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Gema Requena,1 Alexandrosz Czira,1 Victoria Banks,2 Robert Wood,2 Theo Tritton,2 Catherine Castillo,2 Jie Yeap,2 Rosie Wild,2 Chris Compton,1 Kieran J Rothnie,1 Felix JF Herth,3 Jennifer K Quint,4 Afisi S Ismaila5,6 1GSK, R&D Global Medical, Brentford, Middlesex, UK; 2Real-World Evidence, Adelphi Real World, Bollington, Cheshire, UK; 3Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, Heidelberg, Germany; 4National Heart and Lung Institute, Imperial College London, London, UK; 5Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 6Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Gema Requena, Epidemiology, Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, Middlesex, UK, Tel +44 20 80476893, Email gema.x.requena@gsk.comPurpose: Chronic obstructive pulmonary disease (COPD) exacerbations are associated with significant morbidity and mortality and increased economic healthcare burden for patients with COPD. Long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) dual therapy is recommended for patients receiving mono-bronchodilator therapy who experience exacerbations or ongoing breathlessness. This study compared two single-inhaler LAMA/LABA dual therapies, umeclidinium/vilanterol (UMEC/VI) and indacaterol/glycopyrronium (IND/GLY), on moderate-to-severe exacerbation rates in patients with COPD in England.Patients and Methods: This retrospective cohort study used linked primary care electronic health record data (Clinical Practice Research Datalink-Aurum) and secondary care data (Hospital Episode Statistics) to assess outcomes for patients with COPD who had a first prescription for single-inhaler UMEC/VI or IND/GLY (index date) between 1 January 2015 and 30 September 2019 (indexing period). Analyses compared UMEC/VI and IND/GLY on moderate-to-severe, moderate, and severe

Robyn Kendall,1 Alan A Martin,2 Dhvani Shah,3 Soham Shukla,4 Chris Compton,5 Afisi S Ismaila4,6 1ICON Health Economics, ICON plc, Vancouver, BC, Canada; 2Value Evidence and Outcomes, GSK, London, UK; 3ICON Health Economics, ICON plc, New York, NY, USA; 4Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 5Global Respiratory Franchise, GSK, London, UK; 6Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GSK, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +1 919 315 8229, Email afisi.s.ismaila@gsk.comPurpose: For patients with chronic obstructive pulmonary disease (COPD) who remain symptomatic despite maintenance treatment, clinical management guidelines recommend a stepwise escalation from monotherapy to dual therapy, and from dual therapy to triple therapy. However, in clinical practice, patients are often escalated directly from monotherapy to triple therapy based on disease severity. This study evaluated the cost-effectiveness of once-daily, single-inhaler fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) triple therapy compared with long-acting muscarinic antagonist monotherapy with once-daily tiotropium (TIO) in patients with symptomatic moderate-to-very severe COPD, from a UK National Health Service perspective.Patients and Methods: The validated GALAXY-COPD disease progression model was populated with patient baseline characteristics and treatment effect data from the 12-week GSK Study 207626 comparing FF/UMEC/VI with TIO in patients with moderate-to-very severe COPD. UK unit costs and drug costs (British Pound, 2021) were applied to healthcare resource utilization and treatments. The base case analysis was conducted over a lifetime horizon, and costs and health outcomes (except for life years [LYs]) were discounted at 3.5% per year. Model outputs included exacerbation rates, healthcare costs, LYs, quality-adj

Gema Requena,1 Alexandrosz Czira,1 Victoria Banks,2 Robert Wood,2 Theo Tritton,2 Catherine M Castillo,2 Jie Yeap,2 Rosie Wild,2 Chris Compton,1 Kieran J Rothnie,1 Felix Herth,3,4 Jennifer K Quint,5 Afisi S Ismaila6,7 1GSK, R&D Global Medical, Brentford, Middlesex, UK; 2Real-World Evidence, Adelphi Real World, Bollington, Cheshire, UK; 3Department of Pulmonology and Respiratory Care Medicine, Thoraxklinik at the University of Heidelberg, Heidelberg, Germany; 4Translational Lung Research Center Heidelberg, Member of the German Center for Lung Research DZL, Heidelberg, Germany; 5National Heart and Lung Institute, Imperial College London, London, UK; 6Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 7Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Gema Requena, GSK, R&D Global Medical, Brentford, Middlesex, UK, Tel +44 20 80476893, Email gema.x.requena@gsk.comPurpose: Routinely collected healthcare data on the comparative effectiveness of the long-acting muscarinic antagonist/long-acting β2-agonist combination umeclidinium/vilanterol (UMEC/VI) versus tiotropium bromide/olodaterol (TIO/OLO) for chronic obstructive pulmonary disease (COPD) is limited. This study compared rescue medication prescriptions in patients with COPD in England receiving UMEC/VI versus TIO/OLO.Patients and Methods: This retrospective cohort study used primary care data from the Clinical Practice Research Datalink Aurum database linked with secondary care administrative data from Hospital Episode Statistics. Patients with a COPD diagnosis at age ≥ 35 years were included (indexed) following initiation of single-inhaler UMEC/VI or TIO/OLO between July 1, 2015, and September 30, 2019. Outcomes included the number of rescue medication prescriptions at 12-months (primary), and at 6-, 18- and 24-months (secondary), adherence at 6-, 12-, 18- and 24-months post-index, defined as proportion of days covered ≥ 80% (second

Alexandrosz Czira,1 Sneha Purushotham,2 Ike Iheanacho,2 Kieran J Rothnie,1 Chris Compton,3 Afisi S Ismaila4,5 1Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, UK; 2Evidera, London, UK; 3Global Medical, GSK, London, UK; 4Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 5Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Alexandrosz Czira, Value Evidence and Outcomes, R&D Global Medical, GSK, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK, Tel +44 7788 351610, Email alexandrosz.x.czira@gsk.comBackground: Patients with mild or mild-to-moderate chronic obstructive pulmonary disease (COPD), defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD) group A/B, are regarded as having a lower risk of experiencing multiple or severe exacerbations compared with patients classified as GOLD group C/D. Current guidelines suggest that patients in GOLD A/B should commence treatment with a bronchodilator; however, some patients within this population who have a higher disease burden may benefit from earlier introduction of dual bronchodilator or inhaled corticosteroid-containing therapies. This study aimed to provide research-based insights into the burden of disease experienced by patients classified as GOLD A/B, and to identify characteristics associated with poorer outcomes.Methods: A systematic literature review (SLR) was conducted to identify evidence (burden of disease and prevalence data) relating to the population of interest (patients with COPD classified as GOLD A/B).Results: A total of 79 full-text publications and four conference abstracts were included. In general, the rates of moderate and severe exacerbations were higher among patients in GOLD group B than among those in group A. Among patients classified as GOLD A/B, the risk of exacerbation was higher in those with more symptoms (modified Medical Research Council or COPD Assessment Test scales)

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

Alexandrosz Czira,1 Gema Requena,1 Victoria Banks,2 Robert Wood,2 Theo Tritton,2 Catherine M Castillo,2 Jie Yeap,2 Rosie Wild,2 Chris Compton,1 Kieran J Rothnie,1 Felix Herth,3,4 Jennifer K Quint,5 Afisi S Ismaila6,7 1R&D Global Medical, GSK, Brentford, Middlesex, UK; 2Real-World Evidence, Adelphi Real World, Bollington, Cheshire, UK; 3Department of Pulmonology and Respiratory Care Medicine, Thoraxklinik at the University of Heidelberg, Heidelberg, Germany; 4Translational Lung Research Center Heidelberg, Member of the German Center for Lung Research DZL, Heidelberg, Germany; 5National Heart and Lung Institute, Imperial College London, London, UK; 6Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 7Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Alexandrosz Czira, Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, Middlesex, UK, Tel +44 7788 351610, Email alexandrosz.x.czira@gsk.comPurpose: To compare adherence to once-daily umeclidinium/vilanterol (UMEC/VI), a long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA), and twice-daily inhaled corticosteroids (ICS)/LABA single-inhaler dual therapy in patients with chronic obstructive pulmonary disease (COPD) in a primary care cohort in England.Patients and Methods: Active comparator, new-user, retrospective cohort study using CPRD-Aurum primary care data and linked Hospital Episode Statistics secondary care administrative data. Patients without exacerbations in the previous year were indexed on first/earliest prescription date of once-daily UMEC/VI or twice-daily ICS/LABA as initial maintenance therapy between July 2014-September 2019. Primary outcome: medication adherence at 12 months post-index, defined as proportion of days covered (PDC) ≥ 80%. PDC represented proportion of time over the treatment duration that the patient was theoretically in possession of the medication. Secondary outcomes: adherence at

Gema Requena,1 Victoria Banks,2,* Alexandrosz Czira,1 Robert Wood,2 Theo Tritton,2 Rosie Wild,2 Chris Compton,1 Afisi S Ismaila3,4 1Value Evidence and Outcomes, GSK, R&D Global Medical, Brentford, Middlesex, UK; 2Real-World Evidence, Adelphi Real World, Bollington, Cheshire, UK; 3Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 4Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada*At the time of the studyCorrespondence: Gema Requena, Epidemiology, Value Evidence and Outcomes, R&D Global Medical, GSK, Middlesex, UK, Tel +44 20 80476893, Email gema.x.requena@gsk.comPurpose: Selection of treatments for patients with chronic obstructive pulmonary disease (COPD) may impact clinical outcomes, healthcare resource use (HCRU) and direct healthcare costs. We aimed to characterize these outcomes along with treatment patterns, for patients with COPD following initiation of single-inhaler long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) dual therapy in the primary care setting in England.Patients and Methods: This retrospective cohort study used linked primary care electronic medical record data (Clinical Practice Research Datalink-Aurum) and secondary care administrative data (Hospital Episode Statistics) in England to assess outcomes for patients with COPD who had a prescription for one of four single-inhaler LAMA/LABA dual therapies between 1st June 2015– 31st December 2018 (indexing period). Outcomes were assessed during a 12-month follow-up period from the index date (date of earliest prescription of a single-inhaler LAMA/LABA within the indexing period). Incident users were those without previous LAMA/LABA dual therapy prescriptions prior to index; this manuscript focuses on a subset of incident users: non-triple therapy users (patients without concomitant inhaled corticosteroid use at index).Results: Of 10,991 incident users included, 9888 (90.0%) were non-triple therap

Victoria Federico Paly,1 Laura Amanda Vallejo-Aparicio,2 Alan Martin,3 José Luis Izquierdo,4 Juan Antonio Riesco,5 Juan José Soler-Cataluña,6 Catarina Abreu,7 Chandroday Biswas,8 Afisi S Ismaila9,10 1ICON plc, Philadelphia, PA, USA; 2GSK, Madrid, Spain; 3GSK, Brentford, UK; 4Hospital Universitario de Guadalajara, Guadalajara, Spain; 5Hospital San Pedro de Alcántara, Cáceres, Spain; 6Hospital Arnau de Vilanova, Valencia, Spain; 7ICON Plc, New York, NY, USA; 8ICON Plc, Bengaluru, Karnataka, India; 9Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 10Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, CanadaCorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GSK, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +1 919 315 8229, Email afisi.s.ismaila@gsk.comPurpose: Given between-country differences in healthcare systems, treatment costs, and disease management guidelines, country-specific cost-effectiveness analyses are important. This study evaluated the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI among patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations from a Spanish healthcare system perspective.Patients and Methods: Baseline data and treatment effects from the IMPACT trial were populated into the validated GALAXY COPD progression model. Utilities were estimated using Spanish observational data. Direct healthcare costs (2019 €) were informed by Spanish public sources. A 3% discount rate for costs and benefits was applied. The time horizon and treatment duration were 3 years (base case). One-way sensitivity, scenario, and probabilistic sensitivity analyses were performed.Results: FF/UMEC/VI treatment resulted in fewer exacerbations over 3 years (4.130 vs 3.648) versus FF/VI, with a mean (95% confidence interval [CI]) incremental cost of € 444 (€ 149, € 713)

Kieran J Rothnie,1 Sandra Joksaite,1 Leah B Sansbury,2 Chris Compton,3 Valentina Di Boscio,4 Afisi S Ismaila5,6 1Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, London, UK; 2Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, Research Triangle Park, NC, USA; 3Global Medical Affairs, GlaxoSmithKline, Middlesex, UK; 4Global Medical Affairs, GlaxoSmithKline, Ealing, UK; 5Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, Collegeville, PA, USA; 6Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Kieran J Rothnie, Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, London, UK, Tel +44 208 990 3439, Email kieran.j.rothnie@gsk.comPurpose: Inhaled triple therapy is recommended for patients with chronic obstructive pulmonary disease (COPD) who have poorly controlled symptoms and to reduce the risk of exacerbations. This study assessed the clinical characteristics of new users of single- and multiple-inhaler triple therapy (SITT and MITT) treated in a primary care setting in England.Patients and Methods: This cross-sectional, observational study used data from an electronic health record database (CPRD Aurum) of COPD patients registered with a primary care practice in England, with linkage to a secondary care database. Patients were required to have initiated a new triple therapy (index) between November 2017 and November 2018 and have ≥ 12 months of available medical history prior to the index date.Results: In total, 3536 patients initiated fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) SITT for the first time: 65% had a Medical Research Council (MRC) dyspnea score ≥ 3, 45% had forced expiratory volume in 1 second (FEV1)% predicted < 50%, and 64% had a moderate or severe exacerbation in the previous 12 months. The majority (83%) of new FF/UMEC/VI users had a history of MITT use. Immediately prior to FF/UMEC/VI

Gema Requena,1 Victoria Banks,2 Alexandrosz Czira,1 Robert Wood,2 Theo Tritton,2 Rosie Wild,2 Chris Compton,1 Maria Duarte,1 Afisi S Ismaila3,4 1Value Evidence and Outcomes, Epidemiology, GSK, R&D Global Medical, Brentford, Middlesex, UK; 2Real-world Evidence, Adelphi Real World, Bollington, Cheshire, UK; 3Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 4Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Gema Requena, Epidemiology, Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, Middlesex, UK, Tel +44 20 80476893, Email gema.x.requena@gsk.comPurpose: Treatment pathways of patients with chronic obstructive pulmonary disease (COPD) receiving single-inhaler dual therapies remain unclear. We aimed to describe characteristics, prescribed treatments, healthcare resource use (HCRU) and costs of patients with COPD who initiated single-inhaler long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) dual therapy in primary care in England.Patients and Methods: Retrospective study using linked data from Clinical Practice Research Datalink Aurum and Hospital Episode Statistics datasets. Patients with COPD with ≥ 1 single-inhaler LAMA/LABA prescription between June 2015 and December 2018 (index) were included. Demographic and clinical characteristics, prescribed treatments, HCRU and costs were evaluated in the 12 months pre-index. Data are presented for patients not receiving concomitant inhaled corticosteroids at index (non-triple users).Results: Of 10,991 patients initiating LAMA/LABA, 9888 were non-triple users, of whom 21.3% (n=2109) received aclidinium bromide/formoterol, 18.1% (n=1785) received indacaterol/glycopyrronium, 12.0% (n=1189) received tiotropium bromide/olodaterol and 48.6% (n=4805) received umeclidinium/vilanterol. Demographic and clinical characteristics were similar across indexed therapies. LAMA monotherapy was the most frequently prescribed re

Andrea Gabrio,1 Necdet B Gunsoy,2 Gianluca Baio,1 Alan Martin,3 Victoria F Paly,4 Nancy Risebrough,5 David MG Halpin,6 Dave Singh,7 Robert A Wise,8 MeiLan K Han,9 Fernando J Martinez,10 Gerard J Criner,11 Neil Martin,12 David A Lipson,13,14 Afisi S Ismaila15,16 1UCL Statistical Science, University College London, London, UK; 2Value Evidence & Outcomes, GlaxoSmithKline, Brentford, UK; 3Value Evidence and Outcomes, GlaxoSmithKline, Uxbridge, UK; 4Global HTA, Health Economics, Reimbursement & Outcomes, ICON Plc., Philadelphia, PA, USA; 5Global HTA, Health Economics, Reimbursement & Outcomes, ICON plc., Toronto, ON, Canada; 6University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK; 7The Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK; 8The Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 9University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, USA; 10Joan and Sandy Weill Department of Medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA; 11Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA; 12Global Medical Affairs, GlaxoSmithKline, Uxbridge, UK; 13Development Clinical Sciences, GlaxoSmithKline, Collegeville, PA, USA; 14Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 15Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 16Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +19199320430; +19193158229, Email afisi.s.ismaila@gsk.comAbstract: Objectives: In the IMPACT trial (NCT021645

Victoria Neches García,1 Laura Amanda Vallejo-Aparicio,1 Afisi S Ismaila,2,3 Antoni Sicras-Mainar,4 Aram Sicras-Navarro,4 Cruz González,5 Rafael Cuervo,6 Soham Shukla,2 Marcos García-Peñuela6 1Market Access, GlaxoSmithKline, Madrid, Spain; 2Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 3Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; 4Real Life Data, Atrys Health, Barcelona, Spain; 5Pneumology Unit, Hospital Clínico Universitario de Valencia, Valencia, Spain; 6Medical Affairs, GlaxoSmithKline, Madrid, SpainCorrespondence: Victoria Neches García, Market Access, GlaxoSmithKline, P.T.M Severo Ochoa, 2 28760 Tres Cantos, Madrid, Spain, Tel +34 677 50 37 57, Email victoria.x.neches@gsk.comPurpose: To determine the clinical and economic impact of inhaled corticosteroid (ICS) withdrawal in Spanish patients with COPD receiving triple therapy (TT) with ICS, long-acting β2-agonist (LABA), and long-acting muscarinic antagonist (LAMA).Patients and Methods: This was an observational, retrospective study of BIG-PAC database medical records. Patients aged ≥ 40 years receiving TT from 2016 to 2018 were followed for 1 year. Two cohorts were identified: patients continuing TT (ICS+LABA+LAMA), and patients receiving TT with ICS withdrawn (LABA+LAMA). Variables included medication, exacerbations (moderate and severe), pneumonia, mortality, health resource use (HRU), and cost per patient/year. Cohorts were compared using propensity score matching (PSM). Multivariate statistical analysis using analysis of covariance and Cox proportional risks was conducted.Results: Of 6541 patients included, 5740 (87.8%) continued TT and 801 (12.2%) had ICS withdrawn. Patients with ICS withdrawal were younger, had lower disease burden, higher ICS doses, and more exacerbations compared with those continuing ICS. PSM matched 795 patients in each cohort. Mean age was 68.5 years (SD: 11.2), 69.9% were male, and mean Charls

David MG Halpin,1 Robyn Kendall,2 Soham Shukla,3 Alan Martin,4 Dhvani Shah,5 Dawn Midwinter,6 Kai M Beeh,7 Janwillem WH Kocks,8– 11 Paul W Jones,12 Chris Compton,12 Nancy A Risebrough,13 Afisi S Ismaila3,14 1University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK; 2ICON Health Economics, ICON plc, Vancouver, BC, Canada; 3Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 4Value Evidence and Outcomes, GSK, Uxbridge, UK; 5ICON Health Economics, ICON plc, New York, NY, USA; 6Biostatistics, GSK, Brentford, UK; 7Insaf Respiratory Research Institute, Wiesbaden, Germany; 8General Practitioners Research Institute, Groningen, the Netherlands; 9Observational and Pragmatic Research Institute, Singapore; 10Groningen Research Institute Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 11Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 12Global Respiratory Franchise, GSK, Brentford, UK; 13ICON Health Economics, ICON plc, Toronto, ON, Canada; 14Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: David MG Halpin, University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, EX1 2LU, UK, Tel +44 01392 201178, Email d.halpin@nhs.netPurpose: The 24-week INTREPID trial demonstrated the clinical benefits of once-daily single-inhaler triple therapy (SITT) with fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) versus non-ELLIPTA multiple-inhaler triple therapy (MITT) in patients with symptomatic chronic obstructive pulmonary disease (COPD). This analysis assessed the cost-effectiveness of FF/UMEC/VI versus non-ELLIPTA MITT for the treatment of symptomatic COPD from a United Kingdom (UK) National Health Service (NHS) perspective.Patients and Methods: The analysis was conducted using the valid

David MG Halpin,1 Kieran J Rothnie,2 Victoria Banks,3 Alexandrosz Czira,2 Chris Compton,4 Robert Wood,3 Theo Tritton,3 Olivia Massey,3 Rosie Wild,3 Neil Snowise,5 Kirill Nikitin,2 Raj Sharma,4 Afisi S Ismaila,6,7 Claus F Vogelmeier8 1University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK; 2Value Evidence and Outcomes, R&D Global Medical, GSK, Brentford, UK; 3Real-World Evidence, Adelphi Real World, Bollington, UK; 4Global Medical, GSK, London, UK; 5Institute of Pharmaceutical Science, Faculty of Life Sciences and Medicine, King’s College, London, UK; 6Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 7Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; 8Department of Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, GermanyCorrespondence: David MG Halpin, University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, EX1 2LU, UK, Tel +44 (0)1392 201178, Email d.halpin@nhs.netPurpose: Triple therapy comprising a long-acting muscarinic antagonist, long-acting β2-agonist and inhaled corticosteroid is recommended for patients with chronic obstructive pulmonary disease (COPD) who continue to experience frequent exacerbations or symptoms whilst receiving dual therapy. Adherence and persistence to multiple-inhaler triple therapy (MITT) is known to be poor. This study assessed comparative adherence to single-inhaler triple therapy (SITT) versus MITT in a real-world setting in England.Patients and Methods: This was a retrospective cohort study using linked primary care (Clinical Practice Research Datalink Aurum) and secondary care (Hospital Episode Statistics [HES] Admitted Patient Care) data to identify patients with COPD who were newly initiated on SITT or MITT between November 2017 and June 2019. Eligible patients were aged ≥ 35 years and had

Leah B Sansbury,1 David A Lipson,2,3 Chanchal Bains,4 Glenn A Anley,5 Kieran J Rothnie,4 Afisi S Ismaila6,7 1Value Evidence and Outcomes, Epidemiology, R&D Global Medical, GlaxoSmithKline, Research Triangle Park, NC, USA; 2Respiratory Clinical Sciences, GlaxoSmithKline, Collegeville, PA, USA; 3Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 4Value Evidence and Outcomes, R&D Global Medical, GlaxoSmithKline, Uxbridge, UK; 5UK Health Outcomes, GlaxoSmithKline, Uxbridge, UK; 6Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 7Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S Ismaila, Value Evidence and Outcomes, GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USA, Tel +1 919 315 8229, Email afisi.s.ismaila@gsk.comPurpose: Clinical guidelines for COPD management suggest pharmacologic treatment algorithms based on symptoms and exacerbation history. As previous research has suggested that prescribing patterns are not always aligned with these recommendations, this study investigated the burden of disease in patients with COPD receiving, and persisting on, new inhaled maintenance therapy.Patients and Methods: This was a retrospective observational study using two linked electronic databases containing health records of patients in England. Patients aged ≥ 35 years with a confirmed diagnosis of COPD, and who initiated a new inhaled respiratory pharmacologic maintenance regimen between January 1, 2014 and December 31, 2016 (index date) were eligible for inclusion. New treatments could be long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) monotherapy, inhaled corticosteroid (ICS)/LABA or LAMA/LABA dual therapy, or a multiple-inhaler triple therapy (MITT; LAMA/LABA/ICS). Patients were required to have 12 months of available medical history prior to, and after, the index date.Results: In total

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

Leah B Sansbury,1 Robert P Wood,2 Glenn A Anley,3 Yein Nam,2 Afisi S Ismaila4,5 1Epidemiology, Value Evidence and Outcomes, GlaxoSmithKline, Research Triangle Park, NC, USA; 2Observational Research, Adelphi Real World, Bollington, UK; 3UK Health Outcomes, GlaxoSmithKline, Uxbridge, UK; 4Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 5Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaValue Evidence and Outcomes, GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USATel +1 919 315 8229Email afisi.s.ismaila@gsk.comPurpose: To assess if early multiple-inhaler triple therapy (MITT) initiation in patients with chronic obstructive pulmonary disease (COPD) reduces subsequent healthcare resource utilization (HCRU), direct medical costs, and acute exacerbations of COPD (AECOPDs).Patients and Methods: This retrospective, longitudinal cohort study used electronic health records and linked hospital administrative data in England. COPD patients with an AECOPD between July 2012 and May 2016 (index), and who subsequently started MITT within 180 days were eligible. Patients with an AECOPD 6 months prior to index were excluded. HCRU, direct healthcare costs, and AECOPDs were assessed in the following 24-month period for early (≤ 30 days) and delayed (31– 180 days) MITT initiators.Results: A total of 934 patients were included in the analysis and categorized as early (n=367, 39%) or delayed (n=567, 61%) MITT initiators. Mean patient age was 68.5 years and 53.2% were male. A significantly higher proportion of delayed MITT initiators required ≥ 1 outpatient appointment (all-cause) compared with early MITT initiators (87% vs 79%; p=0.0016). A significantly higher proportion of delayed MITT initiators required ≥ 1 COPD‑related inpatient stay versus early MITT initiators (47% vs 40%; p=0.0262). Over the 24-month follow-up, mean all-cause and COPD-relat

Leah B Sansbury,1 Kieran J Rothnie,2 Chanchal Bains,3 Chris Compton,4 Glenn Anley,2 Afisi S Ismaila5,6 1Value Evidence and Outcomes, GlaxoSmithKline, Research Triangle Park, Durham, NC, USA; 2Value and Evidence Outcomes, GlaxoSmithKline, Uxbridge, UK; 3Real World Evidence and Epidemiology, GlaxoSmithKline, Uxbridge, UK; 4Global Respiratory Franchise, GlaxoSmithKline, Brentford, UK; 5Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 6Department of Health Research Methods, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaValue Evidence and Outcomes, GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA, 19426-0989, USATel +1 919 315 8229Email afisi.s.ismaila@gsk.comBackground: Available data on the relationship between COPD symptoms, disease outcomes, and mortality are currently limited. This study investigated the clinical characteristics, outcomes, healthcare utilization, and prescribing practices across GOLD 2017 groups (A, B, C, and D) in a large-scale, population-based cohort of COPD patients managed in an English primary care setting.Patients and Methods: This retrospective analysis included patients aged ≥ 35 years, with a confirmed diagnosis of COPD and ≥ 1 record of pulmonary function testing in their medical history. Medical Research Council dyspnea score and exacerbation history were used to define patients’ GOLD 2017 classification. Patients were identified using the UK Clinical Practice Research Database and were followed for 12 months.Results: Eligible COPD patients’ (N=42,331; mean [SD] age, 69.5 [10.7] years; 54% males), GOLD 2017 categorizations were: Group A: 49.1%, Group B: 30.5%, Group C: 8.2%, Group D: 12.1%. Overall, 37.7% of patients experienced ≥ 1 moderate COPD exacerbation. The rate of moderate exacerbations per person per year (PPPY) was highest in GOLD group D (0.72), followed by C (0.53), B (0.22), and A (0.15), while the rate of exacerbations leading to hospitalization PPPY w

Leah B Sansbury,1 Chanchal Bains,2 David A Lipson,3,4 Afisi S Ismaila,5,6 Sarah H Landis5 1Value Evidence and Outcomes, GlaxoSmithKline, Research Triangle Park, NC, USA; 2Value Evidence and Outcomes, GlaxoSmithKline, Uxbridge, UK; 3Clinical Sciences, GlaxoSmithKline, Collegeville, PA, USA; 4Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 5Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 6Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Leah B SansburyValue Evidence and Outcomes, GlaxoSmithKline, Building 5, 42 Moore Drive, Research Triangle Park, NC, 27709, USATel +1 919 812 0719Email leah.b.sansbury@gsk.comIntroduction: Until recently, triple therapy for chronic obstructive pulmonary disease (COPD) has only been available through treatment with multiple inhalers. Evidence on real-world use of multiple-inhaler triple therapy (MITT), including duration of use and treatment patterns, is limited.Methods: A retrospective, observational study of electronic health records and hospital episodes in patients with COPD initiating MITT between 2013 and 2015 in the UK was performed. This study described patients initiating, treatment persistence and discontinuation, and prior and subsequent COPD treatments.Results: Eligible patients (N=3825) had a mean age of 69.5 years; most were former or current smokers (95%). The majority (86%) initiated MITT with two inhalers and 14% initiated with three inhalers. Mean duration of use was 5.1 (standard deviation: 4.6) months; 24% of patients persisted for 12 months. Patients who had significantly poorer lung function at baseline (12 months prior to initiating MITT) and had experienced significantly more moderate-to-severe acute exacerbation of COPD (AECOPD) and hospitalizations during the baseline period were more likely to persist for 12 months, compared with those who discontinued within 12 months. Most patients stepped

Melanie Schroeder,1 Nicole Benjamin,2 Laura Atienza,3 Chandroday Biswas,4 Alan Martin,5 John D Whalen,6 José Luis Izquierdo Alonso,7 Juan Antonio Riesco Miranda,8 Juan José Soler-Cataluña,9 Alicia Huerta,3 Afisi S Ismaila10,11 1Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK; 2Global Health Economics, ICON plc., Boston, MA, USA; 3Market Access, GlaxoSmithKline SA, Madrid, Spain; 4Global Health Economics, ICON plc., Bengaluru, Karnataka, India; 5Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, UK; 6Global Health Economics, ICON plc., Abingdon, UK; 7Pneumology, Hospital Universitario de Guadalajara, Guadalajara, Spain; 8Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, Spain; 9Pneumology Department, Hospital Arnau de Vilanova-Lliria (Valencia), Valencia, Spain; 10Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA; 11Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaGlaxoSmithKline Plc., 1250 South Collegeville Road, Collegeville, PA 19426-0989, USATel +1 (919) 315 8229Email afisi.s.ismaila@gsk.comPurpose: To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective.Patients and Methods: The validated GALAXY-COPD model was used to simulate disease progression and predict healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 3-year time horizon for a Spanish population. Patient characteristics from published literature were supplemented by data from FULFIL

Shiyuan Zhang,1 Denise King,2 Virginia M Rosen,3 Afisi S Ismaila1,4 1Value Evidence and Outcomes, GlaxoSmithKline plc, Collegeville, PA, USA; 2Value Evidence and Outcomes, GlaxoSmithKline plc, Brentford, UK; 3Optum Inc, Eden Prairie, MN, USA; 4Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaValue Evidence and Outcomes, GlaxoSmithKline plc., 1250 S. Collegeville Road, Collegeville, PA 19426-0989, USATel +1 919 315 8229Email afisi.s.ismaila@gsk.comAbstract: With increasing choice of medications and devices for asthma and chronic obstructive pulmonary disease (COPD) treatment, comparative evidence may inform treatment decisions. This systematic literature review assessed clinical and economic evidence for using a single combination inhaler versus multiple inhalers to deliver the same medication for patients with asthma or COPD. In 2016, Embase, PubMed and the Cochrane library were searched for publications reporting studies in asthma or COPD comparing a single-inhaler combination medicine with multiple inhalers delivering the same medication. Publications included English-language articles published since 1996 and congress abstracts since 2013. Clinical, economic and adherence endpoints were assessed. Of 2031 abstracts screened, 18 randomized controlled trials (RCTs) in asthma and four in COPD, nine retrospective and three prospective observational studies in asthma, and four observational studies in COPD were identified. Of these, five retrospective and one prospective study in asthma, and two retrospective studies in COPD reported greater adherence with a single inhaler than multiple inhalers. Nine observational studies reported significantly (n=7) or numerically (n=2) higher rates of adherence with single- versus multiple-inhaler therapy. Economic analyses from retrospective and prospective studies showed that use of single-inhaler therapies was associated with reduced healthcare res

Ike Iheanacho,1 Shiyuan Zhang,2 Denise King,3 Maria Rizzo,1 Afisi S Ismaila2,4 1Meta Research, Evidera, London, UK; 2Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA; 3Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK; 4Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaValue Evidence and Outcomes, GlaxoSmithKline plc., 1250 South Collegeville Road, Collegeville, PA 19426-0989, USATel +1 919 315 8229Email afisi.s.ismaila@gsk.comBackground and Objectives: Chronic obstructive pulmonary disease (COPD) affects over 250 million people globally, carrying a notable economic burden. This systematic literature review aimed to highlight the economic burden associated with moderate-to-very severe COPD and to investigate key drivers of healthcare resource utilization (HRU), direct costs and indirect costs for this patient population.Materials and Methods: Relevant publications published between January 1, 2006 and November 14, 2016 were captured from the Embase, MEDLINE and MEDLINE In-Process databases. Supplemental searches from relevant 2015– 2016 conferences were also performed. Titles and abstracts were reviewed by two independent researchers against pre-defined inclusion and exclusion criteria. Studies were grouped by the type of economic outcome presented (HRU or costs). Where possible, data were also grouped according to COPD severity and/or patient exacerbation history.Results: In total, 73 primary publications were included in this review: 66 reported HRU, 22 reported direct costs and one reported indirect costs. Most of the studies (94%) reported on data from either Europe or North America. Trends were noted across multiple studies for higher direct costs (including mean costs per patient per year and mean costs per exacerbation) being associated with increasingly severe COPD and/or a history of more frequent or severe exacerbations. Simila

Hannah B Lewis,1 Melanie Schroeder,2 Necdet B Gunsoy,3 Ellen M Janssen,4 Samuel Llewellyn,5 Helen A Doll,1 Paul W Jones,6 Afisi S Ismaila7,8 1Patient Centred Outcomes, ICON plc., London, UK; 2Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK; 3Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, UK; 4Patient Centred Outcomes, ICON plc., Gaithersburg, MD, USA; 5Patient Centred Outcomes, ICON plc., Abingdon, UK; 6Respiratory Therapy Area, GlaxoSmithKline plc., Brentford, UK; 7Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA; 8Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaValue Evidence and Outcomes, GlaxoSmithKline plc., 1250 South Collegeville Road, Collegeville, PA 19426-0989, USATel +1 919 932 0430Email afisi.s.ismaila@gsk.comIntroduction: With increasing availability of different treatments for chronic obstructive pulmonary disease (COPD), we sought to understand patient preferences for COPD treatment in the UK, USA, and Germany using a discrete choice experiment (DCE).Methods: Qualitative research identified six attributes associated with COPD maintenance treatments: ease of inhaler use, exacerbation frequency, frequency of inhaler use, number of different inhalers used, side effect frequency, and out-of-pocket costs. A DCE using these attributes, with three levels each, was designed and tested through cognitive interviews and piloting. It comprised 18 choice sets, selected using a D-efficient experimental design. Demographics and disease history were collected and the final DCE survey was completed online by participants recruited from panels in the UK, USA and Germany. Responses were analyzed using mixed logit models, with results expressed as odds ratios (ORs).Results: Overall, 450 participants (150 per country) completed the DCE; most (UK and Germany, 97.3%; USA, 98.0%) were included in the final analysis. Based on relative attr

Afisi S Ismaila,1,2 Nancy Risebrough,3 Melanie Schroeder,4 Dhvani Shah,5 Alan Martin,6 Emma C Goodall,7 Kerigo Ndirangu,5 Gerard Criner,8 Mark Dransfield,9 David MG Halpin,10 MeiLan K Han,11 David A Lomas12 1Value Evidence and Outcomes, GlaxoSmithKline plc, Collegeville, PA, USA; 2Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; 3ICON Health Economics, ICON plc, Toronto, ON, Canada; 4Value Evidence and Outcomes, GlaxoSmithKline plc, Brentford, UK; 5ICON Health Economics, ICON plc, New York, NY, USA; 6Value Evidence and Outcomes, GlaxoSmithKline plc, Uxbridge, UK; 7Health Economics and Outcomes Research, GlaxoSmithKline plc, Mississauga, ON, Canada; 8Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA; 9Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA; 10Department of Respiratory Medicine, Royal Devon and Exeter Hospital, Exeter, UK; 11University of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA; 12UCL Respiratory, University College London, London, UKCorrespondence: Afisi S IsmailaValue Evidence and Outcomes, GlaxoSmithKline plc, 1250 South Collegeville Road, Collegeville, PA 19426-0989, USATel +1 919 315 8229Email afisi.s.ismaila@gsk.comBackground: We assessed the cost-effectiveness of single-inhaler fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus FF/VI or UMEC/VI from a Canadian public healthcare perspective, incorporating data from the IMPACT trial in chronic obstructive pulmonary disease (COPD) (NCT02164513).Methods: Baseline inputs and treatment effects from IMPACT were populated into the validated GALAXY-COPD disease progression model. Canadian unit costs and drug costs (Canadian dollars [C$], 2017) were applied to healthcare resource utilization and treatments. Future costs and health outcomes were discounted at 1.5% annually. Analyses were probabilistic, and outputs

Antoni Sicras Mainar,1 Alicia Huerta,2 Ruth Navarro Artieda,3 Eduard Monsó,4,5 Sarah H Landis,6 Afisi S Ismaila7,8 1Scientific Direction, Health Economics and Outcomes Research (HEOR) Department, Real Life Data, Madrid, Spain; 2Market Access Department, GlaxoSmithKline SA, Madrid, Spain; 3Medical Documentation Department, Hospital Germans Trias I Pujol, Badalona, Spain; 4Pulmonology Service, Hospital Parc Taulí, Barcelona, Spain; 5CIBERES – Ciber De Enfermedades Respiratorias, Madrid, Spain; 6Real World Evidence and Epidemiology Department, GlaxoSmithKline, Uxbridge, UK; 7Value Evidence and Outcomes Department, GlaxoSmithKline, Collegeville, PA, USA; 8Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Alicia HuertaMarket Access Department, GlaxoSmithKline SA, C/Severo Ochoa 2, Madrid 28760, SpainTel +34 91 807 0821Fax +34 9 187 0500Email donha_ali@hotmail.comPurpose: Guidelines recommend the use of triple therapy with an inhaled corticosteroid (ICS), a long-acting β2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA) to reduce the risk of future exacerbations in symptomatic COPD patients with a history of exacerbations. This study aimed to estimate COPD-related healthcare resource use and costs, and subsequent exacerbation rates, for patients initiating multiple-inhaler triple therapy (MITT) early (≤30 days) versus late (31–180 days) following an exacerbation, in a real-world clinical setting.Patients and methods: This was an observational, longitudinal, retrospective study using electronic medical records from the Spanish database of the Red de Investigación en Servicios Sanitarios Foundation. Patients ≥40 years old with a confirmed COPD diagnosis who were newly prescribed MITT up to 180 days after an exacerbation between January 2013 and December 2015 were included. Patients were followed from the date of MITT ini

Victoria Federico Paly,1 Ian Naya,2 Necdet B Gunsoy,3 Maurice T Driessen,4 Nancy Risebrough,5 Andrew Briggs,6 Afisi S Ismaila7,81ICON Health Economics, ICON, Philadelphia, PA, USA; 2Global Respiratory Franchise, GSK, Brentford, Middlesex, UK; 3Value Evidence and Outcomes, GSK, Uxbridge, Middlesex, UK; 4Value Evidence & Outcomes, GSK, Brentford, Middlesex, UK; 5ICON Health Economics, ICON, Toronto, ON, Canada; 6Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK; 7Value Evidence & Outcomes, GSK, Collegeville, PA, USA; 8Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaPurpose: Clinically important deterioration (CID) in chronic obstructive pulmonary disease (COPD) is a novel composite endpoint that assesses disease stability. The association between short-term CID and future economic and quality of life (QoL) outcomes has not been previously assessed. This analysis considers 3-year data from the TOwards a Revolution in COPD Health (TORCH) study, to examine this question.Patients and methods: This post hoc analysis of TORCH (NCT00268216) compared costs and utilities at 3 years among patients without CID (CID-) and with CID (CID+) at 24 weeks. A positive CID status was defined as either: a deterioration in forced expiratory volume in 1 second (FEV1) of ≥100 mL from baseline; or a ≥4-unit increase from baseline in St George’s Respiratory Questionnaire (SGRQ) total score; or the incidence of a moderate/severe exacerbation. Patients from all treatment arms were included. Utility change was based on the EQ-5D utility index. Costs were based on healthcare resource utilization from 24 weeks to end of follow-up combined with unit costs for the UK (2016 GBP), and reported as per patient per year (PPPY). Adjusted estimates were generated controlling for baseline characteristics, treatment assig

Wilhelmine Meeraus,1 Robert Wood,2 Rafal Jakubanis,2 Tim Holbrook,2 Geoffray Bizouard,3 Johanna Despres,3 Camille Correia Da Silva,4 Gaelle Nachbaur,4 Sarah H Landis,1 Yogesh Punekar,5 Bernard Aguilaniu,6 Afisi S Ismaila7,8 1GlaxoSmithKline, Stockley Park West, Uxbridge, UK; 2Adelphi Real World, Bollington, Cheshire, UK; 3IQVIA, Paris, France; 4GlaxoSmithKline, Rueil-Malmaison, France; 5ViiV Healthcare, Brentford, Middlesex, UK; 6Faculty of Medicine, University Grenoble-Alpes, Grenoble, France; 7GlaxoSmithKline, Collegeville, PA, USA; 8Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada Background: Increasing availability of therapeutic options for COPD may drive new treatment pathways. This study describes COPD treatment in France, focusing on identifying initial treatment modifications in patients with COPD who either initiated long-acting bronchodilator (LABD)-based therapy or escalated to triple therapy (long-acting muscarinic antagonist [LAMA] + long-acting β2-agonist [LABA] + inhaled corticosteroid [ICS]). Methods: This retrospective analysis of patients with COPD in a large general practitioner database (IQVIA Longitudinal Patient Database) in France included two cohorts: Cohort 1 – new initiators of LABD-based therapy (LAMA, LABA, LAMA + LABA, LAMA + ICS, LABA + ICS or LAMA + LABA + ICS); Cohort 2 – patients escalating to triple therapy from mono- or dual-bronchodilator-based maintenance treatment. Both cohorts were indexed on the date of initiation/escalation (January 2008–December 2013), and the first treatment modification (at class level) within the 18-month post-index observational period was described. Five mutually exclusive outcomes were defined: continuous use (no modification), discontinuation (permanent [≥91 days with no restart] or temporary [≥91 days with subsequent restart]), switch, and augmentation (Cohort 1 only). Exploratory analysis of Co

Eline L Huisman,1 Sarah M Cockle,2 Afisi S Ismaila,3,4 Andreas Karabis,1 Yogesh Suresh Punekar2 1Mapi Group, Real World Strategy and Analytics and Strategic Market Access, Houten, the Netherlands; 2Value Evidence and Outcomes, GlaxoSmithKline, Uxbridge, UK; 3Value Evidence and Outcomes, GlaxoSmithKline R&D, Research Triangle Park, NC, USA; 4Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada Background: Several new fixed-dose combination bronchodilators have been recently launched, and assessing their efficacy relative to each other, and with open dual combinations is desirable. This network meta-analysis (NMA) assessed the efficacy of umeclidinium and vilanterol (UMEC/VI) with that of available dual bronchodilators in single/separate inhalers. Methods: A systematic literature review identified randomized controlled trials of ≥10 weeks among chronic obstructive pulmonary disease patients (≥40 years), assessing the efficacy of combination bronchodilators in single or separate inhalers. Comparative assessment was conducted on change from baseline in trough forced expiratory volume in 1 second (FEV1), St George’s Respiratory Questionnaire (SGRQ) total scores, transitional dyspnea index (TDI) focal scores, and rescue medication use at 12 weeks and 24 weeks using an NMA within a Bayesian framework. Results: A systematic literature review identified 77 articles of 26 trials comparing UMEC/VI, indacaterol/glycopyrronium (QVA149), formoterol plus tiotropium (TIO) 18 µg, salmeterol plus TIO, or indacaterol plus TIO, with TIO and placebo as common comparators at 12 weeks and approximately 24 weeks. The NMA showed that at 24 weeks, efficacy of UMEC/VI was not significantly different compared with QVA149 on trough FEV1 (14.1 mL [95% credible interval: -14.2, 42.3]), SGRQ total score (0.18 [-1.28, 1.63]), TDI