title: Cost-effectiveness of roflumilast as an add-on treatment to long-acting bronchodilators in the treatment of COPD associated with chronic bronchitis in the United Kingdom.
abstract: OBJECTIVE
  To estimate the cost-effectiveness of adding a selective phosphodiesterase-4 inhibitor, roflumilast, to a long-acting bronchodilator therapy (LABA) for the treatment of patients with severe-to-very severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of frequent exacerbations from the UK payer perspective.
  
  
  METHODS
  A Markov model was developed to predict the lifetime cost and outcomes [exacerbations rates, life expectancy, and quality-adjusted life years (QALY)] in patients treated with roflumilast, which showed a reduction in the exacerbation rates and lung function improvement in a pooled analysis from two clinical trials, M2-124 and M2-125. Sensitivity analyses were conducted to explore the impact of uncertainties on the cost-effectiveness.
  
  
  RESULTS
  The addition of roflumilast to concomitant LABA reduced the number of exacerbations from 15.6 to 12.7 [2.9 (95 % CI 0.88-4.92) exacerbations avoided] and increased QALYs from 5.45 to 5.61 [0.16 (95 % CI 0.02-0.31) QALYs gained], at an incremental cost of £3,197 (95 % CI £2,135-£4,253). Cost in LABA alone and LABA + roflumilast were £16,161 and £19,358 respectively. The incremental cost-effectiveness ratios in the base case were £19,505 (95 % CI £364-£38,646) per quality-adjusted life-year gained and 18,219 (95 % CI £12,697-£49,135) per life-year gained. Sensitivity analyses suggest that among the main determinants of cost-effectiveness are the reduction of exacerbations and the case fatality rate due to hospital-treated exacerbations. Probabilistic sensitivity analysis suggests that the probability of roflumilast being cost-effective is 82 % at willingness-to-pay £30,000 per QALY.
  
  
  CONCLUSIONS
  The addition of roflumilast to LABA in the treatment of patients with severe-to-very severe COPD reduces the rate of exacerbations and can be cost-effective in the UK setting.
authors: IMS Health, 210 Pentonville Road, London, N1 9JY, UK, ysamyshkin@uk.imshealth.com.
authors: Yevgeniy
authors: Y
authors: Samyshkin
authors: Robert W
authors: RW
authors: Kotchie
authors: Ann-Christin
authors: AC
authors: Mörk
authors: Andrew H
authors: AH
authors: Briggs
authors: Eric D
authors: ED
authors: Bateman
mesh_terms: D000367:Age Factors; D000368:Aged; D000631:Aminopyridines / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D001549:Benzamides / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D001991:Bronchitis / Q000453:epidemiology; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D003521:Cyclopropanes / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005260:Female; D006296:Health Services / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D058988:Phosphodiesterase 4 Inhibitors / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000453:epidemiology; D019057:Quality-Adjusted Life Years; D012129:Respiratory Function Tests; D006113:United Kingdom
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D003692:Delayed-Action Preparations; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast
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