title: Cost-effectiveness analysis, prevention of atopic dermatitis by oral application of bacterial lysate in newborns/small children.
abstract: OBJECTIVE
  The aim of this analysis was to determine the cost-effectiveness compared to placebo of prophylactic treatment with sterile bacterial lysate (Escherichia coli and Enterococcus faecalis) (verum) of newborns/small children with heredity for atopy [atopic dermatitis (AD)]. Infants were followed from the age of 5 weeks until 3 years of age. During this time, the number of children with AD who were treated with verum or placebo was observed at eight visits. Cost-effectiveness analyses were performed at different time points.
  
  
  METHODS
  A randomized, double-blind placebo-controlled clinical trial performed in Germany included 606 newborns. After randomization, n = 303 patients were classified in the placebo group and n = 303 in the verum group. A total of 119 participants left the study, so data from n = 250 patients of the placebo group and n = 237 patients of the verum group were available for analysis. At the beginning of the study, newborns were treated prophylactically with bacterial lysate or placebo for 26 weeks. After this, children were observed until the age of 3 years. A systematic literature research was done to evaluate treatment costs of atopic eczema in newborn/small children. Finally, 17 publications were included and checked for searched treatment costs of AD. A study was then initiated to evaluate the direct costs to statutory health insurance. Based on the described clinical trial, a decision tree model was developed. Using the evaluated direct costs and prevalence according to the clinical trial, the developed model can be used in cost-effectiveness analyses.
  
  
  RESULTS
  The focus of the analyses was on the subgroup "single heredity for atopy" in clinical trials. Cost-effectiveness analysis showed an advantage for bacterial lysate after 3 years. To further support this result a model extension was executed; the model was expanded from 3 to 6 years. Cost-effectiveness of bacterial lysate was also proven after 6 years.
  
  
  CONCLUSIONS
  Prophylactic treatment with bacterial lysate of infants with single heredity for atopy for 26 weeks in the 1st year of life is cost-effective at the age of 3 and 6 years, i.e. prophylactic use of bacterial lysate generated lower costs by leading to lower prevalence compared to placebo.
authors.affiliation: Institute of Empirical Health Economics, Am Ziegelfeld 28, 51399, Burscheid, Germany, peter.kiencke@ifeg.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Kiencke
authors.forename: Kristina
authors.initials: K
authors.lastname: Viehmann
authors.forename: Reinhard
authors.initials: R
authors.lastname: Rychlik
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000191:economics*; D002457:Cell Extracts / Q000008:administration & dosage* / Q000191:economics*; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D003876:Dermatitis, Atopic / Q000191:economics* / Q000235:genetics / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D020022:Genetic Predisposition to Disease; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D018803:Models, Economic; D000095983:Bacterial Lysates
chemical_list: D000276:Adjuvants, Immunologic; D002457:Cell Extracts; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates