Objective: to assess the clinical and economic efficiency and impact on the budget when using the drug Mirabegron in the treatment of an overactive bladder. Materials and methods. Study design — retrospective analysis of published data. Pharmacoeconomic analysis methods — cost analysis, clinical and economic analysis, budget impact analysis. Results. Despite the fact that the drug Mirabegron for the treatment of overactive bladder is less effective in comparison with the use of the botulinum toxin type A-hemagglutinin complex drug, the clinical and economic analysis showed that within the horizon of 12 months the use of the drug Mirabegron will require 66.8 % less costs. Analysis of the impact on the budget showed that when using the drug Mirabegron from the first year in 100 % of patients, the decrease in the burden on the budget will be 66.8 %. Gradual provision of Mirabegron to patients over 3 years instead of Botulinum toxin type A-hemagglutinin complex will reduce the burden on the budget by 44.4 % in 3 years. Sensitivity analysis showed that the results obtained are resistant to changes in prices for compared drugs and a decrease in the volume of therapy with botulinum toxin type A-hemagglutinin complex. Conclusion. The use of the drug Mirabegron in the treatment of patients with an overactive bladder is pharmacoeconomically justified. The inclusion of Mirabegron in the lists of medicines, the costs of which are subject to state reimbursement, is advisable.

Purpose . To evaluate pharmacoeconomic efficiency of dapagliflosin application for intensification of hypoglycemic therapy — in comparison with addition to therapy of group of inhibitors of dipeptidyl peptidase 4 (iDPP-4) or basal insulin. Materials and methods . Budget impact analysis was done retrospectively using published clinical research data. The evaluation was carried out according to 2 scenarios of intensification of therapy of patients with diabetes mellitus: using dapagliflozine in comparison with iDP-4 (scenario No. 1) or using dapagliflozine in comparison with basal insulins (scenario No. 2). In the first scenario, both direct and indirect costs were taken into account, and in the second scenario, only direct costs were taken into account. Results . The analysis of influence on the budget showed that when using a dapagliflozin in comparison with medicines of class IDPP-4 it is possible to reach decrease in the total costs on the 2nd year of therapy, at the same time in 5 years economy will make 19.4-24.2 % or 21,985-29,123 rub per 1 patient. In patients who have not previously received insulin, with the same effectiveness in reducing the level of glycated hemoglobin, the use of dapagliflosin in comparison with basal insulin reduces the cost of drug therapy by 9.3 % or by 3,566 rubles per year. If combined «surrogate» endpoint is used as an efficiency criterion, reduction of glycated hemoglobin level and body weight, intensification of therapy using dapagliflosin is dominant scheme: More patients reach the end point on dapagliflozine compared to basal insulin (57 and 37 % respectively), with direct costs associated with using dapagliflozine less by 9.3 % or 1,763 rubles in 180 days. Conclusion . The use of dapagliflosin to intensify therapy in patients with diabetes mellitus is economically viable. From the point of view of pharmacoeconomics, therapy schemes involving dapagliflosin dominate comparison therapy schemes. Dapagliflosin can be recommended for inclusion in medical care standards, drug programs, and formula lists of medical organizations.

Aim. To assess the pharmacoeconomic feasibility of including the drug upadacitinib in restrictive lists and government funding programs to provide patients with rheumatoid arthritis. Materials and methods . Study Design — Retrospective Analysisof Literary Data. Pharmacoeconomic analysis methods — indirect comparison, clinical-economic analysis (cost-effectiveness analysis) using sensitivity analysis; budget impact analysis using sensitivity analysis. Data on the effectiveness of the analyzed drugs are taken from publications on clinical studies of the compared drugs; on the cost of drugs — the state register of marginal selling prices, data of the manufacturer’s company. Results. According to the results of indirect comparison, with respect to the frequency of achievement of the DAS28 test (CRP) <2.6, the effectiveness of the preparations tofacitinib and baricitinib does not significantly differ — OR = 1.275 (0.842; 1.931). At the same time, the preparation upadacitinib allows to achieve this indicator reliably more effective than the baricitinib — OR = 1.529 (1.021; 2.292) and tofacitinib — OR = 1.95 (1.285; 2.960). Costs for the use of upadacitinib against the background of methotrexate for 52 weeks will amount to 654 983.88 rubles, and will require 4.7 % less costs than the use of tofacitinib or baricitinib against the background of the use of methotrexate (687 217.53 rubles). In an indirect comparison of upadacitinib-baricitinib through the general comparator adalimumab, the effectiveness of upadacitinib with respect to the frequency of achievement of DAS28-CRP <2.6 turned out to be higher than baricitinib per 32.3 %. With indirect comparison of upadacitinib-tofacitinib under the same conditions, the efficiency of upadacitinib is 57.7 % higher than that of tofacitinib. Analysis of the impact on the budget showed that with the inclusion of the drug upadacitinib in the lists of VED and ONLS and a gradual increase in the proportion of patients, receiving upadacitinib instead of tofacitinib and baricitinib in the 1st year before 15 %, in the 2nd year — 30 %, in the 3rd year — 45 % for the group of 2.318 patients for 3 years, the reduction in the budget burden will be 1.4 % or 62.8 million rubles. With the provision of upadacitinib, 100 % of patients from the first year, the budget burden for 3 years will decrease by 4.7 % or 213.1 million rubles in comparison with the current regime. Conclusion . tte drug upadacitinib at a lower course cost has greater effectiveness in achieving clinical remission according to the indicator DAS28-CRP (<2.6), and therefore its use in the conditions of the healthcare system of the Russian Federation for the treatment of patients with rheumatoid arthritis is pharmacoeconomic and expedient.

Aim . Conduct a comparative assessment of the pharmacoeconomic e‘cacy of using the combination Vezomni as compared to a combination of tamsulosin and solifenacin in the form of monopreparations in men with symptoms of the lower urinary tract against a benign prostatic hyperplasia. Methodology . The design of the study is a retrospective analysis of the literature data. Methods of pharmacoeconomic analysis – cost analysis, "budget impact" analysis, cost-effectiveness analysis, sensitivity analysis. Results . The use of Vezomni instead of a combination of monopreparations tamsulosin + solifenacin will reduce the burden on the budget of the state guarantee program by 11.68 % for 3 years. With a target population of 1,000 people, the savings will be 6.28 million rubles. The cost of treatment of symptoms of the lower urinary tract for 1 year will decrease by 2 340.76 rubles for 1 person. At the same cost, the use of a fixed combination will provide therapy with 13.23 % more patients than with monotherapy (1132: 1000 people, respectively). Сonclusion . The use of the combination drug Vezonmi is pharmacoeconomically justified and allows to lower the costs for the treatment of lower urinary tract symptoms that occur against the background of benign prostatic hyperplasia in comparison with the use of a monopreparations of tamsulosin and solifenacin.

This study was aimed at clinical and economic assessment of feasibility of inclusion glycopyrronium bromide/indacaterol fixed combination in the State Program for providing necessary drugs to patients. Methods. This retrospective study was based on previously published clinical data. Change of economic burden was assessed using budget impact analysis. Cost-efficacy was assessed using cost minimization analysis and lost opportunities analysis. Results. Switching COPD patients from free combination of long-acting bronchodilators (LABD) to glycopyrronium bromide/indacaterol fixed combination has led to 20.44% decrease in the economic burden. The 3-year cost reduction of COPD therapy has reached RUB 2,416 bln. Conclusion. The results demonstrated higher cost-efficacy of glycopyrronium bromide/indacaterol fixed combination compared to the standard therapy of COPD. Inclusion of glycopyrronium bromide/indacaterol combination into the State Program for providing necessary drugs to COPD patients could be rational and ecomonically feasible.

AND POSSIBLE SOLUTIONSНесмотря на достигнутые успехи мероприятий, направленных на снижение смертности от туберкулеза, данное заболевание по прежнему крайне распространено, а в некоторых регионах России численность больных достигает показателей, характерных для уровня эпидемии.Многолетнее широкое применение антибиотиков, изменение состава микробиоты человека и ряд других факторов привели к появлению лекарственноустойчивых и высоковирулентных сублиний Mycobacterium tuberculosis.Недостаточность уровня и объема фундаментальных знаний о механизмах возникновения и формирования клонов M. tuberculosis, одновременно устойчивых ко многим антибиотикам и обладающих повышенной патогенностью, усложняет проблему и требует разработки новой концепции борьбы с туберкулезом.Ключевые понятия этой концепции -«суперорганизм», «микробиота» и «резистом».Возникновение форм с множественной (МЛУ) и широкой (ШЛУ) лекарственной устойчивостью следует рассматривать в контексте их формирования в составе некоторого суперорганизма, элементами которого являются собственно организм человека, его микробиота (в том числе влияющая на иммунный статус) и M. tuberculosis.Клинически тестируемые фенотипы и генотипы штаммов МЛУ/ШЛУ формируются на основе клональной изменчивости M. tuberculosis в «суперорганизме».Поэтому при разработке противотуберкулезных препаратов следует обращать особое внимание на создание вакцин, адъювантов и пробиотиков с селективными иммуномодулирующими и антиоксидантными свойствами.In spite of successful measures taken to reduce mortality associated with tuberculosis, this disease is still widely spread.In some Russian regions the number of patients with tuberculosis is no short of the epidemic level.The long-term use of antibiotics, changes in the composition of the human microbiota and a few other factors have contributed to the emergence of drug-resistant and hypervirulent sublineages of Mycobacterium tuberculosis.Insufficient fundamental knowledge of mechanisms underlying the emergence and evolution of M. tuberculosis clones simultaneously resistant to a wide spectrum of antibiotics and exhibiting increased virulence complicates the situation and necessitates a new strategy to combat the disease.The key concepts of this strategy are «superorganism», «microbiota» and «resistome».The emergence of multidrugresistant (MDR) and extensively drug-resistant (XDR) strains should be addressed in the context of the «superorganism»; among its components are the human body, its microbiota (specifically, the bacteria that affect the immune status), and M. tuberculosis itself.Clinically studied phenotypes and genotypes of MDR/XDR strains are a result of clonal variability that M. tuberculosis develops as part of this «superorganism».Therefore, it is important to focus on the development of vaccines, adjuvants and probiotics with selective immunomodulating and antioxidant properties.

AIM:Evaluate immune response in mice against various L-asparaginases and determine their cross-immunogenicity.MATERIALS AND METHODS:The studies were carried out in C57Bl(6j) line mice. Immunogenicity of L-asparaginases was studied: Escherichia coli type II (recombinant) (Medak, Germany) (EcA); Erwinia carotovora type II (ErA); Yersinia pseudotuberculosis type II (YpA); Rhodospirillum rubrum type I (RrA); Wollinella succinogenes type II (WsA). Immune response against the administered antigens was determined in EIA.RESULTS:Y. pseudotuberculosis L-asparaginase was the most immunogenic, E. coli--the least immunogenic. E. carotovora, R. rubrum, W. succinogenes asparaginases displayed intermediate immunogenicity. The results of cross-immunogenicity evaluation have established, that blood sera of mice, that had received YpA, showed cross-immunogenicity against all the other L-asparaginase preparations except E. carotovora. During immunization with E. coli L-asparaginase the developed antibodies also bound preparation from E. carotovora. Sera from mice immunized with W. succinogenes, E. carotovora and R. rubrum L-asparaginases had cross-reaction only with EcA and did not react with other preparations.CONCLUSION:Cross-immunogenicity of the studied L-asparaginases was determined. A sequence of administration of the studied preparation is proposed that allows to minimize L-asparaginase neutralization by cross-reacting antibodies.