title: [Roflumilast in combination with long-acting bronchodilators in the management of patients with severe and very severe COPD. A cost-effectiveness analysis for Germany].
abstract: OBJECTIVE
  To calculate the cost-effectiveness of roflumilast in combination with a long-acting beta agonist (LABA) versus LABA as a monotherapy in patients with severe and very severe COPD in Germany.
  
  
  METHODS
  The cost-effectiveness of Roflumilast plus LABA vs. LABA as monotherapy was calculated by a long-term model (Markov). The effectiveness data are based on the clinical trials AURA and HERMES (M2-124 and M2-125). Roflumilast plus LABA compared to LABA monotherapy reduced the exacerbation rate by 20.7 % (95 % CI, -31,-9) and improved post-bronchodilator FEV1 by 46 ml (2). These data were used to calculate the mean life expectancy of the COPD cohort (start age: 64 years). Costs for the treatment of exacerbations in the inpatient setting and the outpatient setting were included in the model. Endpoints were incremental costs per avoided exacerbation and per quality adjusted life year (QALY). The input variables were addressed in sensitivity analyses. German data on epidemiology and management of COPD were to populate the model and the cost-effectiveness was analyzed from the perspective of German statutory health insurance (SHI).
  
  
  RESULTS
  The model predicts a mean life expectancy of 8.1 years for patients with roflumilast plus LABA and 7.8 years for patients with LABA alone. This corresponds with a gain of 0.26 life years or 0.23 QALYs. Within this time span patients receiving roflumilast plus LABA experienced 2.43 exacerbations less than the comparator group. The incremental cost for roflumilast plus LABA is €1,852 per exacerbation avoided and €19,457 per QALY gained.
  
  
  CONCLUSIONS
  The model calculation indicates that the cost-effectiveness of roflumilast as an add-on to LABA in patients with severe and very severe COPD is comparable to the cost-effectiveness of established and reimbursed treatment options in Germany. Analogue consideration of the cost-effectiveness of the treatment options LAMA, LABA and ICS are advisable.
authors: Institut und Poliklinik für Arbeits-, Sozial- und Umweltmedizin, München. Dennis.Nowak@med.uni-muenchen.de
authors: D
authors: D
authors: Nowak
authors: B
authors: B
authors: Ehlken
authors: R
authors: R
authors: Kotchie
authors: S
authors: S
authors: Wecht
authors: H
authors: H
authors: Magnussen
mesh_terms: D000631:Aminopyridines / Q000191:economics* / Q000627:therapeutic use*; D001549:Benzamides / Q000191:economics* / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D003521:Cyclopropanes / Q000191:economics / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D005858:Germany / Q000453:epidemiology; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D058988:Phosphodiesterase 4 Inhibitors / Q000191:economics / Q000627:therapeutic use; D015995:Prevalence; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000191:economics* / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D004338:Drug Combinations; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast