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Background: Studies have shown that pharmaceutical care can result in favorable clinical outcomes in human immunodeficiency virus (HIV)-infected patients, however, few studies have assessed the economic impact. The objective of this study was to evaluate the clinical and economic impact of pharmaceutical care of HIV-infected patients. Methods: A controlled ambispective study was conducted in Brazil from January 2009 to June 2012. Patients were allocated to either intervention or control group. The control group was followed according to standard care while the intervention group was also followed by a pharmacist at each physician appointment for one year. Effectiveness outcomes included CD4+ count, viral load, absence of co-infections and optimal immune response, and economic outcomes included expenses of physician and pharmaceutical appointments, laboratory tests, procedures, and hospitalizations, at six months and one year. Results: Intervention and control groups included 51 patients each. We observed significant decreases in total pharmacotherapy problems during the study. At six months, the intervention group contained higher percentages of patients without co-infections and of patients with CD4+ >500 cells/mm³. None of the differences between intervention and control group considering clinical outcomes and costs were statistically significant. However, at one year, the intervention group showed higher percentage of better clinical outcomes and generated lower spending (not to procedures). An additional health care system daily investment of US$1.45, 1.09, 2.13, 4.35, 1.09, and 0.87 would be required for each additional outcome of viral load <50 copies/ml, absence of co-infection, CD4+ >200, 350, and 500 cells/mm3, and optimal immune response, respectively. Conclusion: This work demonstrated that pharmaceutical care of HIV-infected patients, for a one-year period, was able to decrease the number of pharmacotherapy problems. However, the clinical outcomes and the costs did not have statistical difference but showed higher percentage of better clinical outcomes and lower costs for some items. [ABSTRACT FROM AUTHOR]

Cost is a measure of resources consumed. By assessing costs, pharmacoeconomic studies complement studies of efficacy and safety, helping to determine the relationships of treatment and outcome. Costs are divided into three categories, including direct cost (resources attributable to the intervention), indirect cost (resulting from reduced productivity), and intangible cost (incurred from pain and emotional suffering). Insurance companies, patients, doctors, and the society all have different perspectives with respect to costs. The present authors review different types of cost analyses and their use in studies of psoriasis, atopic dermatitis, and basal cell carcinoma treatment. Cost studies influence clinicians, policy makers, and third-party payers’ decisions regarding the implementation of particular therapies or programs. Collection of cost data needs to be incorporated into clinical trials to facilitate these decisions. [ABSTRACT FROM AUTHOR]

Objective and methods: The aim of our study was to analyse retrospectively the nature and frequency of antiretroviral prescriptions for 990 HIV-infected patients followed at our outpatient centre in Bologna, Italy, from January 2003 to March 2004. The main focus of the study was to identify the most commonly prescribed combinations and their related expenses, in order to identify the most competitive treatment regimens with regard to costs. Prescriptions were given directly to patients at monthly intervals, and drug treatment adherence data was stored in an electronic database. Antiretroviral regimens administered for the longest period to each patient during the 15 months of the study were selected for the study. All patients treated for <9 consecutive months and/or with treatment adherence levels <90% were excluded. Physicians assessed antiretroviral therapy at least quarterly according to efficacy and safety criteria, but not in terms of pharmacoeconomic considerations. Direct pharmacy expenses were obtained for the 24 most commonly used therapeutic regimens, covering 80.1% of patients. Results: The zidovudine-lamivudine-efavirenz combination proved to be the most prescribed combination (7.3%), followed by zidovudine-lamivudine- nevirapine (7.1%), lamivudine-stavudine (6.2%), zidovudine-lamivudine- lopinavir-ritonavir (5.2%), didanosine-stavudine-lopinavir-ritonavir (4.8%), and lamivudine-stavudine-nevirapine (4.7%). Anti-HIV combinations varied from a minimum yearly cost of €3895.6 for lamivudine-stavudine to €9422.8 for the zidovudine-lamivudine-lopinavir-ritonavir combination (+241.9%) [year of costing 2003]. There was a significant difference between the two first-line regimens for antiretroviral-naive subjects, with lopinavir-ritonavir-based combinations costing more than €9000 per patient/year compared with efavirenz-containing combinations, which were 28% less expensive. Mean daily costs varied substantially, from a minimum of €10.7 per day for lamivudine-stavudine to a maximum of €25.8 per day (+241.1%) for zidovudine-lamivudine-lopinavir-ritonavir. Regimens based on non-nucleoside reverse transcriptase inhibitors (NNRTIs) were less costly than most of those including protease inhibitors (PIs). The increased expense of each combination was compared with the cheapest therapeutic selection (lamivudine-stavudine), and costs of all triple combinations were also compared. Regimens based on NNRTIs accounted for 29.3% of our cohort (nevirapine-containing therapies 15.1%, and efavirenz-based ones 14.2%), while PIs were used in the majority of cases (37.3%), with lopinavir-ritonavir as the leading combination (13.6% of patients), followed by nelfinavir (9.9%) and indinavir (9.2%). When drug-related costs were examined, dual nucleoside analogues showed the lowest expense (€10.7–€11.6 per day), while triple nucleoside/nucleotide analogue combinations cost nearly twice as much (€18.5–€20.4 per day). Among the NNRTIs, there were comparable costs for nevirapine-based combinations (€18.3–€18.7 per day), while efavirenz-including regimens were 10% more costly (€19.2–€20.l per day). A very broad range of combinations and related costs were found with PIs, but apart from indinavir and saquinavir combinations (€15.7–€21.7 per day), all other regimens had a higher daily cost (from €22.0 per day for ritonavir-based regimens to €23.4–€24.3 per day for nelfinavir combinations, and up to €24.9–€25.8 per day with lopinavir-ritonavir). When considering nelfinavir- and lopinavir-containing combinations, the difference compared with NNRTI-based regimens varied from 41% when nevirapine- and lopinavir-ritonavir were compared, to 11.6% when efavirenz and nelfinavir were compared. Conclusions: Investigations that link prescribing patterns and related costs in the setting of HIV disease therapy are needed to improve patient management and help with the planning of healthcare resource allocation. [ABSTRACT FROM AUTHOR]

Objectives: To the extent that current recombinant clotting factor concentrates contain even trace amounts of human or animal protein, there is continuing potential for transmission of nonenveloped viruses, including hepatitis A, and parvovirus, and the theoretical potential for transmission of relatively unknown agents, such as prions (Creutzfeldt-Jakob disease, or its variant). Full-length antihaemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM; Advate®), represents a novel pharmacotherapeutic option for the management of haemophilia A. This investigation was designed to discern: (i) the efficacy-based use pattern (International Units [IUs]) of rAHF-PFM versus B-domain deleted rFVIII (BDDrFVIII; ReFacto®) required to resolve a bleeding episode (event) among previously treated patients with haemophilia A employing on-demand treatment; (ii) the health service expenditure pattern (percentage differential; payor’s perspective) associated with use of rAHF-PFM versus BDDrFVIII among previously treated patients with haemophilia A employing on-demand treatment; and (iii) the fiscal utility attributable to the plasma/albumin-free status of rAHF-PFM under the assumed emergence of a novel and infectious blood (plasma)-borne virus. Materials and methods: Data stemming from phase II/phase III clinical trials of rAHF-PFM, together with published literature on BDDrFVIII, afforded calculation of the probability of occurrence for specific endpoints of interest (e.g. non-response to first infusion). Monte Carlo simulation, a decision-analytical framework parameterised with stochastic (random) and deterministic (fixed) components (10 000 iterations per month [or year] of age examined [3, 6, 9 months; years 1 through 19; and years 20, 30, 40, 50, 60, 70 and 80]) was used to compare: (i) the efficacy-based use pattern by treatment option; and (ii) the health service utilisation-based expenditure pattern by treatment option, accounting for the need for subsequent infusion(s), and potential complications (use of services) stemming from failure of the initial infusion (five scenarios). Theoretical and direct modelling methods for assessing the fiscal utility attributable to the plasma/albumin-free status of rAHF-PFM under the assumed emergence of a novel and infectious blood (plasma)-borne virus were developed. Assumptions included: (i) a low population infection rate (<5%); (ii) annual health service expenditures equivalent to 5% of that observed with HIV/AIDS; and (iii) the number of bleeding events experienced per year were 6, 9 or 12. Results: Monte Carlo simulation-replicated simulations per year of age examined revealed: (i) use of rAHF-PFM resulted in a 12.20% median reduction in the number of IUs required to resolve a bleeding episode (event) relative to BDDrFVIII (p < 0.05); and (ii) a health service utilisation-based savings [primary care; hospital] (p < 0.05; range 13.74–39.34% [dependent on intensity (sequencing) of care required]) with rAHF-PFM relative to BDDrFVIII. The overall scenario-weighted health service utilisation-based savings was 16.94% (p < 0.05). Under the assumption of the emergence of a novel and infectious blood (plasma)-borne virus, deterministic models for persons weighing 20kg, 50kg and 80kg all revealed a savings potential ($US per IU) with use of rAHF-PFM relative to use of a non-plasma/albumin-free product. Conclusion: Use of rAHF-PFM in on-demand management of haemophilia A offers enhanced patient safety and represents a fiscally prudent therapeutic strategy. [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]

Objective: To evaluate the relationship between adherence to antidepressant therapy and economic outcomes. Design: Retrospective database analysis using pharmacy and medical claims from a pharmacy benefit and medical management company serving a large managed care organization (MCO) that provides healthcare coverage for approximately 3.5 million members. Participants: Patient selection was based on the following criteria: (i) newly started on antidepressant therapy between 1 April 1999 through 30 June 1999; (ii) titrated to a usual antidepressant dosage level within 6 months of the initiation of therapy; (iii) continuously enrolled in the health plan between 1 January 1999 through 31 December 1999; and (iv) >18 years of age. Outcome measures: Antidepressant adherence was calculated as a ratio of the total number of day’s supply during the 180-day follow-up period divided by 180 days. Patients were defined as adhering to treatment if they had a ratio of ≥0.70. The means of pharmacy ingredient costs, medical charges and total healthcare charges incurred during the follow-up period were compared. Adjusted means (least squares means) were calculated after adjusting for potential confounding factors that may have influenced relevant outcomes. Results: Of the total cohort (14 190 patients), 39.7% (n = 5638) of patients were deemed to be adhering (≥70.0% completion) to their treatment. Adherent patients were significantly more advanced in age (55.2 vs 54.3 years, p < 0.01) and had a higher mean Chronic Disease Score (3.80 vs 3.47, p < 0.0001). After adjusting for confounding factors, adherent patients incurred lower total healthcare charges ($US11 327 vs $US11 815, p = 0.433) significantly lower medical charges ($US9411 vs $US10 692, p = 0.039) and significantly higher pharmacy charges ($US1915 vs $US1123, p < 0.0001) than non-adherent patients during the initial 6 months of therapy (all 1999 values). Conclusion: In this MCO, patients who were adherent with antidepressant therapy possessed significantly lower medical charges. These findings indicate that patient adherence with antidepressant therapy significantly improved the economic outcomes. It is suggested that there is a need for raising awareness about the importance of patient adherence as well as to improve methods of detecting individuals with depression in order to gain the economic benefits associated with adherence. [ABSTRACT FROM AUTHOR]

Background: Infections with methicillin-resistant Staphylococcus species (MRSS) are associated with higher treatment costs than infections with methicillin-sensitive Staphylococcus species in the United States—partly because of an increased length of hospital stay (LOS).Objective: This study used pharmacoeconomic modeling to evaluate the costs and outcomes associated with the use of IV vancomycin compared with PO linezolid in the treatment of MRSS-infected patients.Methods: A retrospective chart review was used to determine the number of cases with confirmed or presumed MRSS infections treated with IV vancomycin during calendar-year 2000 at the Veterans Affairs Greater Los Angeles Healthcare System inpatient facility. Patients who were eligible for a switch to PO linezolid with or without early discharge to home were identified. Cost differences associated with conversion from IV to PO therapy (compared with continued IV therapy) were estimated based on a mean decreased LOS and a decrease in the costs associated with catheter-related adverse events. Rates and costs of catheter-related adverse events were based on estimates from the literature. Sensitivity analyses were performed by variation of the estimated mean LOS decrease in the SD and by variation of the estimates for incidence and costs related to catheter complications. Cssts were measured in year 2000. US dollars, and differences were not assessed for statistical significance.Results: Of 177 patients treated with IV vancomycin, 103 (58%) were eligible for conversion to PO linezolid and 55 (31%) were eligible for early discharge from the hospital with continuation of PO therapy. Early discharge was associated with a mean (SD) LOS decrease of 3.3 (2.9) days. Annual mean total cost savings in patients eligible for conversion from IV vancomycin to PO linezolid with early discharge were $294, 750 (range, $35, 730-$553, 790). For cases eligible for inpatient conversion from IV vancomycin to PO linezolid therapy (n = 48), the mean total annual cost difference was an increase of $6340 for PO linezolid (range, −$12, 910 to $11, 900).Conclusion: These results—although partly based on estimates from the literature, rather than direct measurements—support the use of PO linezolid with or without early discharge as a potential cost-savings alternative for eligible patients treated with a full course of IV vancomycin for suspected or confirmed MRSS infection. [Copyright &y& Elsevier]

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 behavioral symptoms and reduced caregiver burden in three pivotal randomized 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 payor, treatment was associated with cost savings (inclusive of drug costs) relative to no treatment, regardless of country for which the model was customized. 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 ≈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 behavioral 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 payor perspective. The effects of galantamine on cognition and behavioral 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]

Introduction: Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. When adhered to, they have been shown to have the potential to improve both the process of care and patient health outcomes. Economic issues can be incorporated into guidelines with respect to both recommendations (based on the criteria of cost effectiveness) and defining outcomes for assessing adherence with guidelines. Methods: We reviewed 217 Canadian clinical practice guidelines relating to prescription medications. The role of economics within existing practice guidelines was assessed using standardized abstracting techniques. Results: Costs or economics were considered in only 26% of the guidelines identified. The role of economic considerations within these guidelines varied considerably from a relatively minor to major role. Furthermore, only 4% of guidelines defined measurable outcomes, including economic outcomes, that could be monitored to assess adherence with recommendations. Conclusions: The inclusion of economic considerations in clinical guidelines in Canada is limited. The possible reasons for this lack of economic considerations need to be explored further. Without consideration of economic issues when developed, clinical practice guidelines may lead to a more inefficient healthcare system. [ABSTRACT FROM AUTHOR]

Most pharmacoeconomic studies of mycophenolate mofetil have focused on its use as part of maintenance immunosuppression for renal transplantation, involving short-term (3-12 months) time frames. In general, mycophenolate mofetil reduced the treatment costs for rejection episodes and graft failure which offset its higher drug acquisition cost compared with azathioprine. Several cost analyses have been modeled on the large multicenter trials of adult renal transplant recipients. The use of mycophenolate mofetil was associated with either cost savings or no additional costs after 6 or 12 months in French, US and Canadian analyses of triple or quadruple immunosuppressant therapy. A further cost analysis utilizing a registry database of renal transplant recipients in the US found mycophenolate mofetil to be cost saving compared with azathioprine after 6.4 years when evaluating costs due to graft loss only. Of the limited cost-effectiveness analyses with the drug, one US study modeled the 1- and 10-year cost effectiveness of mycophenolate mofetil and various other immunosuppressants used in combined regimens. Long-term use of mycophenolate mofetil was less cost effective than other regimens, but the use of long-term mycophenolate mofetil in high-risk patients was shown to be a relatively cost-effective strategy. In another US analysis comparing mycophenolate mofetil with azathioprine as part of quadruple therapy, mycophenolate mofetil was associated with slightly lower costs during the first year after renal transplantation as well as improved clinical outcomes. In conclusion, pharmacoeconomic studies support the use of mycophenolate mofetil as part of immunosuppressant therapy in renal transplantation, at least in the short term. Although the cost effectiveness of mycophenolate mofetil in the long term is less clear, limited pharmacoeconomic data available appear promising. Among issues to be examined in future economic analyses in renal transplantation are the calcineurin-sparing potential of mycophenolate mofetil and the feasibility of using more efficient mycophenolate mofetil dosage regimens when using the drug on a long-term basis. Additional pharmacoeconomic analyses of mycophenolate mofetil are also needed in other types of solid organ transplantation. [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]

Highly active antiretroviral therapy (HAART) has dramatically altered the natural history of HIV disease. Studies demonstrate that ≥95% adherence is necessary to garner the full benefits of HAART. However, appropriate adherence to treatment is difficult and challenging. This paper provides an overview of potential clinical and economic outcomes associated with poor adherence to HAART. Since there are no studies exploring the costs associated with poor adherence to HAART, we discuss potential direct and indirect costs accrued with more frequent treatment failures, selection of resistant strains, increased hospitalizations and a faster progression to AIDS associated with poor adherence to HAART. Additionally, we review studies of interventions and strategies to improve adherence to HAART. Although, single-focus interventions have enhanced the chances of achieving viral suppression by 10 to 23%, the literature has demonstrated that for long-term treatments, programs employing diverse interventions that continue over time are more effective. Under constrained healthcare budgets, government, healthcare managers and policy makers require accurate and timely information concerning the cost effectiveness of adherence intervention programs. We discuss considerations in determining the cost effectiveness of an adherence intervention program. [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 ($US12 610) and NLG31 334 ($US12 534), 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 [NLG12 621 ($US5048) versus NLG269 ($US107) 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 ($US18 046) and NLG31 621 ($US12 648), 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: The objective of the study was to develop a procedure to distribute health resources among treatments for the primary prevention of coronary heart disease based on efficiency and equity. Design and Setting: Two procedures to manage pharmaceutical resources for the primary prevention of coronary heart disease in Catalonia, Spain, were developed in this study. The following treatments were considered in these procedures: medical advice and nicotine substitution therapies for smoking cessation; hydrochlorothiazide (diuretic) and propranolol (β-adrenergic antagonist) for moderate/severe hypertension; hydrochlorothiazide and nifedipine (calcium antagonist) for mild hypertension; and lovastatin (HMG-CoA reductase inhibitor) for hypercholesterolemia higher than 7.23 mmol/L or 2.7 g/L. Results: The first procedure was developed based on decision rules of cost-effectiveness analysis, giving a higher priority to treatments with a higher cost effectiveness. The second procedure was developed based on efficiency and equity, deciding allocation of resources based on cost-effectiveness and social preferences. Annual cost of treatments ranged from $US147.30 per individual for smoking cessation to $US2555.20 per individual for treatment with lovastatin 80 mg/day (1998 values). Resources should be allocated in the following order, according to the procedure based on decision rules of cost-effectiveness analysis, to smoking cessation therapies, hypertension treatments and hypercholesterolemia treatments. This is in contrast to the procedure based on efficiency and equity, where a higher priority should be given to the most cost-effective treatment for hypertension, hypercholesterolemia and smoking. The efficiency and equity strategy could reduce the amount of resources necessary to treat all individuals at risk by 26 to 47%, according to age and gender. Conclusions: The procedure based on efficiency alone should be used when the objective is to maximize health gains from available resources. The procedure based on both efficiency and equity should be used when society has an aversion to inequality in the distribution of health gains, treating all individuals with coronary heart disease risk factors at the lowest cost. [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]

Because of the high incidence of morbidity and mortality associated with hypertension in the elderly, the treatment of hypertension in this patient group must involve consideration of clinical, humanistic and economic outcomes. The most frequently used method of pharmacoeconomic analysis for antihypertensive therapy involves cost-effectiveness analysis, although several other methods are available. Current evidence reveals a trend toward cost effectiveness of antihypertensive treatment in elderly patients. However, these formal analyses are limited by the need for extrapolation of data regarding efficacy and level of risk from epidemiological and randomised trials, information which is often lacking. To incorporate economic factors into clinical decision making, other measures of economic impact should be explored. The economic impact of antihypertensive therapy is affected by the level of risk for the patient and the efficacy of the treatment. Data indicate that the risk of morbidity and mortality related to hypertension increases with age and that current antihypertensive drugs reduce this risk. When choosing an antihypertensive agent, the following parameters should be considered: acquisition cost, likelihood of adverse effects and other determinants of treatment adherence, and individual predictors of response. The economic outcomes will be maximised if prudent drug selection is supplemented by appropriate diagnostic and classification procedures and reduction of cardiovascular risk factors other than hypertension. The accumulation of data addressing the risks and benefits of therapy for the very old and the comparative efficacy of newer antihypertensive therapies will further clarify the decision-making process. [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]

About one-quarter of men aged 50 years and older experience voiding problems due to benign prostatic hyperplasia (BPH). Until about 10 years ago, surgery (particularly transurethral resection of the prostate) was the only effective treatment for symptomatic BPH. Over the last decade, several new treatments have been introduced. These include different types of medication (alpha-blockers and finasteride), thermotherapy, laser prostatectomy, needle ablation and vaporisation methods. The diffusion of these less invasive treatment modalities has resulted not only in a decrease in the age-adjusted surgery rates, but also in an increase of the total number of men treated for BPH. A large number of studies on clinical benefits and risks reveal that the conventional types of surgery remain the most effective treatments, whereas new interventional therapies require a shorter hospital stay and result in fewer short term complications. The efficacy of medication is lower than that of interventional treatments. Adverse effects include dizziness and orthostatic hypotension (alpha-blockers) and decreased sexual function (finasteride), but are generally mild. There is some evidence that medication and minimally invasive treatments may preclude eventual surgical treatment, but the precise effect is difficult to estimate because of differences in the study populations and the relatively short study periods. As a result of the dynamic nature of BPH treatment and the lack of long term data, the cost effects of the introduction of the various new treatments are also difficult to assess. Given the aging of the population and the growing percentage of patients with BPH for whom any type of treatment can be considered, a considerable increase of total costs can be expected. Long term prospective studies are necessary to gain insight into the most cost-effective treatment for different patient groups. [ABSTRACT FROM AUTHOR]

Objective: To compare the cost, efficacy and cost efficacy of tazobactam/piperacillin and imipenem/cilastatin in the treatment of intra-abdominal infection.Design: The analysis was retrospective and based on a decision tree. Effectiveness data were obtained from 19 published clinical trials. Direct costs were quantified per patient from the time the decision was made to administer the antibacterial to the end of the first course of treatment or the end of a subsequent course of treatment, if required. The primary end-point was the cost per successfully treated patient. The cost per life saved was also analysed. Various follow-up times were taken into account.Perspective: German National Health Insurance funds.Study Population: 1744 patients with intra-abdominal infection.Interventions: Tazobactam/piperacillin (total daily dosage of 13.5 g/day) and imipenem/cilastatin (total daily dosage of 1.5 to 4 g/day). The mean duration of treatment varied from 5.5 to 8.2 days for tazobactam/piperacillin and 5 to 9.4 days for imipenem/cilastatin.Main Outcome Measure and Results: Compared with imipenem/cilastatin, treatment with tazobactam/piperacillin was more effective and the overall treatment costs were lower. In the base-case analysis, the cost-efficacy ratio (cost per successfully treated patient) was 7881 German deutschmarks (DM) for tazobactam/piperacillin and DM11,390 for imipenem/cilastatin. The incremental cost-efficacy ratio (per life saved) varied between -DM72,567 and -DM350,738 for tazobactam/piperacillin. Sensitivity analyses revealed that the results were robust against various assumptions on cost parameters, clinical outcomes and length of treatment. All costs reflect 1998 values; $US1 = DM1.85.Conclusions: This study suggests that compared with imipenem/cilastatin, tazobactam/piperacillin is more cost efficacious in the treatment of intra-abdominal infections and that it offers a cost advantage through fewer relapses and lower daily therapeutic costs. [ABSTRACT FROM AUTHOR]

Objective: To compare the clinical and economic outcomes associated with triple therapy containing efavirenz or indinavir and 2 nucleoside reverse transcriptase inhibitors (NRTIs; zidovudine and lamivudine) in HIV-positive patients.Design and Setting: An economic model based on viral load and CD4+ cell counts to predict long term outcomes such as progression to AIDS and AIDS-related death was developed and then analysed using data from a randomised clinical trial. Cost estimates from the healthcare system perspective were based on data from 6 state, all-payor databases, the AIDS Cost and Services Utilisation Study, and other literature. Analyses were carried out for time horizons between 5 and 15 years.Patients and Interventions: HIV-positive patients with limited exposure to NRTIs. Initial regimens consisted of efavirenz or indinavir, each combined with 2 NRTIs. A maximum of 2 switches to other regimens was permitted.Main Outcome Measures and Results: The efavirenz-containing triple therapy regimen was predicted to prolong survival at a savings of up to 10,923 US dollars (1998 values) relative to initial therapy with the indinavir-containing regimen. Patients who receive efavirenz are expected to have 11% greater survival at 5 years and fewer treatment failures (28 vs 52%, at 2 years). Overall, the economic and health benefits predicted for the efavirenz-containing regimen were robust to reasonable variation in key parameters.Conclusions: The superior clinical trial outcomes for efavirenz-containing regimens should translate into substantial economic and health benefits. [ABSTRACT FROM AUTHOR]

The prevalence of depression and the high costs associated with its treatment have increased interest in pharmacoeconomic evaluations of drug treatment, particularly in the 1990s as the use of selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitors (SSRIs) expanded substantially. This review presents results from specific studies representing the key study designs used to address the pharmacoeconomics of SSRI use: retrospective administrative database analyses, clinical decision analysis models, and randomised clinical trials. Methodological considerations in interpreting results are highlighted. In retrospective administrative database analyses, most comparisons have been made between SSRIs and tricyclic antidepressants (TCAs). A few studies have addressed differences between SSRIs. The studies focused on healthcare cost (to payer) and cost-related outcomes (e.g. treatment duration, drug switching). Although SSRIs are generally associated with higher drug acquisition costs than are TCAs, total healthcare costs are at least offset, if not decreased, by reductions in costs associated with use of SSRIs. Although studies from the early 1990s show some advantage for fluoxetine, the results are limited by use of data from shortly after the introduction of paroxetine and sertraline; studies from the mid- 1990s on that compare drugs within the SSRI class show general equivalence in terms of cost. Important methodological advances are occurring in retrospective studies, with selection bias and other design limitations being addressed statistically. Clinical decision analysis models permit flexibility in terms of ability to specify different alternative treatment scenarios and varying durations. Sensitivity analysis aids interpretability, although model inputs are limited by data availability. Results from short term (1 year duration or less) studies comparing SSRIs and TCAs suggest that SSRIs are more cost effective or that there is no difference. Longer term studies (lifetime Markov models) focus more on the impact of maintenance antidepressant therapy and show more mixed results, generally favouring SSRIs over TCAs. The results indicate that the effect of SSRIs is mainly through prevention of relapse. Important assumptions of these models include fewer serious adverse effects and lower treatment discontinuation rates with SSRIs. Naturalistic clinical trials provide greater generalisability than traditional randomised clinical trials. One naturalistic trial found that nearly half of TCA-treated patients switched to another antidepressant within 6 months; only 20% of SSRI-treated patients switched. Cost differences between groups were minimal. These studies indicate few differences in medical costs, depression outcomes and health-related quality of life between TCAs and fluoxetine, although fewer fluoxetine-treated patients switched treatment. [ABSTRACT FROM AUTHOR]

The development of mutations associated with resistance to antiretroviral therapy (ART) has been shown to be a major cause of treatment failure in patients infected with HIV-1. These resistance mutations can be assessed by a genotyping test that probes for specific mutations within the HIV genome or sequences specific genes, at a cost $US500/test (2000 prices). The stated goal of HIV-1 genotyping is to target HIV therapy effectively. This, as shown in the preliminary research, should result in better clinical outcomes and a lower incidence of virological failure and may be associated with lower costs of treatment. Failure of ART may result in an increase in costs of at least $US250 per patient per month, as assessed in 1 study, with costs rising further as patients experience multiple virological failures. Therefore, there is an economic as well as a therapeutic premium on the prevention of ART failure. The actual economic cost of genotyping has been preliminarily explored in the context of the antiretroVIRal ADAPTation (VIRADAPT) trial, which found no significant difference in the 1-year treatment cost of patients with and without genotyping. There is some evidence of cost neutrality or savings with genotypic testing but it needs to be further explored within the context of carefully framed prospective trials. [ABSTRACT FROM AUTHOR]

Background: Outpatient parenteral antibiotic therapy (OPAT) programmes have become prevalent over the past 2 decades. From the US perspective, these programmes have been shown to reduce healthcare costs. No comprehensive analysis has been published from the Canadian perspective.Objective: To describe a Canadian OPAT programme for the 3-year period since its inception and to conduct a treatment cost analysis.Design and Methods: Demographics and resource utilisation data (health professional labour, laboratory and diagnostic tests, antimicrobials, delivery, home nursing care, catheters and catheter placement) were prospectively collected for enrollees in the OPAT programme over the evaluation period. Avoided hospital resource utilisation was estimated via retrospective chart review by the investigators. Costs were retrospectively assigned to each resource and total cost avoidance by the OPAT programme was determined from each perspective.Perspective: A teaching hospital and a provincial Ministry of Health (MOH).Main Outcome Measures and Results: 140 treatment courses were initiated for 117 adult patients (mean age 54 years) who were enrolled into the programme. Mean pre-OPAT length of hospital stay was 12 days, and mean OPAT duration was 22.5 days. Bone/joint (39%), skin and soft tissue (16%), cardiac (13%) and respiratory tract (12%) infections were the most common infections managed. The most commonly used antimicrobials were vancomycin (29%), cloxacillin +/- gentamicin (22%) and ceftriaxone +/- gentamicin (11%) 85% of enrollees successfully completed their planned antimicrobial treatment regimens. Premature discontinuation of antimicrobial therapy for various reasons occurred in the remaining 15% of courses. The mean cost per treatment course of OPAT was 1910 Canadian dollars ($Can) from the hospital perspective and $Can6326 from the MOH perspective. Assuming that patients would have otherwise completed their antimicrobial therapy in hospital, the mean cost per treatment course was estimated to be $Can14,271. The overall cost avoidance of the OPAT programme was $Can1,730,520 (hospital perspective) and $Can1,009,450 (MOH perspective) over the 3-year assessment period. Sensitivity analyses revealed the results to be robust to plausible changes.Conclusions: This analysis supports the premise that an adult OPAT programme can substantially reduce healthcare costs in the Canadian healthcare setting. [ABSTRACT FROM AUTHOR]

Objective: To estimate the economic impact of using tibolone 2.5 mg compared with 17 beta-estradiol 2 mg/norethisterone acetate 1 mg (E2/NETA) in postmenopausal women with climacteric symptoms.Design and Setting: This was a modelling study performed from the perspective of the UK's National Health Service (NHS).Methods: The clinical outcomes from a previously reported trial were used as the clinical basis for the analysis, which showed that 48 weeks' treatment with tibolone and E2/NETA significantly alleviated the climacteric symptoms experienced by postmenopausal women. These data were combined with resource utilisation estimates derived from a panel of 10 GPs and 3 gynaecologists, enabling us to construct a Markov model depicting changes in the health status of postmenopausal women. The model was used to estimate the expected NHS costs and consequences after 48 weeks' treatment with tibolone and E2/NETA.Main Outcome Measures and Results: The mean expected direct healthcare cost of using tibolone and E2/NETA to manage postmenopausal women for 48 weeks was estimated to be 260 Pounds and 239 Pounds (1997/1998 prices) per patient, respectively. Starting hormone replacement therapy (HRT) with tibolone instead of E2/NETA was equally effective in alleviating climacteric symptoms (65.9 and 62.2%, respectively; p = 0.516) over 48 weeks and significantly reduced the incidence of vaginal bleeding by 36% (p < 0.0001) and breast tenderness by 57% (p < 0.0001) for a mean additional cost of 21 Pounds (ranging between -3 Pounds and 42 Pounds) per patient. The acquisition cost of HRT was the primary cost driver for tibolone-treated patients, whereas the cost of managing adverse events was the primary cost driver for E2/NETA-treated patients.Conclusions: The true cost of prescribing tibolone and E2/NETA is impacted on by a broad range of resources, not only drug acquisition costs. Although the acquisition cost of tibolone is higher than that of E2/NETA, the difference in the expected NHS cost of the first year of treatment between the 2 HRTs is negligible. This is because of the higher incidence of adverse events among E2/NETA-treated patients, which also results in a higher continuation rate among tibolone-treated patients. Factors such as patient preferences should also be taken into consideration so that treatment choices are not decided solely on the basis of acquisition costs. [ABSTRACT FROM AUTHOR]

The role of Thymoglobulin (TMG), a polyclonal rabbit-derived antithymocyte globulin, in the prevention and treatment of acute renal allograft rejection is the focus of this review. TMG and the polyclonal horse-derived antithymocyte globulin Atgam (ATG) have been compared in a multicentre double-blind, randomised study in 163 renal allograft recipients who were experiencing acute rejection. TMG 1.5 mg/kg/day was significantly more effective than ATG 15 mg/kg/day for the primary end-point (88 vs 76%; return of serum creatinine to baseline at the end of therapy or within 14 days of initiation of treatment). The greatest differences in favour of TMG were seen in patients with moderately severe rejection episodes. Recurrent episodes of rejection occurred significantly less often in patients who achieved the primary end-point and thus were less frequent in recipients of TMG than ATG. For a composite end-point, return of serum creatinine to baseline and a functioning allograft at 30 days, TMG tended to be more effective than ATG, but the difference was not statistically significant. A pharmacoeconomic analysis of this trial suggests that treatment with TMG is a cost saving strategy compared with ATG. In a small randomised trial TMG and muromonab-CD3 demonstrated similar efficacy in patients with acute allograft rejection. TMG was more effective than ATG as induction immunosuppressive therapy in 72 adult renal allograft recipients in a comparative single centre study. During 12 months of follow-up post-transplantation, the overall incidence of acute rejection episodes, a primary end-point, was significantly lower in patients treated for ≥7 days with TMG 1.5 mg/kg/day than ATG 15 mg/kg/day (4 vs 25%). TMG is also used for induction therapy in corticosteroid-free immunosuppressive regimens. Leucopenia occurred in significantly more TMG than ATG recipients who received the drugs for induction therapy or as treatment of acute rejection. Importantly, there was no significant difference in the frequency of infection in the 2 groups. Indeed, the incidence of CMV disease was significantly lower among TMG- than ATG-treated patients (12.5% vs 33.3%) during 1 year of follow-up after induction therapy with either agent. Conclusions: TMG is at least equivalent to ATG for the reversal of acute renal allograft rejection and appears to be superior to ATG when used as induction immunosuppressive therapy in renal transplantation. A pharmacoeconomic analysis of the pivotal US study also suggests that there are cost benefits for TMG compared with ATG. Therefore, TMG is an effective alternative to ATG (and perhaps the currently available monoclonal preparation) and extends the choice of treatments for the management of acute renal allograft rejection. [ABSTRACT FROM AUTHOR]

Objective: To estimate the impact of clinical and non-clinical predictors of patterns of medication use and expenditures for the treatment of hypertension in the USA. Data Sources: The 1987 National Medical Expenditures Survey was used to identify 6398 individuals with hypertension over the age of 18 years. Pharmacological treatment was identified through patient self-reports of antihypertensive medications. Study Design: This retrospective, cross-sectional study used a multivariate two-stage decision model to estimate the demand for antihypertensive medications conditional on receipt of at least one antihypertensive prescription drug. Results: Women and the elderly were more likely to obtain medications and had greater expenditures on antihypertensive medications. Privately insured patients were 59% (if non-elderly) or 163% (if elderly with Medicare) more likely to receive drug therapy than uninsured patients. Patients with only Medicaid coverage were 126% more likely to receive drug therapy than uninsured patients. Compared with patients characterised as lower risk-takers, very high and high risk-takers were 38% and 24% less likely to be on drug therapy, respectively. Black, non-Hispanics were 30% more likely to be on drug therapy than White, non-Hispanics, but had lower annual expenditures on antihypertensive drugs. Severely overweight individuals [bodymass index (BMI) >30] were 62% more likely than patients with a BMI <27 to be on drug therapy and also had higher drug expenditures. Conclusions: Insurance had a more striking effect on access to antihypertensive drug therapy than on patterns of drug use or expenditures. Race/ethnicity and patient attitudes towards risk were important determinants of access to antihypertensive drug therapies, as well as patterns of drug use and expenditures. [ABSTRACT FROM AUTHOR]

Pharmacotherapeutic advances in the treatment of depression have included the development of the selective serotonin reuptake inhibitors (SSRIs), thereby providing alternatives to tricyclic antidepressants. Concurrent with these events have been significant structural (e.g. pharmaceutical formularies) and regulatory (e.g. required pharmacoeconomic evaluations) changes in the delivery, financing, and oversight of healthcare programmes throughout the world. International cost-containment initiatives are increasingly mandating a demonstration of value for money, defined in terms of a measurable health and/or financial outcome, and, in the case of medicines, attributable to a given expenditure, for a given pharmacotherapeutic option. We examine the inherent strengths and weaknesses of 5 study designs used to discern and contrast financial outcomes stemming from the use of antidepressant pharmacotherapy for the treatment of depressive illness [randomised controlled trials (RCTs); meta-analyses; decision-analytical models (DAMs); retrospective database investigations; randomised naturalistic inquiry]. We argue that the economic appraisal of pharmacotherapy requires an iterative process extending from the developmental (RCTs; meta-analyses; DAMs) through to the postmarketing phase (database reviews; naturalistic inquiry), thereby resulting in a portfolio of evidence as to the safety, efficacy and effectiveness of a given pharmacotherapeutic category (e.g. SSRIs) and/or a specific medication. Database reviews, while nonrandomised, and prospective naturalistic inquiry afford greater insight into the patterns of use and financial merits of prescribing specific pharmacotherapeutic options for the treatment of depression within the context of clinical practice as compared with RCTs, meta-analyses and DAMs. The portfolio of evidence to date indicates that the first-line use of SSRIs in the treatment of depression is clinically warranted, and represents value for money. [ABSTRACT FROM AUTHOR]