The economic impact of Parkinson's disease. An estimation based on a 3-month prospective analysis

OBJECTIVE: This study prospectively assesses the medical costs of Parkinson's disease (PD). DESIGN: Over a period of 3 months (from July to September 1995), patients with PD documented all items of healthcare provision. These data were then used to calculate medical costs for an individual patient as well as the costs of PD. PATIENTS AND SETTING: We included 20 outpatients with idiopathic PD from the neurological outpatient clinic, Klinikum Grosshadern, Munich, and 20 patients from two office-based neurologists in South-West Germany. MAIN RESULTS: The mean 3-month medical cost of PD in 1995 deutschmarks (DM) was 5210 ($US3390, 2240 Pounds) consisting of DM1410 ($US920, 610 Pounds) for care and nursing, DM1580 ($US1030, 680 Pounds) for drug therapy, DM1320 ($US860, 570 Pounds) for inpatient hospital care, DM40 ($US26, 17 Pounds) for outpatient care and DM860 for other expenses ($US560, 370 Pounds). The expenditure was related to the disease evolution. Patients complaining of one-sided symptoms [Hoehn and Yahr stage I; (HY I)] were less expensive to treat (DM1930, $US1250, 830 Pounds) than patients who were severely incapacitated (HY V) [DM9740, $US6330, 4200 Pounds; HY V]. After 3 to 5 years of levodopa treatment approximately 50% of patients start to experience fluctuations in motor ability and dyskinesias [Unified Parkinson's disease rating scale, part IV (UPDRS IV)]. This onset of motor complications parallels an increase in costs. For patients who experienced motor fluctuations, annual costs were DM6550 ($US4260, 2820 Pounds) compared with DM3030 ($US1960, 1300 Pounds) for patients lacking this problem. Indirect non-medical costs were not calculated due to the limited number of patients. The impact of the disease on work, however, is clearly apparent from the patients' history: 19 out of 34 patients who had already stopped working attributed this to the disease, and only 6 patients were still working at the time of the survey. CONCLUSION: PD poses a major financial impact to society which is expected to increase in future years as the age distribution shifts to older age groups. On the basis of a prevalence of PD of 183 per 100,000, we calculated an annual expenditure of DM3.0 billion for the direct medical costs of PD in Germany.     

Health-related quality of life and healthcare utilisation in patients with Parkinson's disease: impact of motor fluctuations and dyskinesias.

Idiopathic Parkinson's disease (PD) is a common chronic progressive neuro-degenerative disorder associated with the progressive loss of dopaminergic neurons in the substantia nigra. The natural course of the disease may lead to severe disability despite a variety of pharmacological and surgical treatment options. Levodopa is still the most effective symptomatic treatment for PD; however, long term use can cause a number of adverse effects including motor complications, nausea and vomiting, postural hypotension and changes in mental status. The onset of motor complications marks a crucial point in the management of PD. They may present as changes between akinetic and mobile phases (motor fluctuations) or as abnormal involuntary movements (dyskinesias). After levodopa treatment for 3 to 5 years, motor complications occur in approximately 50% of patients, and after 10 years in >80% of patients. Treatment options have recently expanded as new drugs have been licensed and surgical procedures refined. Patients with motor complications present a demanding task in disease management, and often multiple drugs and high dosages are necessary to achieve only suboptimal control, resulting in increased healthcare utilisation. Costs increase considerably in patients with motor fluctuations and dyskinesias compared with patients without these symptoms. In a French study, 6-month direct medical costs per patient increased from 1648 euros (EUR) to EUR3028 in patients without and with motor fluctuations, respectively. In a recent French study a significant difference in monthly direct medical costs was found in patients with and without dyskinesias (EUR560 vs 170). Unfortunately, no data are available on the effect of motor complications on indirect costs. Several studies have shown that health-related quality of life (HR-QOL) is reduced when motor fluctuations occur. This may also be true of dyskinesias, but because of the limited number of studies a definite conclusion is not yet possible. Recently, surgical treatment options have been used to deal with advanced PD and late stage complications. Although their effect on motor complications and HR-QOL is well documented, they result in increased costs (total medical cost: EUR28920) compared with drug treatment alone and are increasingly restricted by healthcare providers. The purpose of this article is to review the available data from pharmacotherapeutic. surgical and economic studies on HR-QOL and healthcare expenditure in patients with PD, with a major focus on the impact of motor fluctuations and dyskinesias.     

Cost effectiveness of pramipexole in Parkinson's disease in the US.

OBJECTIVE: Pramipexole was recently approved in the US for treatment of the symptoms of idiopathic Parkinson's disease (PD). Although pramipexole has been found to be safe and efficacious when compared with placebo, little data are yet available on its cost effectiveness when compared with baseline treatment. The aim of this study was to estimate the costs and cost effectiveness (cost utility) of pramipexole compared with baseline treatment in patients with early and advanced PD. DESIGN AND SETTING: We developed a cost-effectiveness (CE) model in the US setting that linked Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily life) and III (motor) scores to disease progression, costs and patient utility. Data for the model were obtained from clinical trials, a literature review and a survey of 193 patients' health resource use and utility. We used cost and quality-adjusted life-year (QALY) estimates from the model to estimate the incremental cost effectiveness of pramipexole relative to baseline treatment patterns. We performed separate analyses for patients with early and advanced PD. We also performed extensive sensitivity analyses by adding other dopamine agonists to the no-pramipexole treatment regimen and varying disease progression parameters. The study was conducted from the societal perspective, although data presentation allows interpretation of cost effectiveness from either the societal or payer perspective. MAIN OUTCOME MEASURES AND RESULTS: For patients with both early and advanced PD, treatment with pramipexole had higher costs but was more effective than baseline treatment. For patients with early onset of PD, the incremental total CE ratio for pramipexole was $US8837/QALY. For patients with advanced PD, the incremental CE ratio was $US12 294/QALY (1997 costs). These ratios were lower than the CE ratios of many widely used medical treatments. CONCLUSIONS: Subject to the inherent limitations of modelling chronic disease progression and subsequent healthcare costs and patient utility, the results suggested that pramipexole was a cost effective treatment for patients with early and advanced PD in the US.     

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.     

The burden of age-related macular degeneration: results of a cohort study in two French referral centres

OBJECTIVE: To describe the economic impact of age-related macular degeneration (AMD) and to assess its medical and non-medical costs. DESIGN AND SETTINGS: An observational study was carried out in 105 patients in two French centres in a sample of 105 French patients. All consecutive patients, consulting during a 3-week period, were included provided they were 60 years of age or older and they presented an exudative form of AMD with a distant visual acuity in the best eye < or = 20/40. Data collected included clinical items, treatment modalities, medical follow-up, transport costs, impact of AMD on living conditions and welfare payments related to visual impairment. Costs were presented in 2000 values. PERSPECTIVE: General payer perspective (Social Security, private health insurance and patient). RESULTS: Mean age was 79.3 years and ranged from 62.8-95 years. Average length of disease evolution was 3.5 years. During a 3-month period, patients had a mean of 2.6 visits to the ophthalmologist. Thirty percent of the patients used vascular medications and 72.4% had been previously treated by laser photocoagulation. Only 10% had benefited from visual rehabilitation. Annual AMD cost per patient was 3660.29 euros (EUR) [95% CI: 2881.92-4438.62]. Half of these annual costs were medical costs. Other major cost components were home help costs EUR904.91 [95% CI: 478.88-1330.94] and transport costs for care EUR542.73 [95% CI: 146.31-939.14]. Non-medical costs were significantly higher for patients with more severe disease. CONCLUSIONS: The economic argument that costs are higher in patients with the lowest visual acuity emphasises the necessity of early detection and treatment of patients with AMD.     

The cost of treatment of Alzheimer's disease in The Netherlands: a regression-based simulation model

OBJECTIVE: To examine the potential economic impact of treatment of Alzheimer's disease. DESIGN: Regression-based simulation estimation of the long term costs of Alzheimer's disease under a number of treatment scenarios. Data from an epidemiological study conducted in Rotterdam, The Netherlands, was used to simulate disease progression. Comparison of the costs and effectiveness experienced by the patients were used to measure the impact of treatment. PATIENTS AND INTERVENTION: 2 theoretical cohorts of patients with Alzheimer's disease, one of which receives standard treatment, while the other receives a treatment which slows cognitive decline as measured by the Mini-Mental State Examination (MMSE). MAIN OUTCOME MEASURES AND RESULTS: Under one of the scenarios examined, the baseline cost of Alzheimer's disease was 97,866 euro (EUR; 1996 values) per patient over 10 years' follow-up; the cost was almost EUR100,000 under all scenarios. Life expectancy following onset was about 4.5 years and MMSE decline was approximately 2 points per year for a typical prevalent (existing) patient and almost twice as much for incident (newly diagnosed) patients (1.82 vs 3.42 points per year, respectively). Slowing the rate of cognitive decline results in a slightly increased life expectancy, with more time being spent at home and less in a nursing home. Total costs (excluding those of therapy) will decrease, but savings will be modest and may well be less than the cost of therapy. Under the same scenario, total savings were EUR1,571 per patient which corresponds to an annual break-even cost of just EUR453. Decisions regarding the initiation or termination of therapy will affect both the number of patients treated and the costs and potential savings of treatment. CONCLUSIONS: The savings made in treating Alzheimer's disease will almost certainly be small in comparison with total costs and may well be offset by the cost of the treatment itself. Simulation models can be used to estimate the effect of therapy on the costs of care and can be useful tools in clinical decision-making and allocation of resources. These results show the need for further research into the costs and effects of treatment of Alzheimer's disease.     

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.     

The cost of gastro-oesophageal reflux disease, dyspepsia and peptic ulcer disease in Sweden

BACKGROUND AND OBJECTIVE: Dyspepsia, peptic ulcer disease (PUD) and gastro-oesophageal reflux disease (GORD) involve a substantial cost to Swedish society. There is a lack of up-to-date nationwide cost estimates after 1985. This study was conducted to present a comprehensive and updated cost analysis and study the change over time of the national cost of these disorders. DESIGN AND SETTING: Primarily, data from National Swedish databases and secondly, data from databases from the County of Uppsala for 1997 were used for the calculations and estimations. PERSPECTIVE: Swedish societal perspective. RESULTS: The total cost to Swedish society of dyspepsia, PUD and GORD in 1997 was $US424 million, or $US63 per adult. Direct costs totalled $US258 million (61%) while indirect costs totalled $US166 million (39%). The highest proportions of costs were due to drugs and sick leave, these being 37 and 34%, respectively. CONCLUSIONS: The cost of dyspepsia and GORD is substantial for patients, health providers and society. Since 1985, drug costs have increased substantially while the cost of sick leave has decreased.     

Cost of illness and its predictors for Parkinson's disease in Germany

OBJECTIVE: To prospectively evaluate the health economic burden of patients with Parkinson's disease (PD) in Germany over a 6-month observation period and to identify the predictors of these costs. STUDY DESIGN AND METHODS: Direct and indirect costs were evaluated in 145 patients with PD (mean age 67.3 +/- 9.6 years). PD patients were recruited from an outpatient department for movement disorders, a specialised PD clinic, two office-based neurologists and general practitioners, all located in Germany, and were enrolled between January and June 2000. Relevant economic data were documented in a patient diary over the 6-month period. Clinical evaluations (Unified Parkinson's Disease Rating Scale [UPDRS]) were performed at baseline and at 3 and 6 months. Costs were derived from various German medical economic resources. Costs were calculated from the perspective of healthcare and transfer payment providers and the individual patient. Indirect costs for lost productivity were also calculated. Costs are presented as means +/- standard deviation (SD). Multivariate regression analyses were performed to identify independent cost predictors. Costs are in year 2000-02 values. RESULTS: We estimated average per patient direct, indirect and total costs for the 6-month observation period. The costs from the perspective of statutory health insurance (Gesetzliche Krankenkversicherung [GKV]) consisted of direct medical costs 1370 euro +/- 3240 euro, including rehabilitation (420 euro +/- 1630 euro), hospitalisation (710 euro +/-2520 euro), outpatient treatment (40 euro +/- 30 euro), ancillary treatment (190 euro +/- 280 euro) and ambulatory diagnostic procedures (10 euro +/-30 euro). In addition, parkinsonian drug costs were 1520 euro +/-euro1250. Non-medical direct costs calculated from the GKV perspective were estimated to be euro480 +/-euro1710, which included transportation (10 euro+/- 20 euro), special equipment (420 euro +/- 1640 euro), social/home-help services (10 euro +/-110 euro) and sickness benefit (40 euro +/- 540 euro). The total medical (including drug costs) and non-medical direct costs for the GKV were 3380 euro +/- 4230 euro. Univariate predictors for GKV direct costs included occurrence of motor complications and falls, disease severity, nightmares and dementia. However, multivariate analyses only suggested disease severity and health-related quality of life as significant predictors. For nursing insurance, payments of 1330 euro +/- 2890 euro were calculated. For retirement insurance, payments were 650 euro +/- 1510 euro and there were patient (or caregiver) costs of 1490 euro +/- 2730 euro. Total indirect costs amounted to 3180 euro +/-6480 euro. CONCLUSION: According to our study, PD puts a high financial burden on society and underscores the need for further economic and medical research to optimise treatment for PD.     

The economic costs of caring for people with HIV infection and AIDS in England and Wales

The objectives of this study were firstly to estimate total lifetime care costs for an individual with HIV/AIDS, and secondly to estimate the total costs of caring people with HIV infection and AIDS in England and Wales between 1992 and 1997 inclusive. Questionnaires and monthly diaries were used to collate data on healthcare utilisation from patients with HIV infection over a 6-month period. These data were then used to estimate the annual total direct costs of care (stratified by disease stage), total lifetime costs of care, and present and future total national care costs for England and Wales. Costing data were obtained from providers of services throughout Greater London. In total, 235 patients with HIV infection were recruited from 2 clinics in Greater London. All costs were calculated in 1992-93 pounds sterling (pound; 1 pound = $US1.58, December 1995). Annual care costs were estimated at 4515 pounds ($US7134) for a person with asymptomatic HIV disease, 8836 pounds ($US13,961) for a person with symptomatic non-AIDS and 15 268 pounds ($US24,123) for a person with AIDS. Lifetime care costs were estimated at 84,522 pounds ($US133,545) per patient. The total costs of care for England and Wales were forecast to increase from 116,627,400 pounds ($US184,271,300) in 1992 to 162,638,100 pounds ($US256,968,200) in 1997. In conclusion, our study further emphasises the continued shift in hospital services from the inpatient sector to the outpatient sector. The importance of community care and informal care, in terms of the associated direct economic costs, is also highlighted. This emphasises the need for close collaboration between different agencies and strategic coordination of services. Finally, the study forecasts an increase in care costs in England and Wales during the 1990s.     

Selegiline: an appraisal of the basis of its pharmacoeconomic and quality-of-life benefits in Parkinson's disease

Selegiline (deprenyl) is a selective, irreversible cerebral monoamine oxidase type B inhibitor (MAO-B) that is used in the treatment of Parkinson's disease. It has a relatively mild adverse effect profile without risk of the tyramine ('cheese') reaction at normal therapeutic doses. In about half to two-thirds of patients with mild levodopa response fluctuations, selegiline improves overall disability and 'end-of-dose' fluctuations, with a levodopa-sparing effect. Selegiline thus may improve patient quality of life, although formal cost-utility analyses are required to establish the costs of these benefits. Cost-effectiveness studies may help characterise the relative pharmacoeconomic benefits of selegiline and the dopamine agonists, agents which can also be administered as adjuvant therapy at this stage of the disease. There is also evidence to suggest that selegiline may delay the need for levodopa therapy by up to 11 months in patients with early Parkinson's disease, although the relative contribution of neuroprotective and symptomatic effects of selegiline in these patients has yet to be clarified. From a societal perspective, a theoretical analysis indicates that the economic benefits of selegiline therapy are likely to be substantial. An agent which slowed progression of disability by around 10% would realise savings, through reduction in both direct and indirect costs, in the order of $US330 million per annum in the United States. Available data suggest that selegiline slows progression of symptoms well in excess of 10%. Further, if a simple and inexpensive method is developed to identify preclinical Parkinson's disease before nigrostriatal damage is advanced, selegiline may be useful in a broader patient population with possible financial benefits to society through reduction of the considerable indirect costs of Parkinson's disease.     

Clinical and economic outcomes of olanzapine compared with haloperidol for schizophrenia. Results from a randomised clinical trial.

OBJECTIVE: The purpose of this study was to compare, from the payor perspective, the clinical and economic outcomes of olanzapine to those of haloperidol for the treatment of schizophrenia. DESIGN AND SETTING: Clinical, quality-of-life and resource utilisation data were prospectively collected for US-residing patients with schizophrenia who were participating in a multicentre, randomised, double-blind clinical trial comparing olanzapine and haloperidol. Direct medical costs were estimated by assigning standardised prices (1995 values) to the resource utilisation data. PATIENTS AND PARTICIPANTS: 817 patients with schizophrenia who had a baseline Brief Psychiatric Rating Scale score (BPRS) > or = 18 (items scored 0 to 6) and/or were no longer tolerating current antipsychotic therapy. INTERVENTIONS: Olanzapine 5 to 20 mg/day (n = 551) or haloperidol 5 to 20 mg/day (n = 266) for 6 weeks. Patients showing a predefined level of clinical response entered a 46-week maintenance phase. MAIN OUTCOME MEASURES AND RESULTS: After acute treatment, BPRS-based clinical improvements were seen in 38 and 27% of olanzapine and haloperidol patients, respectively (p = 0.002). Clinically important improvements on the Quality of Life Scale were achieved during acute treatment in 33% of olanzapine recipients and 25% of haloperidol recipients (p = 0.094). Olanzapine treatment in the acute phase led to significantly lower inpatient ($US5125 vs $US5795, p = 0.038) and outpatient ($US663 vs $US692, p = 0.001) costs, resulting in a significant overall reduction in mean total medical costs of $US388 (p = 0.033). This significant reduction in total costs was found despite olanzapine mean medication costs being significantly greater than haloperidol medication costs ($US326 vs $US15, p < 0.001). No significant differences in clinical improvement were observed in the maintenance phase. Maintenance phase olanzapine mean total medical costs were $US636 lower than haloperidol total costs (p = 0.128). Although olanzapine medication costs were significantly higher than haloperidol medication costs ($US3461 vs $US95, p < 0.001), this difference was offset by significantly lower inpatient ($US8322 vs $US10,662, p = 0.044) and outpatient ($US3810 vs $US5473, p = 0.038) costs. CONCLUSIONS: In this study, olanzapine treatment was more effective than haloperidol in producing clinical response in the acute phase. In addition, olanzapine treatment led to reductions in inpatient and outpatient costs that more than offset olanzapine's higher medication costs relative to haloperidol.     

Acute medical costs of fluoxetine versus tricyclic antidepressants. A prospective multicentre study of antidepressant drug overdoses

Despite demonstrated differences in toxicity profiles between tricyclic antidepressants (TCAs) and selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitors (SSRIs), no studies have examined hospital costs associated with acute antidepressant overdoses. Given the high incidence of such overdoses, it is important to examine treatment patterns and associated costs. This prospective, multicentre cohort study compared the hospital and physician costs associated with TCA and fluoxetine drug overdoses. Over a 30-month period, 622 consecutive patients with a fluoxetine or TCA overdose presented to the emergency departments, or were admitted to intensive care or medical units, of 9 participating medical centres across the US. Inclusion criteria were: ingestion of a single antidepressant (fluoxetine or a TCA), without clinically significant co-ingestants; laboratory confirmation of the overdose; and retrievable hospital bills. Patients were followed until discharge from the emergency department or hospital. Hospital and physician charges were collected from billing data. Hospital charges were adjusted using Health Care Financing Administration cost: charge ratios to estimate costs; physician charges were adjusted to estimate costs. Patient demographic and clinical data were prospectively gathered during the course of medical treatment. Clinical data recorded included level of consciousness, cardiopulmonary complications, vital sign or ECG abnormalities, agitation, seizures, CNS depression and death. 136 patients (121 with TCA overdose and 15 with fluoxetine overdose), representing 21.8% of the 622 patients entered, met the inclusion criteria. Mean length of stay varied from 0.73 [+/-standard error of the mean (SEM) 0.33] days for fluoxetine overdose patients to 3.59 (+/-SEM 0.48) days for TCA overdose patients (p = 0.038). Mean hospital costs were $US668 for patients with a fluoxetine overdose compared with $US4691 for those with a TCA overdose (p < 0.0001). No significant differences were observed between the TCA and fluoxetine overdose groups with regard to physician costs. Median hospital and physician costs increased from $US3029 to $US4396 from the first 15-month period of the study to the second 15-month period of the study for the TCA overdose group, but decreased from $US881 to $US396 for the fluoxetine overdose group. Patients with fluoxetine overdoses had lower hospital and total medical costs compared with patients with TCA overdoses. There was some evidence supporting a reduction in the medical costs of treating fluoxetine overdoses over the 30-month study period.     

Economic burden of chronic obstructive pulmonary disease. Impact of new treatment options

The incidence, morbidity and mortality of chronic obstructive pulmonary disease (COPD) is rising throughout the world. The total economic cost of COPD in the US in 1993 was estimated to be over $US15.5 billion, with $US6.1 billion for hospitalisation, $US4.4 billion for physician and other fees, $US2.5 billion for drugs, $US1.5 billion for nursing home care and $US1.0 billion for home care. Office visits, hospital outpatient visits and emergency department visits accounted for 17.3% of the direct costs for COPD in the US. When stratified by severity, COPD treatment costs strongly correlate with disease severity. The American Thoracic Society, the European Respiratory Society and the British Thoracic Society have developed guidelines for the pharmacological treatment of COPD. However, the guidelines establish inhaled bronchodilators (anticholinergic agents and beta 2-adrenergic agonists) as the mainstay of therapy for patients with COPD. The guidelines were not based on cost analyses and thus are not a priori cost-effective guidelines. Since the publication of these guidelines, several new pharmacological products have been approved for use in patients with COPD including a combination of an anticholinergic and selective beta 2-adrenergic agonist [ipratropium/salbutamol (albuterol)] and a long-acting beta 2-adrenergic agonist (salmeterol). Both products are effective bronchodilators in COPD. The purpose of this report is to place these new agents in an updated pharmacological guideline scheme, utilising recently published data on clinical efficacy as well as pharmacoeconomics. The annualised healthcare costs were computed to be $US788/patient/year for the combination ipratropium/salbutamol inhaler and $US1059/patient/year for salmeterol (1999 values). Based upon an improved understanding of the complexity of COPD, the response of patients to newer bronchodilators (given individually or in combination), and recent pharmacoeconomic data for COPD treatment, a new treatment algorithm with associated costs is proposed. The use of an algorithm, based on medical and pharmacoeconomic data, will improve lung function in patients with COPD, improve patient satisfaction (e.g. quality of life, dyspnoea) and outcomes (e.g. exacerbations). It will also result in a positive effect on healthcare costs.     

Trial of Sinemet CR4 in patients with Parkinson's disease.

OBJECTS: to compare the efficacy of Sinemet CR4 (CR4), a slow release levodopa preparation, with that of standard Sinemet in patients with Parkinson's disease and motor fluctuations. METHODS: forty-five patients with Parkinson's disease of mild to moderate severity and motor fluctuations were entered into the 12 month trial. After a four week baseline period of optimal therapy, standard Sinemet was completely substituted by CR4 over 12 weeks, and clinical status monitored regularly over another 36 weeks. Evaluation was based on standard rating scales and patient's and physician's opinion ratings. RESULTS: forty-two patients completed the study. The mean optimum total daily dosage of Sinemet CR4 was 702 mg, significantly greater than the mean optimum daily dose of standard Sinemet--496 mg (p less than 0.01). Median number of doses per day was less, being 3 and 4 respectively (p less than 0.01). There was reduction in tremor (p less than 0.01) and rigidity (p less than 0.05) with Sinemet CR4 therapy compared with standard Sinemet, but no difference in disability scores, bradykinesia, gait, or postural instability. Twenty-five patients rated the change to Sinemet CR4 from standard Sinemet as "more helpful", 15 "about the same", and two "less helpful". There were no serious or unexpected adverse effects. CONCLUSIONS: it was concluded that Sinemet CR4 was at least as effective as standard Sinemet, and it seemed particularly helpful in those patients with wearing-off who require frequent doses of standard Sinemet throughout the day.     

The cost of reaching National Cholesterol Education Program (NCEP) goals in hypercholesterolaemic patients. A comparison of atorvastatin, simvastatin, lovastatin and fluvastatin

OBJECTIVE: Recognising the importance of treating hyperlipidaemia, the National Cholesterol Education Program (NCEP) has established widely accepted treatment goals for low density lipoprotein cholesterol (LDL-C). Medications used most commonly to achieve these LDL-C goals are HMG-CoA reductase inhibitors. The relative resource utilisation and cost associated with the use of reductase inhibitors of different LDL-C lowering efficacy are unknown, but are major health and economic concerns. The objective of this study was to determine the mean total cost of care to reach NCEP goals with various reductase inhibitors. DESIGN: In a randomised, 54-week, 30-centre controlled trial we compared resources used and costs associated with treating patients to achieve NCEP goals using 4 reductase inhibitors: atorvastatin, simvastatin, lovastatin and fluvastatin. PATIENTS AND PARTICIPANTS: The trial studied 662 patients; 318 had known atherosclerotic disease. INTERVENTIONS: Reductase inhibitor therapy was initiated at recommended starting doses and increased according to NCEP guidelines and package insert information. For patients who did not reach the goal at the highest recommended dose of each reductase inhibitor, the resin colestipol was added. MAIN OUTCOME MEASURES AND RESULTS: Patients treated with atorvastatin, compared-with other reductase inhibitors, were more likely to reach NCEP goals during treatment (p < 0.05), required fewer office visits (p < 0.001) and less adjuvant colestipol therapy (p = 0.001). Consequently, the mean total cost of care (1996 values) to reach NCEP goals was lower with atorvastatin [$US1064; 95% confidence interval (CI): $US953 to $US1176] compared with simvastatin ($US1471, 95% CI: $US1304 to $US1648), lovastatin ($US1972; 95% CI: $US1758 to $US2186) and fluvastatin ($US1542; 95% CI: $US1384 to $US1710). Results were similar for patients with or without known atherosclerotic disease. CONCLUSIONS: In patients requiring drug therapy for hypercholesterolaemia, NCEP LDL-C goals are achieved significantly more often using fewer resources with atorvastatin compared with simvastatin, lovastatin or fluvastatin.     

Cost-effectiveness analysis of formoterol versus salmeterol in patients with asthma.

OBJECTIVE: The aim of this study was to determine the relative economic consequences of treating asthmatics with twice daily dry powder formoterol 12 micrograms as compared with salmeterol 50 micrograms from a societal perspective. DESIGN AND SETTING: A randomised, 6-month, open-label study including 482 patients with asthma was conducted in Italy, Spain, France, Switzerland, the UK and Sweden. Medical costs included the costs of medications, physician services, emergency room visits, hospital admissions and lung function and other tests. Travel costs and costs of production loss were also calculated. Unit prices were estimated from external sources. To pool the costs of the 6 countries, European currencies were converted to US dollars using 1995 exchange rates. Outcome measures were the number of episode-free days (EFDs) and the number of patients reaching a clinically relevant improvement in quality of life as measured using the St. Georges Respiratory Questionnaire. MAIN OUTCOME MEASURES AND RESULTS: There were no significant differences between the 2 treatment arms in the frequency of emergency room visits, hospital admissions, use of rescue medication or contacts with general practitioners (GPs), specialists or nurses. Median medical costs over 6 months were $US828 per patient with formoterol and $US850 with salmeterol. This difference was not statistically significant. In both groups, about 60% of all days were episode-free. Average costs per EFD were about $US9 for both treatments. The average cost per patient reaching a clinically relevant improvement in quality of life was between $US1300 and $US1400. Incremental cost-effectiveness ratios were not calculated because both costs and outcomes were not significantly different. Asthma-related absenteeism ranged between 3 days and 6 months per patient in both groups. CONCLUSIONS: There was no evidence to suggest that either treatment was more cost effective than the other.     

Direct costs of hip fractures in patients over 60 years of age in Belgium.

OBJECTIVE: Osteoporosis-related costs are now considered a major burden for health authorities in most developed countries. An accurate and exhaustive evaluation of these costs would be a major contribution to health economic studies evaluating the efficiency of screening and prevention strategies. Osteoporosis is the most frequent underlying cause of femoral neck fractures in the elderly; these fractures weigh heavily on healthcare budgets. However, in Belgium, very few data on the financial burden of hip fractures are available and no updated estimates have been made. The goal of this paper is to estimate the direct medical expenditures associated with hip fractures in Belgium in 1996. DESIGN AND SETTING: This 1-year population-based cross-sectional study is conducted from the social security perspective. The target population in this study are men and women aged 60 years and over. PATIENTS AND PARTICIPANTS: We selected patients who had been hospitalised for a hip fracture during the year 1996 who were also affiliated with a registered social security organisation (covering 25% of the Belgian population). The sample constituted 2374 patients. INTERVENTIONS: For each of these patients, we collected an exhaustive and detailed list of healthcare resource use as well as nursing home admissions following the hip fracture event. Cost items investigated in the analysis were inpatient hospital costs and outpatient costs. Mean annual costs per case recorded in the sample were then extrapolated to the whole country on the basis of an exhaustive list of diagnoses having lead to all countrywide hospitalisations (1,700,000 hospital stays/year). MAIN OUTCOME MEASURES AND RESULTS: The mean hospital inpatient costs for hip fracture were evaluated at 332,148 Belgian francs (BeF) [$US8977] per case and BeF4,367,746,200 ($US118,047,194) for the whole country (10 million inhabitants). Patients with a hip fracture experienced an annual BeF27,825 ($US752) extra outpatient cost during the year following this fracture event, after correcting for costs related to additional comorbidity already present before the hip fracture. Finally, after a proximal femoral neck fracture, the rate of nursing home admission was higher, both for men and women at any age compared with age- and gender-matched population. CONCLUSIONS: With a total cost (acute hospital and outpatient costs) of BeF4,667,894,950 ($US126,159,323) per year in Belgium, proximal femoral neck fracture should be considered a major health economic problem and appropriate measures to prevent this disease should be rapidly undertaken.