Comparative effectiveness of budesonide/formoterol combination and fluticasone/salmeterol combination among chronic obstructive pulmonary disease patients new to controller treatment: a US administrative claims database study.

BACKGROUND: Inhaled corticosteroid/long-acting ß2-agonist combinations (ICS/LABA) have emerged as first line therapies for chronic obstructive pulmonary disease (COPD) patients with exacerbation history. No randomized clinical trial has compared exacerbation rates among COPD patients receiving budesonide/formoterol combination (BFC) and fluticasone/salmeterol combination (FSC) to date, and only limited comparative data are available. This study compared the real-world effectiveness of approved BFC and FSC treatments among matched cohorts of COPD patients in a large US managed care setting. METHODS: COPD patients (≥40 years) naive to ICS/LABA who initiated BFC or FSC treatments between 03/01/2009-03/31/2012 were identified in a geographically diverse US managed care database and followed for 12 months; index date was defined as first prescription fill date. Patients with a cancer diagnosis or chronic (≥180 days) oral corticosteroid (OCS) use within 12 months prior to index were excluded. Patients were matched 1-to-1 on demographic and pre-initiation clinical characteristics using propensity scores from a random forest model. The primary efficacy outcome was COPD exacerbation rate, and secondary efficacy outcomes included exacerbation rates by event type and healthcare resource utilization. Pneumonia objectives included rates of any diagnosis of pneumonia and pneumonia-related healthcare resource utilization. RESULTS: Matching of the identified 3,788 BFC and 6,439 FSC patients resulted in 3,697 patients in each group. Matched patients were well balanced on age (mean=64 years), gender (BFC: 52% female; FSC: 54%), prior COPD-related medication use, healthcare utilization, and comorbid conditions. During follow-up, no significant difference was seen between BFC and FSC patients for number of COPD-related exacerbations overall (rate ratio [RR]=1.02, 95% CI=[0.96,1.09], p=0.56) or by event type: COPD-related hospitalizations (RR=0.96), COPD-related ED visits (RR=1.11), and COPD-related office/outpatient visits with OCS and/or antibiotic use (RR=1.01). The proportion of patients diagnosed with pneumonia during the post-index period was similar for patients in each group (BFC =17.3%, FSC =19.0%, odds ratio=0.92 [0.81,1.04], p=0.19), and no difference was detected for pneumonia-related healthcare utilization by place of service. CONCLUSION: This study demonstrated no difference in COPD-related exacerbations or pneumonia events between BFC and FSC treatment groups for patients new to ICS/LABA treatment in a real-world setting. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01921127 .

Asthma and Chronic Obstructive Pulmonary Disease Overlap Syndrome: Doubled Costs Compared with Patients with Asthma Alone.

BACKGROUND: Patients with asthma and chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS) have more rapid disease progression and more exacerbations than do those with either condition alone. Little research has been performed, however, in these patients. OBJECTIVE: The objective was to summarize the health care utilization, costs, and comorbidities of patients with uncontrolled asthma and patients with ACOS. METHODS: This retrospective analysis used medical and pharmacy claims from large commercial health plans. The study included patients 6 years or older with a diagnosis of asthma and one or more asthma exacerbation (index event). Patients were classified as having asthma alone or ACOS, and the two groups were matched for age, sex, region, index year, index month, and health plan type. Outcomes included rates of comorbid disease, health care utilization, and costs during the 12 months before and after the index exacerbation. RESULTS: Among the matched patients with asthma (6,505 ACOS; 26,060 without COPD), mean annual all-cause health care costs were twice as high as for patients with ACOS ($22,393 vs. $11,716; P < 0.0001). Asthma-related costs, representing 29% of total costs, were nearly twice as high among patients with ACOS ($6,319 vs. 3,356; P < 0.0001). Cost differences were driven by large differences in the proportions of patients with an inpatient hospitalization (34.0% vs. 14.6%; P < 0.0001) or emergency department visit (29.6% vs. 19.9%; P < 0.0001). Nearly all prespecified comorbid conditions were more prevalent in the ACOS group. CONCLUSIONS: Patients with asthma and COPD had nearly double the health care costs as did patients with asthma without COPD. The overall disease profile of patients with asthma should be considered when managing patients, rather than treating asthma as a solitary condition.

Healthcare utilization and costs associated with S. aureus and P. aeruginosa pneumonia in the intensive care unit: a retrospective observational cohort study in a US claims database.

BACKGROUND: Staphylococcus aureus and Pseudomonas aeruginosa are major causes of pneumonia in intensive care unit (ICU) patients. Limited data exist regarding the health economic impact of S. aureus and P. aeruginosa pneumonias in the ICU setting. METHODS: We conducted a retrospective observational cohort study using a 29.6 million enrollee US medical and pharmacy administrative claims database. ICU patients with S. aureus or P. aeruginosa infection per International Classification of Diseases, 9th ed. coding between 01/01/2007-8/31/2012 were compared with ICU patients without any pneumonia or infections of interest. Primary outcomes were costs in 2012 US dollars, healthcare utilization and all-cause mortality associated with hospital-acquired S. aureus or P. aeruginosa pneumonia, and the relative odds of incurring higher costs due to a comorbid condition. RESULTS: Patients with S. aureus or P. aeruginosa pneumonia had longer mean hospital (37.9 or 55.4 vs 7.2 days, P < .001) and ICU stays (6.9 or 14.8 vs 1.1 days, P < .001), a higher rate of mechanical ventilation (62.6 % or 62.3 % vs 7.4 %, P < .001), higher mortality (16.0 % or 20.2 % vs 3.1 %, P < .001), and higher total mean hospitalization costs ($146,978 or $213,104 vs $33,851, P < .001) vs controls. Pneumonia survivors had significantly increased risk of rehospitalization within 30 days (27.2 % or 31.1 % vs 15.3 %, P < .001). Comorbid conditions were not associated with increased cost in the pneumonia cohorts. CONCLUSIONS: Healthcare costs and resource utilization were high among ICU patients with S. aureus or P. aeruginosa pneumonia. Reducing the incidence of these infections could lead to substantial cost savings in the United States.

Propensity score matched assessment of treatment patterns and cost of erythropoiesis stimulating agent treatment in patients with cancer receiving myelosuppressive chemotherapy.

OBJECTIVE: To examine epoetin alfa (EPO) and darbepoetin alfa (DARB) treatment patterns and erythropoiesis stimulating agent (ESA) costs in patients with cancer receiving chemotherapy (CRC), and to compare the results observed in the pre-matched total study population (TSP) with a propensity score matched population (PSMP). METHODS: A medical claims analysis was conducted from 1 January 2004 through 31 July 2009 using the HealthCore Integrated Research Database. Patients were at least 18 years old, newly initiated on EPO or DARB, received ≥ 2 ESA doses, and had ≥ 1 claim for cancer and chemotherapy proximate to ESA treatment. Patients were matched using propensity scores. January 2010 Wholesale Acquisition Cost was used to calculate drug cost. Mean cumulative ESA dose and drug costs were evaluated in the TSP and PSMP. RESULTS: 4921 EPO and 9173 DARB patients with CRC were identified. In the TSP, mean cumulative ESA doses were EPO: 398,770 units and DARB: 1508 mcg, with similar treatment durations for each. Mean cumulative drug costs were EPO: $6041 and DARB: $7861 (30% higher for DARB). The cumulative dose ratio (EPO units: DARB mcg) was 264:1. The PSMP analysis identified 4831 ESA treated CRC patients in each group. Mean drug costs were EPO: $6055 and DARB: $7863 (30% higher for DARB). The observed dose ratio (EPO units: DARB mcg) was 265:1. CONCLUSION: In both analyses, the costs of DARB were higher, even after accounting for baseline differences in the PSMP. Similar trends in dose ratios were also observed in both groups.

Real-world comparison of hospitalization costs for heart failure in type 2 diabetes mellitus patients with established cardiovascular disease treated with canagliflozin versus other antihyperglycemic agents.

Aims: This real-world study compared hospitalization for heart failure (HHF) costs and all-cause healthcare costs in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease treated with the sodium glucose co-transporter 2 inhibitor (SGLT2i) canagliflozin and non-SGLT2i antihyperglycemic agents (AHAs).Materials and methods: Propensity score-matched cohorts from a retrospective observational study (OBSERVE-4D) using the Truven MarketScan Commercial Claims and Encounters and Optum Clinformatics databases were analyzed. HHF and all-cause healthcare costs per-patient-per-month (PPPM) were compared for patients initiated on canagliflozin and non-SGLT2i AHAs in the on-treatment analysis.Results: Baseline characteristics were well balanced between matched cohorts that included new users of canagliflozin or non-SGLT2i AHAs in the Truven (13,954 and 45,101, respectively) and Optum (11,490 and 53,360, respectively) databases. The mean (95% CI) PPPM cost of HHF was lower for canagliflozin than for non-SGLT2i AHAs in analyses of both the Truven ($21.31 [$21.25, $21.37]) and Optum ($30.43 [$30.41, $30.45]) databases. The mean (95% CI) PPPM all-cause healthcare cost was also lower for canagliflozin than for non-SGLT2i AHAs in analyses of both the Truven ($321 [$280, $361]) and Optum ($449 [$402, $495]) databases.Limitations: This study is subject to the limitations inherent to observational research including potential for coding errors and biases and unobserved confounding. Because all patients were in commercially administered health plans, these findings cannot be easily generalized to uninsured or Medicaid populations. Patient costs were evaluated up to and including their first HHF event. Post-discharge costs such as the costs of subsequent rehospitalizations were not included in this analysis.Conclusions: For patients with T2DM and established cardiovascular disease in this real-world study, treatment with canagliflozin was associated with lower HHF costs and all-cause healthcare costs compared with treatment with non-SGLT2i AHAs.

Cancer survivorship, health insurance, and employment transitions among older workers.

This study examined the effect of job-related health insurance on employment transitions (labor force exits, reductions in hours, and job changes) of older working cancer survivors. Using multivariate models, we compared longitudinal data for the period 1997-2002 from the Penn State Cancer Survivor Study to similar data for workers with no cancer history in the Health and Retirement Study, who were also ages 55 to 64 at follow-up. The interaction of cancer survivorship with health insurance at diagnosis was negative and significant in predicting labor force exits, job changes, and transitions to part-time employment for both genders. The differential effect of job-related health insurance on the labor market dynamics of cancer survivors represents an additional component of the economic and psychosocial burden of cancer on survivors.

Factors Associated with the Initiation of Long-Acting Injectable Paliperidone Palmitate Versus Aripiprazole Among Medicaid Patients with Schizophrenia: An Observational Study.

INTRODUCTION: Factors underlying the selection of antipsychotics for patients with schizophrenia are poorly understood. This study investigated variables associated with initiation of treatment with the long-acting injectables paliperidone palmitate (LAI-PP) and aripiprazole LAI (LAI-AP) in Medicaid patients with schizophrenia. METHODS: Adults with at least one medical or pharmacy claim for LAI-PP or LAI-AP from 1 January 2013 to 31 December 2016 were selected from the IBM® MarketScan® Medicaid Database. The date of the first LAI-PP or LAI-AP claim was the index date. Patients who had at least two medical claims, on different days, for a schizophrenia diagnosis and at least 12 months of continuous health plan enrollment prior to index date were included in the analysis. Multivariable logistic regression was performed to determine the factors associated with the initiation of LAI-PP versus LAI-AP. RESULTS: Of included patients, 5501 initiated LAI-PP and 1449 initiated LAI-AP. Patients more likely to initiate LAI-PP versus LAI-AP were older, male, or African American (all p < 0.01). Patients with obesity (odds ratio [OR] 0.84; 95% confidence interval [CI] 0.71, 0.98), post-traumatic stress disorder (OR 0.76; 95% CI 0.63, 0.92), or prior oral antipsychotic use (OR 0.66; 95% CI 0.55, 0.79) were less likely to initiate LAI-PP; whereas, patients with nonorganic psychoses (OR 1.35; 95% CI 1.18, 1.55) or prior use of other injectable antipsychotics (OR 1.26; 95% CI 1.09, 1.47) were more likely to initiate LAI-PP versus LAI-AP. Patients with at least two all-cause hospitalizations were 1.37 times more likely to initiate LAI-PP vs LAI-AP (OR 1.37; 95% CI 1.18, 1.60). CONCLUSION: Factors associated with initiating LAI-PP and LAI-AP differed. Notably, patients who initiated LAI-PP had greater prior use of medical services than LAI-AP patients. Understanding prescribing practices may help optimize treatment strategies and improve disease management. FUNDING: Janssen Scientific Affairs, LLC.

Estimating the Real-World Cost of Diabetes Mellitus in the United States During an 8-Year Period Using 2 Cost Methodologies.

BACKGROUND: Diabetes is associated with substantial clinical and economic burdens on patients and on the US healthcare system. Treatment options for patients with type 1 or type 2 diabetes have increased significantly, from only 3 drug classes in 1995 to more than 12 distinct classes today. Although several of the newer treatments are reported to have improved efficacy and safety profiles, they are often substantially more costly than older medications. Consequently, as drug options increase, the cost of diabetes management continues to grow. OBJECTIVES: To estimate the annual real-world costs of type 1 and 2 diabetes, as well as diabetes prevalence, treatment patterns, care quality, and resource utilization during 8 years. METHODS: In this cross-sectional study, we examined 8 annual cohorts of patients with type 1 or type 2 diabetes, on a biennial basis, using claims data from the HealthCore Integrated Research Database between 2006 and 2014. Patients were matched with controls by age, sex, residency, and health plan type. We assessed the prevalence of diabetes, treatment patterns, care quality measures, and all-cause and diabetes-related healthcare costs using 2 methods. Method 1 calculated the annual costs as the difference in all-cause costs between patients with diabetes and matched controls. Method 2 calculated the costs for healthcare encounters based on specific codes for a diabetes diagnosis or for antidiabetes medications. RESULTS: Between 346,486 and 410,234 patients with type 2 diabetes and between 21,176 and 26,228 patients with type 1 diabetes were included in each study year cohort. Between 2007 and 2014, the prevalence of type 2 diabetes increased from 4.9% to 6.3%. The costs associated with using Method 1 were almost double the cost estimates in Method 2 during most of the study period. For patients with type 1 diabetes, the associated costs were twice greater with Method 1 than with Method 2. Projections to the entire US population in 2014 indicated a total of 19.3 million individuals with diabetes and associated direct costs of $314.8 billion that year. CONCLUSION: Cost estimates can guide the prioritization of healthcare expenditures. The results of this study showed that costs attributable to diabetes differed by approximately 2-fold, depending on the estimation method. The management of the escalating expenses for diabetes management in the United States requires judicious selection of the methods for estimating costs.

Initiation Patterns of Statins in the 2 Years After Release of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) Cholesterol Management Guideline in a Large US Health Plan.

BACKGROUND: The purpose of this study was to characterize changes in statin utilization patterns in patients newly initiated on therapy in the 2 years following the release of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol management guideline in a large US health plan population. METHODS AND RESULTS: This retrospective, observational study used administrative medical and pharmacy claims data to identify patients newly initiated on statin therapy over 4 quarters prior to and 8 quarters following the release of the guideline (average N/quarter=3596). Patients were divided into the 4 statin benefit groups (SBGs) based on risk factors and laboratory lipid levels as defined in the guideline: SBG1 (with atherosclerotic cardiovascular disease [ASCVD]; N=1046/quarter), SBG2 (without ASCVD, with low-density lipoprotein cholesterol ≥190 mg/dL; N=454/quarter), SBG3 (without ASCVD, aged 40-75 years, with diabetes mellitus, low-density lipoprotein cholesterol 70-189 mg/dL; N=1391/quarter), SBG4 (no ASCVD or diabetes mellitus, age 40-75 years, low-density lipoprotein cholesterol 70-189 mg/dL, estimated 10-year ASCVD risk of ≥7.5%; N=705/quarter). Demographic variables, statin utilization patterns, lipid levels, and comorbidities were analyzed for pre- and postguideline periods. Postguideline, gradually increased high-intensity statin initiation occurred in SBG1, SBG2, and in SBG3 patients with 10-year ASCVD risk ≥7.5%. Moderate- to high-intensity statin initiation gradually increased among SBG4 patients. Recommended-intensity statin choice changed to a greater degree among patients treated by specialty care physicians. Regarding sex, target-intensity statin initiation was lower in women in all groups before and after guideline release. CONCLUSIONS: Prescriber implementation of the guideline recommendations has gradually increased, with the most marked change in the increased initiation of high-intensity statins in patients with ASCVD and in those treated by a specialist.

Impact of Nonadherence to Inhaled Corticosteroid/LABA Therapy on COPD Exacerbation Rates and Healthcare Costs in a Commercially Insured US Population.

BACKGROUND: Evidence of poor patient adherence to medications for chronic obstructive pulmonary disease (COPD) is well-documented, but its impact on disease exacerbation rates and associated healthcare costs remains unclear. OBJECTIVE: To assess the association between adherence levels to different inhaled corticosteroid/long-acting ß2-adrenergic agonist (LABA) and COPD exacerbation rates and costs in a commercially insured population. METHODS: In this observational cohort study, patients with COPD (aged ≥40 years) who were treatment-naïve to inhaled corticosteroid/LABA and were initiating budesonide plus formoterol or fluticasone plus salmeterol between March 1, 2009, and January 31, 2014, were identified in a national representative claims database and were followed for up to 12 months. The date of the first prescription fill for either drug was defined as the index date. Patients were divided into 4 cohorts based on adherence to the index therapy, which was measured by proportion of days covered (PDC); the cohorts were classified as adherent (PDC ≥0.8), mildly nonadherent (0.5 ≤ PDC <0.8), moderately nonadherent (0.3 ≤ PDC <0.5), and highly nonadherent (PDC <0.3). Each nonadherent group was matched in a 1:1 ratio to the adherent group independently, based on prognostically important variables, using propensity score analyses. Exacerbation rates and healthcare costs were analyzed for 1 year after treatment initiation. RESULTS: During the study period, 13,657 eligible patients with COPD initiated inhaled corticosteroid/LABA; of these, only 1898 (13.9%) patients were adherent during follow-up. Group matching resulted in 1572 patients per group for comparison 1 (adherent vs mildly nonadherent), 1604 patients for comparison 2 (adherent vs moderately nonadherent), and 1755 patients for comparison 3 (adherent vs highly nonadherent). The moderately and highly nonadherent cohorts had higher exacerbation rates than the adherent patients (comparison 2: rate ratio [RR], 1.11; 95% confidence interval [CI], 1.01-1.21; P = .03; comparison 3: RR, 1.11; 95% CI, 1.01-1.21; P = .02). Adherent patients incurred significantly lower healthcare costs than all the nonadherent groups (comparison 1, $22,671 vs $25,545; P <.01; comparison 2, $22,508 vs $24,303; P <.01; comparison 3, $22,460 vs $25,148; P <.01). CONCLUSIONS: Patients adhered to their inhaled corticosteroid/LABA treatments had lower COPD exacerbation rates and lower healthcare costs compared with the moderately and highly nonadherent patients. Better adherence to maintenance therapies may help to reduce the clinical and economic burdens of COPD.

Increased Burden of Healthcare Utilization and Cost Associated with Opioid-Related Constipation Among Patients with Noncancer Pain.

BACKGROUND: Opioids are widely accepted as treatment for moderate to severe pain, and opioid-induced constipation is one of the most common side effects of opioids. This side effect negatively affects pain management and patients' quality of life, which could result in increased healthcare utilization and costs. OBJECTIVE: To assess healthcare utilization and costs (all-cause, constipation-related, and pain-related) for individuals with and without opioid-induced constipation during the 12 months after initiation of opioid therapy for noncancer pain. METHODS: This retrospective cohort study was conducted using administrative claims data from HealthCore Integrated Research Environment between January 1, 2006, and June 30, 2014. The analysis was limited to patients aged ≥18 years who filled a prescription for continuous opioid treatment (≥28 days) for noncancer pain. Propensity scores were used to match opioid users with constipation (cohort 1) and opioid users without constipation (cohort 2), using a 1:1 ratio. Generalized linear models were used to estimate all-cause, constipation-related, and pain-related healthcare utilization and costs during the 12 months after the initiation of opioid therapy. RESULTS: After matching and balancing for all prespecified variables, 17,384 patients were retained in each cohort (mean age, 56 years; 63% female). Opioid users with constipation were twice as likely as those without constipation to have ≥1 inpatient hospitalizations (odds ratio, 2.28; 95% confidence interval [CI], 2.17-2.39) during the 12 months. The total mean adjusted overall costs per patient during the study period were $12,413 higher for patients with constipation versus those without it (95% CI, $11,726-$13,116). The total mean adjusted overall pain-related costs per patient were $6778 (95% CI, $6293-$7279) higher for the patients with constipation than those without. Among patients using opioids for noncancer pain, the annual mean constipation-related costs per patient totaled $4646 (total average plan-paid costs, $4424; total patient-paid costs, $222). CONCLUSIONS: Patients using opioids with newly diagnosed constipation had significantly greater healthcare utilization and costs than patients without constipation; these costs accounted for approximately 16% of the total healthcare costs per patient during the 12-month study period. Recognition and effective treatment of opioid-induced constipation may decrease healthcare utilization for patients with chronic noncancer pain and may reduce the economic burden of pain therapy.

Long-term cardiovascular risk and costs for myocardial infarction survivors in a US commercially insured population.

OBJECTIVE: To quantify clinical and cost long-term outcomes in cardiovascular stable post-myocardial-infarction patients. RESEARCH DESIGN AND METHODS: Subjects with a history of myocardial infarction (MI) who were 50-64 years old and MI- and stroke-free for ≥12 months (index date) were identified in a large US claims database. Individuals were followed for up to 5 years (mean: 2.0 years) after their index date. MAIN OUTCOME MEASURES: Rates of MI, stroke, all-cause death, and a composite of these were analyzed via Cox regression models, adjusted for covariates. Results are reported for the overall population and the subgroups of those with type 2 diabetes, additional prior MI, and non-end-stage renal disease. As a secondary endpoint healthcare costs were evaluated at baseline and during each year of follow-up. Results Over the follow-up period, which averaged 2 years, 7.6% of all 13,492 subjects (10.5% vs. 5.4% with and without the selected risk factors, respectively) experienced at least one of the outcome events. The cumulative incidence rates over the entire follow-up period for the primary composite outcome were 20.8% and 12.2% for those with and without the selected atherothrombotic risk factors, respectively. The cardiovascular-related per-person-per-year healthcare costs during follow-up were higher in those with ≥1 additional risk factor compared to those without: $15,247 versus $7521. Costs were elevated over baseline costs throughout follow-up. LIMITATIONS: Administrative claims data lack clinical detail. Generalizability of results is limited to the US commercially insured population of a similar age to that included in this study. CONCLUSIONS: High risk MI survivors who have been event free for ≥1 year remained at substantial risk of CV events and had increased healthcare costs for up to 5 years post-MI. These long-term risks have not been previously demonstrated in a working-age US population and suggest an unmet need for continuing secondary prevention long-term post-MI.

Understanding CKD among patients with T2DM: prevalence, temporal trends, and treatment patterns-NHANES 2007-2012.

OBJECTIVE: To describe the estimated prevalence and temporal trends of chronic kidney disease (CKD) treatment patterns, and the association between CKD and potential factors for type 2 diabetes mellitus (T2DM) in different demographic subgroups. RESEARCH DESIGN AND METHODS: This was a cross-sectional analysis of adults with T2DM based on multiple US National Health and Nutrition Examination Survey (NHANES) datasets developed during 2007-2012. CKD severity was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 guidelines using the CKD Epidemiology Collaboration (CKD-EPI) equation: mild to moderate=stages 1-3a; moderate to kidney failure=stages 3b-5. Multivariable logistic regression analyses were performed to assess the associations between CKD and potential factors. RESULTS: Of the adult individuals with T2DM (n=2006), age-adjusted CKD prevalence was 38.3% during 2007-2012; 77.5% were mild-to-moderate CKD. The overall age-adjusted prevalence of CKD was 40.2% in 2007-2008, 36.9% in 2009-2010, and 37.6% in 2011-2012. The prevalence of CKD in T2DM was 58.7% in patients aged ≥65 years, 25.7% in patients aged <65 years, 43.5% in African-Americans and Mexican-Americans, and 38.7% in non-Hispanic whites. The use of antidiabetes and antihypertensive medications generally followed treatment guideline recommendations. Older age, higher hemoglobin A1c (HbA1c), systolic blood pressure (SBP), and having hypertension were significantly associated with CKD presence but not increasing severity of CKD. CONCLUSIONS: CKD continued to be prevalent in the T2DM population; prevalence remained fairly consistent over time, suggesting that current efforts to prevent CKD could be improved overall, especially by monitoring certain populations more closely.

Health Care Utilization and Costs After Initiating Budesonide/Formoterol Combination or Fluticasone/Salmeterol Combination Among COPD Patients New to ICS/LABA Treatment.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) affects approximately 15 million people in the United States and accounts for approximately $36 billion in economic burden, primarily due to medical costs. To address the increasing clinical and economic burden, the Global Initiative for Chronic Obstructive Lung Disease emphasizes the use of therapies that help prevent COPD exacerbations, including inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA). OBJECTIVE: To evaluate health care costs and utilization among COPD patients newly initiating ICS/LABA combination therapy with budesonide/formoterol (BFC) or fluticasone/salmeterol (FSC) in a managed care system. METHODS: COPD patients aged 40 years and older who initiated BFC (160/4.5 µg) or FSC (250/50 µg) treatment between March 1, 2009, and March 31, 2012, were identified using claims data from major U.S. health plans. BFC and FSC patients were propensity score matched (1:1) on age, sex, prior asthma diagnosis, prior COPD-related health care utilization, and respiratory medication use. COPD-related, pneumonia-related, and all-cause costs and utilization were analyzed during the 12-month follow-up period. Post-index costs were assessed with generalized linear models (GLMs) with gamma distribution. Health care utilization data were analyzed via logistic regression (any event vs. none) and GLMs with negative binomial distribution (number of visits) and were adjusted for the analogous pre-index variable as well as pre-index characteristics that remained imbalanced after matching. RESULTS: After matching, each cohort had 3,697 patients balanced on age (mean 64 years), sex (female 52% BFC and 54% FSC), asthma and other comorbid conditions, prior COPD-related health care utilization, and respiratory medication use. During the 12-month follow-up, COPD-related costs averaged $316 less for BFC versus FSC patients ($4,326 vs. $4,846; P = 0.003), reflecting lower inpatient ($966 vs. $1,202; P < 0.001), pharmacy ($1,482 vs. $1,609; P = 0.002), and outpatient/office ($1,378 vs. $1,436; P = 0.048) costs, but higher emergency department ($257 vs. $252; P = 0.033) costs. Pneumonia-related health care costs were also lower on average for BFC patients ($2,855 vs. $3,605; P < 0.001). Similarly, initiating BFC was associated with lower all-use health care costs versus initiating FSC ($21,580 vs. $24,483; P < 0.001, respectively). No differences in health care utilization were found between the 2 groups. CONCLUSIONS: In this study, although no difference was observed in rates of health care utilization, COPD patients initiating BFC treatment incurred lower average COPD-related, pneumonia-related, and all-cause costs versus FSC initiators, which was driven by cumulative differences in inpatient, outpatient, and pharmacy costs.

Assessment of Outpatient and Inpatient Antibiotic Treatment Patterns and Health Care Costs of Patients with Complicated Urinary Tract Infections.

PURPOSE: The goal of this study was to examine treatment patterns, utilization, and costs for complicated urinary tract infections (UTIs) requiring inpatient/emergency department (ED) and outpatient care. METHODS: This observational study evaluated inpatient/ED-treated and outpatient-treated patients (aged ≥18 years) with complicated UTIs from 2 large US administrative claims databases (HealthCore Integrated Research Environment and Premier Perspective Database). Patient identification depended on treatment setting: outpatients had 2 UTI diagnosis-related office visits and 2 claims for different antibiotics within 30 days, and inpatients had a UTI-related hospitalization/ED visit after 1 UTI diagnosis-related office visit plus 2 claims for different antibiotics within 30 days. The index date for outpatients was the date of the first office visit; for inpatients, it was the date of admission/ED visit. Both cohorts had continuous insurance eligibility. Outcomes were assessed by using univariate and multivariate statistics. FINDINGS: The study sample included 1118 inpatient/ED patients (76.6% female subjects; mean age, 62.4 years) and 41,605 outpatients (85.8% female subjects; mean age, 52.3 years). Mean (SD) pharmacy costs were $2971 ($7650) for inpatient/ED patients and $1882 ($3120) for outpatients during the full treatment period. Index hospitalization/ED averaged $38,422 ($51,161). Mean all-cause 90-day follow-up costs for the inpatient/ED cohort were $34,100 ($71,621) and $11,345 ($34,313) for the outpatient cohort. IMPLICATIONS: Relative to outpatient-treated patients, inpatient/ED-treated patients were older, sicker, had higher costs across treatment periods, and had reduced antibiotic use at a lower rate during the 90-day follow-up. Strategies to avoid preventable inpatient/ED visits may help reduce costs in the management of outpatients with complicated UTIs.

Treatment patterns, healthcare utilization, and costs of chronic opioid treatment for non-cancer pain in the United States.

OBJECTIVES: To evaluate treatment patterns, healthcare resource utilization, and costs among patients within a large managed care population chronically using opioids for non-cancer pain. STUDY DESIGN: Retrospective cohort study. METHODS: Patients aged ≥18 years with ≥1 prescription initiating opioids between January 1, 2007, and December 31, 2011, who also had 12 months of continuous pre-index health plan enrollment, were identified. Patients with pre-index opioid use or cancer diagnosis were excluded. Opioid exposure was stratified by treatment duration-short-term (30-182 days) versus chronic (≥183 days)-and by index opioid type (weak vs strong). RESULTS: A total of 2.9 million patients initiating opioids were identified, of which 257,602 had at least 30 days of continuous use and were included in the study. The mean age was 51 years and 52% were female. Overall, 239,998 (93%) patients had short-term opioid use, and 17,604 (7%) had chronic use; 215,424 (84%) initiated treatment with a weak opioid, and 44,712 (17%) with a strong opioid. The specialty most associated with the use of less potent opioids was general/family practice (28%), and for more potent opioids it was surgery (22%). Large increases in health-care utilization were reported between the pre-index and first 6-month post initiation periods for chronic users. Utilization rates decreased after the first 6 months but never reverted to baseline levels. Costs mirrored utilization trends, more than doubling between baseline and the first 6 months of treatment for pharmacy ($2029 vs $4331) and all-cause medical ($11,430 vs $27,365). Costs declined after the first 6 months of opioid use but remained above pre-index levels. CONCLUSIONS: These results demonstrated that healthcare resource utilization and costs increased during the first 6 months following clinical scenarios that necessitated opioid initiation and subsequently declined, suggesting the need to monitor patients beyond the acute care period.

Comparative effectiveness of budesonide/formoterol combination and tiotropium bromide among COPD patients new to these controller treatments.

BACKGROUND: Inhaled corticosteroid/long-acting ß2-agonist combinations and/or long-acting muscarinic antagonists are recommended first-line therapies for preventing chronic obstructive pulmonary disease (COPD) exacerbation. Comparative effectiveness of budesonide/formoterol combination (BFC, an inhaled corticosteroid/long-acting ß2-agonist combination) vs tiotropium (long-acting muscarinic antagonist) in the US has not yet been studied. METHODS: Using US claims data from the HealthCore Integrated Research Environment, COPD patients (with or without comorbid asthma) ≥40 years old initiating BFC or tiotropium between March 1, 2009 and February 28, 2012 and at risk for exacerbation were identified and followed for 12 months. Patients were propensity score matched on demographics and COPD disease severity indicators. The primary outcome was time to first COPD exacerbation. Secondary outcomes included COPD exacerbation rate, health care resource utilization, and costs. RESULTS: The Cox proportional hazards model for time to first exacerbation yielded a hazard ratio (HR) of 0.78 (95% CI =[0.70, 0.87], P<0.001), indicating a 22% reduction in risk of COPD exacerbation associated with initiation of BFC versus tiotropium. A post hoc sensitivity analysis found similar effects in those who had a prior asthma diagnosis (HR =0.72 [0.61, 0.86]) and those who did not (HR =0.83 [0.72, 0.96]). BFC initiation was associated with lower COPD-related health care resource utilization and costs ($4,084 per patient-year compared with $5,656 for tiotropium patients, P<0.001). CONCLUSION: In COPD patients new to controller therapies, initiating treatment with BFC was associated with improvements in health and economic outcomes compared with tiotropium.

Validation of an administrative claims-based diagnostic code for pneumonia in a US-based commercially insured COPD population.

OBJECTIVE: To estimate the accuracy of claims-based pneumonia diagnoses in COPD patients using clinical information in medical records as the reference standard. METHODS: Selecting from a repository containing members' data from 14 regional United States health plans, this validation study identified pneumonia diagnoses within a group of patients initiating treatment for COPD between March 1, 2009 and March 31, 2012. Patients with ≥1 claim for pneumonia (International Classification of Diseases Version 9-CM code 480.xx-486.xx) were identified during the 12 months following treatment initiation. A subset of 800 patients was randomly selected to abstract medical record data (paper based and electronic) for a target sample of 400 patients, to estimate validity within 5% margin of error. Positive predictive value (PPV) was calculated for the claims diagnosis of pneumonia relative to the reference standard, defined as a documented diagnosis in the medical record. RESULTS: A total of 388 records were reviewed; 311 included a documented pneumonia diagnosis, indicating 80.2% (95% confidence interval [CI]: 75.8% to 84.0%) of claims-identified pneumonia diagnoses were validated by the medical charts. Claims-based diagnoses in inpatient or emergency departments (n=185) had greater PPV versus outpatient settings (n=203), 87.6% (95% CI: 81.9%-92.0%) versus 73.4% (95% CI: 66.8%-79.3%), respectively. Claims-diagnoses verified with paper-based charts had similar PPV as the overall study sample, 80.2% (95% CI: 71.1%-87.5%), and higher PPV than those linked to electronic medical records, 73.3% (95% CI: 65.5%-80.2%). Combined paper-based and electronic records had a higher PPV, 87.6% (95% CI: 80.9%-92.6%). CONCLUSION: Administrative claims data indicating a diagnosis of pneumonia in COPD patients are supported by medical records. The accuracy of a medical record diagnosis of pneumonia remains unknown. With increased use of claims data in medical research, COPD researchers can study pneumonia with confidence that claims data are a valid tool when studying the safety of COPD therapies that could potentially lead to increased pneumonia susceptibility or severity.

Statin treatment patterns and clinical profile of patients with risk factors for coronary heart disease defined by National Cholesterol Education Program Adult Treatment Panel III.

OBJECTIVE: To compare clinical characteristics, statin treatment patterns and adherence among patients at different risk for coronary heart disease (CHD) as defined by National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guidelines. METHODS: Patients ≥ 18 years old with ≥ 1 claim for dyslipidemia, ≥ 1 statin claim, or ≥ 1 LDL-C value ≥ 100 mg/dL were identified from 1 January 2007 to 31 July 2012. Patients were classified as low risk (LR) (0-1 risk factor: hypertension, age ≥ 45 years [men] or ≥ 55 years [women], or low HDL-C), moderate/moderately high risk (MR) (≥ 2 risk factors), high risk (HR) (CHD or CHD risk equivalent), or very high risk (VHR) (acute coronary syndrome, or established cardiovascular disease plus diabetes or metabolic syndrome). Medication use and lipid levels during the 12 months before and statin use during the 6 months after index were compared across risk groups. RESULTS: There were 1,524,351 LR, 242,357 MR, 188,222 HR, and 57,469 VHR patients identified. Statin use was observed in 15% of all patients, but was higher in the VHR group (45%) versus LR (12%), MR (18%), and HR (29%) groups. Simvastatin accounted for 50%-52% of all statin use, and average statin dose was higher among VHR patients compared with all other groups. Adherence was low overall (mean proportion of days covered [PDC]: 0.57), but higher among VHR (0.69) versus others (mean PDC: 0.55, 0.59, and 0.59 in LR, MR, and HR groups, respectively). CONCLUSIONS: Statin treatment was low across all risk groups, and VHR patients had higher doses and better adherence compared with other risk groups. However, adherence was not optimal, indicating a potential limited benefit from statin treatment.

Seasonal influenza vaccination trends from 2007-2011 in privately insured children and adults in the United States.

BACKGROUND: To ensure adequate protection from seasonal influenza in the US, the Advisory Committee on Immunization Practices recommends vaccination of all persons aged 6 months or older, with rare exceptions. It also advises starting vaccination as soon as available and continuing throughout the influenza season. This study examined US seasonal vaccination trends during five consecutive influenza seasons in privately-insured children and adults. METHODS: This retrospective, observational cohort study examined trends in influenza vaccination during the 2007-2008 through 2011-2012 influenza seasons using administrative claims data from a large national insurer. RESULTS: The size of analysis population ranged from 1144,098 to 1245,487 (children, ≥6 months-17 years of age) and from 3931,622 to 4158,223 (adults, 18-64 years of age). Vaccination frequency increased through 2010-2011, was most frequent in young children, and decreased with age. Vaccination rates were highest in the Northeast and lowest in the West and were higher in individuals with frequent outpatient office visits than in those with no or rare visits, with larger differences seen in children. Between 2007 and 2011, the use of preservative-free inactivated vaccine increased, the use of multidose vaccines containing preservatives decreased, and the use of live attenuated influenza vaccines increased among children 2-17 years of age. From 2007-2008 through 2009-2010, the timing of vaccination each year began earlier than the previous one; it remained stable from 2009-2010 through 2011-2012. CONCLUSION: Annual influenza vaccination claims for privately-insured children and adults increased and shifted earlier from 2007 through 2009-2011. During the 2011-2012 influenza season, 25.4% of children aged 6 months-17 years and 12.3% of adults aged 18-64 years were vaccinated. Increasing influenza vaccination should remain a priority, and alternative venues for seasonal influenza vaccination should be considered in order to meet the Healthy People 2020 goal of 80% to 90% coverage among children.