Application of the findings of the European Stroke Prevention Study 2 (ESPS-2) to a New Zealand ischaemic stroke cost analysis

The aim of this study was to apply the findings of the European Stroke Prevention Study 2 (ESPS-2) to a paper that quantified and described the annual cost of ischaemic stroke in New Zealand, and to compare the cost of alternative drug regimens in the secondary prevention of ischaemic stroke. Comparisons were made between the costs of low-dosage aspirin (acetylsalicylic acid) monotherapy and a combination of modified-release dipyridamole and low-dosage aspirin. Differences in undiscounted costs were calculated over a 2-year period. The New Zealand cost per stroke event was multiplied by the ESPS-2 incremental reduction in stroke events to derive the cost of strokes avoided. As the focus of the paper was on direct medical costs, the primary perspective adopted was that of a healthcare provider or funder, but a societal perspective was also considered by evaluation of direct nonmedical and indirect costs. Compared with aspirin monotherapy, combination therapy generated incremental net direct costs of 18.22 New Zealand dollars ($NZ) per patient or $NZ18,223 per 1000 patients. However, individually, each treatment regimen resulted in direct cost savings when compared with placebo: combination therapy $NZ905.16 per patient; aspirin monotherapy $NZ923.39 per patient (a difference between the 2 regimens of $NZ18.22 per patient). Total direct and indirect incremental cost savings were $NZ40.96 per patient, and $NZ40,963 per 1000 patients, for the combination therapy. The analysis demonstrates that changing patients from low-dosage aspirin to a combination therapy of modified-release dipyridamole plus low-dosage aspirin would result in a small rise in incremental direct costs (using our conservative assumptions relating to hospital and continuing institutional care costs). If less conservative unit cost assumptions were adopted, a more likely outcome would be a saving in direct incremental costs of up to $NZ400 per patient treated.     

Alglucerase. A pharmacoeconomic appraisal of its use in the treatment of Gaucher's disease

Alglucerase is a modified form of human placental glucocerebrosidase used as enzyme replacement therapy for patients with Gaucher's disease, in whom functional glucocerebrosidase is deficient. Alglucerase has provided a breakthrough in treatment for patients with this relatively rare disease. With alglucerase infusions typical disease manifestations are ameliorated or normalised: hepatosplenomegaly is reduced, haematological parameters improve, and patients experience an increased quality of life usually within 4 to 6 months of treatment. Parameters of bone disease also respond, but generally over a longer period of treatment. Alglucerase is well tolerated by children and adults, with few adverse effects reported. Seroconversion occurs in approximately 15% of patients on high-dose therapy, but does not appear to affect the efficacy of treatment. Several dosage regimens have been used to deliver alglucerase, and the comparative benefits of these remain controversial. High-dose regimens of 60 IU/kg bodyweight administered every 2 weeks are clearly effective; however, smaller dosages given more frequently are also effective and incur a greatly reduced acquisition cost. Patient responses are variable, and the dosage regimen should be tailored to individual needs. Dosage regimens may be considerably reduced for the maintenance phase of treatment, but clinical experience is as yet insufficient to establish the minimum dosages required in the long term. Acquisition cost of alglucerase is $US3.70 per unit (1994 US dollars); thus, a dosage regimen of 60 IU/kg bodyweight administered every 2 weeks for a patient weighing 70kg costs $US404,040 per year. The minimal costs per quality-adjusted life year saved (QALY) have been estimated for 3 dosage regimens over a 10-year period. Cost per QALY was $US147,000 for 60 IU/kg bodyweight administered every 2 weeks, $US75,000 for 30 IU/kg every 2 weeks, and $US49,000 for 2.3 IU/kg administered 3 times per week. These costs were calculated assuming immediate death with no treatment, which suggests that the actual costs per QALY for most patients with type 1 or 3 disease are likely to be much higher. Drug administration costs may become a significant part of the cost during maintenance therapy; in addition, possible cost savings due to increased patient productivity and reduced palliative treatments remain unresolved. Although some patients may obtain increased benefit from high-dosage regimens, the very high cost may preclude general use of these regimens. Healthcare resources consumed by alglucerase therapy represent a large opportunity cost for other therapeutic areas.(ABSTRACT TRUNCATED AT 400 WORDS)     

Cost effectiveness of once-daily oral chelation therapy with deferasirox versus infusional deferoxamine in transfusion-dependent thalassaemia patients: US healthcare system perspective

BACKGROUND: Deferasirox is a recently approved once-daily oral iron chelator that has been shown to reduce liver iron concentrations and serum ferritin levels to a similar extent as infusional deferoxamine. OBJECTIVE: To determine the cost effectiveness of deferasirox versus deferoxamine in patients with beta-thalassaemia major from a US healthcare system perspective. METHODS: A Markov model was used to estimate the total additional lifetime costs and QALYs gained with deferasirox versus deferoxamine in patients with beta-thalassaemia major and chronic iron overload from blood transfusions. Patients were assumed to be 3 years of age at initiation of chelation therapy and to receive prescribed dosages of deferasirox and deferoxamine that have been shown to be similarly effective in such patients. Compliance with chelation therapy and probabilities of iron overload-related cardiac disease and death by degree of compliance were estimated using data from published studies. Costs ($US, year 2006 values) of deferoxamine administration and iron overload-related cardiac disease were based on analyses of health insurance claims of transfusion-dependent thalassaemia patients. Utilities were based on a study of patient preferences for oral versus infusional chelation therapy, as well as published literature. Probabilistic and deterministic sensitivity analyses were employed to examine the robustness of the results to key assumptions. RESULTS: Deferasirox resulted in a gain of 4.5 QALYs per patient at an additional expected lifetime cost of $US126,018 per patient; the cost per QALY gained was $US28,255. The cost effectiveness of deferasirox versus deferoxamine was sensitive to the estimated costs of deferoxamine administration and the quality-of-life benefit associated with oral versus infusional therapy. Cost effectiveness was also relatively sensitive to the equivalent daily dose of deferasirox, and the unit costs of deferasirox and deferoxamine, and was more favourable in younger patients. CONCLUSION: Results of this analysis of the cost effectiveness of oral deferasirox versus infusional deferoxamine suggest that deferasirox is a cost effective iron chelator from a US healthcare perspective.     

Cost-benefit analysis of riluzole for the treatment of amyotrophic lateral sclerosis

We conducted a cost-benefit analysis of riluzole therapy in patients with amyotrophic lateral sclerosis (ALS; motor neuron disease; Lou Gehrig's disease). The survival of patients with ALS increased by around 3 months as a result of riluzole therapy, from 3 to 3.25 years. A 3-month delay in hospitalisation was also expected as a result of riluzole therapy, resulting in a saving of $US40 per patient (1996 values). This gain was opposed by the additional costs per patient of bi-monthly serum ALT monitoring ($US234), 2 days of extra day-hospital observation ($US369) and other medical costs ($US79), as well as extra outpatient visits ($US26) and costs of medication other than riluzole ($US90), resulting from increased longevity. Using riluzole (at a cost of $US2247 per patient) resulted in an extra burden of $US757 on health services for the gain of an extra 3 months of life expectancy. Thus, health-service costs per life-year gained were $US12,013. Despite the increase in health-service costs as a result of increased longevity, the overall resource benefits to society from using riluzole amounted to $US2884 due to increased productivity benefits, giving a benefit: cost ratio of 1.28:1. Total benefits to society, including a valuation of 3 extra months of life ($US3599), amounted to $US6483, giving a benefit: cost ratio of 2.89:1. Therefore, from a societal perspective, the potential benefits of riluzole in patients with ALS clearly exceed costs.     

Olanzapine versus risperidone. A prospective comparison of clinical and economic outcomes in schizophrenia

OBJECTIVE: To compare the clinical and economic outcomes associated with olanzapine and risperidone treatment for schizophrenia. DESIGN AND SETTING: An international, multicentre, double-blind, prospective study. To facilitate economic comparisons, our sample was restricted to patients enrolled in US sites. 150 patients with a Diagnostic and Statistical Manual of mental disorders, 4th edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder were randomised to therapy with either olanzapine 10 to 20 mg/day (n = 75) or risperidone 4 to 12 mg/day (n = 75) for a maximum of 28 weeks. In addition to tolerability and efficacy assessments, use of health services was assessed at baseline and prospectively, at 8-week intervals and at study completion. Clinically important response, defined as a 40% improvement in the Positive and Negative Syndrome Scale total score, maintenance of response and rates of treatment-emergent extrapyramidal symptoms were compared between groups. Direct medical costs were estimated by assigning standardised prices to resource units. Median total, inpatient/outpatient service and medication acquisition costs were compared between treatment groups. MAIN OUTCOME MEASURES AND RESULTS: The mean modal dosages for the olanzapine and risperidone treatment groups were 17.7 +/- 3.4 mg/day and 7.9 +/- 3.2 mg/day, respectively. Olanzapine-treated patients were more likely to maintain response compared with risperidone-treated patients (p = 0.048). In addition, a smaller proportion of olanzapine-treated patients required anticholinergic therapy compared with risperidone-treated patients (25.3 vs 45.3%; p = 0.016). Total per patient medical costs over the study interval were $US2843 (1997 values) [36%] lower in the olanzapine treatment group than in the risperidone treatment group (p = 0.342). Medication costs were significantly higher for olanzapine-treated patients ($US2513 vs $US1581; p < 0.001), but this difference was offset by a reduction of $US3774 (52%) in inpatient/outpatient service costs for olanzapine-treated patients in comparison with risperidone-treated patients ($US3516 vs $US7291, p = 0.083). Median cost findings were consistent with results observed using other robust measures of central tendency and provide conservative estimates of potential savings that may be obtained from olanzapine therapy. CONCLUSIONS: In this study, olanzapine-treated patients experienced clinical improvements that translated into savings in costs of care for both inpatient and outpatient services. These savings offset the difference in medication acquisition cost between olanzapine and risperidone.     

Cost effectiveness of acute imipramine therapy versus two imipramine maintenance treatment regimens for panic disorder

OBJECTIVE: To examine the medical costs and effectiveness of acute treatment with imipramine versus acute treatment plus 2 different maintenance therapies for panic disorder. METHODS: A clinical decision model was constructed to estimate 18-month costs and outcomes associated with these treatment scenarios based on the medical literature and clinician judgment. The clinical parameters and outcomes for the model were derived from a series of systematic clinical trials with imipramine utilising uniform dosage procedures and validated response criteria. Costs were calculated based on standardised treatment regimens. The outcome measures were 18-month medical costs, quality-adjusted life years (QALYs) and costs per QALY gained. A sensitivity analysis was performed to explore the impact of treatment withdrawals on outcomes. STUDY PERSPECTIVE: US mental healthcare system. RESULTS: Over 18 months, the total costs (1997 values) and QALYs associated with half-dose maintenance therapy (imipramine 1.1 mg/kg/day) [$US3377; QALYs = 0.991] and full-dose maintenance therapy (imipramine 2.25 mg/kg/ day) [$US3361; QALYs = 0.991] were almost identical; both were cost saving compared with acute imipramine therapy (2.25 mg/kg/day) with no maintenance treatment ($US3691; QALYs = 0.979). Whether patients withdrawing from treatment were considered to have continued to respond to treatment or to have relapsed, the half-dose and full-dose maintenance treatments were still cost saving compared with acute treatment alone. CONCLUSIONS: The results indicate that imipramine maintenance treatment is cost effective compared with acute imipramine treatment for patients with panic disorder. The basic findings and conclusions are not affected after modifying model assumptions for clinical response in patients withdrawing from treatment.     

Glycoprotein IIb/IIIa receptor therapy in percutaneous coronary intervention and non-ST-segment elevation acute coronary syndromes. Estimating the economic implications

In addition to efficacy and safety, cost is an important determinant of the use of glycoprotein IIb/IIIa (GPIIb/IIIa) therapy in patients with acute coronary syndromes (ACS) or undergoing percutaneous coronary intervention (PCI). In PCI, the average procurement cost of GPIIb/IIIa therapy ranges from $US400 to $US1500 (1999 values) per patient treated, depending on agent, dose and duration of infusion. Prospective economic substudies with abciximab and tirofiban have demonstrated subsequent cost savings that partially offset the procurement costs of the agents. The drug procurement costs per death or myocardial infarction (MI) prevented in PCI appear to vary from $US10,500 to $US37,000, depending on the agent. Abciximab has been proven to provide a survival benefit in the setting of PCI, including coronary stenting. Analyses of abciximab use yield cost-effectiveness ratios of $US2875 to $US14,765 per life-year or quality-adjusted life-year saved, which compares favourably with most widely accepted therapies. In non-ST-segment elevation ACS, drug procurement costs range from $US700 to $US1700 per patient treated, also depending on agent, dose and duration of infusion. Evidence of cost offsets from changes in subsequent resource utilisation are limited and seem contingent upon a conservative risk-stratification approach. Drug procurement costs have been calculated as $US32,000 to $US82,000 per death or MI prevented in the ACS trials. Cost-effectiveness ratios of $US16,000 per life-year saved for the US and Western European cohorts in the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial are favourable. If these analyses prove correct, the cost effectiveness of GPIIb/IIIa receptor therapy for patients with non-ST-segment elevation ACS will also compare favourably with other widely accepted therapies in industrialised countries. More clinical and economic data are necessary to allow better selection of specific patients who will receive the most benefit from GPIIb/IIIa therapy in healthcare systems with limited resources.     

Cost effectiveness of long-term treatment with eszopiclone for primary insomnia in adults: a decision analytical model

OBJECTIVE: Although the clinical benefits of pharmacological treatments for insomnia have been studied, no systematic assessment of their economic value has been reported. This analysis assessed, from a broad payer and societal perspective, the cost effectiveness of long-term treatment with eszopiclone (LUNESTA, Sepracor Inc., [Marlborough, MA, USA]) for chronic primary insomnia in adults in the US. METHODS: A decision analytical model was developed based on the reanalysis of a 6-month placebo-controlled trial, which demonstrated that eszopiclone 3mg significantly improved sleep and daytime function measures versus placebo in adults with primary insomnia. Patients were classified as either having remitted or not remitted from insomnia based upon a composite index of eight sleep and daytime function measures collected during the trial. These data were supplemented with quality-of-life and healthcare and lost productivity cost data from the published literature and medical and absenteeism claims databases. RESULTS: Compared with non-remitted patients, patients classified as remitted had lower monthly healthcare and productivity costs (in 2006 dollars) [a reduction of $US242 and $US182, respectively] and higher quality-adjusted life-year (QALY) weight (a net gain of 0.0810 on a scale ranging from 0 to 1). During the study, eszopiclone-treated patients were about 2.5 times more likely to have remitted than placebo-treated patients. Six months of eszopiclone treatment reduced direct (healthcare) and indirect (productivity) costs by an estimated $US245.13 and $US184.19 per patient, respectively. Eszopiclone use was associated with a cost of $US497.15 per patient over 6 months (including drug cost, dispensing fee, physician visit and time loss to receive care). Thus, after considering the above savings and the costs associated with eszopiclone treatment over 6 months, cost increased by $US252.02 (excluding productivity gains) and $US67.83 (including productivity gains) per person. However, eszopiclone treatment was also associated with a net QALY gain of 0.006831 per patient over the same period. Consequently, the incremental cost per QALY gained associated with eszopiclone was approximately $US9930 (including productivity gains [i.e. $US67.83 / 0.006831]) and $US36 894 (excluding productivity gains [i.e. $US252.02 / 0.006831]). Sensitivity analyses using a variety of scenarios suggested that eszopiclone is generally cost effective. CONCLUSIONS: This analysis suggested that long-term eszopiclone treatment was cost effective over the 6-month study period, particularly when the impact on productivity costs is considered. Given the increasing interest in new pharmacological interventions to manage insomnia, payers and clinicians alike should carefully consider the balance of health and economic benefits that these interventions offer. Accordingly, additional research in this area is warranted.     

Heart failure. A decision analytic analysis of New Zealand data using the published results of the SOLVD Treatment Trial. Studies of Left Ventricular Dysfunction

This study sought to evaluate the changes in direct medical costs and life-years gained or lost by adding enalapril to conventional treatment (digoxin and diuretics) for heart failure (HF). The published results of the Studies of Left Ventricular Dysfunction (SOLVD) Treatment Trial, and a decision analytical model developed by the University of Pennsylvania, were used in combination with New Zealand data to undertake the evaluation. All costs were measured in 1993 New Zealand dollars ($NZ) [$NZ1 = $US0.5509, September 1993]. Potential net cost savings per patient treated over a 4-year period were $NZ652 together with an additional 2 months of life gained. If these individual potential cost savings are extended to the New Zealand population who have HF (but are at present not receiving an ACE inhibitor) then $NZ6 517 000 in discounted health sector costs could be avoided. The model was sensitive to changes in the price of enalapril, to estimates of the population with HF, the percentage of the population with HF treated with enalapril, and to hospital unit costs for nonfatal cases of HF. The study demonstrated that the addition of enalapril to the conventional treatment of HF was cost effective when compared with conventional medical therapy alone.     

Olanzapine. A pharmacoeconomic review of its use in schizophrenia.

Olanzapine is an atypical antipsychotic agent which is at least as effective as the conventional agent haloperidol and the atypical agent risperidone. Olanzapine may be superior to haloperidol in some respects, including treatment of negative symptoms. A major advantage of olanzapine over haloperidol is its lower risk of extrapyramidal symptoms. Olanzapine improves quality of life and other aspects of functioning to a greater extent than haloperidol, and improves quality of life to at least the same extent as risperidone. However, olanzapine has a high acquisition cost compared with conventional antipsychotics. Despite this, most pharmacoeconomic analyses indicate that treatment with olanzapine does not significantly increase, and may even decrease, the overall direct treatment costs of schizophrenia, compared with haloperidol. Total direct medical costs calculated from prospective resource utilisation data were lower with olanzapine than with haloperidol by $US388 (1995 values) per patient over 6 weeks and by $US55 per patient per month during 46 weeks extended treatment. In a mixed effects linear model of the same data, total costs over 1 year were $US10,301 (1996 values) per patient lower with olanzapine than haloperidol, and olanzapine was associated with 18.3 more symptom-free days per patient. Compared with risperidone, mean total direct medical costs over 28 weeks were $US493 (1995 values) per patient lower with olanzapine. In a Markov model of 5 years' treatment, olanzapine was associated with more time in a disability-free state than haloperidol at a total cost per patient that was lower by $US1539 (1995 values), 816 Pounds (1995/1996 values), 977 Dutch guilders (NLG; 1995 values) and 2296 Deutschmarks in US, UK, Dutch and German analyses, respectively. In a similar Spanish analysis, the overall total cost was higher with olanzapine, giving an incremental cost effectiveness for olanzapine of 32,516 pesetas (1995 values) per month of disability-free time gained. When risperidone was a comparator, the total cost per patient was $US1875 and NLG202 lower with olanzapine in US and Dutch analyses, respectively. CONCLUSIONS: The high acquisition cost of olanzapine is offset by reductions in other treatment costs in patients with schizophrenia. Compared with haloperidol, the drug improved patient outcome and quality of life, while overall direct treatment costs were generally not increased, or even decreased. Olanzapine has also been reported to decrease overall treatment costs compared with risperidone, but confirmation is required. Olanzapine is a cost-effective alternative to conventional agents for the treatment of moderately to severely ill patients with longstanding schizophrenia.     

The costs of rheumatoid arthritis

The economic costs associated with rheumatoid arthritis (RA), a chronic, systemic, inflammatory disorder that affects many joints, are high, approximating those of coronary heart disease. The estimated prevalence of RA in the US is 0.9%. Incidence increases with age, and is highest among women in the fourth to sixth decades of life. The primary impact of RA is due to the significant morbidity associated with this disease. Mortality is increased among a poorly defined subgroup of RA patients. The average level of disability among RA patients is moderate, but 6.5 to 12% of patients are severely disabled. Between one- and two-thirds of previously employed patients have a reduced work capacity. Treatment primarily involves the use of nonsteroidal anti-inflammatory drugs and disease modifying antirheumatic drugs. Rehabilitation measures and orthopaedic surgery are also used. Total annual direct costs of RA (total charges) have been calculated to be $US5275 and $US6099 (1991 dollars) per patient. Lifetime medical care charges were estimated at $US12,578 per patient (1991 dollars). The direct costs of RA are substantial, but indirect costs have been calculated to be much higher because of extensive morbidity. The difference between the direct and indirect costs of RA is decreasing because salary increases have not kept pace with rising healthcare costs. The latter are increasing rapidly in RA because of the use of new technology, surgical procedures, and the greater use of drugs with frequent monitoring requirements and significant toxicity. Because intangible costs such as pain form a substantial part of the overall costs of RA but are difficult to evaluate, cost estimates inevitably underestimate the impact of the disease on individuals and society.     

Cost analysis of paroxetine versus imipramine in major depression

A simulation decision analytical model was used to compare the annual direct medical costs of treating patients with major depression using the selective serotonin reuptake inhibitor (SSRI) paroxetine or the tricyclic antidepressant (TCA) imipramine. Medical treatment patterns were determined from focus groups of general and family practitioners and psychiatrists in Boston, Dallas and Chicago, US. Direct medical costs included the wholesale drug acquisition costs (based on a 6-month course of drug therapy), psychiatrist and/or general practitioner visits, hospital outpatient visits, hospitalisation and electroconvulsive therapy. Acute phase treatment failure rates were derived from an intention-to-treat analysis of a previously published trial of paroxetine, imipramine and placebo in patients with major depression. Maintenance phase relapse rates were obtained from a 12-month trial of paroxetine, supplemented from the medical literature. The relapse rates for the final 6 months of the year were obtained from medical literature and expert opinion. Direct medical costs were estimated from a health insurance claims database. The estimated total direct medical cost per patient was slightly lower using paroxetine ($US2348) than generic imipramine ($US2448) as first-line therapy. This result was sensitive to short term dropout rates but robust to changes in other major parameters, including hospitalisation costs and relapse rates. The financial benefit of paroxetine, despite its 15-fold higher acquisition cost compared with imipramine, is attributable to a higher rate of completion of the initial course of therapy and consequent reduced hospitalisation rates.     

Economic benefits of amlodipine treatment in patients with coronary artery disease

OBJECTIVE: To estimate the potential savings in overall cardiovascular disease (CVD) treatment costs for the US population with coronary artery disease (CAD) resulting from the use of amlodipine. STUDY DESIGN AND METHODS: Using patient-level data from a retrospective analysis of the Prospective Evaluation of the Vascular Effects of Norvasc Trial (PREVENT), a randomised, placebo-controlled clinical trial (n = 825), we constructed a Markov cohort simulation model to estimate the health economic outcomes of patients with CAD treated with either amlodipine or placebo. PERSPECTIVE: Healthcare payer perspective. RESULTS: The expected number of CVD events for amlodipine recipients was significantly lower than the number of CVD events in the placebo cohort (p < 0.01). The net present value of the cost per patient for CVD treatment was estimated to be $US14 117 for amlodipine recipients and $US16 683 (1999 values, assuming a 3% discount rate) for placebo recipients over 3 years of follow-up with cost savings realised in the amlodipine cohorts after 6 months. CONCLUSIONS: According to the model, amlodipine results in an expected per patient cost savings of $US2566 over a 3-year period, mainly due to a reduction in hospitalisations for cardiovascular-related events and procedures.     

Cost-Effectiveness of Budesonide Controlled Ileal Release (CIR) Capsules as Maintenance Therapy versus No Maintenance Therapy for Ileocaecal Crohn's Disease in Sweden

A decision-analytic model was designed to estimate the associated costs and outcomes of maintenance therapy for Crohn's disease with budesonide controlled ileal release (CIR) capsules (Entocort((R)) capsules, Astra Draco, Lund, Sweden) versus no maintenance therapy. A third-party payer perspective was adopted to compare the direct costs associated with the medication and healthcare resource use for each therapy over a period of 12 four-week cycles. The costs of routine patient care and the consequences of failure, in terms of relapses, acute therapies, hospitalisations and surgery, were included. The outcome was measured as the average number of days in remission per patient per 12-cycle period. Based on the assumptions in the model, the results show that budesonide CIR capsules are associated with a reduction of 16.6 (26%) days in relapse, i.e. a 6% increase in days in remission, over a one-year period compared with no maintenance therapy. Direct healthcare costs are increased by 6% or Swedish kronor (SEK) 1673 ($US1 ~ SEK7.60). Overall, the model shows that there are substantial (non-drug associated) cost offsets from using budesonide CIR capsules as maintenance therapy in Crohn's disease. These cost offsets, in addition to improvements in patients' well-being and quality of life, indicate that maintenance therapy is cost effective compared with no maintenance therapy. The cost per added day in remission is relatively modest (SEK101 ~ $US13). If indirect costs are added to the calculation, it is realistic to argue that a net saving to society would be most likely.     

Cost of treatment for onychomycosis. Data from a 9-month observational study

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.     

An economic evaluation of atorvastatin for primary prevention of cardiovascular events in type 2 diabetes

OBJECTIVE: The CARDS trial, a multicentre, randomized, controlled trial, found that atorvastatin 10 mg/day for patients with type 2 diabetes mellitus and normal low-density lipoprotein (LDL)-cholesterol significantly reduced cardiovascular (CV) events, including stroke. We estimated the cost effectiveness of atorvastatin as primary prevention against CV disease from the short-term and lifetime US payer perspectives. RESEARCH DESIGN AND METHODS: We constructed a decision analytic (Markov) model to evaluate long-term costs and outcomes for atorvastatin 10 mg/day versus no HMG-CoA reductase inhibitor (statin) therapy for patients with type 2 diabetes and no history of a CV event. CV event rates and survival were based on risk equations calibrated to CARDS and applied to a US type 2 diabetes population; the atorvastatin effect on CV events was based on hazard ratios from CARDS; direct medical care costs were based on US treatment patterns and published costs analyses of patients with diabetes. Costs were valued in $US, year 2005 values; costs and benefits were discounted at 3% per annum. RESULTS: Within the time horizon of the trial (5 years), the cost effectiveness of atorvastatin was $US137 276 per QALY. At 10 years, the incremental cost per QALY improved to $US3640 per QALY. At 25 years, overall costs were lower and QALYs higher in the atorvastatin arm. Costs of managing CV events were lower after 5 years for patients treated with atorvastatin. CONCLUSIONS: For patients with type 2 diabetes and one additional risk factor for CV disease, normal LDL-cholesterol and no history of a CV event, primary prevention with atorvastatin appears to be cost saving and improve outcomes over 25 years, although it is costly from a short-term US payer perspective. From both a medical and an economic viewpoint, primary prevention is desirable in this patient population.     

Methotrexate provides significant cost savings for the treatment of unruptured ectopic pregnancy

The aim of this study was to compare direct and indirect costs of single-dose methotrexate and laparoscopy in the treatment of unruptured ectopic pregnancy. We conducted a prospective study between 1 January 1995 and 31 May 1997 and recorded costs accrued from outpatient and inpatient treatment with methotrexate (group I) and laparoscopy (group II). We used the French National Social Security nomenclature as reference for the different costs. Indirect costs were estimated from national demographic data. 39 patients were included in group I and 38 in group II. Single-dose methotrexate was the most economic management of unruptured tubal pregnancy ($US1436 per case vs $US3170 per case for laparoscopy) since it reduced the total cost by approximately 50%. This was due to a dramatic reduction in charges related to hospitalisation and the operating room. Indirect costs were also reduced, mainly as a result of a shorter recovery time ($US237 vs $US475). However, there was no further evidence of any cost effectiveness of methotrexate therapy when hospitalisation was required. In conclusion, single-dose methotrexate appeared to be the most economic approach for the treatment of unruptured ectopic pregnancy. Selection of cases is mandatory to guarantee a cost savings for the treatment of unruptured ectopic pregnancy.     

Cost analysis of the treatment of severe spinal spasticity with a continuous intrathecal baclofen infusion system.

OBJECTIVE: The purpose of our study was to analyse and evaluate the costs of continuous intrathecal baclofen administration as a modality in the treatment of severe spasticity in the Netherlands. DESIGN: A cost analysis was conducted as part of a prospective, multicentre, multidisciplinary, randomised and placebo-controlled clinical trial. The study covered the period from December 1991 to September 1995. The data on medical consumption and costs were collected over a 3-year period from different sources: administrative databases of health insurance companies, hospital registries and a patient survey. These data were structured by means of a flowchart analysis of the medical decision-making by specialists and general practitioners (GPs). They included data on in- and outpatient care, home care and care in nursing homes. The cost analysis was conducted using data from 18 patients included in the trial and from 15 so-called 'match' patients. The latter group are patients with comparable diseases leading to spasticity and living in comparable circumstances. Next to absolute costs (direct and indirect) of care and treatment for the 2 groups of patients, cost differences between the 2 groups were considered (differential cost analysis). SETTING: Per patient cost data, collected prospectively for 2 years during the phase of clinical evaluation, and retrospectively 1 year before implantation. The data were collected on patients from in- and outpatient care, home care and care in nursing home settings. PATIENTS AND PARTICIPANTS: The trial patients (8 men) had a mean age of 46 years; 11 patients had multiple sclerosis and 7 patients had spinal cord injuries. The match patients (7 men) had a mean age of 48 years; 9 patients had multiple sclerosis and 6 patients had spinal cord injuries. INTERVENTIONS: Trial patients were treated with a subcutaneously implanted programmable continuous infusion pump (SynchroMed, Medtronic), filled with baclofen (a muscle relaxant) to treat patients with chronic disabling spasticity who did not respond to a maximum dose of oral baclofen, dantrolene and tizanidine. MAIN OUTCOME MEASURES AND RESULTS: An analysis of hospital stay between both groups showed a significant difference during the implantation year. The average number of hospital days per patient in the year in the treated group was 31.5 days and in the match group was 18.7 days. Significant cost differences between both groups in the year that started with pump implantation and the following year can be attributed mostly to the costs of implantation of the pump and related hospitalisation days. The total costs of patient selection, testing, implanting the pump and follow-up amounted to $US28,473 for the first year. Savings must be taken into consideration as well. The savings of direct costs were due to withdrawal of oral medication (estimated annual total of between $US1950 and $US2800 per patient). Indirect savings on employment and nursing home costs, amounted annually to $US1047 and $US5814, respectively. Scenarios make it possible to consider policy consequences. The case of 'extending' the indications for this treatment to a larger population has been calculated and visualised. CONCLUSIONS: The costs of the therapy (continuous intrathecal infusion of baclofen) can be attributed mostly to implantation of the pump and related hospitalisation days. Savings originated from withdrawal of oral medication, job preservation and avoidance or delay of admission to a nursing home.     

The cost-effectiveness of maintenance therapy for duodenal ulceration with an H2-antagonist

Data from several sources are used to quantify the expected direct medical costs of a recently healed duodenal ulcer patient prescribed an H2-antagonist (famotidine) for a 6-month period. These costs are compared to the expected direct medical costs associated with not using maintenance therapy. Our results indicate that the estimated direct cost of patients prescribed a 6-month regimen of an H2-antagonist (famotidine) is 30.3% lower than patients who receive no H2-antagonist therapy. Most of the savings result from a reduced risk of hospitalization and surgery. The results of the sensitivity analysis of four varying scenarios indicate that H2-antagonist maintenance therapy remains less costly even when the assumptions underlying the model are varied enormously. We conclude that the decision to withhold maintenance therapy with H2-antagonists should not be based on economics.