OBJECTIVES : The aim of the study was to conduct budget impact analysis of implementation of the dupilumab into existing treatment regimens using monoclonal antibodies drugs for patients with severe bronchial asthma in the Russian Federation.

METHODS : The model of budget impact analysis was developed with a certain time horizon (3 years). The choice of such a time period was justified by the features of state budget planning. The direct costs included costs of the pharmacotherapy, basic therapy, the administration of the drugs, treatment of the exacerbations and side effects. The data was used from DSM group report of the sales of drugs 2018-2019 to determinate drugs share in the pharmaceutical market of the monoclonal antibodies drugs for the treatment patients with severe bronchial asthma. At the end of 2019, the pharmaceutical market distribution was presented as follows: 90% of sales was omalizumab for the treatment of atopic bronchial asthma, 9% was reslizumab and 1% was mepolizumab for the treatment of eosinophilic type of severe bronchial asthma. The following year, after dupilumab was penetrated, omalizumab occupied 78% of the market, reslizumab was 13%, mepolizumab was 5% and dupilumab was 4%. The next year, the market share of omalizumab was 69%, reslizumab was 17%, mepolizumab was 7%, and dupilumab was 7%. In the last year, 58% of sales accounted an omalizumab, 20% was resilizumab, 10% was mepoliuzmab and 12% was dupilumab.

RESULTS : The inclusion of dupilumab in existing treatment regimens led to increase of cost of $ 99,913,297 over 3 years, subject to a discount rate - 5%. The treatment of monoclonal antibodies drugs over three years required additional cost in the amount of $ 2 415 517 664.

CONCLUSIONS : The results of the budget impact analysis demonstrate that the use of dupilumab will require additional funding.