The economic impact of implementing a multiple inflammatory biomarker-based approach to identify, treat, and reduce cardiovascular risk.

OBJECTIVES: To develop an economic model to estimate the change in the number of events and costs of non-fatal myocardial infarction (MI) and non-fatal ischemic stroke (IS) as a result of implementing routine risk-stratification with a multiple inflammatory biomarker approach. METHODS: Reductions in the numbers of non-fatal MI and non-fatal IS events and in related per-member-per-month (PMPM) and 5-year costs (excluding test costs) due to biomarker testing were modeled for a US health plan with one million beneficiaries. Inputs for the model included literature-based MI and IS incidence rates, healthcare costs associated with MI and IS, laboratory results of biomarker testing, MI and IS hazard ratios related to biomarker levels, patient monitoring and intervention costs and use/costs of preventative pharmacotherapy. Preventative pharmacotherapy inputs were based on an analysis of pharmacy claims data. Costs savings (2013 USD) were assessed for patients undergoing biomarker testing compared to the standard of care. Data from MDVIP and Cleveland Heart Lab supported two critical inputs: (1) treatment success rates and (2) the population distribution of biomarker testing. Incidence rates, hazard ratios, and other healthcare costs were obtained from the literature. RESULTS: For a health plan with one million members, an estimated 21,104 MI and 22,589 IS events occurred in a 5-year period. Routine biomarker testing among a sub-group of beneficiaries ≥35 years old reduced non-fatal MI and IS events by 2039 and 1869, respectively, yielding cost savings of over $187 million over 5 years ($3.13 PMPM), excluding test costs. Results were sensitive to changes in treatment response rates. Nonetheless, cost savings were observed for all input values. CONCLUSIONS: This study suggests that health plans can realize substantial cost savings by preventing non-fatal MI and IS events after implementation of routine biomarker testing. Five-year cost savings before test costs could exceed $3.13 PMPM.

Impact of medication adherence to disease-modifying drugs on severe relapse, and direct and indirect costs among employees with multiple sclerosis in the US.

OBJECTIVE: To compare rates of severe relapse and total direct and indirect costs over a 2-year period between US-based employees with multiple sclerosis (MS) who were adherent and non-adherent to disease-modifying drugs (DMDs). METHODS: Employees with ≥1 MS diagnosis (ICD-9-CM: 340.x) and ≥1 DMD pharmacy claim between 1/1/2002-12/31/2007 were identified from a large US administrative claims database. Patients had continuous coverage ≥6 months before (baseline) and ≥24 months after (study period) their index date (first DMD claim). Adherence was measured using medication possession ratio (MPR) over the study period. Patients with MPR ≥80% were considered adherent (n = 448) and those with MPR <80% as non-adherent (n = 200). Multivariate analyses were used to compare rates of severe relapse (inpatient or Emergency Department visit with MS diagnosis) and costs in 2007 dollars between DMD adherent and non-adherent patients. Direct costs were calculated as reimbursements to providers for medical services and prescription drugs excluding DMDs. Indirect costs included disability and medically-related absenteeism costs. RESULTS: DMD adherent patients were on average older (43.5 vs 41.8 years, p = 0.015) and more likely to be male (38.6% vs 26.0%, p = 0.002) compared with non-adherent patients. Adherent patients had lower rates of depression, higher rates of previous DMD use, and higher baseline MS-related costs. After adjusting for differences in baseline characteristics, DMD adherent patients had a lower rate of severe relapse (12.4% vs 19.9%, p = 0.013) and lower total (direct and indirect) costs ($14,095 vs $16,638, p = 0.048) over the 2-year study period. CONCLUSIONS: In this study, DMD adherence was associated with a significantly lower rate of severe relapse and lower total costs over 2 years. Causality cannot be inferred because adherence and outcomes were measured over the same period. The study was subject to limitations associated with use of claims data and the absence of clinical measures.

Direct costs and survival of medicare beneficiaries with early and advanced Parkinson's disease.

BACKGROUND: No recent analysis details Parkinson's Disease (PD) costs or survival for Medicare beneficiaries. This study assesses excess direct costs and survival in Medicare beneficiaries with early and advanced PD. METHODS: Patients with ≥ 2 PD diagnoses (ICD-9-CM: 332.0), ≥ age 65, continuously enrolled in Parts A&B during one-year baseline and study periods were selected from the Medicare 5% sample (N = 3.2 million, 1999-2008). Newly diagnosed patients were defined as having no baseline claims for movement disorder, dementia, Alzheimer's, bipolar disorder, psychosis, falls or related injuries, ambulatory assistance device (walker or wheelchair), or skilled nursing facility. Controls without PD were demographically matched 1:1. Costs to Medicare were compared via Wilcoxon rank-sum tests and inverse probability weighted multivariate regression. Survival was assessed via Cox proportional hazards analysis. RESULTS: Costs in the year post-diagnosis were higher for newly diagnosed patients (N = 9,201, $7423) than controls ($5024), resulting in excess PD-associated costs of $2399 (p < 0.001). Cumulative excess costs were $28,422 from the year prior to index quarter to five years following (p < 0.01). PD patients receiving their first claim for an ambulatory assistance device (N = 11,294) had excess cumulative costs of $50,923 (p < 0.001) over the same period; those receiving their first claim for a skilled nursing facility (N = 10,152) had excess costs of $102,750 (p < 0.001). Hazard rates of mortality were higher among newly diagnosed PD (1.43, p < 0.001), ambulatory assistance device (2.37, p < 0.001) and skilled nursing facility (3.34, p < 0.001) cohorts than in corresponding non-PD groups. CONCLUSIONS: Medicare beneficiaries with PD have substantially and progressively higher costs and mortality compared with controls.

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.

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.

Age differences in major depression: results from the National Comorbidity Survey Replication (NCS-R).

BACKGROUND: Although depression appears to decrease in late life, this could be due to misattribution of depressive symptom to physical disorders that increase in late life. METHOD: We studied age differences in major depressive episodes (MDE) in the National Comorbidity Survey Replication, a national survey of the US household population. DSM-IV MDE was defined without organic exclusions or diagnostic hierarchy rules to facilitate analysis of co-morbidity. Physical disorders were assessed with a standard chronic conditions checklist and mental disorders with the WHO Composite International Diagnostic Interview (CIDI) version 3.0. RESULTS: Lifetime and recent DSM-IV/CIDI MDE were significantly less prevalent among respondents aged 65 years than among younger adults. Recent episode severity, but not duration, was also lower among the elderly. Despite prevalence of mental disorders decreasing with age, co-morbidity of hierarchy-free MDE with these disorders was either highest among the elderly or unrelated to age. Co-morbidity of MDE with physical disorders, in comparison, generally decreased with age despite prevalence of co-morbid physical disorders usually increasing. Somewhat more than half of respondents with 12-month MDE received past-year treatment, but the percentage in treatment was lowest and most concentrated in the general medical sector among the elderly. CONCLUSIONS: Given that physical disorders increase with age independent of depression, their lower associations with MDE in old age argue that causal effects of physical disorders on MDE weaken in old age. This result argues against the suggestion that the low estimated prevalence of MDE among the elderly is due to increased confounding with physical disorders.

Asthma severity categorization using a claims-based algorithm or pulmonary function testing.

OBJECTIVES: This study was performed to determine whether pulmonary function test results would appreciably alter asthma severity categorization determined by an algorithm using information readily available in administrative databases. METHODS: Patients 6 to 64 years of age with asthma diagnosed from 1999-2005, who had at least one pulmonary function test, were identified from a claims database of a medical group practice located in central Massachusetts. Asthma severity for these patients was categorized using information available in an administrative database (claims-based algorithm) and by percent predicted forced expiratory volume in 1 second (FEV(1)) or peak expiratory flow (PEF) abstracted from medical charts (pulmonary function test method). Gamma rank correlation index was used to measure the association between the two severity categorization methods. Total and asthma-related healthcare costs for each severity category were compared between the two different approaches. RESULTS: There was a significant ordinal association between severity categorization with the two classification approaches (p = 0.0002). The pulmonary function test method resulted in more frequent mild categorizations and less frequent moderate and severe categorizations than the claims-based algorithm. In only 10.9% of patients did the pulmonary function test method result in a more severe asthma category than the claims-based algorithm. Patients with more severe asthma, determined by both methods, had higher total and asthma-related health care costs. Total and asthma-related health care costs were similar for each asthma severity categorization for the two classification approaches, except for asthma-related costs in the moderate severity categories. CONCLUSION: The claims-based algorithm generally categorized patients as having more severe asthma than the approach using pulmonary function test results. Pulmonary function test results would have appreciably changed asthma severity categorization in only a small percent of patients. These findings add further support to the use of administrative database analyses for the evaluation of asthma care in large populations.

Development of a COPD severity score.

OBJECTIVE: Treatment of chronic obstructive pulmonary disease (COPD) is based on symptom control. This suggests that COPD severity can be determined by analyzing treatment intensity. The objective of this analysis was to develop and validate a severity score for adult COPD based on treatments. RESEARCH DESIGN: Using principal components analysis, a COPD severity score was developed using data based on treatments extracted from an employer claims database (development group). Variables included were identified from literature review and clinical expert opinion. External validity was tested in a separate group of adult chronic bronchitis patients in whom principal components analysis was re-conducted and factor loadings were compared to the development group. Construct validity was tested by comparing the incidence of acute exacerbations of chronic bronchitis (AECB) in patients with high and lower severity scores. To illustrate the use of the COPD severity score, effectiveness of alternative AECB antibiotic treatments was compared in a separate patient sample categorized by severe versus mild/moderate COPD. RESULTS: In the development group (n = 2068), principal components analysis produced a single main factor for severity scoring. Of the 12 variables contributing to this factor, the 6 with the highest factor loadings were treatment related. The factor performed similarly in the external validity group (n = 9127) as it did in the development group. In construct validity testing, severe COPD patients were 4 times more likely to have AECB episodes than mild/moderate patients. Patients with severe COPD and an AECB were more likely to fail treatment with antibiotics than those with mild/moderate COPD. Based on the COPD severity score developed, we found that treatment of patients with severe COPD and an AECB with fluoroquinolones was more likely to result in treatment failure than treatment with macrolides (OR = 2.01; p = 0.03). CONCLUSIONS: The analysis was successful in developing and validating a method to score COPD severity based on treatments. This method may prove useful in providing insights about the benefits of COPD treatments.

Healthcare and workloss costs associated with patients with persistent asthma in a privately insured population.

OBJECTIVE: The objective of this study was to estimate annual healthcare and workloss costs of patients with persistent asthma by severity. METHODS: A persistent asthma patient sample (<65 years) was selected from an employer claims database. Asthma persistence and severity were determined by a novel algorithm based on Health Plan Employer Data and Information Set criteria, Leidy's Reliever and Oral Steroid Method, and Global Initiative for Asthma guidelines. Healthcare costs were compared between asthma patients and demographically matched controls and by asthma severity. RESULTS: Average annual excess costs for persistent patients were $4412 for health care and $924 for workloss (P < 0.01). Although costs for severe patients were higher than moderate patients (P < 0.05), moderate patients' costs were similar to that for mild patients. Persistent use of inhaled corticosteroids was lower in mild (9.0%) relative to moderate (78.1%) and severe (86.4%) patients. CONCLUSIONS: Persistent asthma is expensive. Underutilization of inhaled corticosteroids is higher in patients with mild persistent asthma.

Economic burden of pneumonia in an employed population.

OBJECTIVE: To estimate the overall economic burden of pneumonia from an employer perspective. METHODS: The annual, per capita cost of pneumonia was determined for beneficiaries of a major employer by analyzing medical, pharmaceutical, and disability claims data. The incremental costs of 4036 patients with a diagnosis of pneumonia identified in a health claims database of a national Fortune 100 company were compared with a 10% random sample of beneficiaries in the employer overall population. RESULTS: Total annual, per capita, employer costs were approximately 5 times higher for patients with pneumonia ($11 544) than among typical beneficiaries in the employer overall population ($2368). The increases in costs were for all components (eg, medical care, prescription drug, disability, and particularly for inpatient services). A small proportion (10%) of pneumonia patients (almost all of whom were hospitalized) accounted for most (59%) of the costs. CONCLUSIONS: Patients with pneumonia present an important financial burden to employers. These patients use more medical care services, particularly inpatient services, than the average beneficiary in the employer overall population. In addition to direct health care costs related to medical utilization and the use of prescription drugs, indirect costs due to disability and absenteeism also contribute to the high cost of pneumonia to an employer.

Assessing the economic impact of psychiatric disorders: where to begin?

Over the past decade, psychiatric disorders have increasingly been regarded as serious public health concerns, with debilitating symptoms as well as high social and economic costs to patients, caregivers, third party payers and society. In this article, we review findings from recent research on psychiatric disorders, while providing a framework for assessing their pharmacoeconomic impact. In particular, we consider the prevalence of psychiatric disorders, their far-reaching impacts, and their associated treatment patterns. These categories present a starting point for analysing the pharmacoeconomic consequences of psychiatric disorders and underlie an expert opinion in this context

Depression and work productivity: the comparative costs of treatment versus nontreatment.

This article discusses the impact of depression on work productivity and the potential for improved work performance associated with effective treatment. We undertook a review of the literature by means of a computer search using the following key terms: cost of illness, work loss, sickness absence, productivity, performance, and disability. Published works were considered in four categories: (1) naturalistic cross-sectional studies that found greater self-reported work impairment among depressed workers; (2) naturalistic longitudinal studies that found a synchrony of change between depression and work impairment; (3) uncontrolled treatment studies that found reduced work impairment with successful treatment; and (4) controlled trials that usually, but not always, found greater reduction in work impairment among treated patients. Observational data suggest that productivity gains following effective depression treatment could far exceed direct treatment costs. Randomized effectiveness trials are needed before we can conclude definitively that depression treatment results in productivity improvements sufficient to offset direct treatment costs.

Impact of illness and its treatment on workplace costs: regulatory and measurement issues.

In an attempt to document a broader spectrum of the benefits of their pharmaceutical products, drug companies increasingly seek to include productivity claims in their promotional campaigns. We describe the existing regulatory framework of the Food and Drug Administration (FDA) for considering productivity claims, distinguishing between the traditional "substantial evidence" standard and the "competent and reliable scientific evidence" standard. But the notion of competent and reliable scientific evidence may itself be problematic, even when it is the appropriate regulatory standard, because there exists no consistent measurement approach across diseases, workplaces, jobs, and worker capabilities that is widely accepted in this emerging area of health outcomes research. We examine the various measurement approaches that have been used to quantify the impact of illness and its treatment on workplace productivity, and we describe some of the shortcomings associated with each alternative. This discussion highlights the possible difficulties faced by the FDA in reviewing productivity-based promotional claims. Finally, we suggest possible strategies for furthering this field of investigation.

The impact of antidepressant use on social functioning: reboxetine versus fluoxetine.

Depression compromises affected individuals' functional well-being and impairs their level of social and workplace performance. Improved social functioning in depressed patients may improve their work productivity. This study evaluated the differential effects of two antidepressants on social functioning outcomes for patients with major depression comparing reboxetine, a non-tricyclic, selective noradrenaline reuptake inhibitor and fluoxetine, a commonly prescribed selective serotonin reuptake inhibitor. A model using data from 284 depressed patients (138 reboxetine, 146 fluoxetine) in two 8-week clinical trials was developed to predict the percentage change over time in continuous outcome assessments as measured by a 21-item self-rating scale called the Social Adaptation Self-evaluation Scale (SASS). The percentage change from baseline SASS score was modelled as a function of both time-invariant and time-varying covariates. Results suggest that, by mid-study, the more severely ill subjects benefitted more from reboxetine treatment in terms of the outcome improvement rate and, by study-end, this effect also extended into the less severely ill population. In addition, a significant relationship was identified between the change in depression symptom severity as measured by the standard Hamilton Depression Rating Scale score and the change in social functioning per the SASS.

Direct and indirect costs of rheumatoid arthritis to an employer.

This study is among the first to estimate the overall economic burden of rheumatoid arthritis (RA) from an employer perspective. The annual, per capita cost of RA was determined for beneficiaries of a major employer by analyzing medical, pharmaceutical, and disability claims data. The incremental costs related to RA were determined by matching RA patients to a case-control group of individuals with no recorded RA treatment. The utilization of health care services as well as the rate of disability among RA patients was substantially higher than among the controls. For example, annual, per capita employer expenditures for RA employees with disability were almost 3 times those for their controls ($17,822 vs $6131, respectively). Treatment to address not only the severity but also the progression of RA may substantially reduce overall employer expenditures for this disease.

Savings in direct medical costs from the use of tobramycin solution for inhalation in patients with cystic fibrosis.

OBJECTIVE: Two identical 24-week, double-blind, placebo-controlled trials of tobramycin solution for inhalation (TOBI [PathoGenesis Corporation, Seattle, Washington]) in cystic fibrosis patients with chronic Pseudomonas aeruginosa infection were conducted in the United States. The aim of the present study was to extrapolate the US trial data to a Canadian setting, using Canadian costs to estimate the savings in direct medical costs that might result from use of a similar 24-week TOBI regimen versus usual care in 2 Canadian provinces. BACKGROUND: Cystic fibrosis is a genetic disease in which persistent respiratory infection, usually due to P. aeruginosa infection, is the major cause of morbidity and mortality. METHODS: The US trials demonstrated that TOBI produced significant improvements in pulmonary function test results, reduced sputum levels of P. aeruginosa, and resulted in a 26% reduction in the probability of hospitalization (95% CI, 2%-43% vs placebo in the clinical trials). Individual patient data from the US trials were used to calculate the mean number of days in hospital as well as the mean number of days of home intravenous or oral antibiotic therapy. To adjust for Canadian pricing, pertinent economic data were obtained from Statistics Canada and the Ontario and Quebec health ministries. Demographic and baseline data were obtained from health surveys conducted by the Canadian Cystic Fibrosis Foundation. RESULTS: Economic analysis showed that the use of TOBI for 24 weeks would result in estimated mean per-patient savings in direct medical costs (in Canadian dollars) of $4055 in Ontario and $4916 in Quebec, which would substantially offset the Canadian acquisition price of $8602 for the same 24-week period. CONCLUSIONS: Assuming that the percentage of reduction in hospital days observed in the US trials would also occur in the Canadian clinical setting, use of TOBI would reduce the use of health care services, particularly hospital days, and lead to substantial savings in direct medical costs that would offset its acquisition price. Whether this reduction actually occurs after TOBI enters the Canadian market is a subject for future investigation.

The costs of cancer to a major employer in the United States: a case-control analysis.

BACKGROUND: Detailed data will be increasingly important in determining the cost of cancer care in the managed care setting. OBJECTIVES: To estimate the full cost of cancer to a major employer in the United States and to determine the nature of the expenditures. STUDY DESIGN: Analysis of medical, pharmaceutical, and disability claims data from 1995 to 1997 for a major employer with more than 100,000 employees. METHODS: The cost of cancer is determined on a per-patient and per-employee basis. Based on a case-control method, cancer patients are matched to individuals with no record of cancer diagnosis or treatment. The incremental cost per employee and the percentage of total healthcare expenditures for cancer are quantified. RESULTS: Approximately $224 per active employee, or 6.5% of the corporation's total healthcare costs, was spent on incremental care for cancer patients in 1997. Medical conditions not directly related to cancer account for approximately half the total excess expenditures for patients with cancer. On average, annual healthcare and disability costs for persons with cancer were approximately 5 times higher than for their counterparts without cancer. CONCLUSIONS: The costs of cancer care are a substantial proportion of healthcare costs for employers. When the full cost of cancer is included in a cost-benefit analysis, expenditures for programs to reduce the risk of cancer in the working population may be justified. Expenditures to reduce the incidence and severity of conditions indirectly associated with cancer may also reduce overall employer healthcare expenses.