Continuity of Care Assessment Within a Vertically Integrated Care Management Organization Before and After COPD-Related Exacerbations.

BACKGROUND: There is currently little research describing patient experience and continuity of care immediately prior, during, and following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This analysis examined clinical characteristics, chronic obstructive pulmonary disease (COPD)­related medication patterns and outpatient visits before and after an AECOPD. METHODS: This retrospective analysis used electronic health records, medical claims, and pharmacy dispensing data for patients within the Kaiser Permanente Northwest Health System. Patients with ≥1 AECOPD between January 1, 2015 and December 31, 2017 were identified. The most recent AECOPD was considered the index date. An AECOPD was defined as an inpatient hospitalization with a primary diagnosis of COPD, or respiratory failure with a secondary diagnosis of COPD, or an outpatient visit with a primary diagnosis of COPD and dispensing of respiratory-related antibiotics and/or oral corticosteroids ±5 days of the visit. Eligible patients were: ≥40 years old; ≥2 encounters within 12 months of each other or ≥1 hospitalization with primary or secondary COPD diagnosis, chronic bronchitis, or emphysema prior to index; and continuously enrolled ±90 days relative to index. COPD-related inhaled maintenance medication, rescue inhalers, oral corticosteroid use, and ambulatory visits were assessed 90-days pre- and post-index. RESULTS: There were 2829 patients included (mean [standard deviation] age: 69.0 [10.5] years) who had an AECOPD (7% severe; 93% moderate). The percentage of patients on inhaled maintenance therapy increased from 60.6% pre-AECOPD to 68.8% post-AECOPD and increased from 60.0% to 87.4% among patients who experienced a severe AECOPD. COPD-related ambulatory visits increased more than four-fold for primary care and more than doubled for pulmonologist visits in the post-AECOPD period. CONCLUSION: The low proportion of patients observed with changes to controller and rescue medication (particularly following a moderate AECOPD), yet higher utilization of COPD-related ambulatory visits before and after an AECOPD suggests that there is opportunity to improve pharmacotherapy management.

Real-world effectiveness of umeclidinium/vilanterol versus fluticasone propionate/salmeterol as initial maintenance therapy for chronic obstructive pulmonary disease (COPD): a retrospective cohort study.

Background and objective: Retrospective claims data in patients with chronic obstructive pulmonary disease (COPD) initiating maintenance therapy with inhaled fixed-dose combinations of long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) versus inhaled corticosteroid (ICS)/LABA have not been reported. Methods: Retrospective observational study in a COPD-diagnosed population of commercial and Medicare Advantage with Part D (MAPD) enrollees aged ≥40 years from a US health insurer database. Patients initiated umeclidinium/vilanterol (UMEC/VI [62.5/25 µg]) or fluticasone propionate/salmeterol (FP/SAL [250/50 µg]) between April 1, 2014 and August 31, 2016 (index date) and had 12 months continuous enrollment pre- and post-index. Exclusion criteria included an asthma diagnosis in the pre-index period/index date; ICS-, LABA-, or LAMA-containing therapy during the pre-index period; or pharmacy fills for both UMEC/VI and FP/SAL, multiple-inhaler triple therapy, a non-index therapy, or COPD exacerbation on the index date. Adherence (proportion of days covered [PDC] ≥80%) was modeled using weighted logistic regression following inverse probability of treatment weighting (IPTW). Weighted Kaplan-Meier and Cox proportional hazards regression following IPTW were performed for incidence of COPD exacerbation and escalation to multiple-inhaler triple therapy. Results: The study population included 5306 patients (1386 initiating UMEC/VI and 3920 initiating FP/SAL). Adjusted odds of adherence were 2.00 times greater among UMEC/VI than FP/SAL initiators (95% confidence interval [CI]: 1.62─2.46; P<0.001). The adjusted hazard ratio (HR) for first exacerbation was 0.87 (95% CI: 0.74-1.01; P=0.067) among UMEC/VI versus FP/SAL initiators. UMEC/VI initiators had 35% lower adjusted risk of escalation to multiple-inhaler triple therapy (HR 0.65; 95% CI: 0.47-0.89; P=0.008) versus FP/SAL. On-treatment, UMEC/VI initiators had an adjusted 30% reduced risk of a first moderate/severe COPD exacerbation (HR 0.70; 95% CI: 0.54-0.90; P=0.006). Conclusion: Patients with COPD initiating UMEC/VI had higher adherence and longer time before escalation to multiple-inhaler triple therapy than FP/SAL initiators.

Medication adherence and persistence in chronic obstructive pulmonary disease patients receiving triple therapy in a USA commercially insured population.

INTRODUCTION: This longitudinal, retrospective cohort study of patients with COPD describes baseline characteristics, adherence, and persistence following initiation of inhaled corticosteroids (ICS)/long-acting ß2-agonists (LABA)/long-acting muscarinic antagonists (LAMA) from multiple inhaler triple therapy (MITT). METHODS: Patients aged ≥40 years receiving MITT between January 2012 and September 2015 were identified from the IQVIA™ Real-world Data Adjudicated Claims-USA database. MITT was defined as subjects with ≥1 overlapping days' supply of three COPD medications (ICS, LABA, and LAMA). Adherence (proportion of days covered, PDC) and discontinuation (defined as a gap of 1, 30, 60, or 90 days of supply in any of the three components of the triple therapy) were calculated for each patient over 12 months of follow-up. In addition, analyses were stratified by number of inhalers. RESULTS: In total, 14,635 MITT users were identified (mean age, 62 years). Mean PDC for MITT at 12 months was 0.37%. Mean PDC for the ICS/LABA and LAMA component at 12 months was 49% (0.49±0.31; median, 0.47) and 54% (0.54±0.33; 0.56), respectively. The proportion of adherent patients (PDC ≥0.8) at 12 months was 14% for MITT. Allowing for a 30-day gap from last day of therapy, 86% of MITT users discontinued therapy during follow-up. CONCLUSION: Patients with COPD had low adherence to and persistence with MITT in a real-world setting. Mean PDC for each single inhaler component was higher than the mean PDC observed with MITT. Reducing the number of inhalers may improve overall adherence to intended triple therapy.

Initiation of Triple Therapy with Multiple Inhalers in Chronic Obstructive Pulmonary Disease: An Analysis of Treatment Patterns from a U.S. Retrospective Database Study.

BACKGROUND: Evidence suggests that real-world treatment patterns of chronic obstructive pulmonary disease (COPD) do not always follow evidence-based treatment recommendations such as those of the Global Initiative for Chronic Obstructive Lung Disease, which recommends treatment escalation based on disease progression. This U.S. database study evaluated treatment patterns in patients with COPD, focusing on time to initiation of triple therapy using multiple inhalers. OBJECTIVES: To (a) estimate time from diagnosis to initiation of long-acting muscarinic antagonist (LAMA) monotherapy, inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) dual therapy, or LAMA/LABA dual therapy; (b) estimate time to initiation of triple therapy from LAMA monotherapy and ICS/LABA or LAMA/LABA dual therapies; and (c) estimate the likelihood of patient progression to triple therapy. METHODS: This study was a retrospective analysis of patients with COPD newly started on LAMA monotherapy, ICS/LABA, or LAMA/LABA therapy between July 1, 2010, and March 31, 2013, as identified in Humana's research database. Patients who were fully insured with commercial or Medicare Advantage insurance plans and were aged ≥ 40 years at index with at least 1 hospitalization, 1 emergency department, or 1 medical office visit claim with a COPD diagnosis in the pre-index year were included in the analysis. Time from diagnosis to initiation of index therapy and time to triple therapy after index therapy were assessed. Multivariable logistic regression models were used to estimate the likelihood of progression to triple therapy. RESULTS: Of 13,541 patients with a confirmed diagnosis of COPD, 4,000 received LAMA monotherapy; 8,207 received ICS/LABA therapy; and 77 received LAMA/LABA therapy at index; mean time (± SD) from COPD diagnosis to initiation of triple therapy was 178 (± 134) days, 185 (± 130) days, and 252 (± 124) days, respectively. During the study, 28% (n = 1,130) of patients receiving LAMA monotherapy and 20% (n = 1,647) of patients receiving dual therapy (ICS/LABA, n = 1,615; LAMA/LABA, n = 32) progressed to triple therapy. Of the patients who progressed to triple therapy, 63% and 57% of patients receiving monotherapy and dual therapy, respectively, progressed in the 12 months after the index date. In the 12 months before initiation of triple therapy, approximately 50% of patients in the LAMA monotherapy, ICS/LABA, and LAMA/LABA therapy groups had an exacerbation. In the multivariable analysis, discontinuation of therapy, smoking history, and concomitant use of xanthenes and short-acting beta2-agonists were significant predictors of progression from index therapy to triple therapy. CONCLUSIONS: Approximately 25% of patients with COPD progressed to triple therapy within 12 months of initiating treatment with monotherapy or dual therapy. Exacerbations were reported in only 50% of these patients, indicating that the other 50% may have escalated to triple therapy for other reasons. Treatment discontinuation, smoking history, the use of a LAMA, and concomitant medication use were significant predictors of progression to triple therapy. DISCLOSURES: This study was a GlaxoSmithKline-sponsored collaborative research study (HO-14-16145). GlaxoSmithKline funded this study and had a role in study design, data analysis, data interpretation, and writing of this report. Stemkowski is a paid employee of Comprehensive Health Insights, which is a wholly owned subsidiary of Humana and was contracted to conduct the study. No funding was provided to Comprehensive Health Insights for manuscript development. At the time of the study, Lane and Tao were paid employees of Comprehensive Health Insights. Stanford is an employee of and stockholder in GlaxoSmithKline.

Clinical characteristics and medication patterns in patients with COPD prior to initiation of triple therapy with ICS/LAMA/LABA: A retrospective study.

BACKGROUND: This study assessed patient-level characteristics and patterns of medication use in patients with chronic obstructive pulmonary disease (COPD) before initiation of multiple inhaler triple therapy (MITT; long-acting muscarinic antagonist/long-acting ß2-agonist/inhaled corticosteroid [ICS/LAMA/LABA] combination). METHODS: This retrospective study was conducted using the Optum Research Database. Patients enrolled in commercial or Medicare Advantage Prescription Drug plans, with a COPD diagnosis and >1 prescription for a COPD medication between January 2014 and March 2016 were included. The dispensing date for the first pharmacy prescription completing MITT with at least 1 day of overlap was the patient's index date. The 12 months prior to this date were used to assess patient characteristics, exacerbations, eosinophil counts and changes in medication. RESULTS: The study population comprised 13,701 patients. At the index date, most patients were using a LAMA (n = 13,353 [97.5%]) and combination ICS/LABA (n = 13,292 [97.0%]) MITT. Overall, 90.4% of patients used a LABA, LAMA, LAMA/LABA, or ICS/LABA or had a moderate or severe exacerbation at any time during the baseline period, indicating that approximately 10% of patients initiated MITT without prior bronchodilator use or exacerbation history. Over 65% of patients with an eosinophil measurement had a value ≥ 150 cells/µL. CONCLUSION: Overall, it appears that in this patient population, ICS/LAMA/LABA as triple therapy is being initiated after use of a bronchodilator and/or after an exacerbation event, in accordance with accepted treatment recommendations.

Rates of escalation to triple COPD therapy among incident users of LAMA and LAMA/LABA.

BACKGROUND: Improved outcomes have been reported for patients with chronic obstructive pulmonary disease (COPD) receiving combination long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) therapy compared with LAMA monotherapy. However, little is known about the relative characteristics of these patients and their rates of escalation to triple therapy (TT, combining a LAMA, LABA, and inhaled corticosteroid). This study aimed to characterize patients initiating treatment with the LAMA tiotropium (TIO) and the fixed-dose LAMA/LABA combination therapy umeclidinium/vilanterol (UMEC/VI), and to compare rates of escalation to TT between patients receiving these therapies. METHODS: Retrospective study of patients with COPD enrolled in a US health insurance plan during 2013-2015 and newly initiated on TIO or UMEC/VI. Patients were ≥40 years of age at index (date of therapy initiation) with continuous enrollment for 12 months pre-index and ≥30 days post-index. LAMA users were propensity score matched 1:1 to LAMA/LABA users, with TT initiation rates reported by cohort using pharmacy claims. RESULTS: 35,357 patients initiating on TIO and 2407 patients initiating on UMEC/VI were identified. After propensity score matching, the rate of TT initiation was significantly higher in new TIO users (n = 1320) than in new UMEC/VI users (n = 1320) (0.92 vs 0.49 per 100 months of exposure, respectively; p < 0.001). Relative to the UMEC/VI cohort, the TIO cohort had an 87% higher risk of TT initiation (hazard ratio: 1.87; 95% confidence interval: 1.4-2.5; p = 0.001). CONCLUSIONS: Patients receiving UMEC/VI progressed to TT more slowly, and were at lower risk of progressing to TT, than patients receiving TIO.

Characteristics and health care resource use of subjects with COPD in the year before initiating LAMA monotherapy or LAMA+LABA combination therapy: A U.S. database study.

PURPOSE: To characterize subjects with chronic obstructive pulmonary disease (COPD) newly initiated on long-acting muscarinic antagonists (LAMA) or dual LAMA/long-acting ß2-adrenergic agonist (LABA) therapy. DESIGN: This pilot/preliminary analysis was a retrospective crosssectional study of subjects with COPD from the Optum Impact National Managed Care Benchmark Database. METHODOLOGY: Subjects with at least one LAMA prescription in the index period (July 2008-June 2009) were included and stratified by treatment. Data were collected in the year before the index date and included comorbidities, medication use, COPD-related costs, health care resource use, and exacerbations. RESULTS: Of 5,311 eligible subjects, 2,057 initiated LAMA therapy (LAMA cohort) and 191 initiated LAMA+LABA therapy (LAMA+LABA cohort). The Charlson comorbidity index was slightly lower in the LAMA+LABA cohort than the LAMA cohort (mean±SD: 0.63±1.13 vs. 0.66±1.28), but the number of prescriptions was higher (mean±SD: 42.9±23.2 vs. 30.5±27.2). The LAMA+LABA cohort had higher short-acting inhaled ß2 agonist (56.0% vs. 35.7%), oral corticosteroid (37.7% vs. 32.6%), and home oxygen therapy use (14.1% vs. 3.2%) than the LAMA cohort. Total medical costs were greater in the LAMA+LABA cohort than the LAMA cohort (mean±SD: $3,320.40±4085.9 vs. $1,226.20±3602.9), although emergency department ($11.00±66.8 vs. $30.70±259.2) and outpatient visit ($39.60±163.1 vs. $41.70±424.3) costs were lower. Resource use and exacerbation incidence were similar between cohorts. CONCLUSION: In this first look, subjects with COPD initiating LAMA or LAMA+LABA therapy exhibited different clinical and resource use characteristics in the year before treatment. Subjects receiving LAMA+LABA were older, with higher COPD co-medication use, more prescriptions, and associated higher pharmacy costs compared with subjects initiating LAMA. These differences may reflect a higher severity of COPD in those starting LABA+LAMA treatment.

Comparing outcomes in patients with persistent asthma: a registry of two therapeutic alternatives.

OBJECTIVE: Clinical trials have demonstrated improved efficacy of fluticasone propionate/salmeterol (100/50 mcg) in a single device (FSC) compared with montelukast (10 mg) (MON). This study was designed to assess asthma control, asthma-related quality of life, asthma-related emergency department (ED) visit/hospitalization, treatment-related satisfaction, and productivity losses in patients newly started on FSC or MON. RESEARCH DESIGN AND METHODS: Patients who were newly prescribed FSC or MON during a regularly scheduled office visit were enrolled in a prospective observational study by nearly 500 physicians from eight managed care plans. Patient survey data were collected at baseline and at months 1, 3, 6, and 12, to measure study outcomes. ED visits/inpatient stays were reported from commercial claims data. Multivariate analyses assessed 12-month outcomes, controlling for several baseline patient characteristics. RESULTS: A total of 1414 patients >or= 15 years old were enrolled in the registry (FSC, n = 1061; MON, n = 353), 90% of which completed a 12-month survey. FSC patients had significantly greater improvement in both asthma control and quality of life, and reported significantly higher satisfaction with their medication (p = 0.003) and fewer days at work/school with asthma symptoms (p = 0.04) than MON. Other parameters of productivity losses such as missed work/school days due to asthma were not significantly different between the two groups. FSC use was also significantly associated with a lower risk of an asthma-related ED visit/hospitalization compared with MON (odds ratio = 0.35, 95% confidence interval: 0.15-0.92). CONCLUSION: In a 12-month office-based observational study, patients age 15 and older with persistent asthma, newly started on FSC, improved in symptom, quality of life, treatment, and utilization-related outcomes compared with patients newly started on MON. These results should be interpreted in light of the inherent limitations of non-randomized, uncontrolled studies.