SOCIOECONOMIC EVALUATION OF THE INFLUENCE OF RHDNASE ON THE COSTS OF TREATING RESPIRATORY-TRACT INFECTIONS IN PATIENTS WITH CYSTIC-FIBROSIS

Background: Data from a multicenter, placebo-controlled, double-blind, parallel clinical trial on the use of aerosolized recombinant human D Nase (rhDNase), known as Pulmozyme(R) produced by Genentech, about the treating of respiratory-tract infections among patients with cystic f ibrosis (CF), has been used to evaluate possible economic effects by i dentifying the direct medical costs. To calculate the cost an intentio n-to-treat approach has been used. Patients and Method: The patients w ere randomly placed in one of three treatment groups. The first group was treated with a 2.5 mg dose of rhDNase and one dose of placebo dail y, the second group with placebo twice a day. The third patient group (treated with a 2.5 mg dose of rhDNase twice a day) was not included i n this study. Results: The main measurements of resource utilization o f services for treatment of respiratory-tract infections were the numb er of hospitalizations in the follow-up period of 24 weeks (0.31 rhDNa se once daily, 0.56 placebo), the number of total days in hospital (4. 9 rhDNase, 6.4 placebo), the number of total days of outpatient intrav enous antibiotic therapy (2.9 rhDNase, 4.4 placebo), the number of tot al days of inpatient intravenous antibiotic therapy (4.8 rhDNase, 6.2 placebo), the number of total days of outpatient oral antibiotic thera py (23.5 rhDNase, 25.2 placebo) and the number of total days of inpati ent oral antibiotic therapy (0.59 rhDNase, 0.55 placebo). From a healt h insurance perspective the total direct cost based on a weighted per diem for German CF-centres was 5,879 DM (rhDNase) vs 7,849 DM (placebo ) per patient respectively. Costs of antibiotics were estimated using all available information on the consumption of antibiotic drugs revea ling 2,954 DM per patient in the rhDNase-group and 4,213 DM in the pla cebo-group. The large cost differences remain also true in a sensitivi ty analysis introducing minima and maxima as key factors. Conclusion: As a result of this study we conclude that the use of rhDNase in treat ment of respiratory-tract infections in patients with cystic fibrosis is cost saving and less burdened for the patients. However, all cost e stimates do not include the cost of rhDNase itself, which are DM 9,094 for the period of follow-up.