title: Cost effectiveness of treating multi-drug resistant tuberculosis by adding Deltyba™ to background regimens in Germany.
abstract: OBJECTIVE
  To assess the cost-effectiveness of adding delamanid (Deltyba™) to a background regimen (BR) for treating multidrug-resistant tuberculosis (MDR-TB) in Germany.
  
  
  METHODS
  The incremental cost-effectiveness of treating a cohort of MDR-TB patients, 38-years old on average, with Deltyba™ plus BR versus a five drug- BR regimen alone was compared in a Markov model over a period of 10 years. Cost per quality-adjusted life year (QALY) and disability-adjusted life years (DALY) were determined from a societal perspective. Recent data from a German cost calculation on MDR-TB were applied to the 24-month outcome results of patients participating in the placebo-controlled, phase II Otsuka's Trial 204. Costs and effectiveness were discounted at a rate of 3% and subjected to deterministic as well as probabilistic sensitivity analysis in a Monte Carlo simulation.
  
  
  RESULTS
  Based on the current market prices the total discounted cost per patient on BR plus Deltyba™ was €142,732 compared to €150,909 for BR alone. The total discounted QALYs per patient were 8.47 for Deltyba™ versus 6.13 for BR alone. Accordingly, the addition of Deltyba™ proved to be dominant over the BR alone-strategy by simultaneously saving €8177 and gaining 2.34 QALYs. Deltyba™ was cost saving in 73% of probabilistic sensitivity analyses compared to BR alone and 100% cost effective at a willingness-to-pay (WTP) threshold of €10,000.
  
  
  CONCLUSIONS
  Under conditions prevalent in Germany, Deltyba™ added to a five drug BR regimen is likely to be cost-saving compared to BR alone under a wide range of assumptions. Adding delamanid remained cost-effective when costs due to loss of productivity were excluded as the QALYs gained by lower lethality and a higher proportion of successfully treated patients outweighed the delamanid drug costs. These results strongly support the application of Deltyba™ in treating MDR-TB patients.
authors: Institute for Epidemiology, University Medical Hospital Schleswig-Holstein, Kiel, Germany; Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Germany. Electronic address: roland.diel@epi.uni-kiel.de.
authors: Roland
authors: R
authors: Diel
authors: Otsuka Novel Products, Munich, Germany.
authors: Norbert
authors: N
authors: Hittel
authors: Department of Pneumology, Diaconess Hospital Rotenburg/Wümme, Germany.
authors: Tom
authors: T
authors: Schaberg
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage* / Q000191:economics*; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008390:Markov Chains; D009593:Nitroimidazoles / Q000008:administration & dosage* / Q000191:economics*; D010080:Oxazoles / Q000008:administration & dosage* / Q000191:economics*; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D017211:Treatment Failure; D016896:Treatment Outcome; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy* / Q000191:economics*
chemical_list: D000995:Antitubercular Agents; D009593:Nitroimidazoles; C516022:OPC-67683; D010080:Oxazoles
keywords: Cost effectiveness-analysis; MDR-TB; Monte Carlo simulation; Tuberculosis