OBJECTIVES : Crohn's disease (CD) is a chronic recurrent disease of the gastrointestinal tract. Due to its severity CD has serious socio-economic consequences for both the patient and society. The goal of the treatment is the induction and maintenance of persistent clinical and endoscopic remission. The most effective treatment of patients with moderate-to-severe CD is the biological drugs (BD). Treatment choice should be also aimed at rational allocation of resources in the healthcare system. Before 2019 there were 2 types of BD for CD treatment registered in Russia: tumor necrosis factor inhibitors (adalimumab, infliximab, certolizumab pegol), anti-integrins (vedolizumab). In 2019 the new class was registered - anti-interleukin 12/23 (ustekinumab). The aim of the study was to conduct budget impact analysis when ustekinumab using in clinical practice.

METHODS : A simulation model with 3-years time horizon was created. Only direct costs were estimated: pharmacotherapy and administration. The number of patients receiving BD was estimated about 9000. During this analysis the set number of patients in the first year of therapy was constant and didn’t change in the 2-nd and subsequent years. Ustekinumab manufacturer used cost-sharing program so the induction dose were provided to the hospitals for free (3 vials per patients weighing 75 kg). The exchange rate used € 1 = 80 RUB.

RESULTS : According to the budget impact analysis of CD treatment switching of 15% of patients to ustekinumab from other competitors will save € 864 211 in the 1-st year and € 1 106 762 in 3 years in the healthcare system budget.

CONCLUSIONS : The results of the budget impact analysis showed that switch of 15% patients to ustekinumab would lead to the budget savings for the healthcare system in the Russian Federation.