title: The cost-effectiveness of OM-85 in managing respiratory tract infections in China.
abstract: OBJECTIVE
  To demonstrate the health economic impact of OM-85, a bacterial lysates based immunostimulant, for its approved indications in China.
  
  
  METHODS
  A cost-effectiveness decision tree model was constructed comparing OM-85 with the best supportive care/placebo therapy for managing the acute exacerbation of chronic bronchitis and rhinosinusitis in the Chinese population. Clinical efficacy and adverse events (AE) data were included in the model based on a thorough literature review. All localized direct treatment costs, including drug cost, AE costs, and medical treatment costs for underlining diseases were included from a Chinese third party payer perspective. A Key Opinion Leaders (KOL) survey was conducted with 20 senior physicians specialized in respiratory, ENT, allergy, and immunology fields from tertiary hospitals in Beijing, Shanghai, Guangzhou, Hangzhou, Shenyang, and Wuhan to validate the local treatment costs. Incremental cost-effectiveness ratio (ICER) was calculated based on the above efficacy and cost information.
  
  
  RESULTS
  OM-85 is a cost-effective therapy when compared with placebo (standard care). OM-85 can treat/prevent one additional full episode exacerbation of chronic bronchitis and one additional full episode exacerbation of rhinosinusitis with only additional costs of RMB 653 and RMB 1182.84, respectively. In comparison, each acute exacerbation of chronic bronchitis will cost RMB 4510.10, and each acute exacerbation of rhinosinuisitis will cost RMB 1807.21 in a Chinese clinical management setting. One-way sensitivity analyses were performed and the ICER result was demonstrated to be consistent.
  
  
  CONCLUSIONS
  OM 85 reduces acute exacerbations among patients with chronic bronchitis and chronic rhinosinusitis when compared with Placebo (standard care). From a Chinese payer perspective, OM 85 is a cost-effective therapy in the clinical management of both chronic bronchitis and rhinosinusitis in the adult population.
authors.affiliation: University of Florida , Gainesville, FL , USA.
authors.forename: Jianwei
authors.initials: J
authors.lastname: Xuan
authors.forename: Lijie
authors.initials: L
authors.lastname: Wang
authors.forename: Hongjun
authors.initials: H
authors.lastname: Yin
authors.forename: Dennis
authors.initials: D
authors.lastname: Xuan
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhou
authors.forename: Shanlian
authors.initials: S
authors.lastname: Hu
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy; D002457:Cell Extracts / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D002681:China; D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D005102:Health Expenditures; D006801:Humans; D017059:Models, Econometric; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D012220:Rhinitis / Q000188:drug therapy; D012852:Sinusitis / Q000188:drug therapy; D000095983:Bacterial Lysates
chemical_list: D000276:Adjuvants, Immunologic; D002457:Cell Extracts; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates
keywords: China; Chronic bronchitis; Cost-effectiveness; Respiratory tract infections