Fixed antidiabetic drugs’ combinations have aim to improve of Diabetes Mellitus type 2 (DMT2) control as well as a safety treatment increasing. Soliqua SoloStar® is a new registered drug for control of fasting and prandial glucose levels, contained insulin glargine 100 UI/ml and lixisenatide. In the published non-direct comparison, it was more effective for DMT2 control vs insulin glargine 100 UI/ml and lixisenatide separately, and daily insulin dose was less on 22 UI.

Aim: To evaluate of Soliqua SoloStar® reasonability og inclusion from pharmacoeconomics point of view into the State program of the free medical Aid guarantees.

Materials and methods: Retrospective comparative economic analysis based on the published data of new methodology treatment with Soliqua SoloStar® in compare with the current treatment methodology with usage of insulin glargine and lixisenatide separately. Common used methodology of clinical-economic analysis was used, and target group of patients was created based on the Federal Diabetes Register. Direct medical cost was defned as a cost of medications. Differentiation between direct medical cost for the proposed methodology and current practice of the separate usage of insulin glargine and lixisenatide was calculated. Discounting at 5 % annually used in the calculation of the three years time horizon. Te results of health technology assessment are confrmed by sensitivity analysis. Microsof Excel was used for calculation.

Results: Calculation has been performed for two pens of Soliqua SoloStar® with different prices (Variation 1 and 2) in compare with different drugs of insulin glargine 100 UI/ml and lixisenatide. Soliqua SoloStar® had less daily dose (by insulin glargine) on 22 UI vs free combination, and dose of lixisenatide was 20 mkg per day. Amount of patients who have reached HbA1c<7 % was higher in Soliqua group vs free combination group on 29 % (95 % CI: 20.2-30.7; p<0.0001). Cost of daily dose in Variation 1 is 269.72 RUR., for Variation 2 — 214.28 RUR. In the same time cost of the free combination of insulin glargine 100 UI and lixisenatide is depended from trade’s name of the drug, while cost of lixisenatide per day is the same for free combination and has 158.8 RUR. Soliqua SoloStar® usage can decrease budget impact in comparison with free combination on 10.46-35.02 % (depending on cost of insulin glargine 100 UI from different manufacturers and Soliqua pen cost). Cost-effectiveness analysis has shown that Soliqua SoloStar® had economic advantages in compare with free components’ combination on 51.95-65.08 % (depending on cost of insulin glargine 100 UI from different manufacturers and variations of Soliqua pen cost).

Conclusion: Soliqua SoloStar® has pharmacoeconomics evidences to be included into the Governmental program of free medical Aid in Diabetes Mellitus type 2.

Introduction. Despite the high level of resistance of E.coli as the main causative agent of urinary tract infections, fluoroquinolones are among the most frequently used antimicrobial agents in empirical therapy of uroinfections.

Aim. Clinical and economic evaluation of the effectiveness of different antibacterial strategies of community-acquired uncomplicated acute pyelonephritis with the predicted dynamics of resistance of E.coli as the main causative agent of uroinfections.

Materials and methods. Te calculations take into account the literature data on the effectiveness and safety of the starting regime of antibacterial therapy of uncomplicated pyelonephritis with cephalosporins of the 3rd generation, fluoroquinolones, aminoglycosides and carbapenems in terms of hospital specialized medical care. Te model of «decision tree» is constructed. A list of direct and indirect costs was compiled, on the basis of which the cost of 1 case of acute uncomplicated pyelonephritis therapy for each strategy of antibacterial therapy was calculated. Te «cost-effectiveness analysis» and budget impact analysis were performed.

Results. Te cost of 1 case of therapy with acute uncomplicated pyelonephritis gentamicin was the lowest in comparison with alternative strategies (33 679,89 rubles). Cost-effectiveness analysis showed that the strategy of antibacterial therapy of acute uncomplicated pyelonephritis with gentamicin dominated alternative strategies: at lower costs, it was also more effective.

Summary. For a more accurate calculation of clinical and economic efciency of antimicrobial agents it is necessary to monitor the dynamics of the resistance level in the territory of the Russian Federation.

Introduction. Results of both clinical and epidemiological studies demonstrate a high frequency of work incapacity associated with headache, reduced socio-economic activity, low quality of life, greater number of comorbid diseases and mental disorders in patients with chronic migraine (CM) compared to those who suffer from episodic primary headache.

Objectives. Te objective of the study was comparative assessment of the disease cost and clinical and economic consequences of using various therapeutic approaches for preventive treatment of CM from the societal perspective in the Russian Federation.

Methods. Te following types of pharmacoeconomic analyses were used: disease cost analysis, budget effect analysis. Models based on literature data (Scenario No. 1) and based on expert opinion (Scenario No. 2) were constructed in parallel with subsequent interpretation and discussion of the results obtained. Direct and indirect costs were considered. Efcacy criteria were clinical outcomes of the use of therapeutic options in question — change in the frequency of use of migraine-associated aid: change in the frequency of use of emergency medical care; change in the frequency of inpatient treatment.

Results. CM is a disease associated with a signifcant socio-economic burden: the cost of managing a target population of 1 470 840 patients with current distribution of therapeutic approaches can reach up to 402 569 527 778 RUB with clinical and economic modeling based on literature data, and 444 918 119 377 RUB with clinical and economic modeling based on expert opinion surveys. Indirect costs constitute a signifcant proportion of the socio-economic cost of CM, estimated at 61 995 589 503 RUB to 88 794 056 961 RUB. Te use of various therapeutic approaches for treating CM can reduce the cost of the disease for the target population. Te cost of managing one patient with Botox® per year (141 820 RUB) was up to 40 % lower than the cost of preventive treatment of a patient with CM with oral medications (202 894 RUB), up to 192 % lower than the cost of managing patients without preventive treatment (414 305 RUB). Te use of Botox is associated with signifcantly smaller indirect costs in comparison with the use of other therapeutic approaches in managing patients with CM.

Te purpose of the study is to assess the economic consequences of the use of various anti-VEGF drugs in patients with diabetic macular edema (DME).

Materials and methods. Te cost–effectiveness analysis and budget impact analysis was conducted from the payer perspective (health insurance system).

Results. In accordance to the results from RCT (Protocol T) aflibercept required a lower number of intravitreal injections (IVI) and laser coagulations for frst year and it has tendency for lower number of IVI for the second year of treatment that resulted in lower costs for aflibercept therapy by 122,819 rubles (12.7 %) per patient within frst 2 years (1st year – 66,632 rubles, 2nd year – 61,186 rubles) in comparison with ranibizumab. Te cost–effectiveness analysis showed that aflibercept is a “cost–effective” method of treating patients with DME compared to ranibizumab in Pro Re Nata (PRN) mode. Te budget impact analysis has shown savings for the health insurance system (12 million rubles) for the analyzed patient cohort (n = 100) with aflibercept in 2 years (1st year – 6.163 million rubles; 2nd year – 6.119 million rubles). Te analysis of “lost opportunities” in a cohort of 100 patients showed that the use of aflibercept in DME can free up to 216 hospitalizations within 2 years (109 cases in the 1st year and 107 in the 2nd year). As a result, about 14 patients with DME can be additionally treated with aflibercept for two years within a fxed budget.

Conclusion. Treatment of DME with aflibercept can save resources of health insurance system compared to use of ranibizumab.

Progress achieved in the identifcation and characterization of the risk factors for congenital anomalies occur mainly from epidemiological studies, which gave many associations between risk factors and groups of birth defects. However, in clinical practice the transmission of these associations as the actual reasons remains very difcult. Characteristics and epidemiological analysis of possible factors, including drugs, associated with the occurrence of congenital anomalies, are crucial for the development of prevention activities that have an impact on the incidence of defects. To further reduce the global burden of birth defects can help the integration of studies in epidemiology, genetics and epigenetics through personalized and population oriented preventive strategies.

Tis article presents a literature review of hepatotoxicity of new oral anticoagulants which was obtained by different methods options of pharmacovigilance. Te overview includes 35 information sources 24 articles, 4 methodic or regulatory guidelines, 3 expert group publications, 3 new drug application overviews and 1 source being clinical trial register search results. Upon the results of the literature review, it was concluded that pharmacovigilance methods analyzing data obtained within real world medical practice give more opportunities for safety signal management comparing to those analyzing only data obtained within randomized clinical trials.