Economic burden of privately insured non-vertebral fracture patients with osteoporosis over a 2-year period in the US.

UNLABELLED: This study assesses the costs of non-vertebral osteoporosis-related fractures patients compared with osteoporosis patients without fractures, focusing on the second year following a fracture. Since fracture patients remained more costly in the second year, their economic burden extends beyond the year in which the fracture occurs. INTRODUCTION: The purpose of this study is to examine the comorbidity profile, resource use, and direct costs of patients who incur osteoporosis-related non-vertebral (NV) fractures in the United States during the 2 years following an incident fracture, focusing on the second year following a fracture. METHODS: Osteoporosis patients (ICD-9-CM: 733.0) with a NV fracture (hip, femur, pelvis, lower leg, upper arm, forearm, rib, and multiple sites) were selected from a privately insured health insurance claims database (>8 million lives, ages 18-64, 1999-2006). These NV fracture patients were randomly matched 1:1 on age, gender, employment status, and geographic region to controls with osteoporosis but without a fracture history. Year-by-year and month-by-month rates of comorbidities, resource use, and direct costs were calculated for the matched sample (N = 3,781). RESULTS: Comorbidity rates and resource use remained significantly higher among NV fracture patients during second year following an NV fracture compared with controls, although absolute rates of comorbidities and service utilization declined. Mean direct excess costs for NV fracture patients fell from $5,267 in the first year to $2,072 in the second year after a fracture, but remained statistically significant (p < 0.01). Patients with fractures of the pelvis, hip, and femur had the highest excess costs in the second year ($5,121, $3,930, and $3,828, respectively). Although hip fractures had highest excess costs over both years, non-vertebral, non-hip fracture patients made up a larger proportion of the sample and were significantly more costly than controls. CONCLUSIONS: Patients with osteoporosis-related NV fractures have substantial excess costs beyond the first year in which the fracture occurs.

Prevalence and costs of osteoporotic patients with subsequent non-vertebral fractures in the US.

UNLABELLED: This study assesses prevalence of subsequent fractures during the year after incident osteoporosis-related non-vertebral fractures among privately insured and Medicare populations and compares costs between patients with and without subsequent fractures. Many non-vertebral fracture patients incur subsequent fractures, and those who do are significantly more costly during the year after incident fracture. INTRODUCTION: To estimate the prevalence of subsequent osteoporosis-related non-vertebral (NV) fractures during the year following an incident NV fracture and compare costs between NV fracture patients with and without subsequent fractures. METHODS: Using insurance claims data (1999-2006), privately-insured (ages 18-64 years) and Medicare (ages 65+ years) patients with ≥1 subsequent osteoporosis-related NV fracture within a year of an incident osteoporosis-related NV fracture were matched to controls with incident NV fractures but no subsequent fractures. Subsequent fractures were identified as any claim for an NV fracture occurring >3 months after the incident NV fracture (>6 months were required for fractures occurring at the same site as the incident fracture). The study assessed prevalence of subsequent fractures and compared costs (from the payer's perspective) between patients with and without subsequent fractures over the year following an incident NV fracture. RESULTS: Among privately insured NV fracture patients, 14.1% had any subsequent NV fractures, 1.6% had subsequent hip fractures, and 13.0% had subsequent non-vertebral, non-hip (NVNH) fractures, while 22.6% of Medicare NV fracture patients had subsequent NV fractures, 9.4% had subsequent hip fractures, and 15.5% had subsequent NVNH fractures. Mean excess health care costs per privately insured subsequent fracture patient were $9,789 ($19,072 vs. $9,914, p < 0.01), while excess medical costs per Medicare subsequent fracture patient were $12,527 ($31,904 vs. $19,377, p < 0.01). CONCLUSIONS: NV fracture patients are at substantial risk for subsequent NV fractures within 1 year, and patients who incur subsequent fractures are significantly more costly than those who do not during the year following an incident fracture.

Effectiveness of antipsychotic treatment for schizophrenia: 6-month results of the Pan-European Schizophrenia Outpatient Health Outcomes (SOHO) study.

OBJECTIVE: To present the 6-month outcomes associated with antipsychotic treatment of patients participating in the Schizophrenia Outpatient Health Outcomes (SOHO) study. METHOD: SOHO is a 3-year, prospective, observational study of the health outcomes associated with antipsychotic treatment in 10 European countries. The study included over 10,000 out-patients who were initiating or changing their antipsychotic medication. RESULTS: Clinical Global Impression (CGI)-severity and quality of life (QOL) scores improved in all treatment cohorts. There was a higher response in the CGI-overall symptoms and in the CGI-schizophrenia positive, negative, cognitive and depressive symptom scales in the olanzapine (Olz) and clozapine (Cloz) cohorts compared with other treatment cohorts. Changes were associated with an improvement in QOL. CONCLUSION: Patients starting Olz and Cloz tend to have better outcomes at 6 months than patients who start other antipsychotics in actual out-patient clinical practice. The results should be interpreted conservatively because of the non-randomized study design.

Olanzapine vs. other antipsychotics in actual out-patient settings: six months tolerability results from the European Schizophrenia Out-patient Health Outcomes study.

OBJECTIVE: The European Schizophrenia Out-patient Health Outcomes study is an observational study investigating treatment in schizophrenia. We report treatment-emergent adverse events during the first 6 months of treatment. METHOD: The rate of extrapyramidal symptoms (EPS), anticholinergic use, weight gain and sexual related dysfunctions were assessed in 8,400 out-patients. RESULTS: Patients typical antipsychotics and risperidone experienced significantly more EPS and anticholinergic use than patients in the clozapine, olanzapine, and quetiapine cohorts. Patients treated with amisulpride, typical antipsychotics and risperidone were significantly more likely to have sexual related dysfunctions and/or amenorrhea. Increases in weight and body mass index occurred in all cohorts, but were significantly greater in the olanzapine and clozapine cohorts. CONCLUSION: Patients treated with olanzapine, quetiapine and clozapine had better tolerability outcomes regarding EPS and sexual related dysfunctions compared with patients receiving risperidone, amisulpride and typicals. Patients treated with olanzapine and clozapine had higher weight increases than patients treated with risperidone, quetiapine and typicals.

[Bipolar I disorder in France: prevalence of manic episodes and hospitalisation-related costs]. / Le trouble bipolaire I en France: prévalence des épisodes maniaques et coût des hospitalisations pour ce motif.

Bipolar disorder is a chronic, highly disabling illness. However, few studies have evaluated the economic impact of this illness. The objective of this study was to estimate: 1) the annual number of manic episodes in patients with bipolar I disorder, and 2) the costs of hospitalisations related to manic episodes in France. We only included data on bipolar I disorder, as there is greater consensus and better documentation for this subgroup of patients with bipolar disorder. The prevalence of manic episodes was estimated using published epidemiological data. A computerised literature search was performed using the traditional scientific and medical databases. Additional epidemiological references were identified from published studies and textbooks. For hospitalisation data, we used the statistics of the Medical Information Department of a large psychiatric hospital in Paris for the year 1999. We estimated the annual number of manic episodes in France based on: 1) the lifetime prevalence of bipolar I disorder, 2) the average cycle duration, 3) the proportion of rapid cycling patients, and 4) the proportion of depressive vs. manic episodes for patients with bipolar I disorder. In order to estimate the prevalence of bipolar I disorder, we conducted a random effects meta-analysis using published international data. Results of the meta-analysis, which was based on a total of 62 736 patients, showed the lifetime prevalence of bipolar I disorder to be 0.82% [95% CI: 0.42, 1.21]. Applied to the adult population in France, this prevalence implies that the number of persons who have ever experienced a bipolar I -disorder is approximately 390,000 [95% CI: 200,000, 575,000]. Few studies provide information on the duration of cycles in patients with bipolar I disorder. Available estimates suggest the cycle duration to be approximately 12 months. Regarding the proportion of rapid cyclers, data from the meta-analysis by Tondo et al. show that 18% of patients with bipolar disorder experience at least four episodes of mood disorder per year. Finally, based on findings provided by cohort studies, the number of depressive episodes appears to be roughly equal to the number of manic episodes during the course of bipolar disorder. A rapid cycling rate of 18% and a cycle duration of 12 months imply that, on average, among 100 bipolar patients, 18 will have a 3-month cycle duration and 82 a 14-month cycle duration. Given an equal proportion of manic and depressive episodes, the annual number of manic episodes would then be 68 for a cohort of 100 bipolar patients (0.68 episode per patient per year). Applying this figure to the estimate of the total number of patients with bipolar I disorder in France suggests that the annual number of manic episodes in France is 265,000 [95% CI: 136,000, 391,000]. Based on data from a psychiatric hospital in Paris, the proportion of manic episodes that require hospitalisation was estimated to be around 63% with an average length of stay of 32.4 days. Hence the annual number of hospitalisations for manic episodes in France is estimated to be 167 000 [95% CI: 86 000, 246 000] and the hospitalisation-related costs 1,3 billion euros approximately. Our review of literature highlights the lack of medical and economic data at the national level on the frequency and hospitalisation-related costs of manic episodes in patients with bipolar I disorder in France. Given the lifetime prevalence of bipolar I disorder which may be as high as 3% among adults, further studies are required in order to provide representative national data and to allow economic evaluations of costs related to bipolar disorder in France.

The European Schizophrenia Outpatient Health Outcomes Study: baseline findings across country and treatment.

OBJECTIVE: To describe the baseline findings and study population of the Schizophrenia Outpatient Health Outcomes (SOHO) Study. METHOD: The SOHO study is an ongoing, large, prospective, long-term observational study of schizophrenia treatment in 10 European countries. The study population consists of out-patients who initiate therapy or change to a new antipsychotic. RESULTS: A total of 1096 investigators enrolled 10 972 patients. Approximately 60% of patients were men and the mean age was 40 years. Patients treated with clozapine and more than one antipsychotic are more severely ill, patients receiving depot medications have a history of non-compliance, and patients receiving their first antipsychotic for schizophrenia are most likely to receive an atypical agent. CONCLUSION: The SOHO study population appears to represent European out-patients with schizophrenia in whom a treatment decision is required. Baseline findings reflect European clinical practice with respect to patients treated with individual antipsychotics.

A Rasch model analysis to test the cross-cultural validity of the EuroQoL-5D in the Schizophrenia Outpatient Health Outcomes Study.

OBJECTIVE: To investigate the pan-European, cross-cultural validity of the EuroQol-5D (EQ-5D) for assessing quality of life in the Schizophrenia Outpatient Health Outcomes (SOHO) Study. METHOD: The EQ-5D items investigated were mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A Rasch rating scale model (a form of differential item functioning) was used to identify invariance of item calibrations for the 10 European countries participating in the SOHO study. RESULTS: There was general congruence in the EQ-5D item calibration pattern. The rank of average EQ-5D item calibrations was similar for all countries except Denmark. Denmark showed slight misfits for mobility and pain/discomfort. CONCLUSION: The EQ-5D is an appropriate measure of health-related quality of life across European countries and translations.

Unit costs in international economic evaluations: resource costing of the Schizophrenia Outpatient Health Outcomes Study.

OBJECTIVE: We present unit costs corresponding to resource information collected in the Schizophrenia Outpatient Health Outcomes (SOHO) Study. METHOD: The SOHO study is a 3-year, prospective, observational study of health outcomes associated with antipsychotic treatment in out-patients treated for schizophrenia. The study is being conducted across 10 European countries (Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and the UK) and includes over 10,800 patients and over 1000 investigators. To identify the best available unit costs of hospital admissions, day care and psychiatrist out-patient visits, a tariff-based approach was used. RESULTS: Unit costs were obtained for nine of the 10 countries and were adjusted to 2000 price levels by consumer price indices and converted to US dollars using purchasing power parity rates (and on to Euro). CONCLUSION: The paper illustrates the need to balance the search for sound unit costs with pragmatic solutions in the costing of international economic evaluations.

The European Schizophrenia Outpatient Health Outcomes (SOHO) study: rationale, methods and recruitment.

OBJECTIVE: The objective of the European Schizophrenia Outpatient Health Outcomes (SOHO) study is to understand the comparative costs and outcomes of antipsychotic drug treatment, with specific focus on olanzapine. The study will also provide a large database for research into the treatment and outcome of schizophrenia. The role of observational studies in the assessment of the effectiveness of antipsychotic agents is reviewed, and the rationale, design and recruitment issues surrounding the SOHO study are presented. METHOD: SOHO is a 3-year, prospective, observational study of the health outcomes associated with antipsychotic treatment in Europe. RESULTS: Over 10 000 patients have been recruited from 10 countries. Baseline evaluation included measures of clinical status, social functioning, quality of life, service use and pharmacological treatment. Patients will be followed for 3 years. CONCLUSION: The SOHO study will complement randomized controlled trial findings on the treatment of schizophrenia and will address relevant clinical and policy research questions.

Olanzapine versus haloperidol in the treatment of acute mania: clinical outcomes, health-related quality of life and work status.

We aimed to compare clinical outcomes, health-related quality of life (HRQOL) and work status associated with olanzapine and haloperidol treatment in patients with bipolar disorder. This double-blind, randomized controlled trial, comparing flexible dosing of olanzapine (5-20 mg/day, n = 234) to haloperidol (3-15 mg/day, n = 219), consisted of a 6-week acute phase, followed by a 6-week continuation phase. Symptomatic remission rates were similar for olanzapine- and haloperidol-treated patients at weeks 6 and 12. At week 6, significant changes in five dimensions of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) [general health (P = 0.010), physical functioning (P < 0.001), role limitations due to physical problems (P < 0.001), social functioning (P < 0.05) and vitality (P < 0.01)] and the SF-36 physical components summary score were found in favour of olanzapine compared to haloperidol. At week 12, olanzapine treatment maintained the significantly favourable HRQOL changes. At the end of week 12, patients on olanzapine showed significantly greater improvement than haloperidol in work activities impairment and household activities impairment scores on the Streamlined Longitudinal Interview Clinical Evaluation from the Longitudinal Interval Follow-up Evaluation (SLICE/LIFE) activities impairment scores. Subgroup analyses revealed that olanzapine treatment significantly increased a proportion of employed patients and their weekly paid working hours. In conclusion, compared to haloperidol, olanzapine treatment was comparably effective in the remission of bipolar mania and significantly improved HRQOL and work status in patients with bipolar I disorder.

Functional outcomes in schizophrenia: a comparison of olanzapine and haloperidol in a European sample.

The primary aim of this study was to compare functional outcomes between patients with schizophrenia treated with olanzapine or haloperidol in Europe. The sample consisted of European patients from a large, international, double-blind, randomized clinical trial. Patients were randomized to receive either olanzapine (n = 520) or haloperidol (n = 258) for a 6-week acute phase followed by a 46-week maintenance phase for responders. Olanzapine-treated patients experienced superior improvements compared to haloperidol-treated patients on all efficacy measures assessed in both phases. A greater percentage of olanzapine-treated patients had > or = 20% improvement in the Quality of Life Scale total score during both the acute (50.0% versus 31.0%, P = 0.071) and maintenance (69.5% versus 41.7%, P = 0.006) phases compared to haloperidol-treated patients. For patients who entered the maintenance phase as outpatients, olanzapine-treated patients were significantly less likely to require subsequent hospitalization compared to haloperidol-treated patients (P = 0.001). A significantly greater percentage of the olanzapine group compared to the haloperidol group worked part-time or full-time (15.1% versus 5.3%, P = 0.018), participated in useful work > or = 75% of the time (21.0% versus 10.5%, P = 0.038), and socialized more than once a month (53.8% versus 37.9%, P = 0.004) during the maintenance phase. The findings from this study suggest that olanzapine's clinical profile leads to reduced hospitalization and improvements in work and social functioning superior to that achieved with haloperidol treatment.

Initial treatment choice in depression: impact on medical expenditures.

OBJECTIVE: The purpose of this study was to examine the economic outcomes associated with initial treatment choice following a diagnosis of depression. METHODS: Insurance claims data were used to classify patients into one of 4 treatment cohorts: no therapy, psychotherapy, drug therapy and combination therapy. Potential sample selection bias was accounted for by using a 2-stage econometric estimation procedure where initial treatment choice was estimated using a multinomial logistic regression model in the first stage, and total and mental healthcare costs were estimated in ordinary least squares regression models in the second stage. Log predicted costs from the second stage were compared to determine the relative costs associated with each cohort. RESULTS: Significant differences (p < 0.008) in total costs were found between the combination therapy (log predicted cost = 9.526) and psychotherapy cohorts (log predicted cost = 8.120) in the analysis that included all observations (n = 9110). In the analysis that included patients who initiated therapy with a non-mental health provider (n = 2673), the drug therapy cohort (log predicted cost = 8.238) was found to be significantly more costly as compared to the no therapy cohort (log predicted cost = 7.788). CONCLUSIONS: These results indicate that after controlling for both observed and unobserved factors, total healthcare costs may be higher in patients who initiate therapy with drug therapy and combination therapy as opposed to no therapy or psychotherapy. In addition, the finding that patients initially receiving psychotherapy alone tend to have higher mental healthcare costs but lower total healthcare costs than other patients may indicate that psychotherapy has an impact on comorbid illness and may subsequently reduce total healthcare 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.

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.

A framework for drug utilization evaluation in depression: insights from outcomes research.

BACKGROUND: Drug utilization evaluation (DUE) offers the prospect of improving the quality of care in depression by focusing on drug-related problems (DRPs). Outcomes research in depression can provide a basis on which to address difficulties in implementing DUE programs in the outpatient environment of managed care. OBJECTIVE: The purpose of this paper is to facilitate the development of a drug utilization evaluation program for depressed patients receiving care in an outpatient environment. METHODS: The literature was reviewed in the area of depression treatment, drug-related problems, and current outcomes research. This information was synthesized into a framework with potential DUE criteria. CONCLUSION: The quality of care for depression can be improved if these efforts are focused on solving DRPs. Outcomes research findings may be used as the basis for developing DUE criteria and as a first step in selecting and targeting interventions.

A review of health-related quality-of-life measures used in end-stage renal disease.

Health-related quality of life (HRQOL) is a critical issue in the treatment of end-stage renal disease (ESRD) patients. The variety of symptoms, comorbidities, and treatments of ESRD over the course of its chronic disease trajectory necessitate comprehensive assessment of the impact of interventions on HRQOL. A literature review of ESRD HRQOL studies was performed to provide an overview of the instruments used and to provide recommendations for HRQOL assessment in future studies. Instruments were classified based on the health domains they assess and whether they are generic or disease targeted. The instruments were judged in terms of their comprehensiveness, reliability, and validity.