Cost-effectiveness analysis, prevention of atopic dermatitis by oral application of bacterial lysate in newborns/small children.

OBJECTIVES: 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. CONCLUSION: 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.

Cost-intensive, time-consuming, problematical? How physicians in private practice experience the care of urticaria patients.

BACKGROUND: Urticaria is a common and frequently debilitating disease. Nevertheless, there are only few studies examining the situation of urticaria patient care. PATIENTS AND METHODS: In this cross-sectional study, we surveyed dermatologists, pediatricians and general practitioners in the practice setting regarding the epidemiology, situation of care as well as the perception of their patients with chronic spontaneous urticaria. RESULTS: 776 data sets were available. The results show a high frequency of consultations due to chronic spontaneous urticaria. Most of the patients were reported to suffer moderately to severely and to have had history of disease of well over one year. The pediatricians indicated fewer diseases and shorter courses. The majority of participants stated that the time and cost spent on care, as well as the frequency of follow-up visits, are above average. In addition, chronic spontaneous urticaria patients were reported to be a group with a strong emotional burden and high expectations as well as a group that is difficult to satisfy and hard to guide. Only a small minority of physicians rated patient satisfaction with current treatment options and therapy success as high. CONCLUSIONS: Chronic spontaneous urticaria plays an important role in daily practice. Problems are reported on various areas of care. Resolving these problems presents a major challenge and is crucial for improving the quality of patient care.