Veselov A.V., Kniazev O.V., Kulikov A.Y., Nanaeva B.A., Romanov R.I., Serpik V.G., Shkurko T.V. 601

Budget impact analysis of seculinumab for the treatment of ankylosing spondylitis in the Russian Federation

With its high disability and severity, Crohn’s disease (CD) is a serious socio- economic burden for both the patient and society as a whole. Therefore, the choice of a therapy strategy for CD should be aimed not only at controlling the disease but also at the rational allocation of resources in health care system. Taking into account the appearance of innovative biologic drugs (biologics) that offer additional options for the treatment of the CD with new data from clinical studies, the decrease of registered maximal selling prices, the development and output of biological analogues (biosimilars) as well as taking into account the limited budget of the health care system, it became obvious that it is necessary to update the pharmacoeconomic evaluation of biologics in CD therapy. The purpose of this study was to evaluate the introduction of ustekinumab drug into clinical practice of CD therapy basing on cost analysis, cost-effectiveness analysis and budget impact analysis in comparison with alternative biologics. The study found that the sum of costs for the use of ustekinumab in the regimen of 1 injection at 12 weeks was the lowest among vedolizumab, adalimumab and infliximab biosimilars and comparable in costs among adalimumab, infliximab and certolizumab pegol. The cost-effectiveness analysis showed that treatment of CD with ustekinumab is characterized by lower costs per effectiveness unit (share of patients who achieved a CDAI-100 response, share of patients who achieved a CDAI remission of <150, and QALY) in a 1/12 weeks dosing regimen compared to all other biologics and in the 1/8 weeks dosing regimen among infliximab biosimilars; in the first year of therapy ustekinumab is also a “cost-effectiveness” technology compared to vedolizumab. Switching of 15% of patients to ustekinumab (1/12) is characterized by budget slight increase in costs within the ONLS and RLO financing channels for the 1st year and three years of therapy. Within the OMI system there is a decrease in costs allocated by the OMI Fund for a treatment facility and there is a decrease in the difference between the amount of payment received by a treatment facility for cases with the use of biologics and the cost of purchasing biologics. As a result of the study, the introduction of ustekinumab in clinical practice is justified from the pharmacoeconomics point of view.
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