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Purpose Many hospital-based infusion centers treat patients with rheumatoid arthritis (RA) with intravenous biologic agents, yet may have a limited understanding of the overall costs of infusion in this setting. The purposes of this study were to conduct a microcosting analysis from a hospital perspective and to develop a model using an activity-based costing approach for estimating costs associated with the provision of hospital-based infusion services (preparation, administration, and follow-up) in the United States for maintenance treatment of moderate to severe RA. Methods A spreadsheet-based model was developed. Inputs included hourly wages, time spent providing care, supply/overhead costs, laboratory testing, infusion center size, and practice pattern information. Base-case values were derived from data from surveys, published studies, standard cost sources, and expert opinion. Costs are presented in year-2017 US dollars. The base case modeled a hospital infusion center serving patients with RA treated with abatacept, tocilizumab, infliximab, or rituximab. Findings Estimated overall costs of infusions per patient per year were $36,663 (rituximab), $36,821 (tocilizumab), $44,973 (infliximab), and $46,532 (abatacept). Of all therapies, the biologic agents represented the greatest share of overall costs, ranging from 87% to $91% of overall costs per year. Excluding infusion drug costs, labor accounted for 53% to 57% of infusion costs. Implications Biologic agents represented the highest single cost associated with RA infusion care; however, personnel, supplies, and overhead costs also contributed substantially to overall costs (8%–16%). This model may provide a helpful and adaptable framework for use by hospitals in informing decision making about services offered and their associated financial implications.

OBJECTIVE To assess the impact of rheumatoid arthritis (RA) on absence time, absence payments, and other health benefit costs from the perspective of US employers. METHODS Retrospective regression-controlled analysis of a database containing US employees' administrative health care and payroll data for those who were enrolled for at least 1 year in an employer-sponsored health insurance plan. RESULTS Employees with RA (N = 2705) had $4687 greater average annual medical and prescription drug costs (P < 0.0001) and $525 greater (P < 0.05) indirect costs (because of sick leave, short- and long-term disability, and workers' compensation absences) than controls (N = 338,035). Compared with controls, the employees with RA used an additional 3.58 annual absence days, including 1.2 more sick leave and 1.91 more short-term disability days (both P < 0.0001). CONCLUSION Employees with RA have greater costs across all benefits than employees without RA.

Background:Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease that often results in joint pain, inflammation and bone erosions. Perhaps the most notable change in RA treatment during the last decade is the advent of biologics, and, in particular, anti-tumour necrosis factor agents. Given these advances, it is useful to assess how healthcare and work-loss costs of patients with RA have changed. Abstract: Objective:Objective: Our objective was to assess changes in healthcare utilization and costs from 1997 to 2006 for patients diagnosed with RA. Abstract: Methods:Methods: Two cohorts (1997 and 2006) of patients with RA and matched controls were identified from two administrative claims databases along with subsamples of employed patients and matched controls. The analysis focused on the more homogeneous employee subsample. We compared annual excess co-morbidity rates, resource utilization and healthcare and work-loss costs per patient between the 1997 (n - 279) and 2006 cohorts (n - 837) with difference-in-differences methodology. Results with p < 0.05 were considered statistically significant. Abstract: Results:Results: In the employee subsample, there were no statistically significant differences in the excess prevalence of non-RA co-morbidities or Charlson Co-morbidity Index results, except for cardiovascular disease, which decreased by 11.1%. Excess number of ED visits and days hospitalized decreased by 1.1 visits/patient and 0.9 days/patient, respectively, while rheumatologist visits increased by 0.9 visits/patient. Excess per-patient direct costs were unchanged. However, drug costs increased by &dollar;US633/patient, but medical costs decreased by &dollar;US618/patient (not significant) &lsqb;year 2006 values&rsqb;. Abstract: Conclusion:Conclusion: For employed patients with RA, there were significant reductions in per-patient excess hospital days, as well as ED visits, and no changes in excess total direct costs over time. New treatments introduced during the study period may be associated with cost savings that offset changes in employee utilization of drug and medical services. In addition, the reductions in excess ED visits and hospital days suggest improvements in patient quality of life.

Background and objectives: Rheumatoid arthritis (RA) causes considerable disability and often results in loss of work capacity and productivity. This study evaluated the impact of adalimumab, a tumour necrosis factor antagonist with demonstrated efficacy in RA, on long-term employment. Methods: Data from an open-label extension study (DE033) of 486 RA patients receiving adalimumab monotherapy who previously did not respond to at least one disease-modifying antirheumatic drug (DMARD) and had baseline work status information were compared with data from 747 RA patients receiving DMARD treatment in a Norway-based longitudinal registry. Primary outcomes included the time patients continued working at least part time and the likelihood of stopping work. Secondary outcomes included American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) responses and disease remission. Outcomes were compared 6, 12 and 24 months after enrolment. Results: During a 24-month period, the 158 patients who received adalimumab and were working at baseline worked 7.32 months longer (95% CI 4.8 to 9.1) than did the 180 patients treated with DMARDs, controlling for differences in baseline characteristics. Regardless of baseline work status, patients receiving adalimumab worked 2.0 months longer (95% CI 1.3 to 2.6) and were significantly less likely to stop working than those receiving DMARDs (HR 0.36 (95% CI −0.30 to 0.42) for all patients and 0.36 (95% CI 0.15 to 0.85) for patients working at baseline, respectively). The patients who received adalimumab were also considerably more likely to achieve ACR responses and disease remission than DMARD-treated patients. Patients who achieved EULAR good response and remission were less likely to stop working, but this relationship was only seen in patients receiving DMARDs. Conclusions: Patients with RA who received adalimumab experienced considerably longer periods of work and continuous employment, and greater rates of clinical responses, than patients receiving DMARDs. The mechanism by which adalimumab decreases likelihood of stopping work seems to be different from that of DMARD treatment and independent of clinical responses.

To describe dosing patterns for tumor necrosis factor (TNF) antagonists in patients with rheumatoid arthritis from health care provider and payer point of interest.Using privately insured US claims data from 31 large employers covering 31 companies across the US, rheumatoid arthritis (RA) patients were identified and three cohorts were defined based on first TNF-antagonist treatment (adalimumab, etanercept, or infliximab) administered after January 1, 2003. Dosage-adjustment patterns were assessed during the following 12-month period. Changes in dosage (both increases and decreases) and maintenance of a stable dosage were evaluated. For the health care provider point of interest, a new algorithm was developed to assess treatment patterns with chronic injectable therapies that incorporated the potential inconsistency between days of supply and prescription-gap data, thus providing the actual use of TNF-antagonist treatment. For the payer, usage data addressed whether the TNF antagonist was used at a greater dosage than recommended. Differences in baseline characteristics and dosage change rates between cohorts were tested using Chi-Square tests for categorical variables and Wilcoxon tests for continuous variables.From the health care provider point of interest, 83.4% of adalimumab-treated patients (n = 205) initially received the recommended dosage, 10.2% received less, and 6.3% received more; 87.7% of etanercept-treated patients (n = 455) initially received the recommended dosage, 11.2% received less, and 1.1% received more; and 83.8% of infliximab-treated patients (n = 148) started with 2-4 vials (the recommended dosage is based on the weight of the patient, not total milligrams). All treatments had similar dosage decrease and discontinuation rates. Maintenance of stable dosage was lower for infliximab (20.9%) than adalimumab (37.1%) and etanercept (39.1%); both p0.01. The infliximab dosage-increase rate (35.1%) was greater than adalimumab (3.9%) and etanercept (0); both p0.01. From the payer point of interest, dosage-increase rate was greater for infliximab (28.3%) than adalimumab (8.7%) and etanercept (6.9%), both p0.01.Infliximab had greater dosage-increase rates than adalimumab and etanercept. Adalimumab and etanercept had similar dosage-increase rates. All treatments had similar dosage-decrease and discontinuation rates. Maintenance of stable dosage was lower for infliximab than for adalimumab and etanercept. The study has the usual limitation of claims data analysis in that clinical details might be insufficient to draw causal inference.

To compare the cost of care for rheumatoid arthritis (RA) patients treated with adalimumab, infliximab, and etanercept.RA patients were identified from a privately insured database. Three mutually exclusive treatment cohorts were formed based on the date of first tumor necrosis factor (TNF) antagonist treatment (index date) after January 1, 2003. Baseline characteristics were assessed in the 3-month pretreatment period. Healthcare (i.e., medical service and prescription medications) utilization and cost were assessed for the following 12 months. RA-related medical cost included the total cost for medical service associated with RA diagnosis. RA-related healthcare cost included RA-related medical and drug cost. Uneven distribution of baseline characteristics were adjusted with the propensity score method. Cost was compared between treatment cohorts.Twelve-month TNF-antagonist therapy cost ($12 853 vs. 17 299, p = 0.002), total RA-related drug cost ($13 794 vs. 17 647, p = 0.006), total RA-related medical cost ($971 vs. 2920, p0.001), total RA-related healthcare cost ($14 764 vs. 20 566, p = 0.002), and total drug cost ($16 210 vs. 19 769, p = 0.028) were significantly less for adalimumab (n = 217) than infliximab (n = 234). Twelve-month healthcare cost for adalimumab was comparable to etanercept (n = 546).Annual healthcare cost for adalimumab patients was significantly less than for infliximab patients and was comparable to etanercept patients. This analysis is subject to the usual limitation of claims data analyses in that few clinical details are available and causal inference conclusions are limited.

Objective: To evaluate the effects of adalimumab on patient-reported outcomes of joint- and skin-related functional impairment, health-related quality of life (HRQOL), fatigue, and pain in patients with psoriatic arthritis (PsA). Methods: Patients with moderately to severely active PsA were treated with adalimumab 40 mg every other week or placebo in this 24-week, randomised, controlled trial. Patient-reported outcomes included the Health Assessment Questionnaire Disability Index (HAQ DI), Short Form 36 Health Survey (SF-36), the Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue), and the Dermatology Life Quality Index (DLQI). Results: Adalimumab (N=151) and placebo (N=162) groups were comparable with respect to baseline demographics and disease severity. Statistically significant changes from baseline in HAQ DI were reported for adalimumab vs. placebo (-0.4 vs. & -0.1, p

Background: Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance. Methods: In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7–9) and the follow-up visit (days 20–25). Results: Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae . At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, −5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, −6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, −18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (≤7% each). Conclusions: Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.

We used decision-analysis modeling to compare costs and outcomes of clarithromycin extended-release (Biaxin XL, Abbott Laboratories, Abbott Park, Illinois, USA) and clarithromycin immediate-release (Biaxin, Abbott Laboratories, Abbott Park, Illinois, USA) for outpatients with lower respiratory tract infections (LRTI). More patients achieved clinical cure with extended-release (83.9%) versus immediate-release (72.8%); fewer discontinued due to adverse events. Total costs with extended-release were $32 (16%) less; incorporating greater adherence for extended-release (once-daily) therapy resulted in greater savings. Results indicate that clarithromycin extended-release is cost-saving compared with immediate-release for LRTI.

Objective: To compare parent-reported outcomes (satisfaction, tolerability, compliance, and work/daycare missed) for children (aged 6 months to 6 years) receiving either cefdinir or amoxicillin/clavulanate for acute otitis media. Method: In a phase IV, investigator-blinded, parallel-group, randomized, multicenter study, parents or legal guardians were asked to complete the Otitis Parent Questionnaire (OPQ) 12–14 days after the first dose of cefdinir or amoxicillin/clavulanate oral suspensions. Responses in each of the outcome domains were analyzed using non-parametric statistical analysis. Results: Of 367 parents/guardians who completed the questionnaire, better ease of use (p = 0.009) and taste (p < 0.0001) were associated with cefdinir versus amoxicillin/clavulanate treatment, and children were significantly more likely to experience vomiting with amoxicillin/clavulanate (16% vs 8%; p = 0.016). Parents also reported that their children were much more likely to take all of their medication if receiving cefdinir (68% vs 53% for amoxicillin/clavulanate; p = 0.005). There were no statistically significant differences between groups in work/daycare missed. Conclusion: Based on parents’ assessment using the OPQ, cefdinir was easier to administer and tasted better than amoxicillin/clavulanate. Children who received cefdinir also experienced less vomiting and had greater compliance than children who received amoxicillin/clavulanate.

ObjectivesTumour necrosis factor inhibition plus methotrexate is believed to inhibit radiographic progression independent of inflammation. This analysis assessed whether these protective effects are exerted on bone (joint erosion; JE) and/or cartilage (joint space narrowing; JSN), and what the independent effects of JE/JSN progression are on longer-term patient-reported outcomes.MethodsPREMIER was a 2-year, randomised, controlled trial of adalimumab plus methotrexate (ADA+MTX) versus the monotherapies. The impact of treatment on the relationships between time-averaged disease activity (TA-DAS28(CRP)) and changes in JE/JSN and associations of JE/JSN with the disability index of the health assessment questionnaire (HAQ-DI) at baseline and weeks 52 and 104 were assessed through non-parametric approaches of analysis of variance and quantile regression. JE/JSN association with employment status was evaluated at baseline and weeks 52 and 104 through logistic regression.ResultsIncreasing tertiles of TA-DAS28(CRP) were associated with JE and JSN progression in the monotherapy groups, a phenomenon largely absent in ADA+MTX-treated patients. Although JSN was not associated with HAQ-DI at baseline, it was at 52 and 104 weeks. In contrast, JE was not associated with HAQ-DI at any time point examined. Odds of being employed at baseline, 52 weeks and 104 weeks were significantly associated with lower JSN, but not JE, scores.ConclusionsADA+MTX inhibited both JE and JSN progression independently of disease activity. JSN played a more prominent role in patient-reported outcomes than JE. Preventing the onset or worsening of JSN probably represents a critical aspect of effective disease management of early rheumatoid arthritis patients.

New classification criteria for axial spondyloarthritis (SpA) have been validated by the Assessment of SpondyloArthritis international Society (ASAS) working group. We applied these criteria to estimate prevalence of SpA in randomly selected, retrospectively reviewed medical records from representative US rheumatology practices.Rheumatologists from 101 US practices identified at-risk patients, ages 18-44 years, with chronic back pain. Medical records were reviewed against ASAS criteria. The proportion of patients meeting ASAS criteria was compared to an estimate of the total number of at-risk patients treated at participating sites and, following weighting, was extrapolated to 5,520 US rheumatology practices. US Census data were used to estimate national prevalence.In a sample of 816 randomly selected records, 514 (63%) at-risk patients (95% confidence interval [95% CI] 59.6-66.3%) met ASAS criteria. By applying this proportion to 1,217,097 Americans estimated at risk, 766,652 were projected to meet ASAS criteria. This projection corresponds to a national prevalence of 0.70% (95% CI 0.38-1.1%) or 701 per 100,000 individuals. The prevalence estimates of ankylosing spondylitis and nonradiographic axial SpA are 0.35% (95% CI 0.18-0.554%) and 0.35% (95% CI 0.18-0.554%), respectively. Rheumatologists diagnosed axial SpA in 491 (60%) of those at risk, corresponding to 0.67% (95% CI 0.36-1.01%) prevalence overall. However, of 514 patients meeting ASAS criteria, 124 (24%) were undiagnosed by rheumatologists.This is the first systematic epidemiology study of axial SpA using ASAS criteria. Better recognition of axial symptoms is needed, as rheumatologists' expert clinical diagnoses are not always in agreement with ASAS criteria.

To estimate comprehensive cost of rheumatoid arthritis (RA) patients to society and individual stakeholders, including patients/employees, employers, family members/caregivers, and government.Administrative claims databases covering privately insured and Medicare and Medicaid beneficiaries in the US were used to compute the excess payer and beneficiary-paid costs per patient with RA compared with matched controls. Similarly, per-person excess costs for caregivers and uninsured patients with RA were estimated. Costs were estimated for other burdens, including costs of work-loss to employers, adaptations to home and work environments, lost on-the-job productivity, informal and hired care/household help, and job turnover costs. Intangible costs associated with quality-of-life deterioration were estimated based on legal system jury awards, whereas costs for premature mortality were based on lifetime earnings data. Per-capita cost estimates were weighted by the relevant population to estimate societal costs. Because data were incomplete, several assumptions were required; these assumptions could lead to an over- or under-estimation of cost burdens.Annual excess health care costs of RA patients were $8.4 billion, and costs of other RA consequences were $10.9 billion. These costs translate to a total annual cost of $19.3 billion. From a stakeholder perspective, 33% of the total cost was allocated to employers, 28% to patients, 20% to the government, and 19% to caregivers. Adding intangible costs of quality-of-life deterioration ($10.3 billion) and premature mortality ($9.6 billion), total annual societal costs of RA (direct, indirect, and intangible) increased to $39.2 billion.Societal costs of RA in the US are $19.3 billion and $39.2 billion (in 2005 dollars) without and with intangible costs, respectively. This study was one of the first to attempt to quantify the comprehensive burdens of RA. Despite several assumptions made in areas in which few data exist, the findings generate useful insights into the full burden of RA.

Objective: Rheumatoid arthritis (RA) greatly affects patients’ abilities to perform work, which can translate into substantial employer costs. We developed a customizable model that allows employers to calculate workplace impacts of RA therapies in employees with RA. Methods: Costs of medical leave (absenteeism)/disability, reduced productivity, job turnover, and work-equipment adaptations for employees with RA were calculated. Costs of the tumor necrosis factor antagonist adalimumab were compared with those of other RA treatments. Default parameters were based on literature, clinical trials, government sources, and employers’ data. Results: Annual per-employee workplace cost was $9071 for adalimumab versus $16,335 for other RA therapies. Costs included reduced productivity (57%), absenteeism/disability (21%), and job turnover (21%). Conclusion: RA imposes a large financial burden on employers, predominantly owing to lost productivity. When compared with other RA therapies, adalimumab substantially reduced employers’ costs.

Background: Rheumatoid arthritis (RA) causes pain and serious functional impacts and substantially affects patients' daily lives, including their ability to work. Objective: This review examines recent studies of patients with RA treated with TNF antagonists and the impacts these therapies have on the workplace. Methods: A total of 133 articles and 14 poster abstracts were reviewed that matched specific criteria. Results/conclusion: The results of early studies of TNF antagonists varied regarding their effects on patients with RA in the workplace. However, recent studies of adalimumab showed positive impacts across a range of workplace burdens. Treatments such as adalimumab may help employees with RA to remain in the workforce and lead to reduced workplace costs to the employers and employees.

In patients with longstanding severe rheumatoid arthritis (RA) receiving chronic treatment with adalimumab, health related quality of life (HRQOL) was assessed using new instruments [Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) and Health Utilities Index Mark 3 (HUI3)] and a more conventional instrument [Medical Outcomes Study Short Form-36 Health Survey (SF-36)].Different measures for collecting patient-reported outcomes were applied simultaneously during the 3-year study period. Sociodemographic and medical history data were assessed at the baseline visit. Clinical examinations (e.g., joint examination and morning stiffness), disease assessments, and HRQOL data were recorded every 8 weeks. For dichotomous and categorical variables, absolute and relative frequencies were calculated. Metric measures were described using mean and standard deviation and/or standard error of the mean. HRQOL data were analyzed using observed cases.All assessed measures (FACIT-Fatigue, HUI3, SF-36) showed a rapid and statistically significant improvement from baseline following initiation of adalimumab therapy. This effect was maintained over the study period for a mean of 1.6 years in all applied measures. HRQOL data from all tested instruments were significantly correlated with each other.Chronic therapy with adalimumab improved measures of fatigue and HRQOL in patients with longstanding RA.

To compare the efficacy and safety of cefdinir to that of cephalexin in adolescents and adults with mild to moderate uncomplicated skin and skin structure infections (USSSI).This was an investigator-blinded, multicenter study in which patients at least 13 years of age with USSSI were randomized to receive 10 days of cefdinir 300 mg twice daily (BID) or cephalexin 250 mg four times daily (QID). Patients were evaluated at baseline, by telephone on Days 3-5, and during office visits on Days 12-14 (end-of-therapy [EOT] visit) and Days 17-24 (test-of-cure [TOC] visit).Clinical response was evaluated at the TOC visit. Patient reported outcomes, including a usefulness questionnaire, were also assessed.Three hundred and ninety-one patients were treated. The treatment groups were well matched with regard to demographic characteristics and types of infection. Abscess(es) (26%), wound infection (24%), and cellulitis (21%) were the most common infections. At the TOC visit, the clinical cure rate for both treatment groups was 89% (151/170 for cefdinir and 154/174 for cephalexin) in clinically evaluable patients (95% CI for difference in cure rates [-6.7 to 7.3]). In the intent-to-treat analysis, cure rates were 83% for cefdinir vs. 82% for cephalexin. Clinical cure rates for infections caused by methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) Staphylococcus aureus were 93% (37/40) and 92% (35/38) for cefdinir vs. 91% (29/32) and 90% (37/41) for cephalexin (p0.999 comparing treatment groups for MSSA; p0.999 for MRSA). The usefulness questionnaire demonstrated that cefdinir was more highly rated in the mean composite score (87.4 vs. 83.6, p = 0.04), with the difference primarily due to the respondents' preference for the convenience of taking the study medication (mean score 93.5 vs. 74.1 for cephalexin, p0.001). The study had the following limitations: the requirement for culture at baseline likely skewed the enrollment of patients towards those with abscesses; the results of culture in patients with USSSIs are often nonspecific; in some patients entering the study with a diagnosis of cellulitis, the cellulitis was associated with an abscess; and, incision and drainage (ID), spontaneous drainage, and needle aspiration are likely to have contributed to clinical response for purulent infections, and in particular MRSA-associated infections. Both study drugs were well tolerated. The most common treatment-related adverse events were diarrhea (10% cefdinir, 4% cephalexin, p = 0.017), nausea (3% and 6%, respectively, p = 0.203), and vaginal mycosis (3% and 6% of females, respectively, p = 0.500).This study demonstrated that empiric coverage of USSSIs with cephalosporin therapy remains an appropriate clinical strategy. MRSA infections responded well in both arms of the study, suggesting that the choice of a cephalosporin did not adversely affect patient outcome. However, cephalosporins do not have accepted, clinically relevant in vitro activity against MRSA. Hence, the clinical response rates seen in this study against MRSA infections must be interpreted with caution. Cefdinir was more highly rated than cephalexin in a composite usefulness assessment.

We used decision-analysis modeling to compare costs and outcomes of clarithromycin extended-release (Biaxin XL, Abbott Laboratories, Abbott Park, Illinois, USA) and clarithromycin immediate-release (Biaxin, Abbott Laboratories, Abbott Park, Illinois, USA) for outpatients with lower respiratory tract infections (LRTI). More patients achieved clinical cure with extended-release (83.9%) versus immediate-release (72.8%); fewer discontinued due to adverse events. Total costs with extended-release were $32 (16%) less; incorporating greater adherence for extended-release (once-daily) therapy resulted in greater savings. Results indicate that clarithromycin extended-release is cost-saving compared with immediate-release for LRTI.

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.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.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).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.

Background Tumor necrosis factor (TNF)–inhibiting drugs are provided to patients with rheumatoid arthritis in the form of an intravenous infusion or subcutaneous injection. Although anti-TNF infusions are typically provided in hospital-based centers, the administrators of these centers often have limited understanding of the associated treatment costs. Objectives To estimate the total cost of anti-TNF infusion care from a hospital perspective using an activity-based costing approach. Methods An activity-based model was developed using several types of infusion center inputs: hourly wages, times to provide care, supply and overhead costs, laboratory test costs, infusion center size, and practice pattern information. The model assumed 8 infusions of infliximab annually. Base case values were derived from a survey of 5 community hospital infusion centers, previously published nurse and pharmacist time estimates, and expert opinion. Costs were derived from standard national sources. An overhead charge of 29.5% was applied to all costs. All costs were measured in or inflated to 2011 US dollars. Results The total cost per infusion, including drug and laboratory costs, was estimated to be $3185. Most of this cost was attributable to the acquisition cost of the infused medication. Of the $427 not associated with drug, $93 was associated with recommended laboratory tests. Infusion costs—including labor and supplies associated with preparation, administration, and premedication and treatment of adverse events if necessary—were estimated at $334 per infusion. Of this amount, $121 was attributable to nonlabor categories (eg, capital equipment) and management (eg, inventory and documentation). In contrast, total Medicare reimbursement for a 3-hour infusion would be less than $120. A separate module including indirect costs (ie, lost productivity of patient and/or caregiver, transportation) estimated each infusion visit to be associated with an additional $146 cost to the patient. Conclusions Although drug costs contribute most to the cost of anti-TNF infusion care, personnel, supply, and overhead costs can also be substantial. The model developed in this research can be used to quantify the total cost of providing anti-TNF infusion services so that financially responsible treatment strategies can be implemented at a given institution. In a market in which reimbursement and the efficient use of personnel are keenly important, such a tool can help hospital administrators make informed choices about the services to be offered and their financial implications. Disclosure of Interest J. Schmier Employee of: Exponent, which received a research grant from Abbott, M. Cifaldi Shareholder of: Abbott, Employee of: Abbott, J. Shaw Shareholder of: Abbott, Employee of: Abbott, M. Halpern Grant/Research support from: Abbott, N. Nickman Consultant for: Exponent, which received a research grant from Abbott

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.

OBJECTIVES: Morbidity due to respiratory infections leads to significant adverse societal and economic consequences. This study investigates the extent to which treatment for respiratory infections imposes a financial burden on an employer, and documents variations in employer payments between specific respiratory infections. METHODS: The data source is a rich administrative claims database for a national, Fortune 100 manufacturer. It includes 1997 medical, pharmaceutical, and disability claims for employees, spouses, dependents, and retirees (n> 100,000) under age 65. The research sample consists of individual patients with one or more medical or disability claims for at least one of eleven respiratory infection condition. Resource utilization is contrasted with a 10 percent random sample of the employer's overall beneficiary population. RESULTS: Direct (medical and pharmaceutical) and indirect (disability and sporadic absenteeism) costs are analyzed. The average per capita annual costs are: for the entire employer population, $2,368; for all respiratory infections patients, $4,397; and for respiratory infections employees eligible for disability, $6,838. Total costs for respiratory infections patients are 1.8 times those for the typical beneficiary. Total costs are highest for patients with pneumonia ($11,544) and lowest for patients with acute tonsillitis and acute pharyngitis ($2,180). Medical and pharmaceutical treatment account for 65% of total costs for all respiratory infections employees, while the remaining 35% of costs are attributable to disability and sporadic absenteeism. CONCLUSIONS: Respiratory infections impose a significant financial burden on the employer. Resource utilization by respiratory infections patients is substantial, not only for the direct treatment of respiratory infections, but also for the treatment of co-morbid medical conditions of respiratory infections patients. These costs also vary considerably by type of respiratory infection. The study also shows that respiratory infections impose substantial indirect costs on employers from work loss associated with these infections.