The article sets out the results of analysis of existing models of risk sharing agreements, which are used in foreign countries at reimbursement of costs for public drug supply. The author estimates the opportunities to use risk sharing agreements in theRussian Federation, taking into consideration the existing legislative environment. The role of medical technologies evaluation system is regarded as one of the elements of decision system, which element is necessary for introduction of risk sharing agreements. The article also proposes the specific amendments to applicable law, which are to be made for successful introduction of risk sharing agreement in theRussian Federation

Objective: to calculate cost difference between two approaches for immunosuppressive therapy after renal transplantation: everolimus plus reducedexposure cyclosporine and mycophenolic acid plus standard-exposure cyclosporine. Methods. We calculated the two-year difference in costs that resulted from effectiveness and safety differences of alternatives employing the probability-statistical model. Data on safety and efficiency were taken from D. Cibrik et al. (2013) randomized control trial. We also estimated the budget impact for everolimus inclusion into 7 expensive diseases program (7EDP). 7 EDP is the special federal program of drug provision for patients suffering from 7 certain diseases and health states including organ posttransplantation period. Results. Everolimus plus reduced-exposure cyclosporine leads to cost reduction by 161 RUB thousands (17%) per patient in a two-year period. The reduction mainly results from cheaper medication in everolimus plus reduced-exposure cyclosporine approach compared to mycophenolic acid plus standard-exposure cyclosporine. Everolimus inclusion into 7 expensive diseases program leads to reduction in federal budget spending starting from the first year; the total five-year budget savings are 275 RUB millions. 

The purpose of the paper is to clarify the conceptual framework and terminology that underlies state policy formulation in the area of R&D in theRussian Federationand to propose respective amendments to effective legislation. Sources and methods. Based on comparison and analogy, the paper analyses the application the concepts of main types of research and development in Russian and international practices of state policy formulation with the aim of improving the conceptual framework of policy analysis and improving the efficiency of R&D budgeting inRussia, as well as ensuring its compatibility with other countries. Results. The authors propose approaches to normative regulation of R&D conceptual framework. The paper proposes and discusses the required amendments to the latest revision of the Federal Law on Science and State R&D Policy. Сonclusion. The lack of clearly defined concepts results in the confusion of the types of R&D in terms of which the policy of providing state support of science is formulated. As the classification of the types of R&D in Russian practice is used not only for statistical reporting, but also for strategic and budget planning, it is important to bring the conceptual framework determined by the Federal Law on Science in accordance with international standards. This would contribute to clearer formulation of state R&D policy, to improving the efficiency of state outlays on R&D and to better targeting of state interventions at R&D priorities. It will also ensure the application of a uniform approach to providing state support to R&D in the form of government funding and tax benefits. 

Chronic liver diseases are a serious problem and a common cause of suffering and death in all countries. Non-alcoholic fatty liver disease (NAFLD) is a major cause of chronic liver diseases. Alcoholic liver disease (ALD) is a disease that occurs in the case of the long-term alcohol consumption. ALD may show signs of fatty liver (steatosis), alcoholic hepatitis and cirrhosis. Increase in the prevalence of ALD is also related to the increased alcohol consumption inRussia. Viral hepatitis is a global problem leading to disability and death. About 500 million people are infected with hepatitis B or C, one million annually die from liver diseases associated with hepatitis (2.7% of all deaths). The use of essential phospholipids (EPL) as hepatotropic therapy is widespread inRussia. However, the real practice on its use had not been systematically studied. Primary objective was to characterize under conditions of real life, the profile of consecutive outpatients with newly diagnosed or known diagnosis of liver conditions with gastrointestinal symptoms and receiving a treatment with EPL as an adjunctive treatment to standard care. Materials and methods. 2450 patients were included in 98 sites. Non-interventional on therapeutic strategy study consisting of two phases: Phase 1 – a cross-sectional study to assess the profile of patients who are prescribed EPL; Phase 2 (prospective ) – the follow-up study on 20% patients participated in the Phase 1to assess compliance treatment regimen. Study results. Steatosis was the most frequent liver disease (59.7% patients). Hepatic diseases related to obesity was 23.8% patients, hepatic diseases related to diabetes – 336/2450 (13.7%). Chronic viral hepatitis observed in 21.7% cases. Taking into account that 15.8% patients suffered from combined pathology, data describing morbidity structure were the following: isolated hepatic steatosis occurred in 46.7% cases, hepatic diseases related to obesity – in 12.8% and hepatic diseases related to diabetes – at 6.4%, chronic viral hepatitis – at 18.3%. Patients most often complained about feeling of pressure in the right epigastric 74.4%, general weakness and apathy – 1497/2450 (61.1%), abdominal distension – 1438/2450 (58.7%), nausea – 51.9%. Almost a third of patients complained of irritability – 35.8%, headache and muscle pain – 35.4% and lack of appetite – 26.9%. The main non-pharmacologic management measures for liver disease were: diet therapy – 1387/2450 (97.4%), complete refusal of alcohol – 1726/2450 (70.5%), daily exercise of moderate intensity – 1495/2450 (61.0%), complete smoking cessation – 608/2450 (24.8%). Most often prescribed treatment for liver diseases were hepatoprotectors at inclusion visit – 2291/2450 (93.5%), hypotensive – 1201/2450 (49.0%), hypolipidemic – 1060/2450 (43.3%), hypoglycemic – 457/2450 (18.7%) drugs. Lipotropic products administered at 319/2450 (13.0%) cases, detoxifying – in 282/2450 (11.5%), antiviral – in 147/2450 (6.0%) and immunotropic – in 73/2450 (3.0%). 

We have performed the first-ever Budget Impact Analysis (BIA) in a Russian context of bendamustine in the first line of therapy of a multiple myeloma for patients more senior 65 years old with clinical manifestations of a polineuropathy, which autological transplantation of stem cells isn’t shown. Research was conducted from a position of the state health system of the Russian Federation. Within the BIA the analysis of economic efficiency and availability of technology was carried also out to be allowing to estimate expediency of introduction of technology in the presence of the budgetary restrictions. It was as a result shown that use of bendamustine in comparing with strategy of a bortezomib is more preferable strategy from the point of view of BIA: application of a bendamustine allows to keep considerable budget funds – to 159 153 118 rub, thus the saved means allow to treat with this strategy in addition 29 patients during 25 month. It was defined that application of strategy of a bendamustin in comparison with the bortezomib involves smaller load of the budget, thus growth of efficiency is observed for indicator “time to disease progression”.

Study objective: to perform assessment of the social and economic burden (analysis of the cost of disease) of five natural focal transmitted infectious diseases in theRussian Federationon the whole and in certain regions: ixodic tick-borne borreliosis, Siberian tick-borne typhus,Astrakhanrickettsial fever, Crimean hemorrhagic fever, andWest Nileencephalitis. Materials and methods. Direct and indirect costs caused with the studied diseases and the number of lost Disability Adjusted Life Years (DALY) are calculated in the probability model. Results. The total value of social and economic losses associated with vector-borne infectious diseases comprised 909 million rubles in prices of 2011; most of the value is represented with ixodid tick-borne borreliosis. Totally, these diseases cause the loss of 16,599 DALY.