OBJECTIVES Clinical-economics evaluation of Dupilumab, the new immunobiologic agent, is very important for reimbursement status decision.

METHODS Comparative analysis of direct (DC) and non-direct (ND) cost of Dupilumab and Omalizumab has been performed based on the data of non-direct comparison of their efficacy in severe bronchial asthma. DC included: drugs cost for treatment period, cost of hospitalization and out-treatment in case of exacerbation, NDC included GDP losses due to temporary disability. Cost-effective parameters and budget impact analysis on horizon of 3 years were calculated, sensitivity analysis was performed for prove of results.

RESULTS Expected results for Dupilumab usage in 191 patients (target group) were estimated as $2,7 mln. annually, DC related with hospitalization and out-patients treatment were 0,16 mln., NDC - $0,71 mln., that in sum was calculated as $3,57 mln. In the comparative group (Omalizumab) cost of drug - $2,97 mln., DC medical - $0,22 mln., NDC- $1,25mln., in the sum - $4,44 mln. annually (on 24,3% higher in compare with Dupilumab). NDC for omalizumab were higher in compare with Dupilumab due to more higher rate of severe exacerbations of asthma (in 1,7 times higher). Cost-effective ratio for Dupilumab was $3,4 thousands, in the same time ratio for Omalizumab was $6,6 thousands. Budget impact analysis of Dupilumab has shown decreasing of DC on 11% that can use for additional 53 patients treatment during one year. Sensitivity analysis has confirmed the results.

CONCLUSIONS Dupilumab has economic advantages in compare with Omalizumab and can be recommended for state reimbursement program for severe asthma treatment.