robust to reasonable changes in model parameter values. [ABSTRACT FROM AUTHOR]

Objective: Anaemia is a common haematological complication of cancer and cytotoxic treatment. The incremental economic burden associated with medical care and short-term disability of anaemia in patients with malignancy and receiving chemotherapy has not been well documented. This study evaluates the effect of anaemia on the costs associated with cancer treated with chemotherapy.Methods: Patients receiving chemotherapy within 6 months of their initial cancer diagnosis were identified in a commercial claims database for 1999-2000. Data for these individuals were linked to their employers' short-term disability records via unique encrypted personal identification numbers provided by employers. Patients with anaemia were identified by a diagnosis of anaemia or treatment with transfusion or erythropoietin alfa (EPO). Healthcare expenditure and short-term disability leave were observed for up to 6 months following initial cancer diagnosis and were summarised into monthly averages. Exponential conditional mean models and zero-inflated negative binomial models were used to analyse mean monthly healthcare expenditures and short-term disability days.Results: Twenty-five percent of the 619 newly diagnosed cancer patients treated with chemotherapy had anaemia. The presence of anaemia and longer length of transfusion therapy were associated with increased expenditures, while longer length of EPO treatment was associated with lower expenditures. The incremental costs due to anaemia among patients receiving chemotherapy were US$5,538 (year 2001 values) per month in the first 6 months following cancer diagnosis, 10.8% of which were costs related to short-term disability leave.Conclusion: Anaemia in patients undergoing chemotherapy presents a substantial burden to employers and payers. The findings also suggest that patients with anaemia treated with erythropoietin alfa can achieve expenditure levels similar to those patients without anaemia. [ABSTRACT FROM AUTHOR]

There are numerous studies examining the pharmacoeconomic impact of HMG-CoA reductase inhibitor (statin) therapy on healthcare costs and outcomes. A recently published review demonstrated that the cost-benefit of these agents depends primarily on the risk of developing a coronary event. That is, as the risk of a coronary event increases, the cost-effectiveness ratio decreases. The typical cost per life-year saved (LYS) ranged from USD 1800 to USD 40,000 in patients with pre-existing coronary artery disease (CAD) and from USD 15,000 to > USD 1 million per LYS in patients without pre-existing CAD. The literature is sparse on the pharmacoeconomics of medication non-compliance in patients taking statin medications. Data from two studies suggest that >75% compliance results in decreased coronary events such as myocardial infarction. However, retrospective database analyses indicate that the average compliance rate hovers around the 65% mark. Many of the studies discuss medication non-compliance as a factor, but do not independently analyse compliance pharmacoeconomically. We examined the pharmacoeconomic impact of non-compliance using published studies that contained pharmacoeconomic data and/or compliance data. In general, we used the placebo arm of these published studies as the surrogate marker for complete non-compliance. The results suggest that for almost 100% compliance versus initial non-compliance, the cost effectiveness of statin medications ranges from USD 4500 to over USD 250,000 per LYS depending on patient age, presence or absence of risk factors and whether the statin is being used for primary or secondary prevention. Alternate-day or weekly dosing studies were also used to examine the impact of compliance on cost and health outcomes. Alternate-day dosing represented 50% compliance and weekly dosing 29% compliance. Less than full compliance had the expected effect of worse health outcomes and lower drug costs. However, the studies were small and not designed as true pharmacoeconomic studies looking at the relationship between medication compliance and cost. The results of this review suggest that there needs to be further examination of the relationship between compliance with statins and cost effectiveness, and studies need to include compliance in their data collection and analysis. [ABSTRACT FROM AUTHOR]

Introduction: Low molecular weight heparins are effective and have a good tolerability profile as first-line prophylaxis for venous thromboembolism (VTE) in major orthopaedic surgery. However, pharmacological inequivalence within the class could lead to differences in cost-effectiveness ratios.Objective: To quantify the potential economic impact of subcutaneous bemiparin sodium 3500 IU/day compared with enoxaparin sodium 40 mg/day as prophylaxis for VTE in patients undergoing total knee replacement (TKR) surgery, considering both in-hospital and post-discharge outcomes and costs during 6 weeks of postoperative follow-up.Methods: A cost-effectiveness analysis was performed using a decision modelling approach. The results were expressed in terms of costs and incremental cost effectiveness in Euro (2002 values). The treatment costs (hospital stay, physician services, drug administration) and costs incurred due to complications such as pulmonary embolism and/or proximal deep vein thrombosis, bleeding events, wound haematoma and thrombocytopenia were considered for this analysis. The target population comprised all adult patients undergoing TKR surgery included in a previous clinical trial (n = 381). The study was conducted in the setting of the Spanish National Health System. The time horizon chosen was 6 weeks.Results: Bemiparin provided cost savings of Euro144.48 per patient compared with enoxaparin when costs derived from treatment and complications during the 6-week postoperative period were considered (Euro4675.01 vs Euro4819.49). Pharmacy costs per patient were lower for bemiparin during hospital stay (Euro43.34 vs Euro50.20; difference, Euro-6.86) and for post-discharge prophylaxis (Euro68.63 vs Euro87.78; difference Euro-19.15). Bemiparin was calculated to avoid 42 additional VTE events per 1000 patients treated at 6 weeks. The incremental cost-effectiveness analysis indicated that bemiparin was dominant over enoxaparin, producing better outcomes and cost savings. The sensitivity analysis supported the cost effectiveness of bemiparin in all the ranges tested for complications and costs.Conclusions: Our model suggests, based on its underlying assumptions and data, that bemiparin may be more cost effective than enoxaparin for thromboprophylaxis in total knee replacement surgery in the Spanish healthcare setting. [ABSTRACT FROM AUTHOR]

Background: Monitoring of microemulsion ciclosporin (cyclosporine; Neoral®) by 2-hour post-dose drug concentrations (C2) is an accurate measure of ciclosporin absorption efficiency and exposure, and appears superior to trough (C0) monitoring for prediction of rejection risk. A predictive decision model was used to determine if this approach also reduces total treatment costs in the first 12 months after renal transplantation. Methods: Parameter estimates for key clinical events were derived from the literature and from prospective pharmacokinetic studies comprising 234 adult HLA-non-identical renal graft recipients at seven Canadian centres. Patients were treated with microemulsion ciclosporin (Neoral®), corticosteroids and azathioprine or mycophenolate mofetil. Using the perspective of the Canadian healthcare provider, total treatment costs for the C2 versus the C0 strategy were modelled over 12 months, and then remodelled using conservative estimates to extend the timeframe to 5 years. Health resources were valued in 1999 Canadian dollars. Results: The incidence of acute rejection was estimated to be 25% at 1 year in patients monitored by C0 and 18% in those monitored by C2. Patient survival was considered to be independent of monitoring strategy, and graft loss was predicted to be 1.4% lower in the C2 group. The studies suggested no important differences in comorbidity and the costs of C0 and C2 monitoring and ambulatory-based adverse events were held equivalent. Using these inputs, the average cost per patient for the first year post-transplant was $Can46 857 for C0 monitoring and $Can45 306 for C2 monitoring, rising to $Can146 879 and $Can142 569 after 5 years. The predicted cost for initial hospitalisation was $Can11 280 for C0 and $Can10 806 for C2 monitoring. The cost of maintenance immunosuppressive drug use, graft loss and dialysis was $Can19 098 in the C0 group and $Can18 612 in the C2 group, while acute rejection treatment costs were $Can2169 and $Can1577, respectively. An additional $Can14 310 was consumed by other events, including repeat hospitalisation, for each group. Sensitivity analysis indicated that the most influential parameters affecting savings due to C2 monitoring were a reduction in the duration of initial and follow-up hospitalisations and reduced risks of acute rejection and subsequent graft loss. Conclusions: Compared with traditional trough concentration monitoring, ciclosporin monitoring at 2 hours post-dose produced a predicted saving of $Can1551 during the first year after renal transplant. Although modelling assumptions become more restrictive over time, this projection allows a preliminary assessment of the long-term economic impact of the routine use of C2 monitoring. [ABSTRACT FROM AUTHOR]

Objective: To assess the cost effectiveness of aspirin 25 mg plus dipyridamole 200 mg twice daily in the secondary prevention of ischaemic stroke, according to the French social security perspective, using efficacy data from the second European Stroke Prevention Study (ESPS-2). The ESPS-2 was a double-blind, placebo-controlled clinical trial which assessed the efficacy of four secondary prevention strategies: (i) placebo; (ii) aspirin (acetylsalicylic acid) 25 mg twice daily; (iii) dipyridamole 200 mg twice daily; and (iv) aspirin 25 mg plus dipyridamole 200 mg twice daily.Method: We performed a cost-effectiveness analysis with Monte Carlo simulations to compute confidence intervals. We combined data from various sources including the Dijon Stroke Registry, Institut National de la Statistique et des Etudes Economiques, Etude du Coût de l'Infarctus Cérébral (Study of the Cost of Cerebral Infarction [ECIC]) study and the ESPS-2 trial.Results: According to our findings, a preventive strategy with aspirin 25 mg plus dipyridamole 200 mg twice daily is associated with net benefits per avoided stroke recurrence amounting to USD 23,932 (95% CI -USD 32,609, USD 35,772) compared with aspirin 25 mg twice daily alone, and USD 31,555 (95% CI USD 4921, USD 74,515) compared with dipyridamole alone (1997 values). Sensitivity analysis demonstrated that dipyridamole plus aspirin was still cost effective when the average cost of adverse effects per episode (ignored in the original estimation of the cost-effectiveness ratios due to a lack of data) was assumed to be USD 8600 (50,000 French francs); this cost is unlikely as most of the adverse effects associated with aspirin plus dipyridamole are only slight to moderate in severity.Conclusions: In the secondary prevention of stroke in France, this study suggests, given its underlying assumptions and data, that aspirin 25 mg plus dipyridamole 200 mg twice daily is likely to be a cost-effective strategy from the social security perspective, when compared with other relevant strategies that were evaluated in the ESPS-2 trial. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost effectiveness of representatives of three different classes of antidepressants used in major depression in the UK NHS. DESIGN, PATIENTS AND INTERVENTIONS: A decision-tree model for the treatment of major depression was constructed by interviewing UK GPs and psychiatrists (as part of a Delphi panel). An important part of the tree was that patients in primary care were treated until remission (pre-morbid state). Three classes of antidepressants (serotonin and noradrenaline reuptake inhibitors [SNRIs; venlafaxine], selective serotonin reuptake inhibitors [SSRIs; fluoxetine, paroxetine and fluvoxamine] and tricyclic antidepressants [TCAs; amitriptyline]) were compared by populating the tree with clinical success rates determined by a meta-analysis and a clinical trial. Where there were insufficient data from clinical trials a Delphi panel was used. Costs within the tree were taken from UK data sources. Six-monthly costs and cost effectiveness were then calculated.Main Outcome Measures and Results: Treatment costs for 6 months were pound 1285 for venlafaxine, pound 1348 for SSRIs and pound 1385 for amitriptyline. Cost effectiveness as measured by cost per symptom-free day was pound 21 for venlafaxine, pound 26 for SSRIs and pound 32 for TCAs (2001 values). Incremental cost-effectiveness analyses showed a treatment strategy of using venlafaxine and switching if necessary to an SSRI was dominant over all other strategies considered. Sensitivity testing demonstrated that the cost of an SSRI could be reduced to 4 pence daily and amitriptyline to zero before the expected 6-monthly cost of venlafaxine ceased to be the lowest.Conclusion: The SNRI, venlafaxine, may be a cost-effective option compared with the SSRIs and TCAs when used as a first-line drug for depression in primary care in the UK. As this is a model, cost effectiveness can be suggested but not proven. [ABSTRACT FROM AUTHOR]

High-intermediate grade non-Hodgkin's lymphoma (NHL) is an aggressive form of the disease, which can respond well to combination chemotherapy, with long-term survival seen in 40-50% of patients. When NHL relapses following standard treatment, high-dose chemotherapy with peripheral blood stem cell or bone marrow support may still cure a significant proportion of patients. Despite a significant rise in the incidence of NHL over recent years, there remains only limited published economic study concerning the overall lifetime cost of treatment, the cost effectiveness of specific treatments or the overall societal cost burden of the disease. The majority of studies identified for the purposes of this review considered the cost of alternative forms of chemotherapy and bone marrow support strategies for patients with advanced disease. Data from these studies suggest that there is a definite trend towards reduced costs for high-dose therapy, possibly reflecting increasing technical experience and improved bone marrow recovery through the use of stem cell transplantation and growth factors. The limited number of cost-effectiveness evaluations suggest that high-dose therapy, following a chemosensitive relapse, is likely to be considered favourable against commonly quoted cost-effectiveness thresholds. Cost effectiveness is becoming an increasingly important factor to consider in the formal assessment of new interventions conducted by groups such as the UK National Institute for Clinical Excellence. In light of the increasing incidence of NHL and the extended use of high-dose treatments in other subgroups of patients, there is a need for increased research into the economics of new interventions for NHL. [ABSTRACT FROM AUTHOR]

Objective: To decompose drug spending in Sweden between the years 1990 and 2000. This paper updates a previous study, which looked at the period 1990–1995, by providing an additional 5 years of data (1995–2000) and extending the previous analysis in a number of ways. Methods: The paper builds on the earlier work that showed that changes in drug spending could be decomposed into three components: price, quantity and a residual. The size of the residual is a measure of the impact of changes in drug treatment patterns on drug spending. The data set used in this paper was collected from Apoteket AB (The National Corporation of Swedish Pharmacies) and was based on comprehensive information (inpatients as well as outpatients) on drug deliveries from wholesalers to pharmacies. Data were obtained for aggregate drug spending (from 1990–2000) and for spending according to anatomical therapeutic chemical (ATC) classification system group. Results: Real drug spending increased by 119% during the study period. The residual rose by 67% indicating the switch from cheaper to more innovative and expensive drug therapies was a major cost driver. Real drug spending would have increased by about 31% if there had been no changes in treatment patterns. The second driver of drug spending was the quantity of drugs consumed, which increased by 41%. The main reason for the larger quantity sold appears to be increases in the intensity of medication in terms of defined daily doses per patient, rather than a larger number of patients starting drug treatment. Real prices decreased during the 10-year study period. We found large differences between ATC groups in terms of spending growth. The ATC groups that have contributed the most to the increase in spending are: drugs that affect the CNS (N), the alimentary tract and metabolism (A) and the cardiovascular system (C), which are also the three largest groups in terms of sales. For all three groups, it was the residual that mainly drove costs. Conclusion: This study indicates very clearly that the main driving force behind the increase in drug costs in Sweden between 1990 and 2000 was the change in drug therapy from old to new and more innovative and expensive drug therapies. This shows the importance of carrying out economic evaluations of new more costly drugs in order to make an assessment of the social benefits of a switch from a cheaper to a more expensive drug. [ABSTRACT FROM AUTHOR]

The prevailing uncertainty about the pharmacoeconomic positioning of granulocyte colony-stimulating factor (G-CSF) in the prevention and treatment of chemotherapy-induced febrile neutropenia has resulted in a number of pharmacoeconomic evaluations published in the past 10 years. These studies vary considerably regarding the approaches used and the results presented. In order to contribute to a clearer pharmacoeconomic positioning of G-CSF, a systematic review of economic evaluations was carried out. The focus of the review was prophylaxis and therapy of chemotherapy-induced neutropenia in patients with cancer. A computerised bibliography search of several databases was conducted yielding 33 studies. The findings demonstrated the cost-saving potential of G-CSF in standard-dose chemotherapy to be limited, with lower costs often seen in the control group. The results of these studies were too heterogeneous to extract a clear recommendation from a cost-saving point of view. The administration of G-CSF after high-dose chemotherapy with stem cell support resulted more often in cost savings in the G-CSF group as compared with standard-dose chemotherapy, illustrating a possible cost-saving potential of G-CSF. In the treatment of established chemotherapy-induced febrile neutropenia, cost savings were found in all studies. This result is surprising but hampered by the small number of studies (n = 5) and remains to be confirmed by more rigourously designed prospective economic analyses. Despite the substantial research on this topic, the economic evaluation of G-CSF is far from being settled and needs further investigation. [ABSTRACT FROM AUTHOR]

Objective: To assess the short-term direct medical costs and effectiveness associated with achieving recommended glycaemic goals using commonly prescribed first-line oral antihyperglycaemic medications in type 2 diabetes mellitus.Materials and Methods: A literature-based, decision-tree model was developed to project the number of patients achieving glycosylated haemoglobin values of <7% on oral therapies and the associated costs over a 3-year timeframe. For each first-line strategy, patients could progress to combination therapy using two or more agents prior to the introduction of insulin. The overall cost of treatment included costs (2001/2002 values; US dollars) of comprehensive medical care, laboratory tests, patient education, drug therapy, home glucose monitoring and adverse events.Results: At 3 years, the overall cost of treatment for the various first-line strategies was 6,106 US dollars for glipizide gastrointestinal therapeutic system, 6,727 US dollars for metformin immediate release, 6,826 US dollars for metformin extended release, 7,141 US dollars for glibenclamide (glyburide)/metformin, 7,759 US dollars for rosiglitazone and 9,298 US dollars for repaglinide. Costs of comprehensive routine medical care ranged from approximately 1,538-2,128 US dollars in year 1 and from approximately 952-1,543 US dollars in subsequent years, for controlled and uncontrolled patients, respectively. Adverse events represented <1%, and drug therapies represented approximately 50%, of the overall cost, respectively. Substantial cost differences between the strategies were seen within the first year. Regardless of first-line therapy, patients progressed quickly to combination therapies, with effectiveness among the agents being similar.Conclusions: Short-term costs required to provide comprehensive diabetes care and achieve glycemic goals can be substantial. The model suggests a sulphonylurea strategy may provide similar effectiveness with cost savings over other agents and should be considered when selecting an initial drug therapy in newly diagnosed patients with type 2 diabetes mellitus. [ABSTRACT FROM AUTHOR]

Introduction: The objective of this study was to assess the cost effectiveness of a continuous combined oral preparation of norethisterone (norethindrone) acetate and ethinylestradiol (NA/EE) [FemHRT] as both a first-line and second-line therapy for menopausal women.Perspective: Third-party payer.Methods: The cost effectiveness of NA/EE was assessed as both a first- and second-line therapy in comparison with conjugated equine oestrogen 0.625mg and medroxyprogesterone acetate 2.5mg (CEE/MPA) and no therapy. Analysis was conducted within a Markov model with states relating to the presence and absence of vaginal bleeding, menopausal symptoms and hip fracture. Analysis forecasted life expectancy, QALYs and lifetime costs for a 50-year-old menopausal woman. Compliance was modelled related to menopausal symptoms and vaginal bleeding. For the base-case analysis, it was assumed that compliant women would take therapy for up to 5 years. Sensitivity analysis assumed therapy was taken only for 1 year.Results: Compared with both CEE/MPA and no therapy, NA/EE led to an increase in both costs and QALYs, both as a first- and second-line therapy. For first-line therapy, the incremental cost per QALY gained for NA/EE was $2200 Canadian dollars ($Can; 1999 values) [compared with no therapy] and was $Can20 300 (compared with CEE/MPA). For second-line therapy, the incremental cost per QALY gained for NA/EE was $Can900 (compared with no therapy) and was $Can16 400 (compared with CEE/MPA). Results were robust to most sensitivity analyses.Conclusions: NA/EE is a cost-effective therapy for women with menopausal symptoms both as a first-line and second-line therapy. [ABSTRACT FROM AUTHOR]

Bipolar disorder is a chronic affective disorder that causes significant economic burden to patients, families and society. It has a lifetime prevalence of approximately 1.3%. Bipolar disorder is characterised by recurrent mania or hypomania and depressive episodes that cause impairments in functioning and health-related quality of life. Patients require acute and maintenance therapy delivered via inpatient and outpatient treatment. Patients with bipolar disorder often have contact with the social welfare and legal systems; bipolar disorder impairs occupational functioning and may lead to premature mortality through suicide. This review examines the symptomatology of bipolar disorder and identifies those features that make it difficult and costly to treat. Methods for assessing direct and indirect costs are reviewed. We report on comprehensive cost studies as well as administrative claims data and program evaluations. The majority of data is drawn from studies conducted in the US; however, we discuss European studies when appropriate. Only two comprehensive cost-of-illness studies on bipolar disorder, one prevalence-based and one incidence-based, have been reported. There are, however, several comprehensive cost-of-illness studies measuring economic burden of affective disorders including bipolar disorder. Estimates of total costs of affective disorders in the US range from $US30.4–43.7 billion (1990 values). In the prevalence-based cost-of-illness study on bipolar disorder, total annual costs were estimated at $US45.2 billion (1991 values). In the incidence-based study, lifetime costs were estimated at $US24 billion. Although there have been recent advances in pharmacotherapy and outpatient therapy, hospitalisation still accounts for a substantial portion of the direct costs. A variety of outpatient services are increasingly important for the care of patients with bipolar disorder and costs in this area continue to grow. Indirect costs due to morbidity and premature mortality comprise a large portion of the cost of illness. Lost workdays or inability to work due to the disease cause high morbidity costs. Intangible costs such as family burden and impaired health-related quality of life are common, although it has proved difficult to attach monetary values to these costs. [ABSTRACT FROM AUTHOR]

Although febrile episodes in neutropenic patients remain a potentially life-threatening complication of anticancer chemotherapy, considerable progress has been achieved in understanding this issue. Febrile neutropenic patients represent a heterogeneous population that displays a very variable risk for serious medical complications. It has also been ascertained that in low-risk patients, the standard of care can be safely and effectively shifted from traditional hospital-based, parenteral, empiric, broad-spectrum antibacterial therapy to outpatient treatment, even for the entire duration of the febrile episode. Furthermore, in the last years some risk assessment models have been developed to identify, at the onset of febrile episodes, low-risk neutropenic patients who are most likely to have a favourable outcome (and who can effectively and safely be treated on an outpatient basis). With respect to traditional hospital-based therapy, the outpatient treatment of low-risk patients is associated with several advantages, including a conspicuous cost saving. Some strategies for inpatient therapy, such as switching from intravenous to oral antibacterials and early discharge, can allow some cost containment; however, the most substantial decrease in costs can be obtained by using outpatient treatment over the entire febrile episode, especially by using oral antibacterials. In spite of the considerable number of clinical studies published over the past 20 years, only limited pharmacoeconomic data on this issue are available. Future comparative studies between outpatient and inpatient treatment of febrile neutropenia, in addition to clinical outcomes (e.g. survival, time to clinical response), should therefore include the following: (i) a detailed analysis of total costs, specifying the setting of outpatient treatment and the method of administration of antimicrobial agents (home nursing, self administration or treatment at infusion centres or at a low-care unit of the hospital); (ii) cost of inpatient treatment if outpatient therapy fails; and (iii) out-of-pocket expenses incurred by the patients. [ABSTRACT FROM AUTHOR]

Background: Alzheimer's disease (AD) is a devastating illness that causes enormous emotional stress to affected families and is associated with substantial medical and nonmedical costs.Objective: To determine the effects of 28 weeks of memantine treatment for patients with AD on resource utilisation and costs.Study Design and Methods: Multicentre, prospective, double-blind, randomised, placebo-controlled clinical trial performed in the US. The Wilcoxon-Mann-Whitney test was used to examine the resource utilisation variables and logistic regression models were used for multivariate resource utilisation analyses. Analysis of covariance (ANCOVA) models (log and non-log) were computed to examine costs from a societal perspective. All costs were calculated in 1999 US dollars.Study Population: Outpatients with moderate to severe AD. Overall, 252 patients received randomised treatment, and 166 patients (placebo n = 76, memantine n = 90) formed the treated-per-protocol (TPP) subset for the health economic analyses, on which the main cost analysis was based.Main Outcome Measure: Resource Utilisation in Dementia (RUD) scale, measuring patient and caregiver resource utilisation, and various sources for cost calculations.Results: Controlling for baseline differences between the groups, significantly less caregiver time was needed for patients receiving memantine than for those receiving placebo (difference 51.5 hours per month; 95% CI -95.27, -7.17; p = 0.02). Analysis of residential status also favoured memantine: time to institutionalisation (p = 0.052) and institutionalisation at week 28 (p = 0.04 with the chi-square test). Total costs from a societal perspective were lower in the memantine group (difference dollars US 1089.74/month [non-overlapping 95% CI for treatment difference -1954.90, -224.58]; p = 0.01). The main differences between the groups were total caregiver costs (dollars US-823.77/month; p = 0.03) and direct nonmedical costs (dollars US-430.84/month; p = 0.07) favouring memantine treatment. Patient direct medical costs were higher in the memantine group (p < 0.01), mainly due to the cost of memantine.Conclusion: Resource utilisation and total health costs were lower in the memantine group than the placebo group. The results suggest that memantine treatment of patients with moderate to severe AD is cost saving from a societal perspective. [ABSTRACT FROM AUTHOR]

Galantamine is one of several orally administered cholinesterase inhibitors that improve cognition in patients with mild to moderate Alzheimer's disease. Compared with placebo, galantamine 16 or 24 mg/day improved cognition and activities of daily living, delayed emergence of behavioural symptoms and reduced caregiver burden in three pivotal randomised studies of 5 or 6 months' duration. Galantamine may reduce the considerable economic burden of Alzheimer's disease by delaying the need for full-time care (FTC) in patients with mild to moderate Alzheimer's disease. In pharmacoeconomic analyses with a time horizon of 10 years conducted in Canada, Sweden, The Netherlands and the US, data from the pivotal trials were incorporated into a model to examine economic implications associated with galantamine treatment. FTC was defined in the model as the consistent requirement for caregiving and supervision for the greater part of each day regardless of the location of care and the identity of caregiver. When the effect of galantamine 16 or 24 mg/day was analysed from the perspective of a comprehensive healthcare payer, treatment was associated with cost savings (inclusive of drug costs) relative to no treatment, regardless of country for which the model was customised. Cost savings resulted from the delay in the time until FTC was required in patients with mild to moderate disease. In sensitivity analyses, cost savings were most sensitive to the cost of institutional care. In the analyses that considered the effect of galantamine 24 mg/day solely on cognition, galantamine was predicted to reduce the time FTC was required by approximately 10% in patients with mild to moderate Alzheimer's disease compared with no pharmacological treatment. Greater reductions in the time that FTC was required were predicted when the effects of galantamine 16 or 24 mg/day on behavioural symptoms in addition to cognition were considered in the US analysis or in sensitivity analyses in studies in other countries. In conclusion, pharmacoeconomic analyses, which were based on modelling of data from pivotal clinical trials with galantamine and included drug costs, indicate that galantamine treatment may result in cost savings from a healthcare payer perspective. The effects of galantamine on cognition and behavioural symptoms in patients with mild to moderate Alzheimer's disease are predicted to delay the need for FTC, which may result in cost savings. From a societal perspective, the caregiver burden of caring for a patient with Alzheimer's disease in the community may be decreased and the time that patients have without severe disease may be prolonged. [ABSTRACT FROM AUTHOR]

Background: In the Balloon Angioplasty and Anticoagulation Study (BAAS), coumarins added to routine aspirin therapy before coronary angioplasty reduced cardiac events at the cost of a slightly higher risk of bleeding complications.Objective: To determine the cost effectiveness of coumarin treatment, based on the occurrence of both cardiac and bleeding events.Methods: Effectiveness was measured, applying two definitions, in terms of the number of events occurring at one year. In the first definition, the occurrence of death, myocardial infarction (MI), or stroke was assessed. The second definition also included revascularisations and major bleeding episodes as an event. Costs were limited to direct medical costs. Cost effectiveness was addressed by probability ellipses representing the point estimates and uncertainties surrounding both costs and effectiveness.Results: At 1 year, death, MI or stroke occurred 1.1% less often when treating with aspirin plus coumarins rather than aspirin therapy alone. When revascularisations and major bleeding events were also included, the difference was 5.0%. Overall, the additional costs in relation to coumarin treatment were compensated by a reduction in repeat interventions. When including all costs, the savings associated with coumarin treatment were estimated at Euros 235 per patient after 1 year. The probability that coumarins are cost saving was estimated at 0.85. The probability that coumarins combine additional effectiveness with cost savings was estimated at 0.70 when survival free of MI or stroke as an effectiveness measure was considered, and at 0.83 when survival free of MI, stroke, revascularisation or major bleeding was considered.Conclusion: Coumarin therapy added to routine aspirin therapy before coronary angioplasty, and continued during follow-up, may not only be considered more effective but also cost saving relative to aspirin therapy alone. [ABSTRACT FROM AUTHOR]

The implantable cardioverter defibrillator (ICD) is a therapy for patients at risk of sudden cardiac death due to ventricular tachycardia (VT) or ventricular fibrillation (VF). But the apparent high cost of ICD therapy relative to antiarrhythmic drugs such as amiodarone has raised questions about the cost effectiveness of ICD therapy versus drug therapy. To inform this debate we reviewed the literature on ICD cost effectiveness. An electronic and manual search was conducted for articles published since 1980 reporting original data on the cost effectiveness of ICD versus drug therapy for patients at risk of VT/VF. Data on costs and life-years gained were abstracted and studies were grouped into those that used decision-analysis models and those that were trial-based analyses. Cost-effectiveness ratios were inflated to 2001 US dollars. Nine studies were included in the review; five studies were modelling studies and four were part of randomised trials of ICD therapy. Studies varied in time horizon, but all except one indicated that ICD therapy was more costly than drug therapy. Early decision models assumed larger survival benefits than those observed in subsequent trials and therefore had attractive incremental cost-effectiveness ratios in the range of dollars US 27000 to dollars US 60000 per life-year gained. Trial-based studies, with the exception of one small trial, indicated cost per life-year gained in the range dollars US 44000 to dollars US 144000. Stratified analysis shows clearly that patients with a greater risk of mortality due to structural heart disease (e.g. left ventricular ejection fraction < or =35%) benefit more from ICD therapy and therefore have a more attractive cost effectiveness ratio than patients at lower risk. ICD therapy is still evolving over time with implant costs declining and device technology improving. Current evidence is that, in selected patients who are at high risk of VT/VF, ICD therapy can be a cost-effective option. Future research should focus on (i) patient selection to optimise benefits for available resources; and (ii) more comprehensive outcome measures to include health-related quality of life. [ABSTRACT FROM AUTHOR]

Background: A clinical trial of patients with de novo acute myeloid leukaemia (AML) showed that haematopoietic support with filgrastim (granulocyte colony-stimulating factor, G-CSF) following induction and consolidation chemotherapy accelerated recovery from neutropenia. The clinical benefits included reductions in infections, anti-infective therapy and length of hospital stay. Objective: The objective of this economic analysis is 2-fold. First, it aims to determine if the observed clinical benefits from the use of filgrastim would lead to cost savings from the perspective of a healthcare institution in the UK. Second, the analysis compares the results of two methods on collection of resource use data. Design: A retrospective cost-minimisation analysis was undertaken based on the clinical results of all UK patients enrolled in the trial. Two cost models were developed: a model based only on the medical resource use collected in the case report forms (the CRF model); and a model based on all medical resources collected from patient medical files (the PF Model). Treatment costs of AML between filgrastim and the placebo arm were compared for the first induction cycle as well as the first induction and the first consolidation cycles combined. Results from the two models were compared. Setting and Patients: The CRF model was applied to two samples of patients: all UK patients (n = 82) and patients enrolled at one centre [the Manchester Royal Infirmary (MRI) (n = 30)], whereas the PF model was applied to the MRI patient sample only. Results: For all UK patients, using the CRF model, the filgrastim-treated arm produced cost savings of £747 (9.0%) and £2135 (14.4%) [1998 values] per patient in the first induction cycle and in the induction and consolidation cycles combined, respectively. For the patients at MRI the CRF model resulted in cost savings with filgrastim of £177 (2.2%) and £414 (3.2%) per patient respectively. Using the PF model the savings at MRI were £910 (8.6%) and £1285 (8.0%) per patient, respectively. Conclusion: Use of filgrastim in the treatment of AML in the UK may result in net cost savings. A retrospective analysis using total resources obtained through patient files produced higher cost savings estimates than that obtained by resources noted in the CRFs. The models based on PF resource data may be more reliable because they are more comprehensive. However, the cost estimates in this study may have been impacted by sample size, site characteristics, disease and treatment settings. Therefore, further evaluation on the methods for collecting resource use data in larger, multicentred studies is warranted. [ABSTRACT FROM AUTHOR]

Amyotrophic lateral sclerosis (ALS) is a difficult to diagnose, fatal, progressive degenerative disease with an average survival time of 2 to 5 years. Percutaneous endoscopic gastrotomy (PEG) and bi-level intermittent positive pressure (BIPAP) ventilation may be the major interventions leading to longer survival of patients with ALS. Riluzole has been shown to have modest effects on survival (as opposed to functional) gains and is currently the only drug approved for the treatment of ALS. There is conflicting evidence with regard to the ability of recombinant human insulin-like growth factor (rhIGF-I) to retard ALS progression. Mechanical ventilation (via a tracheostomy tube) is expensive, but is widely used in later stage patients with ALS in the US. A review of nine cost-effectiveness studies of riluzole and one of rhIGF-I found the following: drug costs and survival gains are the major drivers of cost effectiveness; survival gains are estimated from truncated databases with a high degree of uncertainty; more accurate stage-specific utility weights based on patients who agreed to treatment are needed; case incidence-based evaluations should be carried out; cost-effectiveness ratios are insensitive to discount rates; employment and caregiver issues or externalities have been widely ignored; threshold acceptance cost-effectiveness values are ill-defined and evaluations are not generalisable to other countries because of cost and treatment style differences. On account of the high degree of uncertainty pertaining to survival gains and the relatively high costs per life years or quality-adjusted life-years gained, and while acknowledging that not every therapy has to be cost effective (e.g. orphan drugs), it is still inconclusive as to whether or not riluzole or rhIGF-1 can be considered as cost-effective therapies for ALS. [ABSTRACT FROM AUTHOR]

Objective: To determine whether the use of risperidone in a US managed-care environment is associated with a reduction in the use of mental healthcare services.Methods: Mental health service use and costs for patients with psychoses treated with risperidone versus those treated with conventional antipsychotic agents were compared by both between-group and within-group comparisons. The study controlled for differences between the groups. Only direct medical costs were considered. All costs were for the years 1994 to 1996.Perspective: US managed care plan.Results: Costs (excluding antipsychotic drug costs) per member per month (PMPM) were 180 US dollars lower with risperidone (p < 0.05); per member per year (PMPY) costs were 2160 US dollars lower. In patients who received both risperidone and conventional treatments, PMPM costs were 212 US dollars (2544 US dollars PMPY) lower during risperidone treatment. Total costs (including antipsychotic drug costs) were 624 US dollars PMPY lower with risperidone by between-group comparisons and 1008 US dollars PMPY lower by within-group comparisons.Conclusions: These results show that higher risperidone acquisition costs are offset by reductions in other mental healthcare costs, particularly inpatient hospitalisation costs. This indicates that risperidone may be a more economical choice than traditional antipsychotics for the treatment of psychoses. [ABSTRACT FROM AUTHOR]

Objective: To compare the costs to the Spanish healthcare system of 35 days' treatment with triflusal (600 mg/day) and aspirin (300 mg/day) in patients with confirmed acute myocardial infarction within 24 hours of onset of symptoms.Design: A cost minimisation analysis based on the results of the Triflusal in Acute Myocardial Infarction study (TIM) was conducted. The hypothesis was that despite a higher acquisition cost of triflusal, savings would result because of differences in efficacy and safety outcome (non-fatal cerebrovascular event and haemorrhagic events). Diagnostic Related Groups were used as a proxy for determining hospital costs in Spain and the values were obtained from different sources and refer to year 2000 costs. Only direct medical costs were considered for the economic analysis.Results: Although the acquisition cost of triflusal was more expensive than that of aspirin, the cost of prevented events - non-fatal ischaemic cerebrovascular events and cerebral haemorrhages - entirely compensated for the cost of triflusal. The overall cost of treating patients with triflusal, compared with aspirin, represented a net saving of 28.4% per patient treated.Conclusion: Our study showed that triflusal is cost saving compared with aspirin in the treatment of the acute phase of myocardial infarction. [ABSTRACT FROM AUTHOR]

Background and Objective: Glycoprotein (GP) IIb/IIIa receptor inhibitors enhance thrombolysis in patients with acute coronary syndromes. This analysis evaluates the economic impact of abciximab, a GP IIb/IIIa inhibitor, as an adjunct to urokinase in peripheral artery occlusions of less than 6 weeks duration.Study Design: A post-hoc economic analysis was performed using clinical data and inpatient resource utilisation derived from the prospective comparative phase II Platelet Receptor Antibodies in Order to Manage Peripheral Artery Thrombosis (PROMPT) pilot study. Study endpoints were amputation-free survival and survival without open surgery or major amputation after 90 days, and the rate of major complications at 30 days.Perspective: Third-party payer and the societal perspective.Patients and Methods: Seventy patients with lower extremity thrombi were randomised (2 : 5 ratio) to urokinase plus placebo or to urokinase plus abciximab. Economically relevant data were retrospectively derived from the clinical study database from a specific evaluation of patient records and from expert opinion.Results: From the viewpoint of the society, average total per-patient direct and indirect costs accruing over 3 months were more favourable for treatment with abciximab plus urokinase than for urokinase alone [9723 euros (EUR) vs EUR10 322; 2000 values], despite higher initial hospitalisation costs of the combination therapy. Abciximab plus urokinase was the dominant strategy at 3 months due to a clinically higher rate of survival without amputation or bypass surgery coupled with a lower average per-patient cost. From the perspective of the third-party payer, treatment with abciximab plus urokinase was economically also superior to urokinase alone (EUR8773 vs EUR9663).Conclusions: Based on the preliminary findings of the PROMPT trial, the use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase alone, in terms of clinical and economic outcomes. Further trials are needed to confirm these clinical and economic findings. The preliminary clinical benefits experienced by patients treated with abciximab plus urokinase in the PROMPT trial translated into cost savings in terms of reduced direct medical costs at 3 months. These cost savings more than offset the cost of abciximab. The use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase-alone in terms of clinical and economic outcomes, but further trials are needed to confirm the these clinical and economic findings. [ABSTRACT FROM AUTHOR]

Objective: To estimate the economic impact of using low dose polyethyene glycol 3350 (PEG 3350) plus electrolytes (PEG+E) compared with lactulose in the treatment of idiopathic constipation in ambulant patients. DESIGN AND PERSPECTIVE: This was a decision analytic modelling study performed from the perspective of the UK's National Health Service (NHS).Methods: The clinical outcomes from a previously reported single-blind, randomised, multicentre trial were used as the clinical basis for the analysis. These data were combined with resource utilisation estimates derived from a panel of six general practitioners (GPs) and four nurses enabling a decision model to be constructed depicting the management of idiopathic constipation with either PEG+E or lactulose over 3 months. The model was used to estimate the expected 3-monthly NHS cost of using either laxative to manage idiopathic constipation.Main Outcome Measures and Results: The expected 3-monthly NHS cost of using PEG+E or lactulose to manage idiopathic constipation was estimated to be 85 pound sterling and 96 pound sterling per patient, respectively (1999/2000 values). However, significantly more patients were successfully treated with PEG+E than lactulose (53% versus 24%; p < 0.001) at 3 months. GP visits were the primary cost driver for both PEG+E- and lactulose-treated patients, accounting for 56% (2.9 visits) and 73% (4.4 visits), respectively, of the expected NHS cost per patient at 3 months. Among PEG+E-treated patients, the acquisition cost of PEG+E was the secondary cost driver, accounting for 30% of the expected NHS cost per patient at 3 months, whereas the acquisition cost of lactulose accounted for only 11% of the expected NHS cost per lactulose-treated patient. District nurse domiciliary visits accounted for 4% and thyroid function tests for 2%. The costs of switched laxatives, concomitant laxatives, and gastroenterologist and colorectal surgeon visits collectively accounted for up to 9% of the total.Conclusions: The true cost of managing idiopathic constipation is impacted on by a broad range of resources and not only laxative acquisition costs. This study indicated that managing idiopathic constipation with PEG+E instead of lactulose reduces the expected 3-monthly NHS cost by 11 pound sterling per patient. Moreover, using PEG+E instead of lactulose is expected to double the percentage of patients successfully treated at 3 months. Hence, PEG+E is a dominant treatment compared with lactulose. This suggests that the decision to use either PEG+E or lactulose to treat idiopathic constipation should be based on efficacy, safety, patient preferences and total management costs, and not drug acquisition costs. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and cost effectiveness of two treatments of pressure sores on the heel: a collagenase-containing ointment and a hydrocolloid dressing.Design: Study and cost data were collected prospectively in a randomised clinical trial in The Netherlands by counting the resource use for each patient until wound healing occurred.Study Participants: All 24 female study participants were inpatients from the same hospital with grade IV pressure sores on the heel following orthopaedic surgery.Interventions: Two different treatment strategies were analysed: a collagenase-containing ointment (Novuxol) and a hydrocolloid dressing (Duoderm).Perspective: Hospital perspective.Main Outcome Measures and Results: The average costs per patient for treatment with the hydrocolloid dressing were about 5% higher than those with the collagenase-containing ointment. The treatment costs were similarly distributed within both groups, with 34% for materials and 66% for personnel. The cost-effectiveness analysis revealed that cost savings of 899 Dutch guilders (1998 values) per successfully treated patient could be expected using the collagenase-containing ointment instead of the hydrocolloid dressing. In addition, wound healing was achieved, on average, within a shorter time period with the collagenase treatment (10 weeks) compared with the hydrocolloid treatment (14 weeks). The robustness of the results were also tested using sensitivity analyses. These analyses served to confirm that collagenase treatment provides a better cost-effectiveness ratio than hydrocolloid treatment.Conclusions: With regard to overall costs and costs per successfully treated patient, this study showed collagenase treatment to be more cost effective than the hydrocolloid treatment in patients with grade IV pressure sores on the heel and that the amount of time needed for wound healing was shorter. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the total costs associated with the administration of two different tumour necrosis factor (TNF) strategies used in the treatment of rheumatoid arthritis (RA): etanercept, a soluble TNF receptor that can be administered at home by subcutaneous injection, versus infliximab, an antibody that requires an intravenous infusion in a hospital outpatient setting.Design and Setting: The main analytical framework of the study was a cost-cost analysis comparing the total annual costs associated with the administration of etanercept and infliximab in adult RA patients. The perspective of the study was that of the Dutch society. An economic model was constructed to determine the costs of both treatments. The cost evaluation included direct medical costs, direct nonmedical costs and indirect costs. The base-case analysis compared monotherapy with etanercept versus a combination therapy with infliximab and methotrexate. Data for the economic model came from published literature, expert opinion and official price and tariff lists. All costs were in 1999 values.Patients and Participants: The analysis was performed for the adult RA population eligible for treatment with etanercept or infliximab in The Netherlands.Main Outcome Measures and Results: The analysis showed that the total annual drug costs per patient do not differ substantially between infliximab and etanercept, with costs of Netherland guilders (NLG)31,526 (12,610 US dollars) and NLG31,334 (12,534 US dollars), respectively. However, the other medical costs (i.e. excluding the costs of the two drugs themselves) are substantially higher for infliximab due to the additional costs associated with administration in an outpatient clinic and the use of methotrexate [NLG 12,621 (5048 US dollars) versus NLG269 (107 US dollars) for etanercept]. The impact of direct nonmedical costs (transportation) and indirect costs were negligible. Overall treatment with infliximab is more expensive than treatment with etanercept with total costs of NLG45 115 (18,046 US dollars) and NLG3I,621 (12,648 US dollars), respectively (42.7% increase).Conclusions: Based on the assumptions used in the model, we may conclude that the use of etanercept compares favourably with infliximab from a budgetary and health economic perspective: the total costs are substantially lower when the efficacy of etanercept is assumed to be at least equivalent to the efficacy of infliximab. [ABSTRACT FROM AUTHOR]

Objective: To investigate the cost effectiveness of adding the beta-blocker bisoprolol to standard treatment in patients with congestive heart failure (CHF).Design and Setting: A cost-effectiveness study was based on the Cardiac Insufficiency Bisoprolol Study II (CIBIS-II), a randomised clinical trial investigating the efficacy of adding bisoprolol to standard therapy of CHF. The cost-effectiveness analysis was carried out from a societal perspective.Methods: Health effects were measured in terms of years of life gained. On the cost side, treatment costs for pharmaceuticals and hospitalisations were included. Data on healthcare resource consumption from CIBIS-II were used and were combined with average Swedish retail prices for medicines, and average costs for hospitalisations based on hospital admissions, in the base case. The costs of added years of life, i.e. consumption net of production during life-years gained were also included.Results: If costs of added years of life were not included, then bisoprolol therapy increased life expectancy at an incremental cost of Swedish kronor (SEK) 13 094 (1999 values) per year of life gained. If costs of added years of life were included, then the incremental cost-effectiveness ratio of bisoprolol therapy was SEK 168 858 per year of life gained.Conclusions: For patients with CHF with the characteristics of those in CIBIS-II, the cost effectiveness of bisoprolol therapy compares favourably with that of other cardiovascular therapies. [ABSTRACT FROM AUTHOR]

Objective: The primary objective of this study was to estimate the cost effectiveness of treating diabetic foot ulcers with becaplermin (Regranex) plus good wound care (GWC) compared with GWC alone in a variety of European healthcare settings. A secondary objective was to analyse the effect of different treatment practices on the economics of caring for diabetic foot ulcers.Design and Setting: Markov-based simulation study from the perspective of a national health system.Methods: A 12-month Markov computer simulation model was used to assess the cost effectiveness in 4 European countries of treating diabetic foot ulcers with becaplermin plus GWC versus GWC alone. Transition probabilities were taken from a prospective study of 183 patients and becaplermin efficacy was based on 20-week healing rates in a recent meta-analysis of clinical trials involving 449 patients. Country-specific treatment cost data were collected in collaboration with local economic consultations and combined with the disease model to estimate the incremental cost per ulcer-free month gained. The model was then run using hypothetical low- and high-intensity resource usage profiles to investigate the economics of caring for diabetic foot ulcers.Results: Over the course of 1 year, individuals who received becaplermin plus GWC were, on average, predicted to spend an additional 0.81 months (24% longer) free of ulcers and to experience a 9% lower risk of undergoing a lower extremity amputation than individuals who received GWC alone. Consequently, becaplermin plus GWC was estimated to be net cost saving in Sweden, Switzerland and the UK. In France, the addition of becaplermin was estimated to add $US19 (1999 values) for each additional ulcer-free month gained. There were substantial intercountry differences in treatment practices and the costs of treating diabetic foot ulcers.Conclusions: Becaplermin may be a cost-effective treatment for neuropathic diabetic foot ulcers in a wide range of European settings. In Sweden, Switzerland and the UK, becaplermin may even be cost saving. Substantial intercountry differences in resource patterns appear, at least partly, to be the logical outcome of differences in unit costs. [ABSTRACT FROM AUTHOR]

The progressive disability of Parkinson's disease results in substantial burdens for patients, their families and society in terms of increased health resource use, poorer quality of life, caregiver burden, disrupted family relationships, decreases in social and leisure activities, deteriorating emotional well-being, and direct and indirect costs of illness. Health-related quality of life (HR-QOL) measures have been used successfully in cross-sectional studies to identify and characterise these burdens; however, there is not yet substantial evidence that these instruments will be responsive to changes in patients over time and that the results will provide patients and health professionals with clinically meaningful information useful in making decisions about treatment strategies. The few studies documenting direct and indirect costs indicate increased use of ancillary health and community services, significant adaptations in home and transportation, increased use of mobility and self-care aids, and lack of access to appropriate healthcare providers. Patients with Parkinson's disease incur higher hospital expenses, have increased number of prescriptions, and experience earnings loss; the latter also applies to family caregivers. The choice, intensity and timing of therapy are determined by a variety of factors: presenting symptoms, age, employment status, comorbidity, cognitive impairment and level of functional impairment. Choices must be individually tailored to a patient's physical and personal needs. To be useful for patients with Parkinson's disease in clinical practice, clinicians should be able to use HR-QOL measures to identify appropriate medical interventions or socio-behavioural modifications to modify the HR-QOL deficits. However, while the interplay of interventions and clinical outcomes are often well understood, the effects of interventions on HR-QOL outcomes have not been studied extensively. Little research has been done that explicitly links the signs and symptoms of Parkinson's disease to the HR-QOL outcomes. The only Parkinson's disease cost-effectiveness study as yet performed indicated higher costs for patients receiving pramipexole than for those not taking the drug, but additional quality life-years were gained. Longer term effectiveness of many treatment strategies, and the usefulness of HR-QOL instruments to assess these treatments for individual patients over time, are critical areas for future research. [ABSTRACT FROM AUTHOR]

Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and morbidity. Relatively few pharmacoeconomic studies have been conducted on this disease. This article reviews available information about the utilisation of healthcare resources and cost of care, and the cost or cost effectiveness of therapeutic interventions reported for this disease. Burden-of-illness data indicate that hospital care, medications and oxygen therapy were the major cost drivers in these studies. Mean annual Medicare expenditures in the US were $US11 841 (2000 values) for patients with COPD compared with $US4901 for all covered patients. Utilisation was skewed; the most expensive 10% of the Medicare beneficiaries accounted for nearly 50% of total expenditures for this disease. Costs are associated with health status, age, physician specialty, geographic location and type of insurance coverage. Six types of interventions were assessed in the literature - pharmacotherapy, oxygen therapy, home care, surgery, exercise and rehabilitation and health education. The studies used different analytic strategies (e.g. cost-minimisation and cost-effectiveness analyses) and even within the realm of cost-effectiveness analyses, no uniformity existed as to how outcome was measured. Patient severity was not always delineated, and the length of the follow-up period, while quite short, varied. Only 11 of the 34 evaluations were based on randomised controlled trials. Cost-minimisation studies generally found no significant difference in the cost of antimicrobial treatment for first-line, second-line and third-line agents. Studies of bronchodilators indicated that ipratropium bromide alone or in combination with salbutamol (albuterol) was the preferred medication. The major area for achieving cost savings is by reducing hospital utilisation. As the annual rate of hospitalisation is relatively low, large patient samples will be required to demonstrate an economic advantage for a new therapy. The major challenges will be financing such a study, and selecting an outcome measure that satisfies both clinical and economic conventions. [ABSTRACT FROM AUTHOR]

Unlabelled: Torasemide is a loop diuretic used for the treatment of hypertension and for oedema in chronic heart failure (CHF), renal failure and cirrhosis. The efficacy of torasemide in reducing salt and water retention in CHF has been established in double-blind comparative studies against furosemide. Torasemide has been shown to be at least as effective as furosemide in terms of total volume of urine excreted and also has a longer duration of action. The efficacy of torasemide (in terms of improved CHF symptoms and reduced pulmonary congestion, oedema and bodyweight) has been shown in randomised controlled trials and confirmed in large postmarketing studies. In addition, data from postmarketing studies have shown that patients receiving torasemide had significantly reduced hospital admission rates compared with patients receiving furosemide. Pharmacoeconomic assessments of torasemide have focused on its effect in reducing hospitalisation. Hospitalisation costs due to CHF decreased by 86% during the 11.2-month period of torasemide treatment, compared with the 6-month period prior to treatment, in a US retrospective study assessing medical and pharmacy claims data. Overall, average monthly costs for patients decreased by 56.6% after 5.1 months (from $US1,897.28 to $US823.70 per patient per month; PPPM), and by 76% after 11.2 months (from $US1,944.76 to $US470.76 PPPM) of torasemide treatment. In the furosemide group, average monthly costs for patients increased moderately from $US227.28 to $US261.18 PPPM after 12 months. Direct comparison of the torasemide and furosemide study groups was not possible because the group receiving torasemide had much higher healthcare resource use at baseline. Compared with furosemide, torasemide was associated with reduced rates of hospital admissions for CHF and/or cardiovascular causes in 3 studies, a retrospective analysis conducted in Germany, a prospective US study of patients enrolled from hospital admissions and a decision-analysis model. As a result, the direct costs of treatment for CHF or cardiovascular diseases for patients treated with torasemide were less than those with furosemide. However, in the US study, there was no statistically significant difference in hospital admissions for all causes and/or in overall direct medical costs, although the study was not powered to show this. In another US study of managed care patients with New York Heart Association (NYHA) class II or III CHF, no difference in clinical or economic outcomes was observed between patients taking torasemide or furosemide; despite the higher acquisition costs for torasemide, total costs were similar for both groups. Torasemide was found to be more cost effective than furosemide in terms of cost per patient with improved functional (NYHA) class of CHF severity in a retrospective German analysis, although this measure is not ideal. This study also evaluated indirect costs (for loss of productivity of employed patients) and resultssuggest torasemide has a favourable effect in reducing days off work compared with furosemide, although the population of employed patients in the study was very small. Torasemide has been shown to improve some measures of quality of life in 2 studies. It was associated with higher quality-of-life scores than furosemide in a 6-month study, but the differences were only significant at month 4. In another study, torasemide significantly improved fatigue, but full study details are yet to be published.Conclusions: Despite the higher acquisition cost of torasemide over furosemide, pharmacoeconomic analyses have shown that torasemide is likely to reduce overall treatment costs of CHF by reducing hospital admissions and readmissions. Torasemide has generally shown clinical and economic advantages over furosemide, although more long term data are needed to confirm these results and to further investigate effects on quality of life. There are limitations to the currently available pharmacoeconomic data, but present data support the use of torasemide as a first-line option for diuretic therapy in patients with CHF presenting with oedema and especially in those patients not achieving relief of symptoms with furosemide. [ABSTRACT FROM AUTHOR]

Objective: To determine the cost of using systemic therapy to treat newly diagnosed cytomegalovirus (CMV) retinitis in persons with AIDS. Design: Incidence-based simulation model of CMV treatment from a government payer perspective. Setting: Swiss healthcare system. Patients and participants: Patients with AIDS and newly diagnosed CMV retinitis. Interventions: Patients were assigned to 1 of 4 treatment regimens for induction and maintenance therapy: intravenous (IV) cidofovir induction and maintenance (cidofovir IV/IV); IV foscarnet induction and maintenance (foscarnet IV/IV); IV ganciclovir induction and maintenance (ganciclovir IV/IV); and IV ganciclovir induction and oral (PO) ganciclovir maintenance (ganciclovir IV/PO). Following a second relapse, patients were assigned to one of the other regimens. Main outcome measures: Time to first and subsequent progression, duration of maintenance treatment and direct medical expenditures [1998 Swiss francs (SwF)]. Results: The median time to first progression was longest for cidofovir IV/IV, followed by foscarnet IV/IV, ganciclovir IV/IV and ganciclovir IV/PO. Mean survival was 13 months and mean costs for this period in the base case were lowest in those initially treated with cidofovir (SwF146 742), followed by initial treatment with foscarnet IV/IV (SwF194 809), ganciclovir IV/PO (SwF195 190) and ganciclovir IV/IV (SwF243 964). Costs were most sensitive to changes in efficacy estimates. Conclusions: Of the regimens studied, initiation of treatment with systemic cidofovir appears least costly over a 13-month period. [ABSTRACT FROM AUTHOR]

Pharmacological treatment of hypertension has been shown to reduce the risk of stroke, coronary events, heart failure and progression of renal disease. However, rates of successful blood pressure control remain low among treated patients while antihypertensive medication represents a large and increasing proportion of healthcare expenditure in many countries. Several influential pharmacoeconomic analyses have confirmed the cost effectiveness of conventional antihypertensive treatments, usually involving monotherapy with diuretics or beta-blockers, compared with alternative strategies. Recent research has shown that a considerable proportion of the total cost of antihypertensive treatment in general practice is due to factors such as inadequate blood pressure control, poor compliance with therapy, discontinuation and switching between therapies. These factors operate to a much lesser extent in well-conducted clinical trials, and have not been fully incorporated into most economic studies. Some novel strategies, particularly low dose combinations of antihypertensive agents, may offer advantages in terms of efficacy, reduced adverse effects and improved compliance with treatment. There is therefore a need for comprehensive pharmacoeconomic analyses of novel strategies, taking these additional factors into account. Until such studies are available, the wider use of low dose combination therapy and other novel strategies should not be held back on the basis of earlier economic studies that have not included all relevant considerations. [ABSTRACT FROM AUTHOR]

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in the treatment of patients with HIV infection. Both US and British treatment guidelines for HIV infection recommend NNRTI- or protease inhibitor-based combinations [i.e. with nucleoside reverse transcriptase inhibitors (NRTIs)] as first-line treatment options in the management of HIV disease. Results of a pivotal randomised study (DMP 266-006) comparing efavirenz- versus indinavir-based triple combination therapy in patients with HIV infection (the majority of whom were antiretroviral therapy-naive) showed the efavirenz-based regimen was better tolerated and had greater success in achieving reductions in viral load below the limit of detection. These and other clinical data were incorporated into economic models in 2 analyses, one conducted in the US and the other in Canada. The US analysis examined long term clinical and economic outcomes predicted on the basis of response (viral load and CD4+ cell counts), tolerability and willingness to adhere to therapy. The efavirenz-based regimen was the dominant treatment strategy as it was predicted to improve survival and reduce direct medical costs in the US healthcare system. Compared with the indinavir-containing regimen, survival was increased by 11% (absolute difference) and cumulative costs were reduced by $US10 326 per patient (1998 discounted costs) at 5 years after starting treatment with efavirenz-based therapy. The Canadian analysis was conducted from the perspective of the Ontario healthcare system. This study did not consider differences in clinical efficacy between treatment groups, costs of study medication or outcomes beyond 1 year - all factors that would have favoured the efavirenz-based regimen. Of the 2 treatment options, the efavirenz-based regimen was associated with 7.4% lower average annual medical care costs, primarily because of greater costs associated with adverse clinical events with the indinavir-based regimen. In conclusion, current treatment guidelines for HIV infection recognise efavirenz-based combination regimens as a first-line treatment option. A pivotal comparative clinical trial (DMP 266-006) showed a significantly greater virological response to efavirenz- than indinavir-based triple combination therapy, and the efavirenz-based regimen was better tolerated. These clinical data are supported by pharmacoeconomic analyses conducted in the US and Canada, both of which showed lower medical care costs with the efavirenz-based regimen. The US analysis also predicted long term health benefits, such as improved survival, with efavirenz- versus indinavir-based triple combination therapy. These results must be weighed against the inherent difficulties of predicting long term treatment failure rates from short term data, and the limited number of pharmacoeconomic analyses conducted with efavirenz to date. [ABSTRACT FROM AUTHOR]

Objective: To assess the cost effectiveness of emedastine, a new antihistamine, versus levocabastine in the treatment of acute allergic conjunctivitis (AAC) in Belgium, France, Germany, The Netherlands, Norway, Portugal and Sweden.Design and Setting: Randomised double-blind multicountry clinical trial followed by economic modelling from the treatment provider perspective.Patients: A total of 221 patients (109 emedastine, 112 levocabastine) with AAC were included.Methods: The clinical trial compared the efficacy and safety of emedastine 0.05% and levocabastine 0.05%, both twice daily, for 42 days, using ocular redness, itching, days without symptoms and clinical failure as outcome measures. The cost of first-line treatment failure, including visits, drugs and laboratory examinations, was established in each country from a panel of ophthalmologists and general practitioners. Full sensitivity analyses were conducted.Results: From day 7 to 42, patients treated with emedastine had less itching (p < 0.001) and less redness (p < 0.001). The failure rate was 10% less (p < 0.02) with emedastine and patients treated with emedastine had an incremental 8.5 days (p < 0.01) without symptoms. Emedastine and levocabastine were equally well tolerated. In all European countries, the cost of failure was lower with emedastine. Emedastine was found to be economically dominant relative to levocabastine, i.e. more effective and less expensive, in Belgium, Germany, Portugal and Sweden; in France, The Netherlands and Norway the incremental cost was low (less than 1 euro per additional symptom-free day).Conclusion: Through a model based on a randomised clinical trial and cost estimates of treatment failure derived from practitioner interviews, emedastine is a cost-effective treatment of AAC. [ABSTRACT FROM AUTHOR]

Objectives: To estimate component and total costs of treatment and to examine differences in cost and cost effectiveness between oral antifungal medication and local therapy for patients with toenail onychomycosis.Design: Prospective, observational study of patients with onychomycosis who visited dermatologists and podiatrists in the US. Physicians provided data on clinical management, disease severity, nail improvement and resource utilisation. Patients completed questionnaires on resource utilisation and symptoms at base-line, 4 and 9 months. To estimate costs, reported utilisation was multiplied by unit costs expressed in 1997 US dollars ($US) and derived in 2 ways: first, using Medicare fees; and second, using standard physician fees.Results: After adjustment for key demographic and clinical variables, participants receiving oral medication had higher total costs based on standard fees ($US794 vs $US575) and medication costs ($US564 vs $US109), lower procedure costs ($US0 vs $US122) and physician visit costs ($US200 vs $US330), and greater clinical effectiveness as measured by global improvement rating (86 vs 35%) and Toenail Symptom Index (94 vs 49%). For participants receiving oral medication, 90% of total costs were incurred during the first 4 months of follow-up, whereas for those receiving local therapy, costs were more evenly distributed throughout the study period. Incremental cost-effectiveness analysis showed $US304 to $US491 per additional case improved with oral medication over a 9-month timeframe. Extrapolation of these results using 2 time-points (months 4 and 9) suggested that cost equivalence would be reached 17 to 21 months following the initiation of treatment.Conclusions: During 9 months of follow-up in patients with toenail onychomycosis, the use of oral antifungal medication resulted in superior patient outcomes, but at higher total cost compared with local therapy. [ABSTRACT FROM AUTHOR]

Alzheimer’s disease is associated with a large cost burden, of which institutionalised care constitutes a major component. Therefore, the decision to move a patient from the community to institutionalised care is associated with a significant increase in direct costs. About three-quarters of patients with Alzheimer’s disease are admitted to a nursing home within 5 years of diagnosis. Unpaid or informal caregiver time is another large cost in Alzheimer’s disease, especially for patients cared for in the community; informal care can account for up to three-quarters of healthcare costs in non-institutionalised patients. Several cholinesterase inhibitors, of which rivastigmine is one, are available for the treatment of patients with mild to moderate Alzheimer’s disease. By improving cognitive function and slowing the rate of cognitive decline, cholinesterase inhibitor therapy may reduce a significant part of the economic burden of the disease by delaying the move to institutionalised care. In the absence of prospective long term data which focus on pharmacoeconomic end-points, modelling techniques have been used to extrapolate clinical data available for some cholinesterase inhibitors, including rivastigmine. Four economic analyses, based on a single model of cognitive decline, have been performed with rivastigmine from the perspective of the provider or society. All show that rivastigmine therapy (excluding drug-related costs) is associated with cost savings in patients with mild to moderate Alzheimer’s disease by delaying the time to institutionalisation. If the acquisition cost of the drug was factored in, the cost savings completely or partially offset treatment costs. The magnitude of the cost savings increased as the time horizon increased (up to 2 years). The largest savings were realised in patients with mild disease over a 2-year time-frame, suggesting that treatment should be initiated early from an economic viewpoint. Pharmacoeonomic data comparing different cholinesterase inhibitors are, as yet, unavailable. Conclusion: Pharmacoeconomic analyses, based on modelled data excluding drug costs, indicate that rivastigmine completely or partially offsets the costs of treatment by delaying cognitive decline and the time to institutionalisation in patients with mild to moderate Alzheimer’s disease. From a societal perspective, cost savings are realised if the drug is introduced early in the disease. Additional benefits offered by rivastigmine on behavioural symptoms, which may reduce caregiver burden, have yet to be investigated from a pharmacoeconomic perspective. [ABSTRACT FROM AUTHOR]