OBJECTIVES: To conduct budget impact analysis (BIA) of canakinumab treatment group comparing to symptomatic treatment in retrospective group of patients suffering from Muckle–Wells Syndrome (MWS). METHODS: BIA was conducted of the canakinumab treatment group versus retrospective group with only symptomatic treatment. According to the expert opinion canakinumab treatment accompanied by vial sharing and it has been taken into consideration of drug cost therapy. Following direct medical costs were also included into analysis and based on expert opinion: administration costs, costs of diagnostic laboratory and instrumental procedure, costs of inpatient and outpatient visits, costs of treating MWS complications and costs for correction adverse events. One-year time horizon was used.  RESULTS: Cost of canakinumab therapy course was 40,830,937 RUB/ 668,220 EUR for 20 MWS patients within 1 year. The difference in the required budget funds between canakinumab treatment group and retrospective group with symptomatic treatment was 38,787,076 RUB/ 634,771 EUR for 20 patients within 1 year. Decrease of direct medical costs (excluding costs for drug therapy) was obtained in canakinumab treatment group and amounted 763,705  RUB/ 12,498 EUR for 20 patients within 1 year due to a lower frequency of inpatient and outpatient visits, complications of MWS and lower administration costs in group treated with canakinumab. CONCLUSIONS: Usage of canakinumab in the treatment of patients with MWS led to budget spending. However, good efficacy of canakinumab helped to reduce direct medical costs for 763,705 RUB/12,498 EUR for 20 patients within 1 year in canakinumab treatment group.