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.

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.

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.

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.

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.

Using healthcare claims data for outcomes research and pharmacoeconomic analyses.

Healthcare claims data are a practical complement to data from randomised controlled trials (RCTs) for evaluating health outcomes in non-experimental settings and for generalising results to a broader population. Claims data are a relatively inexpensive way to obtain useful information about patient demographics, as well as healthcare resources used for specific medical conditions and procedures from large numbers of patients over extended periods of time. With claims data, it is possible to identify patients who meet specific medical or sociodemographic criteria, estimate their costs, define episodes of medical care, and measure outcomes more globally than is possible with RCT data. Statistical methods exist to address some of the inherent issues with claims data due to their limited clinical detail. We also identify extensions of claims data to productivity issues, the use of centralised claims data such as in Canada, and the application of new statistical methods to outcomes research literature such as sample selection correction methods.

Depression in the workplace: effects on short-term disability.

We analyzed data from two national surveys to estimate the short-term work disability associated with thirty-day major depression. Depressed workers were found to have between 1.5 and 3.2 more short-term work-disability days in a thirty-day period than other workers had, with a salary-equivalent productivity loss averaging between $182 and $395. These workplace costs are nearly as large as the direct costs of successful depression treatment, which suggests that encouraging depressed workers to obtain treatment might be cost-effective for some employers.

Pharmacoeconomics and health policy. Current applications and prospects for the future.

The use of pharmacoeconomic tools has grown dramatically in the past decade as provision of healthcare throughout the industrialised world has required increased cost consciousness. However, pharmacoeconomic analysis has not yet been fully exploited as a conceptual underpinning for public or private health policy decisions. Pharmacoeconomics is likely to become an increasingly important basis for health policy decisions as a number of significant dynamics evolve in the marketplace, including: (i) consumers acting on their growing access to information and becoming more actively involved in treatment decisions; (ii) payers, providers and patients deepening their interaction and overcoming their traditional (narrow) focus on either costs or benefits alone; and (iii) manufacturers being challenged by other healthcare constituencies as sponsors of cost-based outcomes studies.

The Home Infusion Therapy/Relative Benefit Index: summary of an analysis using insurance claims data.

OBJECTIVES: The cost of providing services is the traditional criteria used by payers in making selective contracting decisions regarding home care providers in general, and home infusion therapy (HIT) vendors specifically for this analysis. This approach assumes comparable health outcomes, for which adequate measures often are unavailable. In practice, poor quality can result in a need for remedial services. The objective of this research is to develop a method to use health insurance claims data to incorporate the hidden costs of adverse outcomes into an analysis of the costs of a vendor's HIT. METHODS: The Home Infusion Therapy/Relative Benefit Index (HIT/RBI) model incorporates measures of both the cost of providing HIT services as well as the cost of remedial treatment for the adverse outcomes that may result from HIT care, eg, emergency room visits. The data source for the analysis is the health care claims for a sample of managed care patients of national insurer for the period 1990 to 1994. RESULTS: The analysis confirms that adverse clinical outcomes can lead to additional demand for remedial health care with resultant negative financial consequences. When the cost of the adverse outcomes is incorporated into the analysis, vendors who appeared to be low cost on the basis of HIT services, in fact were higher cost vendors, whereas vendors with a high cost of services but with few adverse events were low cost vendors. CONCLUSIONS: Payers should consider both the clinical and economic consequences of providing care into account in selecting vendors. The HIT/RBI model is a useful tool for incorporating the cost of adverse outcomes into a comprehensive comparison of the cost multiple vendors of HIT services.

What does hospice cost?

This paper presents the preliminary results of the economic analyses of the National Hospice Study (NHS), mandated by the United States Congress to investigate the implications of including hospice services in Medicare. Data were collected over an 18-month period from approximately 4,000 patients receiving hospice and conventional terminal care in 25 hospices and 12 conventional care sites. Subsequent analysis may lead to changes in the specific results, and some of the differences may be due to confounding variables that cannot be adjusted for. According to these data, hospital based (HB) hospice costs per day are 44 per cent higher than home care (HC) hospice costs per day ($95 versus $66, respectively). In addition, per patient hospice costs are 24 per cent more for patients enrolled in HB than in HC hospices ($5,890 versus $4,758, respectively). The proportional difference between HB and HC in cost per patient is smaller than the cost per day difference due to the shorter average HB length of stay, 62.3 days compared to 72.5 days for HC. Regarding the cost savings of hospice compared to conventional care, HC hospice costs are lower than conventional care costs regardless of length of stay. However, HB costs seem lower than conventional care costs only for patients with lengths of stay less than two months. Hospice and conventional care patients appear to differ with respect to predisposition toward intensive health care utilization. When this difference is explored more thoroughly in subsequent analyses, the estimated cost differential between hospice and conventional care may change.