Search

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

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

Soham Shukla,1 Dhvani Shah,2 Alan Martin,3 Nancy A Risebrough,4 Robyn Kendall,5 Claus F Vogelmeier,6 Isabelle Boucot,3 Lee Tombs,7 Leif Bjermer,8 Paul W Jones,3 Edward Kerwin,9 Chris Compton,3 François Maltais,10 David A Lipson,11,12 Afisi S Ismaila1,13 1Value Evidence and Outcomes, GSK, Collegeville, PA, USA; 2ICON, New York, NY, USA; 3Value Evidence and Outcomes, GSK, Brentford, Middlesex, UK; 4Global Health Economics, and Outcomes Research and Epidemiology, ICON, Toronto, ON, Canada; 5Global Health Economics, and Outcomes Research and Epidemiology, ICON, Vancouver, BC, Canada; 6Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany; 7Precise Approach Ltd, Contingent Worker on Assignment at GSK, Brentford, Middlesex, UK; 8Respiratory Medicine and Allergology, Lund University, Lund, Sweden; 9Altitude Clinical Consulting and Clinical Research Institute of Southern Oregon, Medford, OR, USA; 10Centre de Pneumologie, Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Québec, QC, Canada; 11Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 12Respiratory Clinical Sciences, GSK, Collegeville, PA, USA; 13Department 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.comIntroduction: Dual bronchodilators are recommended as maintenance treatment for patients with symptomatic COPD in the UK; further evidence is needed to evaluate cost-effectiveness versus monotherapy. Cost-effectiveness of umeclidinium/vilanterol versus umeclidinium and salmeterol from a UK healthcare perspective in patients without exacerbations in the previous year was as

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

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

Dhvani Shah,1 Nancy A Risebrough,2 Johnna Perdrizet,1 Neeraj N Iyer,3 Cory Gamble,4 Tam Dang-Tan3 1ICON, Commercialisation and Outcomes, Health Economics, New York, NY, USA; 2ICON, Commercialisation and Outcomes, Health Economics, Toronto, ON, Canada; 3HEOR & Data Analytics, Novo Nordisk Inc, Plainsboro, NJ, USA; 4Medical and Scientific Affairs, Novo Nordisk, Plainsboro, NJ, USA Background: The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcomes Results (LEADER) clinical trial demonstrated that liraglutide added to standard-of-care (SoC) therapy for type 2 diabetes (T2D) with established cardiovascular disease (CVD) or elevated cardiovascular (CV) risk was associated with lower rates of death from CVD, nonfatal myocardial infarction (MI), or nonfatal stroke than SoC alone.Objective: The objective of this study was to assess the cost-effectiveness (CE) and budget impact of liraglutide vs SoC in T2D patients with established CVD or elevated CV risk, over a lifetime horizon from a US managed care perspective.Methods: A cohort state-transition model (costs and benefits discounted at 3% per year) was used to predict diabetes-related complications and death (CV and all-cause). Events, treatment effects, and discontinuation rates were from LEADER trial; utility and cost data (US$, 2017) were from literature. Sensitivity analysis explored the impact of uncertainty on results. Additionally, a budget impact analysis was conducted to evaluate the financial impact of liraglutide use in this population, with displacement from dulaglutide, assuming a health care plan with 1 million members.Results: Liraglutide patients experienced 6.3% fewer events, had event-related cost-savings of $15,182, gained additional life-years of 0.67 and quality-adjusted life-years (QALYs) of 0.57, and had additional total costs ($60,928) vs SoC. Liraglutide was cost-effective with an incremental CE ratio of $106,749/QALY which was below the willingness-to-pay thres

Background and objectives: Exacerbations are important outcomes in COPD both from a clinical and an economic perspective. Most studies investigating predictors of exacerbations were performed in COPD patients participating in pharmacological clinical trials who usually have moderate to severe airflow obstruction. This study was aimed to investigate whether predictors of COPD exacerbations depend on the COPD population studied. Methods: A network of COPD health economic modelers used data from five COPD data sources - two population-based studies (COPDGene (R) and The Obstructive Lung Disease in Norrbotten), one primary care study (RECODE), and two studies in secondary care (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoint and UPLIFT) - to estimate and validate several prediction models for total and severe exacerbations (= hospitalization). The models differed in terms of predictors (depending on availability) and type of model. Results: FEV1% predicted and previous exacerbations were significant predictors of total exacerbations in all five data sources. Disease-specific quality of life and gender were predictors in four out of four and three out of five data sources, respectively. Age was significant only in the two studies including secondary care patients. Other significant predictors of total exacerbations available in one database were: presence of cough and wheeze, pack-years, 6-min walking distance, inhaled corticosteroid use, and oxygen saturation. Predictors of severe exacerbations were in general the same as for total exacerbations, but in addition low body mass index, cardiovascular disease, and emphysema were significant predictors of hospitalization for an exacerbation in secondary care patients. Conclusions: FEV1% predicted, previous exacerbations, and disease-specific quality of life were predictors of exacerbations in patients regardless of their COPD severity, while age, low body mass index, cardiovascular disease, and em

Martine Hoogendoorn,1 Talitha L Feenstra,2,3 Melinde Boland,1 Andrew H Briggs,4 Sixten Borg,5 Sven-Arne Jansson,6 Nancy A Risebrough,7 Julia F Slejko,8 Maureen PMH Rutten-van Mölken1 1Institute for Medical Technology Assessment (iMTA)/Erasmus School of Health Policy & Management (ESHPM), Erasmus University Rotterdam, Rotterdam, the Netherlands; 2Department for Prevention and Health Services Research, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands; 3Department of Epidemiology, Groningen University, University Medical Centre Groningen, Groningen, the Netherlands; 4Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK; 5Health Economics Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden; 6Department of Public Health and Clinical Medicine, Occupational and Environmental Medicine, The OLIN Unit, Umeå University, Umeå, Sweden; 7ICON Health Economics, Toronto, Canada; 8Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, USA Background and objectives: Exacerbations are important outcomes in COPD both from a clinical and an economic perspective. Most studies investigating predictors of exacerbations were performed in COPD patients participating in pharmacological clinical trials who usually have moderate to severe airflow obstruction. This study was aimed to investigate whether predictors of COPD exacerbations depend on the COPD population studied. Methods: A network of COPD health economic modelers used data from five COPD data sources – two population-based studies (COPDGene® and The Obstructive Lung Disease in Norrbotten), one primary care study (RECODE), and two studies in secondary care (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoint and UPLIFT) – to estimate and validate several prediction models for total and severe exacerb