title: Cost-effectiveness of combination therapy umeclidinium/vilanterol versus tiotropium in symptomatic COPD Spanish patients.
abstract: OBJECTIVE
  Umeclidinium/vilanterol (UMEC/VI) is a novel fixed dose combination of a long-acting muscarinic receptor antagonist (LAMA) and a long-acting beta 2 receptor antagonist (LABA) agent. This analysis evaluated the incremental cost-effectiveness ratio (ICER) of UMEC/VI compared with tiotropium (TIO), from the Spanish National Health System (NHS) perspective.
  
  
  METHODS
  A previously published linked equations cohort model based on the epidemiological longitudinal study ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points) was used. Patients included were COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% and the presence of respiratory symptoms measured with the modified Medical Research Council dyspnea scale (modified Medical Research Council ≥2). Treatment effect, expressed as change in FEV1 from baseline, was estimated from a 24-week head-to-head phase III clinical trial comparing once-daily UMEC/VI with once-daily TIO and was assumed to last 52 weeks following treatment initiation (maximum duration of UMEC/VI clinical trials). Spanish utility values were derived from a published local observational study. Unitary health care costs (€2015) were obtained from local sources. A 3-year time horizon was selected, and 3% discount was applied to effects and costs. Results were expressed as cost/quality-adjusted life years (QALYs). Univariate and probabilistic sensitivity analysis (PSA) was performed.
  
  
  RESULTS
  UMEC/VI produced additional 0.03 QALY and €590 vs TIO, leading to an ICER of €21,475/QALY. According to PSA, the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of €30,000/QALY.
  
  
  CONCLUSIONS
  UMEC/VI could be considered as a cost-effective treatment alternative compared with TIO in symptomatic COPD patients from the Spanish NHS perspective.
authors: Pneumology Department, Hospital Universitari Vall d'Hebron, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.
authors: Marc
authors: M
authors: Miravitlles
authors: Pneumology Department, Hospital Universitario de Cruces, CIBER de Enfermedades Respiratorias (CIBERES), Bilbao, Spain.
authors: Juan B
authors: JB
authors: Gáldiz
authors: GlaxoSmithKline, Madrid, Spain.
authors: Alicia
authors: A
authors: Huerta
authors: Oblikue Consulting, Barcelona, Spain.
authors: Alba
authors: A
authors: Villacampa
authors: Oblikue Consulting, Barcelona, Spain.
authors: David
authors: D
authors: Carcedo
authors: Pneumology Department, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
authors: Francisco
authors: F
authors: Garcia-Rio
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D001592:Benzyl Alcohols / Q000191:economics / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000627:therapeutic use; D002722:Chlorobenzenes / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D004338:Drug Combinations; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy / Q000191:economics / Q000453:epidemiology; D019057:Quality-Adjusted Life Years; D011812:Quinuclidines / Q000191:economics / Q000627:therapeutic use; D012720:Severity of Illness Index; D013030:Spain / Q000453:epidemiology; D063189:Symptom Assessment / Q000379:methods; D000069447:Tiotropium Bromide / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D004338:Drug Combinations; C573971:GSK573719; D011812:Quinuclidines; C550468:vilanterol; D000069447:Tiotropium Bromide
keywords: COPD; cost-effectiveness analysis; cost-utility analysis; tiotropium; umeclidinium/vilanterol