Economic impact of Alzheimer's disease in the United Kingdom. Cost of care and disease severity for non-institutionalised patients with Alzheimer's disease.

BACKGROUND: While the costs associated with Alzheimer's disease have been shown to be significant, there are few data relating cost of care to severity of the disease. AIMS: We aimed to compare the costs associated with different severities of Alzheimer's disease with those incurred by control subjects over a three-month period. METHOD: In this cross-sectional, multicentre, naturalistic analysis, non-institutionalised patients with Alzheimer's disease (128), their care-givers (128), and 56 matched controls were interviewed once to establish resource use over the previous three months. Patients were stratified into three severity groups according to their Mini Mental State Examination score. Costs were calculated from the perspective of society as a whole. RESULTS: Over the three-month period, total mean cost per control subject (387 Pounds) was minor compared with mean cost incurred by patients with mild (6616 Pounds), moderate (10,250 Pounds) and severe (13,593 Pounds) Alzheimer's disease. Indirect cost, mainly time spent by care-givers, was the main cost component in all groups (68.6%), followed by direct medical costs (24.7%). CONCLUSIONS: The cost of care for an Alzheimer's disease patient is directly related to the severity of the patients illness.

Predicting factors for absenteeism in patients with major depressive disorders.

This study examines the predicting factors for absenteeism in depressed patients. Using a 'cross-sectional' design, we observed 345 patients diagnosed with major depressive disorders as assessed by the Diagnostic and Statistical Manual for Mental Disorders, third edition revised (DSM-III-R) criteria and Hamilton Depression Rating Scale (HAM-D) [12] score higher than 12. The treatment group (n = 268) were treated with antidepressants (n = 98 with fluoxetine and n = 170 with tricyclics [amitriptyline, clomipramine]) for at least one week and the non treated group (n = 67) had not received antidepressants for at least one month. Sociodemographic, clinical and therapeutic data was collected. The primary endpoint was absenteeism from work. Logistic regression analysis of these data was used to identify potential predictive variables. The rate of absenteeism from work was greater in non treated (70.2%) compared to treated patients (39.8% for fluoxetine group and 57.7% for tricyclics group). The risk of absenteeism for patients treated with tricyclics was 2.45 times greater than for patients treated with fluoxetine (odds-ratio = 2.45, CI 95% = 1.1-4.7). For all patients, the strongest predictors of absenteeism from work were symptom severity (odds-ratio = 44.4, CI 95% = 7.9-250) followed by past history of depression (odds-ratio = 6.85, CI 95% = 2.6-18.4) and past history of absenteeism (odds-ratio = 6.51, CI 95% = 2.0-204). In conclusion, the risk of absenteeism from work increases with depression severity and is higher with tricyclics compared to fluoxetine.

Economic evaluation of Nootropil in the treatment of acute stroke in France.

The primary objective of this study was to investigate the economic impact of treatment of acute ischaemic stroke with piracetam vs placebo according to the societal perspective in France. Socio-demographic, clinical and resource utilisation data for piracetam and placebo patients during the acute phase following stroke was obtained from the Piracetam Acute Stroke Study (PASS) clinical trial database. The economic analysis was based on the population defined as being treated within 6 h 59 min following stroke and presenting an initial Orgogozo score of less than 55. Resource utilisation data concerning the rehabilitation phase, outpatient follow-up and institutionalisation was obtained from decision tree analysis. There was a higher percentage of autonomous patients in the piracetam group (27.8%) compared to placebo (22.9%). The mean duration of hospitalisation (autonomous 21.8 days; non-autonomous 30.3 days) and the cost of an autonomous patient was lower than a non-autonomous patient. The total cost per stroke patient receiving piracetam was estimated at 103 KF during the 6-month period, compared to 106 KF per placebo patient. The major cost driver was hospitalisation during the acute phase, representing approximately 50% of the total cost per patient. In patients with moderate to severe stroke treated within 6.59 h, piracetam was cost-effective compared to placebo over the 6-month study period.

Relationship between seizure frequency and costs and quality of life of outpatients with partial epilepsy in France, Germany, and the United Kingdom.

PURPOSE: The relationship between seizure frequency and both health care costs and quality of life (QOL) was investigated in a retrospective, cross-sectional, multicenter study in France, Germany, and the United Kingdom. METHODS: Three hundred outpatients with stable partial epilepsy were approximately evenly distributed among five seizure-frequency groups, ranging from seizure-free in the last 3 months (group 1) to daily seizures (group 5). Economic data, obtained through patient interviews and record abstraction, comprised direct medical costs, direct nonmedical costs, and indirect costs for the preceding 3 months. Total societal costs in the three countries were pooled and converted to United States dollar equivalents. QOL was assessed through a self-administered questionnaire, the Functional Status Questionnaire (FSQ). RESULTS: Mean total costs increased from $780 in group 1 to $2,171 in group 5 (p = 0.0001), with significant increases in each cost category as seizure frequency increased. Greater seizure frequency also significantly (p = 0.0270) correlated with lower employment rates, which ranged from 57% in group 1 to 30% in group 5. QOL declined as seizure frequency increased. Particularly affected were basic and intermediate activities of daily living (ADL), mental health, social activity, and feeling about health. CONCLUSIONS: The study results show that higher seizure frequencies are associated with higher direct and indirect costs and with reduced QOL for patients with epilepsy.

Economic analysis of antibiotic regimens used in the treatment pharyngitis: a prospective comparison of azithromycin versus roxithromycin.

The economic impacts in terms of cost and effectiveness (speed of resolution of symptoms) of 3- and 5-day courses of azithromycin and a 10-day course of roxithromycin were compared in a randomized, open study in patients with symptoms suggestive of beta-haemolytic streptococcal pharyngitis. Direct medical costs and absence from work were recorded and symptom scores and compliance were used to assess the effectiveness of therapies. Although no differences between treatment groups in terms of overall clinical response rates were detected 2 and 4 weeks after the start of treatment, more rapid resolution of symptoms was achieved with 3- and 5-day courses of azithromycin than with a 10-day course of roxithromycin. There was also a significant reduction in the time absent from work in the azithromycin treatment groups. The total costs of care over the 4-week evaluation period were lower for the 3- and 5-day azithromycin courses (US$193.60 and US$195.30 respectively) than for roxithromycin (US$202.10). The major cost components were absence from work (58.6%), visits to the physician (15.3%) and utilization of antibiotics (14.9%). Compliance was significantly better (P < 0.01) in patients prescribed azithromycin for 3 and 5 days (58.0% and 42.9% respectively) than in those who received roxithromycin (20.3%) and a significantly longer symptom-free period (P < 0.01) was reported in azithromycin- compared with roxithromycin-treated patients. These findings support the hypothesis that a 3- or 5-day course of azithromycin is as effective as a 10 day course of roxithromycin in the treatment of patients with pharyngitis and is associated with lower costs. Furthermore, azithromycin is associated with faster resolution of symptoms and improved patient compliance.

Economic analysis of the use of recombinant human granulocyte colony stimulating factor in autologous bone marrow transplantation.

The aim of this study was to assess the economic impact of the use of granulocyte colony stimulating factor (RHu-G-CSF) in patients treated by autologous bone marrow transplantation (ABMT) for lymphomas. Demographic, clinical and economic data were collected retrospectively from a random sample of 55 patients in four French centres who underwent ABMT (usual care) without or with administration of RHu-G-CSF over a period of 100 days post-ABMT. The patients treated with RHu-G-CSF had a shorter period of infection, neutropenia and severe neutropenia (P < 0.05) when compared with usual care recipients. Compared to usual care, the use of G-CSF was associated with a 3% reduction in total cost of care for ABMT over 100 days post-ABMT or US$1316, including RHu-G-CSF cost. This cost reduction was mainly due to a reduced length of stay in hospital and fewer laboratory tests.

Cost of allogeneic and autologous blood transfusion in Canada. Canadian Cost of Transfusion Study Group.

OBJECTIVE: To determine the cost, from a societal perspective, of blood transfusion in Canada. STUDY DESIGN: Cost-structure analysis. SETTING: Data were collected from eight hospitals and from six blood centres operated by the Canadian Red Cross Society in four provinces. OUTCOME MEASURES: Costs associated with four stages of transfusion-- collection, production, distribution and delivery--in 1933 were assessed. Costs were divided into the following categories; personnel, purchases, external services, overhead, donors' time, patients' time (for autologous transfusion), wastage and infection. RESULTS: The mean overall cost of a transfusion performed on an inpatient basis was $210 per unit of red blood cells for an allogeneic transfusion and $338 per unit of blood for an autologous transfusion. The mean cost of an allogeneic transfusion performed on an outpatient basis was $280 per unit of red blood cells. CONCLUSION: The costs determined in this study can be used in future studies comparing the cost-effectiveness of allogeneic transfusion with that of alternative methods.

Is paclitaxel and cisplatin a cost-effective first-line therapy for advance ovarian carcinoma?

BACKGROUND: Paclitaxel and cisplatin use for the treatment of advanced ovarian carcinoma (AOC) has been shown to increase median survival duration. An evaluation was performed on the economic consequences of treating AOC patients with combined paclitaxel and cisplatin chemotherapy compared with current usual care, i.e., combined cyclophosphamide and cisplatin chemotherapy. METHODS: Linear modeling techniques combined with retrospective chart analysis were used to predict the clinical progression and treatment of AOC patients until death. Cost-effectiveness analysis comparing paclitaxel and cisplatin and usual care was performed from a simplified Ministry of Health perspective. RESULTS: Assuming a 50% increase in survival for paclitaxel and cisplatin patients, an assumption supported by recent clinical trial data, this treatment showed an average lifetime cost per patient of $50,054 Cdn compared with a cost of $36,837 Cdn for usual care. The incremental cost of the paclitaxel and cisplatin treatment over the usual treatment was $20,355 Cdn per life year gained. These results withstood extensive sensitivity analyses. CONCLUSIONS: Paclitaxel, in combination with cisplatin, appears to be a cost-effective first-line treatment for AOC. A moderate increase in incremental cost compares favorably with other life-saving strategies currently in use. As more data become available for the use of paclitaxel, this pilot study will provide a basis for more extensive economic evaluation of paclitaxel.

Quality of life in depressed patients: comparison of fluoxetine and major tricyclic antidepressants.

Quality of life is one of the effectiveness measures used to assess the impact of medical interventions. This paper describes results of a study on quality of life of depressed patients treated with fluoxetine or tricyclic antidepressants (TCAs) such as amitriptyline and clomipramine. The quality of life of patients was measured using the Short Form (SF-36), a widely accepted and validated questionnaire. Depressed patients (n = 845) were observed using a cross-sectional design. Patients who had been under treatment for at least 1 week (amitriptyline, clomipramine or fluoxetine) and met the DSM-III-R criteria for major depressive disorder were included. Similar sociodemographic profiles were found across treatment groups. However, more patients with a history of depression were found in the TCA vs the fluoxetine group. Compliance was dramatically lower and length of treatment higher for TCA-treated groups. Controlling for confounding variables, the TCA-treated group also scored lower than the fluoxetine-treated one for general health perception, and social and physical functioning. These differences are not explained by symptom severity since Hamilton scores were similar across treatment groups. These results suggest that fluoxetine treatment may be associated with higher levels of social functioning and health perception than usual TCA treatment.

A multinational economic evaluation of rhDNase in the treatment of cystic fibrosis.

Economic evaluations of pharmaceuticals are increasingly being conducted in conjunction with randomized phase III clinical trials to meet the demand for pharmacoeconomic data when new products are launched. While the need for such data is often global, the trials in which relevant information may be collected are often conducted in only one or a limited number of countries. A critical issue is how data from pivotal clinical trials in one setting can serve as the basis for pharmacoeconomic evaluations in others. We address this issue and report on four economic evaluations that we undertook in conjunction with a recent U.S. phase III clinical trial of recombinant human deoxyribonuclease (rhDNase), which is used to improve pulmonary function in patients with cystic fibrosis (CF). The objective of these evaluations was to estimate the potential impact of rhDNase therapy in France, Germany, Italy, and the United Kingdom on the direct costs of medical care for the treatment of respiratory tract infections (RTIs) in patients with CF. Analyses of economic impact were undertaken both with and without adjustment for differences in practice patterns between the United States and the countries of interest. Our findings suggest that rhDNase therapy may reduce the cost of RTI-related care by between US$600 and US$1,100 over a 24-week period; the cost of rhDNase is not included in these figures, as a price was unavailable when our analyses were undertaken. Despite methodologic challenges, economic evaluations that meet the information needs of decision makers in diverse countries can nonetheless be undertaken in conjunction with phase III clinical trials.

A Markov process analysis comparing the cost effectiveness of maintenance therapy with citalopram versus standard therapy in major depression.

The objective of this study was to demonstrate the cost effectiveness of long term maintenance treatment with citalopram versus standard therapy (defined as short term antidepressant treatment) in patients with major depression in Germany. We chose doxepin, amitriptyline and trimipramine as standard therapy because these drugs are the leading antidepressants in that country. A Markov process analysis was used to model health status and economic outcomes as they accrued over a 1-year follow-up period. The main outcome measures were time without depression, direct costs and indirect costs (work days lost). All costs were in 1993 Deutsche marks. The clinical data were obtained from the published literature and US clinical practice guidelines; the associated unit costs of the medical resources used were derived from official German tariff lists. The results show that, compared with standard therapy, long-term maintenance treatment with citalopram is associated with a mean increase in time without depression of 7.9% (8.2 vs 7.6 months). The total costs of maintenance treatment with citalopram were substantially lower than with standard therapy (DM7985 vs DM11,948 per patient per year. In addition, both the direct and indirect costs of maintenance treatment with citalopram (DM3764 vs DM4221 per patient, respectively) were lower than with standard therapy (DM4577 vs DM7371 per patient, respectively). In conclusion, the study demonstrates that one year's maintenance treatment with citalopram is both more effective and less costly than standard therapy in the treatment of patients with major depression.

Economic analysis of Alzheimer's disease in outpatients: impact of symptom severity.

To assess the economic burden of Alzheimer's disease (AD), we carried out a cross-sectional prevalence cost-of-illness study in France. Fifty-one probable AD patients (NINCDS-ADRDA) actually treated in ambulatory care were recruited in two university outpatient centers. Demographic, clinical (including actual Mini-Mental State Examination scores), and economic data were collected by clinical investigators and trained interviewers. Total costs included actual expenditures such as direct medical costs and direct nonmedical costs, as well as indirect costs (loss of earnings due to loss of productivity). Cost valuation was based on the societal perspective using an opportunity costing approach. We found that indirect costs represented a significant portion of total costs (36%-40%). In terms of expenditures, patients and caregivers were found to bear the major part of AD total costs. We found a positive and significant correlation between disease severity and costs. Our findings support the hypothesis of a relationship between disease evolution and healthcare costs.

Economic evaluation in mental disorders: community versus institutional care.

Psychiatric illnesses have been shown to have a dramatic economic impact. The concept of economic efficiency is particularly relevant in the field of psychiatry because of different factors such as the high prevalence, the chronicity or cyclical nature of many mental disorders and the duration of most of their treatments. Despite the international diversity of healthcare systems, most developed nations spend approximately 10% of their total healthcare expenditures on the treatment of mental disorders. The current trends, including growth of the outpatient sector with no decline in institutional costs and increasing evidence of less expensive care in community based treatment facilities, have been confirmed by several studies. The costs of mental disorders consist largely of direct costs involving healthcare expenditures and indirect costs resulting from loss of productivity by individuals because of illness or death. Both direct costs with specific emphasis on hospital care, and indirect costs represent the major economic burden of psychiatric disorders. While increased detection and treatment might add to direct costs for the health delivery system, effective treatment might avert greater expenses that would be incurred as indirect costs. Therefore, to be efficient, any new therapeutic interventions in psychiatry would have to reduce both hospital costs (number or length of admissions) and indirect costs (loss of productivity). Increasingly, the chronic mentally ill are treated in community based facilities. Several studies support the cost effectiveness of community based social psychiatric treatment versus inpatient care.(ABSTRACT TRUNCATED AT 250 WORDS)

Methodological approaches to pharmaco-economics.

Due to the increased need for cost-containment policies, most decision makers are facing the issue of the efficiency of health care strategies. In this context, economic evaluation becomes a major instrument. However, the credibility of economic data depends on a number of methodological steps: selection of strategy of economic evaluation (cost/effectiveness, cost/benefit, generation of economic hypotheses, study design (cross-sectional, prospective, naturalistic), data collection (data-base, physicians), data analysis (costing, statistics). In this respect, the conduct of proper economic evaluation relies on a combination of expertise in clinical epidemiology as well as in health economics.

Cost of anxiety disorders: impact of comorbidity.

The aim of this study was to assess the relative impact of co-mobidity and of symptom severity on the costs of caring for patients with generalized anxiety disorders (GAD). One thousand and forty-two patients with GAD according to DSM III-R were observed by psychiatrists using a cross-sectional methodology. Demographic, clinical, therapeutic as well as health care utilization data were collected at a single point in time. Patients were stratified according to prevalence of co-morbidity. An economic analysis was performed based on a societal perspective. Hospitalizations and losses of productivity were the two major components of costs both in patients with and without co-morbidity. On the other hand costs of pharmaceuticals remain a marginal component of costs associated with GAD in the two groups. Controlling for confounding variables, the prevalence of health care utilisation was found to be significantly higher in patients with co-morbidity for hospitalization, laboratory tests, medications and absenteeism from work. Most of cost components were found to be significantly higher in patients with co-morbidity. The relative risk of health care utilization was higher in patients with co-morbidity, past history of anxiety, high level of anxiety as well as in older patients. Overall our findings suggest that both co-morbidity and symptom severity play a role in cost generation in GAD patients.

Economic analysis of lenograstim in the correction of neutropenia following chemotherapy for non-Hodgkin's lymphoma.

A prospective economic analysis of lenograstim and placebo was performed as part of a randomised double-blind trial in 162 patients receiving chemotherapy for non-Hodgkin's lymphoma (NHL). The primary clinical end-point was the percentage of patients experiencing > or = 1 documented infection in each treatment group. The cost of hospitalisation and the cost of medical services used were the primary economic end-points. Economic analysis was based on the French Hospital perspective. Over the 56-day study period, patients in the placebo group received more days of inpatient intravenous (8.9 vs 5.3 days; p < 0.01) and oral (5.3 vs 4.2 days) antibiotic therapy than those in the lenograstim group. This difference was due to a higher rate of documented infection in the placebo group. Patients treated with placebo also spent more days in hospital for reasons other than administration of chemotherapy (18.5 vs 14.4; p < 0.05). The number of days of chemotherapy was significantly greater in the lenograstim group than in the placebo group (19.4 vs 17.5; p < 0.001) because of shorter delays between chemotherapy cycles in the lenograstim group. The use of lenograstim to prevent chemotherapy-induced neutropenia in patients with NHL was associated with a reduction in total direct medical costs (excluding the cost of lenograstim) of FF7297 as a result of reduced patient morbidity. Furthermore, the higher rate of completion of chemotherapy in the lenograstim group may lead to better long term survival; this observation deserves further clinical investigation.

[Interest in amd methodology of medical-economic studies in perspective]. / Intérêt et méthodologie des études médico-économiques en situation.

Clinicians and economists must collaborate for conception and achievement of clinical-economic studies. If economists are more involved in some decisions such as costs or perspectives selection, other aspects such as general design, data collection methods, endpoints, comparator or procedures must be chosen both by clinicians, epidemiologists and economists. This is the condition for a good data validity, a wide diffusion and exploitation of clinical-economic studies in the future. The introduction of this type of studies should bring interesting data on the care of diabetic patients.

[Impact of therapeutics on sex. Value of measurements of quality of life]. / Impact des thérapeutiques sur la sphère sexuelle. Intérêt des mesures de la qualité de vie.

Quality of Life is a new clinical dimension with the objective of evaluating the impact of a disease or of a treatment on patients well being. Quality of life is a measure of increasing interest. It is a global and cumulative measure, relevant for the evaluation of the therapeutic benefit of a treatment. It can be measured through "specific" or "generic" tools. Very few experimental literature exploring the impact of pathologies over the sexual sphere exists today. Only generic scales have been used, because no specific scale has been developed up to now. The impact of certain pathologies such as depression or diabetes has been documented, but very little objective information exists concerning the sexual repercussion of the chronic use of drugs (anti depressive, anxiolytics). Sexual quality or life as a risk factor for disease development is also dimension that has been explored, but only superficially. In a general way, no evidence exists concerning a reel correlation link between pathologies, treatments and sexual quality of life and this specific dimension of the quality of life still remains to be explored further.

[Economic aspects of pharmacovigilance in the pharmaceutical industry]. / Aspects économiques de la pharmacovigilance dans l'industrie pharmaceutique.

The economical aspects of pharmacovigilance in the pharmaceutical industry can be assessed by two ways. First the balance between cost of avoiding adverse drug reactions (ADR) and cost of ADR should be evaluated during the development. The company will have to take into account both efficacy and safety of its compound. However if it increases the costs of avoiding ADR it will reduce the costs of avoiding ADR occurring after commercialisation. On the other hand the cost of side effects of a marketed compound can also be appreciated. This assessment will always have to be comparative with an other drug and to take into account the benefit of both drugs, if their efficacy is not deemed identical.