Objectives. To evaluate the cost-effectiveness of dapagliflozin in combination with metformin in the treatment T2DM in comparison with glimepiride and sitagliptin also combined with metformin. Methods. Cost-utility analysis, discounting and economic feasibility assessment were performed. The results are expressed in QALY and ICUR. Pharmacoeconomic analysis showed that the application of the strategy of treatment: metformin + dapagliflozin vs metformin + sitagliptin provided 9.83 and 9.82 QALYs respectively, and the ICUR — 341.413 rubles; metformin + dapagliflozin vs metformin + glimepiride provided 9.82 and 9.47 QALY respectively, and the ICUR — 145.213 rubles. The use of combination therapy metformin + dapagliflozin is economically acceptable treatment strategy compared with combination therapy with metformin + sitagliptin and metformin + glimepiride, as ICUR indicators for dapagliflozin + metformin therapy did not exceed the cost-effectiveness threshold — «willingness to pay ratio» for Russia in any of the compared treatment strategies. Conclusion. Combination therapy metformin + dapagliflozin for treating T2DM provide good value for money for Russian state reimbursement system.

A pharmacoepidemiology study was performed of the use of botulinum toxin type A drugs (BTA) in the combined therapy of post-stroke spasticity in Russian Federation. Experts survey was the major method used and followed by application of the Delphi method. Questionnaire consisted of 30 questions. 12 completed questionnaires from 12 cities of Russia were analyzed as a result. Practicing neurologist participated in the survey who had experience of BTA use in combined treatment of post-stroke spasticity. Several indicators were identifi ed that represent signifi cant interest for their subsequent use, in particular, during the pharmacoeconomic studies, scientifi c analysis of outcomes with Markov modelling use, development of mathematical models.

The absolute majority of clinical trials of generic drugs aimed to compare the therapeutic efficacy of the tested drug and the drug of an active control. It is necessary to estimate that the test drug is not less effective (or non-inferior) than the control drug. The designs of the aforementioned trials are called “non-inferiority” study; often, these are phase III of clinical trials. The primary criterions of effectiveness which are quite often used in the clinical trials are frequencies of signs, as a result of the analysis of binary data. Binary data are analyzed by comparing proportions. One of the most important conditions for a correct interpretation of the data obtained during the clinical trials — to provide necessary and suffi cient sample size. The purpose of this article is to show how to plan the study, how to provide necessary and sufficient sample size to ensure that the results and conclusions would be reliable; how to interpret the data in a comparative controlled study aimed to establish “non­inferiority” using proportions comparing in parallel groups.

Difficult economic situation in the country requires the government decision urgently measures aimed at improving the efficient use of available financial and material resources, including through the development of domestic production of medicines and increasing the share of the cost of their acquisition in the implementation of government programs. The study of purchases of medicines by health care organizations in Moscow Region over the past 3 years (2012 – 9 mon

Review article presents the features of the state of the Russian pharmaceutical industry at the present stage, the main problems and difficulties of the transition of Russian pharmaceutical manufacturers to the standards of GMP, the state program of development of the industry.