Clinical and economic burden of COPD in a medicaid population.

OBJECTIVE: To evaluate the clinical and economic burden of COPD patients to Medicaid. STUDY DESIGN: Retrospective, observational matched cohort design. METHODS: We calculated the incremental costs incurred and medical resources used by COPD patients relative to those without COPD. Data were obtained from 8 Medicaid states during 2003-2007. COPD patients were defined as Medicaid beneficiaries ≥40 years with a COPD diagnosis (ICD-9 CM: 491.xx, 492.xx, 496.xx) and treated with maintenance drugs for COPD. Patients were matched (1:3) to Medicaid beneficiaries without a COPD diagnosis on age, gender, race, index year, Medicare/Medicaid dual eligibility, and use of long-term care. Results were stratified by Medicare/Medicaid dual eligibility status and race. RESULTS: A total of 10,221 COPD and 30,663 non-COPD patients were included. Cohorts were on average 65 years of age, 80% White, and 64.8% having Medicare/Medicaid dual eligibility. Inpatient hospitalizations and home healthcare visits/durable medical equipment were primary drivers of incremental medical costs. COPD patients were more than twice as likely to have a hospitalization (odds ratio [95% confidence interval] = 2.32 [2.19, 2.45]) or home healthcare visit/durable medical equipment (2.95 [2.82, 3.08]) compared to non-COPD patients. Medicaid incurred $2118/year in incremental costs due to COPD. On average, incremental costs were 7 times greater for non-dual-eligible patients ($4917) compared to dual-eligible patients ($667), and were more than double for Blacks compared to Whites ($4141 vs $1593). CONCLUSION: COPD imposes a substantial economic and clinical burden on the Medicaid program; this burden differs by dual eligibility status and race.

Observational study on the impact of initiating tiotropium alone versus tiotropium with fluticasone propionate/salmeterol combination therapy on outcomes and costs in chronic obstructive pulmonary disease.

BACKGROUND: This retrospective cohort study compared the risks of exacerbations and COPD-related healthcare costs between patients with chronic obstructive pulmonary disease (COPD) initiating tiotropium (TIO) alone and patients initiating triple therapy with fluticasone-salmeterol combination (FSC) added to TIO. METHODS: Managed-care enrollees who had an index event of ≥ 1 pharmacy claim for TIO during the study period (January 1, 2003-April 30, 2008) and met other eligibility criteria were categorized into one of two cohorts depending on their medication use. Patients in the TIO+FSC cohort had combination therapy with TIO and FSC, defined as having an FSC claim on the same date as the TIO claim. Patients in the TIO cohort had no such FSC use. The risks of COPD exacerbations and healthcare costs were compared between cohorts during 1 year of follow-up. RESULTS: The sample comprised 3333 patients (n = 852 TIO+FSC cohort, n = 2481 TIO cohort). Triple therapy with FSC added to TIO compared with TIO monotherapy was associated with significant reductions in the adjusted risks of moderate exacerbation (hazard ratio 0.772; 95% confidence interval [CI] 0.641, 0.930) and any exacerbation (hazard ratio 0.763; 95% CI 0.646, 0.949) and a nonsignificant reduction in COPD-related adjusted monthly medical costs. CONCLUSIONS: Triple therapy with FSC added to TIO compared with TIO monotherapy was associated with significant reductions in the adjusted risks of moderate exacerbation and any exacerbation over a follow-up period of up to 1 year. These improvements were gained with triple therapy at roughly equal cost of that of TIO alone.

Observational study of the outcomes and costs of initiating maintenance therapies in patients with moderate exacerbations of COPD.

BACKGROUND: There are limited data describing patients with moderate COPD exacerbations and evaluating comparative effectiveness of maintenance treatments in this patient population. The study examined COPD patients with moderate COPD exacerbations. COPD-related outcomes were compared between patients initiating fluticasone propionate-salmeterol 250/50 mcg (FSC) vs anticholinergics (ACs) following a moderate COPD exacerbation. METHODS: This retrospective observational study used a large administrative claims database (study period: 2003-2009) to identify and describe patients with an initial, moderate COPD exacerbation. A descriptive analysis of patients with moderate COPD exacerbations was done evaluating maintenance treatment rates, subsequent COPD exacerbation rates, and COPD-related costs during a 1-year period. A cohort analysis compared COPD exacerbation rates and associated costs during a variable-length follow-up period between patients initiating maintenance therapy with FSC or ACs. COPD exacerbations were reported as rate per 100 patient-years, and monthly costs were reported (standardized to USD 2009). COPD exacerbation rates between cohorts were evaluated using Cox proportional hazards models, and costs were analyzed using generalized linear models with log-link and gamma distribution. RESULTS: 21,524 patients with a moderate COPD exacerbation were identified. Only 25% initiated maintenance therapy, and 13% had a subsequent exacerbation. Annual costs averaged $594 per patient. A total of 2,849 treated patients (FSC = 925; AC = 1,924) were eligible for the cohort analysis. The FSC cohort had a significantly lower rate of COPD exacerbations compared to the AC cohort (20.8 vs 32.8; P = 0.04). After adjusting for differences in baseline covariates, the FSC cohort had a 42% significantly lower risk of a COPD exacerbation (HR = 0.58; 95% CI: 0.38, 0.91). The FSC cohort incurred significantly higher adjusted pharmacy costs per patient per month by $37 (95% CI: $19, $72) for COPD-related medications vs the AC cohort. However, this increase was offset by a significant reduction in adjusted monthly medical costs per patient for the FSC vs the AC cohort ($82 vs $112; P < 0.05). Total monthly COPD-related costs, as a result, did not differ between cohorts. CONCLUSIONS: Only a quarter of patients with a moderate COPD exacerbation were subsequently treated with maintenance therapy. Initiation of FSC among those treated was associated with better clinical and economic outcomes compared to AC.

Short-acting ß-agonist use and its ability to predict future asthma-related outcomes.

BACKGROUND: Short-acting ß-agonist (SABA) use is well established in predicting asthma events in adults. However, this predictive ability has yet to be established in a pediatric population together with an assessment of amount of use. OBJECTIVE: To identify the number of SABA canisters that best predicts future asthma-related exacerbations and the optimal length of time for measurement of SABA use in pediatric and adult asthma patients. METHODS: Asthma patients were identified from a Medicaid and a commercially insured database (January 1, 2004, through December 31, 2005, and January 1, 2004, through June 30, 2006, respectively). Following the date of first asthma medication, an assessment period (3, 6, or 12 months) was used to measure SABA use. Asthma-related exacerbations were identified in the subsequent 12-month period. Receiver operating characteristic curve analyses and logistic regression were used to select the critical values of SABA use and optimal assessment periods and to conduct incremental analysis, respectively. RESULTS: A total of 33,793 Medicaid and 101,437 commercial patients met the study criteria. Use of 3 or more SABA canisters during 12 months was identified in both pediatric Medicaid and commercial populations to best predict an increased risk of an asthma-related exacerbation. For adults, use of 2 or more SABA canisters was found as the critical value with shorter optimal assessment periods of 3 and 6 months. Each additional SABA canister resulted in an 8% to 14% and 14% to 18% increase in risk of an asthma-related exacerbation in children and adults, respectively. CONCLUSION: The study identified critical values of SABA use that predict future asthma events. Each additional SABA canister predicted increases in exacerbation risk in children and adults.

A United States cost-benefit comparison of an apodized, diffractive, presbyopia-correcting, multifocal intraocular lens and a conventional monofocal lens.

PURPOSE: To demonstrate the value, from the patient's perspective, of an apodized, diffractive, presbyopia-correcting multifocal intraocular lens (MF-IOL) compared to a conventional monofocal intraocular lens (CM-IOL). SETTING: Open-label, multi-site U.S. clinical trial. METHODS: A cost-benefit analysis was conducted using cataract patients' willingness-to-pay (WTP) for spectacle independence as the measure of economic benefit. WTP was elicited from participants in a clinical trial comparing a MF-IOL and a CM-IOL. Costs borne by patients were obtained from standard reference sources. A 14-year analytical timeframe was used, and a 3% annual discount rate was applied to both costs and benefits. The outcome of interest was net benefit (difference between benefits and costs). A probabilistic sensitivity analysis was used to confirm the robustness of the economic results. RESULTS: Four hundred ninety-five patients provided WTP estimates for spectacle independence (MF-IOL, n = 339; CM-IOL, n = 156). Eighty percent of all patients were willing to pay at least $5 per day to be spectacle independent. The incremental acquisition cost associated with bilateral implantation of 2 MF-IOLs was estimated at $4,000. Eighty percent in the MF-IOL group and 8% in the CM-IOL group reported post-operative spectacle independence. The net benefit was $11,670 in the MF-IOL group and $155 in the CM-IOL group. The probabilistic sensitivity analysis confirmed the robustness of the economic outcomes. CONCLUSION: The net benefit of the MF-IOL exceeded its acquisition cost and the net benefit of the CM-IOL, demonstrating its value to select cataract patients willing to pay a premium for spectacle independence.

Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan.

BACKGROUND: Pharmacotherapy constitutes an important adjunct to behavioral therapy for the treatment of overactive bladder (OAB). Tolterodine and oxybutynin are commonly prescribed drugs for OAB treatment that exert their beneficial effect by suppressing bladder muscle contractions. However, high discontinuation rates have been observed for these drugs in clinical trials, as well as in real-world settings, in part due to adverse effects. Extended-release (ER) formulations were introduced with an improved tolerability profile over immediate-release (IR) versions of the 2 drugs. No study has compared persistence and adherence to therapy for both the ER and IR versions of tolterodine and oxybutynin. OBJECTIVE: To compare persistence, adherence, and switch rates for the IR and ER formulations of oxybutynin and tolterodine for patients enrolled in a regional managed care plan. METHODS: Study patients were adults (aged e 18 years), with at least 1 pharmacy claim for either tolterodine extended-release (tol-ER), oxybutynin extended-release (oxy-ER), tolterodine immediate-release (tol-IR), or oxybutynin immediate-release (oxy-IR) during the period from July 1, 1999, to December 31, 2003, and were continuously eligible for benefits from 6 months before through 12 months after the initial OAB pharmacy claim (index) date. A retrospective cohort study design was used following patients from the index date to the occurrence of non-persistence with the index medication (i.e., a gap of > 45 days between successive prescription fills or a switch to any other OAB medication), or the end of a 1-year follow-up period, through December 31, 2004. Switching was defined as any change from the index medication, including a change in dose form (e.g., tol-IR to tol-ER), to one of the other 3 study drugs, or to a different OAB treatment (e.g., trospium chloride, oxybutynin patch, flavoxate, hyoscyamine sulfate, or propantheline bromide) during the follow-up period. Adherence was measured as the proportion of patients with a medication possession ratio (MPR) of at least 80%. MPR was calculated as (1) the sum of days supply for all pharmacy claims except the last pharmacy claim, divided by (2) the total number of days from the first fill date to the fill date of the last pharmacy claim. The association of drug therapy with study outcomes was assessed with bivariate and adjusted (multivariate) analyses. Multivariate analyses controlled for demographic and clinical characteristics, plan type, patient out-of-pocket cost for the index medication, and year of therapy initiation. RESULTS: 1,117 patients had at least 1 pharmacy claim for an OAB study drug (n = 454 for tol-ER [40.6%], n = 249 for oxy-ER [22.3%], n = 306 for tol-IR [27.4%], n = 108 for oxy-IR [9.7%]), of whom 81.6% were women. The mean (standard deviation [SD]) age of the study population was 55.7 (14.5) years. Only 53.7% had at least 1 OAB diagnosis recorded during the 18-month eligibility period. 44.5% of patients did not have a refill after the initial (index) pharmacy claim (39.4% for oxy-ER, 42.7% for tol-ER, 46.1% for tol-IR, and 59.3% for oxy-IR; P = 0.004). Only 13.2% persisted with treatment for at least 1 year (tol-ER = 15.0%, oxy-ER = 15.3%, tol-IR = 11.4%, oxy-IR = 6.5%; P = 0.050). The median days to discontinuation (non-persistency) were 31.0 overall, 33.0 for tol-ER, 34.0 for oxy-ER, 32.0 for tol-IR, and 0 for oxy-IR; P = 0.010. The overall switch rate as a percentage of all study patients was 13.3%, ranging from 9.9% for tol-ER, 13.7% for tol-IR, 16.5% for oxy-ER, and 19.4% for oxy-IR; P = 0.020. Of patients who refilled their initial prescription at least once, 24.0% made a medication switch. Adherence rates as measured by percentage of patients with MPR >or= 80% were 30.3% overall and higher for the ER formulations: 35.2% for tol-ER, 36.1% for oxy-ER, 23.5% for tol-IR, and 14.8% for oxy-IR; P < 0.001. CONCLUSIONS: Adherence was significantly better for ER than IR agents. The high rate of non-persistence (44.5%) following the first (index) prescription highlights the need for medication counseling by health care professionals.

Costs of Diagnostic Assessment for Lung Cancer: A Medicare Claims Analysis.

PURPOSE: To assess the diagnostic costs leading up to a lung cancer diagnosis in patients with abnormal computed tomography (CT) scans. PATIENTS AND METHODS: A retrospective cohort study using the 5% Medicare claims data (January 1, 2009, to December 31, 2011) was conducted. Patients aged 65 to 74 years with an abnormal chest CT scan were identified. Index was defined as the date of the abnormal chest CT scan. Outcomes assessed over a 12-month follow-up after index included lung cancer diagnosis rate and the use and associated costs of follow-up diagnostic tests up to diagnosis of lung cancer. RESULTS: Of 8979 patients identified with an abnormal chest CT scan (mean age, 69.3 ± 2.9 years), 13.9% were diagnosed with lung cancer over 12 months. Chest x-rays were the most common diagnostic test. Of the 19% who underwent a biopsy, 43.6% were not diagnosed with lung cancer during follow-up. The average total diagnostic assessment cost per patient was higher for those with versus without lung cancer ($7567 vs. $3558). Among patients not diagnosed with lung cancer, the median diagnostic cost per patient for those with versus without biopsy was ∼ 28 times higher. Adverse events significantly increased the average cost per biopsy (approximately 4-fold). CONCLUSION: Total lung cancer diagnostic cost was $38.3M in the defined study sample, of which 43.1% was accounted for by biopsied patients without a lung cancer diagnosis. Additional risk stratification is required to decrease unnecessary biopsy referrals and costs. Further, adverse events significantly increased costs.

Health care resource use and cost differences by opioid therapy type among chronic noncancer pain patients.

The study assessed 12-month chronic pain (CP)-related health care utilization and costs among chronic noncancer pain (CNCP) patients who initiated various long-term opioid treatments. Treatments included monotherapy with long-acting opioids (mono-LAOs), mono-therapy with short-acting opioids (mono-SAOs), both LAOs and SAOs (combination), and opioid therapy initiated with SAO or LAO and switched to the other class (switch). Using MarketScan® claims databases (2006-2012), we identified CNCP patients with ≥90 days opioid supply after pain diagnosis and continuous enrollment 12 months before pain diagnosis (baseline period) and 12 months after opioid start (post-index period). Outcomes included CP-related health care utilization and costs. Among CNCP patients (n=21,203), the cohort distribution was 74% mono-SAOs, 22% combination, 2% mono-LAOs, and 2% switch. During follow-up, the average daily morphine equivalent dose was highest in mono-LAO patients (96.4 mg) compared with combination patients (89.8 mg), switch patients (64.3 mg), and mono-SAO patients (36.2 mg). After adjusting for baseline differences, the mono-LAO cohort had lower total CP-related costs ($4,933) compared with the mono-SAO ($8,604), switch ($10,470), and combination ($15,190) cohorts (all: P<0.05). Mono-LAO patients had greater CP-related prescription costs but lower medical costs than the other cohorts during the follow-up period, including lower CP-related hospitalizations (1% vs 11%-20%), emergency department visits (4% vs 11%-18%), and diagnostic radiology use (21% vs 54%-61%) (all: P<0.001). Use of pain-related medications and other treatment modalities was also significantly lower in the mono-LAO cohort relative to the other cohorts. CNCP patients using long-term monotherapy with LAOs had the lowest CP-related total health care costs in the 12 months after opioid initiation compared with mono-SAO, switch, or combination patients despite higher opioid daily doses and higher prescription costs. Future research accounting for severity and duration of pain would aid in determining the optimal long-term opioid regimen for CNCP patients.

An appraisal of pharmacoeconomic evidence of maintenance therapy for COPD.

COPD is projected to be the third-leading cause of death by the year 2020. Pharmacotherapy for COPD is palliative at best, having no impact on slowing the progression of the disease. The introduction of newer therapies such as long-acting forms of bronchodilator and anticholinergic agents, together with the inclusion of inhaled corticosteroids (ICSs) in the recent Global Initiative for COPD therapeutic algorithm, have expanded the pharmacotherapy options for the treatment of COPD. This article provides a methodologic critique of the available pharmacoeconomic evidence on drug therapy for stable COPD in an effort to complement treatment guidelines and to identify any need for future pharmacoeconomic research. Relevant search strategies revealed a total of 28 economic evaluations of which 7 satisfied the study inclusion criteria. The Drummond 10-point checklist was used for the methodological critique of the economic evaluations. Five of seven pharmacoeconomic studies were conducted alongside a randomized controlled trial, and six of seven were cost-effectiveness analyses. Of the bronchodilators, the long-acting anticholinergic agent tiotropium is considered to be cost-effective relative to ipratropium. No conclusive information could be reached for the cost-effectiveness of long-acting beta-agonists. A Markov analysis showed ICSs to be cost-effective for patients with moderate-to-severe COPD relative to standard care. However, assumptions of the model may bias this conclusion, and additional studies are warranted, especially compared to other treatments. The authors suggest that additional pharmacoeconomic studies be conducted to assess the cost-effectiveness of long-acting beta-agonists and ICSs, between classes of bronchodilators, and between various combination therapies.

Hypoglycemia Incidence Rates and Associated Health Care Costs in Patients with Type 2 Diabetes Mellitus Treated with Second-Line Linagliptin or Sulfonylurea After Metformin Monotherapy.

BACKGROUND: Hypoglycemia poses a significant clinical and economic burden to patients with type 2 diabetes mellitus (T2DM). Minimizing the risk of hypoglycemia is an important component when managing patients with T2DM. Understanding hypoglycemia rates and the associated economic consequences can help to inform health care decision makers. OBJECTIVE: To assess hypoglycemia incidence rates and associated costs in patients who initiated second-line treatment with the antidiabetic agents linagliptin or a sulfonylurea (SU) after metformin. METHODS: A large U.S. administrative claims database was used to identify patients with T2DM (during the identification period July 2011-October 2013) who initiated linagliptin or a SU after metformin use. The date of the first prescription for linagliptin or a SU during the identification period was designated as the index date. Linagliptin users were matched to SU users based on demographic and clinical characteristics identified within a 12-month period before the index date using propensity scores (1:3 ratio, caliper: ±0.001). Rates and costs (2013 U.S. dollars) of hypoglycemia resulting in any health care resource use were quantified during a variable follow-up period (i.e., end of the study, end of the 12-month follow-up, treatment regimen change, or disenrollment, whichever came first). Hypoglycemia rates per 100 person-years were compared using univariate Poisson regression, and hazard of hypoglycemia was obtained from multivariate Cox proportional hazards regression. Mean monthly hypoglycemia-related costs, all-cause costs, and T2DM-related costs were computed for patients with hypoglycemia and compared using t-tests. RESULTS: Propensity-score matching resulted in a sample of 11,536 patients (linagliptin = 2,884; SU = 8,652) with a mean age of 56 years and 59% male. The rate of hypoglycemia (per 100 person-years) was lower in the linagliptin than the SU user groups (2.51 vs. 3.63; P= 0.049). Linagliptin users had a 33% lower risk of hypoglycemia compared with SU users (HR = 0.67; 95% CI = 0.47-0.97; P= 0.031). Among patients who had hypoglycemia, linagliptin users showed numerically lower mean monthly hypoglycemia-related costs compared with SU users ($300 vs. $890; P= 0.092), which was primarily driven by differences in hypoglycemia-related costs in the hospital setting. A similar theme was observed with monthly all-cause costs (linagliptin users, $1,971 vs. SU users, $3,758; P= 0.092). CONCLUSIONS: Linagliptin use was associated with a lower incidence rate of hypoglycemia compared with SU use in patients initiating second-line therapy after metformin monotherapy. Among patients who experienced hypoglycemia, linagliptin users appeared to have lower monthly hypoglycemia-related and all-cause costs than SU users. Careful consideration of newer treatment alternatives may be prudent for optimal T2DM management, especially with regard to hypoglycemia. DISCLOSURES: Funding for the research study and resultant publication was provided by Boehringer Ingelheim. Shetty is an employee of Boehringer Ingelheim. Cai was an employee of Boehringer Ingelheim at the time of the study. Raju and D'Souza are employees of Xcenda, which received research funding from Boehringer Ingelheim for the conduct of this study and for the preparation of this manuscript. All authors contributed to concept and study design. Raju took the lead in data analysis, along with D'Souza, and all authors contributed equally to data interpretation. The manuscript was written by Raju, D'Souza, Cai, and Shetty and revised primarily by Raju, along with Shetty and D'Souza.

Single- versus multiple-tablet HIV regimens: adherence and hospitalization risks.

OBJECTIVES: To evaluate the impact of antiretroviral therapy as a single-tablet regimen (STR) and multiple-tablet regimen (MTR) on outcomes in human immunodeficiency virus (HIV)/AIDS patients using electronic health records from the Veterans Healthcare Administration (VHA). STUDY DESIGN: Retrospective cohort. METHODS: This study evaluated VHA patients to whom HIV medications were dispensed as STRs or MTRs during the study period (January 1, 2006, to July 30, 2012). Patients were followed from the index date (ie, start of regimen) until treatment discontinuation, end of study period, last date of healthcare-related activity, or death. Differences in outcomes of hospitalization, adherence defined as a medication possession ratio of ≥ 95%, and undetectable viral load were evaluated using a Cox-proportional hazard and logistic model controlling for covariates measured during a 6-month baseline period. RESULTS: A total of 15,602 patients (6191 STR and 9411 MTR) met all study criteria. The study sample was, on average, aged 52 years with similar CD4 counts (mean ± SD: 432.2 ± 282.8 vs 419.3 ± 280.9; P = .287), but a significantly lower proportion of STR versus MTR patients had an undetectable viral load at baseline (42% vs 46%; P < .001). After controlling for baseline covariates, the STR cohort had twice the odds of being adherent (odds ratio [OR], 1.98; P < .001), 31% had a significantly lower hazard of having a hospitalization (hazard ratio, 0.69; P < .001), and 21% had higher odds of having an undetectable viral load during follow-up (OR, 1.21; P < .001). CONCLUSIONS: STR is associated with higher adherence rates, decreased hospitalizations, and more patients with an undetectable viral load in VHA patients with HIV/AIDS.

Treatment patterns of chronic obstructive pulmonary disease in employed adults in the United States.

BACKGROUND: This study evaluated patterns of pharmacotherapy in chronic obstructive pulmonary disease (COPD) as they relate to recommended guidelines in a prevalent COPD patient population with employer-sponsored health insurance in the US. METHODS: Health care claims data from 2007 and 2008 were retrospectively analyzed for the study population defined as patients aged 40 years and older, continuously enrolled during the study period, and having at least one inpatient or one emergency department (ED) visit, or at least two outpatient claims coded with COPD (International Classification of Diseases, 9th Revision, Clinical Modification code 491.xx, 492.xx, 496.xx). Rates of any pharmacotherapy (both maintenance and reliever), long-acting maintenance pharmacotherapy in patients with an exacerbation history, and short-term treatment of acute exacerbations of COPD were evaluated in the overall population, newly diagnosed, and previously diagnosed patients (including maintenance-naïve and maintenance-experienced). Stratified analyses were also conducted by age group (40-64 years, ≥65 years) and physician specialty. RESULTS: A total of 55,361 patients met study criteria of whom 39% were newly diagnosed. The mean age was 66 years, and 46% were male. Three-fourths (74%) of all COPD patients had some pharmacotherapy (maintenance or reliever) with less than half (45%) being treated with maintenance medications. The combination of an inhaled corticosteroid and a long-acting beta-agonist was the most prevalent drug class for maintenance treatment followed by tiotropium. Only 64% of patients with an exacerbation history had a prescription for a long-acting maintenance medication, and short-term treatment with oral corticosteroids or antibiotics was higher for hospitalization exacerbations compared to ED visit exacerbations (68% vs 44%). In general, the rates of pharmacotherapy were highest in patients who were maintenance-experienced followed by newly diagnosed and maintenance-naïve. CONCLUSION: The majority of COPD patients received maintenance or reliever COPD medications, but less than half received guideline-recommended care, especially those with an exacerbation history or receiving short-term treatment for acute exacerbations.

Glycemic parameters with multiple daily injections using insulin glargine versus insulin pump.

This study compared external insulin pump treatment using insulin lispro or insulin aspart with multiple daily injections (MDI; four or more injections per day) using insulin glargine and insulin lispro or insulin aspart. An electronic database was used to retrieve various parameters of glycemic control for 515 adult patients with type 1 diabetes. An insulin pump was used by 216 patients, and 299 patients were taking insulin glargine for at least 6 months. The mean age (approximately 33 years), duration of diabetes (approximately 16 years), and duration of treatment (approximately 12 months) were similar for both the pump and insulin glargine groups. The mean (+/-SEM) A1C values were significantly reduced in both groups from the baseline to the end of the study (7.7 +/- 0.1% to 7.5 +/- 0.1% for the pump group and 8.0 +/- 0.1% to 7.7 +/- 0.1% for the insulin glargine group, P< 0.001) with similar weight gain (P> 0.05) in both groups. The insulin glargine group significantly reduced basal insulin intake at follow-up. The premeal boluses were similar throughout the study for both groups. The subjects reporting severe hypoglycemic episodes were similar in the two groups; however, there were 12 cases of diabetic ketoacidosis reported in the pump group and none in the insulin glargine group. Patients with type 1 diabetes can achieve similar glycemic control using insulin glargine with premeal insulin lispro or by using an external infusion pump with insulin lispro or insulin aspart. However, costs and episodes of diabetic ketoacidosis are significantly higher for insulin pump users.

Differences in hospital length-of-stay, charges, and mortality in congestive heart failure patients.

The aim of this study was to demonstrate differences in hospitalization outcomes including length-of-stay (LOS), charges, and mortality in congestive heart failure patients using the Healthcare Cost and Utilization Project dataset. Hospitalizations with International Classification of Diseases, Ninth Revision, clinical modification (ICD-9-CM) codes for congestive heart failure were extracted from a 10% random Healthcare Cost and Utilization Project sample to yield 19,693 hospitalizations between January 1 and December 31, 1997. Mean hospital charges were $11,688 and mean LOS was 5.83 days. The overall in-hospital mortality rate was 4.7%. Both LOS and hospital charges were higher in urban compared with rural hospitals (p< or =0.05). LOS and charges also increased with hospital size (p< or =0.05). Among patient characteristics, patient health status significantly affected LOS, charges, and mortality. Privately insured/health maintenance organization patients had 9% shorter LOS than Medicare patients, and Medicaid patients had 6.6% lower charges and 42% lower mortality than Medicare patients (p< or =0.05). Other significant predictors of study outcome variables included age, gender, race, hospital region, and hospital experience.

Fluticasone propionate-salmeterol versus inhaled corticosteroids plus montelukast: outcomes study in pediatric patients with asthma.

BACKGROUND: The purpose of this study (GSK ADA111194) was to compare asthma-related health care utilization and costs associated with fluticasone propionate (an inhaled corticosteroid [ICS]) and salmeterol (a long-acting beta-agonist) in a single inhalation device (fluticasone propionate-salmeterol) versus the combination of ICS + montelukast in the treatment of pediatric patients with asthma. METHODS: This was a retrospective, observational cohort study using a large health insurance claims database spanning January 1, 2000 to January 31, 2008. The target population was patients aged 4-11 years with at least one pharmacy claim for fluticasone propionate-salmeterol, any ICS, or montelukast during the study period. The date of first claim for the medication of interest was deemed the index date. Patients were required to be continuously eligible to receive health care services one year prior to and 30 days after the index date, and have at least one claim with an ICD-9-CM code for asthma (493.xx) in the one-year pre-index period. Patients with prescriptions for fluticasone propionate-salmeterol, ICS + montelukast, or long-acting beta-agonists during the pre-index period were excluded. Patients were matched on a 1:1 basis according to three variables, ie, pre-index use of oral corticosteroids, ICS, and presence of pre-index respiratory-related hospitalizations/emergency department visits. The risk of asthma-related hospitalization, combined hospitalization/emergency department visit, and monthly asthma-related costs were assessed using multivariate methods. RESULTS: Of the 3001 patients identified, 2231 patients were on fluticasone propionate-salmeterol and 770 were on ICS + montelukast. After matching, there were 747 pairs of fluticasone propionate-salmeterol and ICS + montelukast patients, which were well matched for baseline characteristics. Patients who started fluticasone propionate-salmeterol compared with patients on ICS + montelukast had a significantly (P < 0.02) lower rate of asthma-related hospitalizations (0.3% versus 3.5%) and asthma-related hospitalizations/emergency department visits (3.5% versus 5.7%). After controlling for baseline and patient characteristics, fluticasone propionate-salmeterol users were associated with a significantly lower risk of an asthma-related hospitalization (adjusted hazard ratio 0.039; 95% confidence interval 0.004-0.408) or hospitalization/emergency department visit (hazard ratio 0.441; 95% confidence interval 0.225-0.864), and $151 (95% confidence interval 67-346) lower asthma-related monthly costs compared with ICS + montelukast. CONCLUSION: In patients aged 4-11 years with asthma, use of fluticasone propionate-salmeterol was associated with lower asthma-related health care utilization and costs compared with use of ICS + montelukast.

Predicting asthma outcomes in commercially insured and Medicaid populations?

OBJECTIVES: To assess the predictive ability of the ratio of controller-to-total asthma medication in commercially insured and Medicaid patients. STUDY DESIGN: Retrospective cohort. METHODS: Medical and pharmacy claims were used to identify asthma patients between 2004 and 2006. Ratios were computed during 3-, 6-, and 12-month assessment periods and asthma exacerbations were assessed during a subsequent 12-month follow-up period. Receiver operating characteristic curve analyses and logistic regression were used to select optimal ratio number, assessment time period, and incremental ratio analysis. RESULTS: The ratio significantly predicted future asthma exacerbations. An optimal value of >0.7 was identified in pediatric and adult Medicaid patients with a shorter assessment period in adults (3 months) than in children (6 months). In commercially insured patients, an optimal value of >0.5 during a 6-month assessment period was identified for children and adults. In commercially insured patients, a 0.1-unit increase in the ratio below the 0.5 value resulted in a 72% (odds ratio [OR] 0.28; 95% confidence interval [CI] 0.13-0.57) and 80% (OR 0.20; 95% CI 0.12-0.33) risk reduction among pediatric and adult patients, respectively. Similarly, a 0.1-unit increase in the ratio below the 0.7 optimal value in the Medicaid population resulted in significant risk reduction in the pediatric (OR 0.65; 95% CI 0.43-0.97) but not the adult cohort. CONCLUSIONS: The ratio is a significant predictive risk marker in commercially insured and Medicaid asthma populations. Incremental risk reductions can be realized by unit increases in the ratio up to the identified optimal value.

Clinical and economic outcomes for patients initiating fluticasone propionate/salmeterol combination therapy (250/50 mcg) versus anticholinergics in a comorbid COPD/depression population.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is frequently associated with comorbid depression and anxiety. Managing COPD symptoms and exacerbations through use of appropriate and adequate pharmacotherapy in this population may result in better COPD-related outcomes. METHODS: This retrospective, observational study used administrative claims of patients aged 40 years and older with COPD and comorbid depression/anxiety identified from January 1, 2004 through June 30, 2008. Patients were assigned to fluticasone propionate/salmeterol 250/50 mcg combination (FSC) or anticholinergics (AC) based on their first (index) prescription. The risks of COPD exacerbations and healthcare utilization and costs were compared between cohorts during 1 year of follow-up. RESULTS: The adjusted risk of a COPD-related exacerbation during the 1-year follow-up period was 30% higher in the AC cohort (n = 2923) relative to the FSC cohort (n = 1078) (odds ratio [OR]: 1.30, 95% confidence interval [CI]: 1.08-1.56) after controlling for baseline differences in covariates. The risks of COPD-related hospitalizations and emergency department visits were 56% and 65% higher, respectively, in the AC cohort compared with the FSC cohort. The average number of COPD-related hospitalizations during the follow-up period was 46% higher for the AC cohort compared with the FSC cohort (incidence rate ratio [IRR]: 1.46, 95% CI: 1.01-2.09, P = 0.041). The savings from lower COPD-related medical costs ($692 vs $1042, P < 0.050) kept the COPD-related total costs during the follow-up period comparable to those in the AC cohort ($1659 vs $1677, P > 0.050) although the pharmacy costs were higher in the FSC cohort. CONCLUSIONS: FSC compared with AC was associated with more favorable COPD-related outcomes and lower COPD-related utilization and medical costs among patients with COPD and comorbid anxiety/depression.

Rehospitalization risks and outcomes in COPD patients receiving maintenance pharmacotherapy.

OBJECTIVE: To determine clinical and economic outcomes following COPD-related hospitalization/emergency department (ED) care in patients receiving COPD maintenance therapy. METHODS: In this retrospective, observational study using administrative claims data, we identified COPD patients age ≥40 years who received maintenance therapy within 30 days of an initial COPD-related hospitalization or ED visit with: (1) fluticasone propionate/salmeterol combination (FSC 250 mcg/50 mcg) as new therapy, or (2) an anticholinergic (AC; tiotropium or ipratropium with or without albuterol). The FSC and AC patients were matched (1:3 ratio) on various baseline characteristics using propensity scores to mitigate selection bias at baseline. The proportion of patients with COPD-related healthcare events, the mean event rates, and the mean costs in the subsequent 12 months were calculated. RESULTS: The FSC cohort (N = 484) had a significantly lower proportion of rehospitalized patients during follow-up than did the AC cohort (N = 1452), 3.1% versus 4.6% (P = 0.047). The mean number of rehospitalizations was 0.03 in the FSC cohort and 0.07 in the AC cohort (P = 0.001). The proportion of patients with an exacerbation resulting in an ED or physician-outpatient visit and the mean number of such visits did not differ between cohorts. Total annual COPD-related medical costs were lower for FSC than for AC ($2080 versus $2636, P = 0.006), with lower medical and higher pharmacy costs. CONCLUSIONS: Patients receiving FSC as maintenance therapy following an initial COPD-related hospitalization or ED visit experienced better clinical and economic outcomes than patients receiving AC.

Outcomes associated with timing of maintenance treatment for COPD exacerbation.

OBJECTIVES: To examine the impact of timing of maintenance treatment initiation (early vs delayed) on risk of future exacerbations and costs in chronic obstructive pulmonary disease (COPD) patients. STUDY DESIGN: Retrospective cohort design using data (January 1, 2003, through June 30, 2009) from a large, US-based integrated pharmacy and medical claims database. METHODS: Administrative claims from January 1, 2003, through June 30, 2009, were used. Methotrexate (MTx)-naïve patients (aged >40 years) with at least 1 COPD-related hospitalization/emergency department (ED) visit were included (discharge date was index date). Patients initiating MTx within the first 30 days and 31 to 180 days post-index were classified into early and delayed cohorts, respectively. Clinical and economic outcomes related to COPD exacerbations were assessed for 1 year post-index and compared between cohorts using regression models controlling for baseline characteristics. The incremental effect on outcomes of every 30-day delay in MTx initiation up to 6 months after the index event was also assessed. RESULTS: The majority of the 3806 patients (78.6%) received early MTx. A significantly higher proportion of patients in the delayed cohort had a COPD-related hospitalization/ED visit compared with the early cohort (25.6% vs 18.0%; P <.001). After controlling for baseline differences, the delayed cohort had a 43% (P <.001) higher risk of a future COPD-related hospitalization/ED visit compared with the early cohort. Every 30-day delay was associated with 9% risk increase (P = .002). Treatment delay also increased COPD-related costs ($5012 vs $3585; P <.001). CONCLUSION: Early MTx initiation is associated with reduced risk of future COPD exacerbations and lower costs.

COPD-related healthcare utilization and costs after discharge from a hospitalization or emergency department visit on a regimen of fluticasone propionate-salmeterol combination versus other maintenance therapies.

OBJECTIVES: To quantify healthcare use and costs associated with chronic obstructive pulmonary disease (COPD) among patients discharged from a COPD-related hospitalization or emergency department (ED) visit on a regimen of fluticasone propionate-salmeterol combination versus other inhaled maintenance therapies. STUDY DESIGN: Retrospective cohort study. METHODS: Managed care enrollees with an index hospitalization (with a primary or secondary [ie, in the second position] diagnosis of COPD) or ED visit (with a primary diagnosis of COPD) were identified for placement into study cohorts during a 60-day period following the index date. Time to COPD-related events and healthcare costs were compared during up to 1 year of follow-up between the 2 cohorts. RESULTS: The sample comprised 5677 patients (1291 in the fluticasone propionate-salmeterol cohort and 4386 in the other maintenance therapies cohort). The adjusted rate of COPD-related hospitalizations or ED visits was 35% lower in the fluticasone propionate-salmeterol cohort (P <.05). Adjusted COPD-related total (medical plus pharmacy) costs were lower in the fluticasone propionate-salmeterol cohort ($240 vs $279 per patient per month, P <.05), mostly because of lower medical costs ($113 vs $160 per patient per month, P <.05). Pharmacy costs did not differ between fluticasone propionate-salmeterol and other maintenance therapies. Results were similar in the subset of patients 65 years or older. CONCLUSIONS: Initiation of fluticasone propionate-salmeterol after discharge from a COPD-related hospitalization or ED visit significantly reduced the risk of a recurrent event during the ensuing months and decreased COPD-related medical costs, without an increase in COPD-related pharmacy costs, in a real-world setting.