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Michael Bogart,1 Gary Yat-Hung Leung,2 Anissa Cyhaniuk,2 Kristi DiRocco3 1Customer Engagement, Value, Evidence and Outcomes (CEVEO) US Medical Affairs, GSK, Research Triangle Park, NC, USA; 2STATinMED Research, Dallas, TX, USA; 3US Medical Affairs, GSK, Collegeville, PA, USACorrespondence: Kristi DiRocco, US Medical Affairs, GSK, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA, Tel +1 610-412-7175, Email kristi.k.dirocco@gsk.comPurpose: Patients with chronic obstructive pulmonary disease (COPD) who are hospitalized are more likely to die from their illness and have increased likelihood of re-admission than those who are not. Subsequent re-admissions further increase the burden on healthcare systems. This study compared inpatient admission rates and time-to-first COPD-related inpatient admission among Medicare beneficiaries with COPD indexed on umeclidinium/vilanterol (UMEC/VI) versus tiotropium (TIO).Patients and Methods: This retrospective study used the All-Payer Claims Database to investigate hospital admission and re-admission outcomes in Medicare beneficiaries with COPD with an initial pharmacy claim for UMEC/VI or TIO from 1 January 2015 to 28 February 2020. Inpatient admissions, baseline, and follow-up variables were assessed in patients indexed on UMEC/VI and TIO after propensity score matching (PSM), with time-to-first on-treatment COPD-related inpatient admission as the primary endpoint. Re-admissions were assessed among patients with a COPD-related inpatient admission in the 30- and 90-days post-discharge.Results: Post-PSM, 7152 patients indexed on UMEC/VI and 7069 on TIO were eligible for admissions analysis. The mean (standard deviation [SD]) time-to-first COPD-related inpatient admission was 46.71 (87.99) days for patients indexed on UMEC/VI and 44.96 (85.90) days for those on TIO (p=0.06). The mean (SD) number of inpatient admissions per patient was 1.24 (2.92) for patients indexed on UMEC/VI and 1.26 (3.05) for those on TIO (p=0.49). Proporti

Michael Bogart,1 Lindsay GS Bengtson,2 Mary G Johnson,2 Scott H Bunner,2 Noelle N Gronroos,2 Kristi K DiRocco3 1US Value Evidence & Outcomes, R&D US, GSK, Research Triangle Park, NC, USA; 2Health Economics and Outcomes Research, Optum, Eden Prairie, MN, USA; 3USA, Medical Affairs, GSK, Collegeville, PA, USACorrespondence: Kristi K DiRocco, US Medical Affairs, GSK, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA, Tel +1 610-412-7175, Email kristi.k.dirocco@gsk.comPurpose: Patients with chronic obstructive pulmonary disease (COPD) have been shown to benefit from triple therapy commonly delivered by multiple-inhaler triple therapy (MITT); however, the complexity of MITT regimens may decrease patient adherence. Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), a once-daily single-inhaler triple therapy (SITT), became available in the United States (US) in 2017, but real-world data comparing outcomes for SITT versus MITT are currently limited. This study compared outcomes among patients with COPD initiating MITT versus SITT with FF/UMEC/VI who were either Medicare Advantage with Part D (MAPD) beneficiaries or commercial enrollees in the US.Methods: Retrospective study using administrative claims data from the Optum Research Database for patients with COPD who initiated FF/UMEC/VI or MITT between September 1, 2017, and March 31, 2019 (index date: first pharmacy claim for FF/UMEC/VI cohort; earliest day of ≥ 30 consecutive days-long period of overlap in the day’s supply of all triple therapy components for MITT cohort). COPD exacerbations, adherence to triple therapy, and all-cause and COPD-related health care resource utilization (HCRU) and costs were compared between FF/UMEC/VI and MITT initiators.Results: In total, 4659 FF/UMEC/VI initiators and 9845 MITT initiators for the MAPD population, and 821 FF/UMEC/VI initiators and 1893 MITT initiators for the commercial population were included in the study. MAPD beneficiaries initiating FF/UMEC/VI

Michael Bogart,1 Guillaume Germain,2 François Laliberté,2 Malena Mahendran,2 Mei Sheng Duh,3 Kristi DiRocco,4 Stephen G Noorduyn,5,6 Rosirene Paczkowski,7 Ronald Balkissoon8 1U.S. Value Evidence and Outcomes, R&D U.S., GSK, Research Triangle Park, Durham, NC, USA; 2Groupe d’Analyse, Ltée, Montréal, QC, Canada; 3Analysis Group, Inc., Boston, MA, USA; 4U.S. Medical Affairs, GSK, Collegeville, PA, USA; 5Global Value Evidence and Outcomes, GSK, Mississauga, ON, Canada; 6Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; 7Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 8National Jewish Health, Denver, CO, USACorrespondence: Kristi DiRocco, U.S. Medical Affairs, GSK, Collegeville, PA, USA, Tel +1 610-412-7175, Email kristi.k.dirocco@gsk.comPurpose: Real-world asthma control data among patients initiating fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) are limited. This study assessed rescue medication use and asthma-related exacerbations in patients with asthma before and after initiating single-inhaler FF/UMEC/VI using administrative claims data.Patients and Methods: This retrospective, pre-post cohort study analyzed data from the IQVIA PharMetrics Plus database (September 18, 2016‒March 31, 2020). Patients aged ≥ 18 years that had ≥ 1 dispensing of single-inhaler FF/UMEC/VI 100/62.5/25 mcg (first dispensing = index date), ≥ 12 months of continuous health insurance enrollment prior to (pre-treatment) and following (post-treatment) FF/UMEC/VI initiation and ≥ 1 diagnosis of asthma during the pre-treatment period or on the index date were included. The primary endpoint was the number of oral corticosteroid (OCS) dispensings per patient per year during pre- and post-treatment periods. Secondary endpoints included asthma-related exacerbation rates and short-acting β2-agonist (SABA) use. Comparisons between pre- and post-treatment periods were made using risk and rate ratios.Results: O

Michael Bogart,1 Carl B Abbott,2 Mohan Bangalore,3 Donna McMorrow,4 Elizabeth R Packnett,4 Kristi DiRocco3 1US Value Evidence and Outcomes, GSK, Durham, NC, USA; 2US Medical Affairs, GSK, Durham, NC, USA; 3US Medical Affairs, GSK, Collegeville, PA, USA; 4Merative, Ann Arbor, MI, USACorrespondence: Kristi DiRocco, US Medical Affairs, GSK, 1250 S. Collegeville Road, Collegeville, PA 19426, USA, Tel +1 610-412-7175, Email kristi.k.dirocco@gsk.comPurpose: Oral corticosteroids (OCS) play a role in the treatment of acute chronic obstructive pulmonary disease (COPD) exacerbations; however, chronic use is not recommended due to the high rate of systemic complications, development of comorbidities, and increased mortality. Data assessing the real-world impact of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) on OCS utilization rates are limited. This study assessed the impact of FF/UMEC/VI on OCS use among patients with COPD previously treated with OCS.Patients and Methods: A retrospective database study of patients with COPD aged ≥ 40 years who initiated FF/UMEC/VI from 1 November 2017 to 31 December 2018, identified through the MarketScan® Commercial and Medicare Supplemental databases. Patients were required to have ≥ 1 dispensing of an OCS prior to initiation of FF/UMEC/VI (index) and were followed up for 12 months post-index. OCS utilization patterns, potential OCS-related adverse events, healthcare resource utilization (HCRU), and costs were compared between the 12-month pre- and post-index periods.Results: A total of 2013 patients were identified (mean age 63.5 years, 55.7% female). The proportion of patients with ≥ 1 OCS claim decreased by 32.2% between the pre- and post-index period (67.8% vs 100%; p < 0.001). Comparing the post-index period to the pre-index period, mean number of OCS pharmacy claims per patient decreased from 3.3 to 2.5 (p < 0.001) and mean daily dose was reduced from 3.1 to 2.6 mg/day (p = 0.004); 30.0% of patients reduced t

Michael Bogart,1 Guillaume Germain,2 François Laliberté,2 Dominique Lejeune,2 Mei Sheng Duh3 1U.S. Value Evidence and Outcomes, R&D US, GSK, Research Triangle Park, NC, USA; 2Groupe d’analyse, Ltée, Montréal, QC, Canada; 3Analysis Group, Boston, MA, USACorrespondence: Mei Sheng Duh, Analysis Group, 111 Huntington Ave 14th Floor, Boston, MA, 02199, USA, Tel +1 617 425 8131, Email mei.duh@analysisgroup.comPurpose: There is limited literature regarding real-world treatment patterns of patients with COPD, particularly since the introduction of once-daily single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol in 2017. Here, we evaluated treatment patterns of patients with COPD before and after a COPD exacerbation.Patients and Methods: Retrospective, descriptive study using medical and pharmacy claims data and enrollment information from the Optum® Clinformatics® Data Mart database. Patients aged ≥ 40 years with ≥ 1 COPD exacerbation on or after September 18, 2017 were included. The index date was the last day of the first COPD exacerbation (ie day of visit for a moderate exacerbation or discharge date for a severe exacerbation). The baseline period was 12 months prior to index and the follow-up period (≥ 3 months) spanned from index until the earliest of health plan disenrollment, end of data availability (September 30, 2020), or death. Treatment patterns were evaluated during baseline and follow-up, with a focus on medication switching in the 90 days pre- and post-index.Results: COPD exacerbations were identified in 307,727 patients (125,942 severe; 181,785 moderate). Mean age at index was 72.8 years; 56.3% were female. Before and after first exacerbation, 37.7% and 48.2% of patients used ≥ 1 controller medication, respectively. In the 90 days pre-index, ICS, LABA, and LAMA medications were used by 27.5% of patients. Of these users, 64.3% remained on the same medication class, 21.7% discontinued, and 14.1% switched medication

Nicola A Hanania,1 Scott H Bunner,2 Lindsay GS Bengtson,2 Afisi S Ismaila,3,4 Michael Bogart5 1Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA; 2Optum, Eden Prairie, MN, USA; 3Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 4Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; 5US Value Evidence & Outcomes, GSK, Research Triangle Park, NC, USACorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GSK, 1250 S. Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +1 919-3158229, Email afisi.s.ismaila@gsk.comPurpose: To examine the impact of initiating fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in a single device on chronic obstructive pulmonary disease (COPD) exacerbations, COPD exacerbation-related costs, and all-cause and COPD-related healthcare resource utilization (HCRU) and costs in patients with COPD.Methods: Retrospective database analysis of patients with COPD aged ≥ 40 years who initiated FF/UMEC/VI between September 1, 2017, and December 31, 2018 (index date: first pharmacy claim for FF/UMEC/VI), following evidence of multiple-inhaler triple therapy (MITT) (≥ 30 consecutive days) in the year prior to index. COPD exacerbations, COPD exacerbation-related costs, and all-cause and COPD-related HCRU and costs were compared between the baseline period (12 months prior to and including index) and follow-up period (12 months following index).Results: Data from 912 patients (mean [SD] age: 71.2 [8.1], 51.2% female) were included in the analyses. Among the overall cohort, mean count of total COPD exacerbations (moderate or severe) per patient was statistically significantly lower in the follow-up period compared to baseline (1.2 vs 1.4, p=0.001). The proportion of patients with ≥ 1 COPD exacerbation (moderate or severe) was also statistically significantly lower in the follow-up period compared to baseline (56.4% vs 62.4%, p=0.00

Neil Bhattacharyya,1 Jared Silver,2 Michael Bogart,2 Kalé Kponee-Shovein,3 Wendy Y Cheng,3 Mu Cheng,3 Hoi Ching Cheung,3 Mei Sheng Duh,3 Beth Hahn2 1Mass Eye & Ear and Harvard Medical School, Boston, MA, USA; 2GSK, Durham, NC, USA; 3Analysis Group, Boston, MA, USACorrespondence: Neil Bhattacharyya, Mass Eye & Ear and Harvard Medical School, 243 Charles St, Boston, MA, 02114, USA, Tel +1 617-936-6118, Fax +1 617-936-6170, Email neiloy@bhattacharyya.orgPurpose: Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with high healthcare resource utilization (HRU) and economic cost; however, heterogeneity of clinical burden among patients with differing clinical characteristics has not been fully elucidated. Here, an unsupervised machine learning approach supported by clinical validation identified distinct clusters of patients with CRSwNP and compared healthcare burden.Patients and Methods: This retrospective analysis identified adult patients with ≥ 2 claims for CRSwNP and date of first diagnosis (index date) between January 2015 and June 2019 from a healthcare database. Patients were required to have enrollment in the database 6-months pre- and 12-months post-index. Patients were assigned to clusters using latent class analysis. All-cause and nasal polyp (NP)-related HRU and costs were compared between clusters.Results: Among 12,807 patients, 5 clusters were identified: cluster 1: no surgery/low comorbidity/low medication use (n = 4076); cluster 2: no surgery/low comorbidity/high medication use (n = 2201); cluster 3: no surgery/high comorbidity/high medication use (n = 2093); cluster 4: surgery/low comorbidity/moderate medication use (n = 3168); cluster 5: surgery/high comorbidity/high medication use (n = 1269). All-cause HRU was similar across clusters. NP-related HRU was highest in the surgical clusters (clusters 4 and 5). All-cause costs were similar in clusters 1– 3 ($15,833–$17,461) and highest in clusters 4 ($31,083) and 5 ($31,103), dri

David Mannino,1 James Siddall,2 Mark Small,2 Adam Haq,2 Marjorie Stiegler,3 Michael Bogart3 1Department of Medicine, University of Kentucky, Lexington, KY, USA; 2Respiratory DSP Franchise, Adelphi Real World, Bollington, UK; 3US Value Evidence and Outcomes, GlaxoSmithKline plc, Durham, NC, USACorrespondence: Michael Bogart, US Value Evidence and Outcomes, GlaxoSmithKline plc, 5 Moore Dr, Research Triangle Park, Durham, NC, USA, Tel +19198897413, Email michael.r.bogart@gsk.comPurpose: There is a high prevalence of chronic obstructive pulmonary disease (COPD) in the United States (US). Although guidelines are available for the treatment of COPD, evidence suggests that management of COPD in clinical practice is not always aligned with this guidance. This study aimed to further understand the current use of COPD maintenance medication in the US.Patients and Methods: This study was an analysis of data from the Adelphi Respiratory Disease Specific Programme (DSP™) 2019. Point-in-time data were collected from participating US physicians and their COPD patients. Physicians were either primary care physicians (PCPs) or pulmonologists, with a minimum workload of ≥ 3 COPD patients per month. Patients were aged ≥ 18 years with a physician-confirmed diagnosis of COPD.Results: In total, 171 physicians completed the survey (92 PCPs and 79 pulmonologists). Mean patient age was 66.4 years, 45% were female, with moderate COPD in 49.4% of patients and severe/very severe in 19.3%. Pulmonologists more frequently prescribed dual bronchodilation and triple therapy than PCPs, whereas inhaled corticosteroid/long-acting β2-agonist was more frequently prescribed by PCPs than pulmonologists. For both physician types, the most common reason for prescribing their patients’ current treatment was 24-hour symptom relief. The majority of PCPs (70.1%) and pulmonologists (71.9%) reported referring to COPD guidelines when making treatment decisions.Conclusion: Prescribing patterns for COPD pat

David Mannino,1 Michael Bogart,2 Guillaume Germain,3 Shirley P Huang,2 Afisi S Ismaila,4,5 François Laliberté,3 Young Jung,3 Sean D MacKnight,3 Marjorie A Stiegler,6,7 Mei Sheng Duh8 1Department of Medicine, University of Kentucky, Lexington, KY, USA; 2GlaxoSmithKline, Value Evidence and Outcomes, Research Triangle Park, NC, USA; 3Groupe d’analyse, Ltée, Montréal, QC, Canada; 4GlaxoSmithKline, Value Evidence and Outcomes, Collegeville, PA, USA; 5Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; 6GlaxoSmithKline, Medical Affairs, Research Triangle Park, NC, USA; 7Department of Anesthesiology and Critical Care, University of North Carolina, Chapel Hill, NC, USA; 8Analysis Group, Boston, MA, USACorrespondence: Michael Bogart, GlaxoSmithKline, Value Evidence and Outcomes, 5 Moore Drive, PO Box 13398, Research Triangle Park, NC, 27709-3398, USA, Tel +1919-889-7413, Email michael.r.bogart@gsk.comPurpose: Triple therapy (TT; inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting β2-agonist) is recommended for patients with chronic obstructive pulmonary disease (COPD) at risk of exacerbation, although the optimum timing of TT initiation remains unclear. This study evaluated the impact of prompt versus delayed initiation of single-inhaler TT (fluticasone furoate, umeclidinium, and vilanterol [FF/UMEC/VI]) following a COPD exacerbation.Patients and Methods: This retrospective cohort study used data from the IQVIA PharMetrics® Plus database. Patients initiating FF/UMEC/VI following a COPD exacerbation between September 18, 2017 and September 30, 2019 (exacerbation = index date) were categorized as prompt (within 30 days of index) or delayed (31– 180 days after index) FF/UMEC/VI initiators. Patients were aged ≥ 40 years at index, had ≥ 12 months’ continuous health insurance coverage before index (baseline), and ≥ 6 months’ coverage after index (follow-up). Patients with a COPD exacerba

Michael Bogart,1 Yuhang Liu,2 Todd Oakland,2 Marjorie Stiegler1,3 1Value Evidence and Outcomes, GlaxoSmithKline, Research Triangle Park, NC, USA; 2GNS Healthcare, Somerville, MA, USA; 3University of North Carolina Chapel Hill, Chapel Hill, NC, USACorrespondence: Michael Bogart, GlaxoSmithKline, Five Moore Drive, PO Box 13398, Research Triangle Park, NC, 27709-3398, USA, Tel +19198897413, Email michael.r.bogart@gsk.comPurpose: Inhaled triple therapy (TT) comprising a long-acting muscarinic antagonist, long-acting β2 agonist, and inhaled corticosteroid is recommended for symptomatic chronic obstructive pulmonary disease (COPD) patients, or those at risk of exacerbation. However, it is not well understood which patient characteristics contribute most to future exacerbation risk. This study assessed patient predictors associated with future exacerbation time following initiation of TT.Patients and Methods: This retrospective cohort study used data from the Optum™ Clinformatics™ Data Mart, a large health claims database in the United States. COPD patients who initiated TT between January 2008 and March 2018 (index) were eligible. Patients were required to be aged ≥ 18 years at index and have continuous enrollment for the 12 months prior to index (baseline) and the 12 months following index (follow-up). Patients who had received TT during baseline were excluded. Data from eligible patients were analyzed using a reverse engineering forward simulation machine learning platform to predict future COPD exacerbation time.Results: Data from 73,625 patients were included. The model found that prior exacerbation was largely correlated with post-index exacerbation time; patients who had ≥ 4 exacerbation episodes during baseline had an average increase of 32.4 days post-index exacerbation, compared with patients with no exacerbations during baseline. Likewise, ≥ 2 inpatient visits (effect size 27.1 days), the use of xanthines (effect size 11.5 days), or rheumatoid arthrit