Background. Research on the development and implementation of new principles and methods applicable in the evaluation of medical devices (MD) will allow to accumulate new, as well as the most effective long-used and proven approaches to the clinical and economic evaluation of such an important and extensive class of medical technologies.Aims. The aim of the study is to identify and analyze developed, approved recommendations for the assessment of MD in the world and domestic practice of assessing health technologies, as well as to find and summarize the current principles, optimal proven and innovative methods for assessing MD for the draft modern recommendations for MD assessment in Moscow.Materials and methods. The sources of the study were scientific articles on the topic of MD assessment and recommendations published over the past five years.Results. A review of publications revealed disunity in the approaches to assessing MD according to international sources, as well as the lack of unified agreed recommendations in Russia. A number of problems and aspects that need to be taken into account when formulating uniform recommendations are clearly defined.Conclusion. It is obvious that there is a need to formulate and adopt clear recommendations on the assessment of medical technologies (HTA) of MD, taking into account positive international experience.

Introduction. Such medical technology like a direct antiviral drugs for treatment for chronic hepatitis C (CHC) remains inaccessible due to high absolute cost for health care systems, lack of assessment in specific region of Russian Federation and correlation with results of used antiviral therapy options. The purpose of the study is to determine most cost-effective option of drug provision with direct antiviral drugs for the treatment of chronic hepatitis C. Material and methods. Based on the population of chronic hepatitis C adult patients receiving medications at expense of Moscow budget funds, was performed a pharmacoeconomic analysis of drug therapy with direct antiviral drugs. Results.The use of new pangenotypic direct antiviral drugs for the treatment of CHC in a clinically heterogeneous population of Russian adults with 1-6 genotypes of the hepatitis C virus is economically justified. Both alternative scenarios demonstrated an advantage over the baseline scenario in the form of financial savings of 66,028,192. 45 rubles and 83,647,819.27 rubles and an increase in the number of effectively treated patients by 197 and 287 people per year, respectively. Conclusion. An increase in the share of new direct antiviral drugs in drug supply programs will increase the efficiency of the use of financial resources and increase the availability of direct antiviral drugs, which may ultimately lead to the achievement of an epidemiological effect on a population scale.

Background. Systematic research work on the assessment of medicines consumption allows timely identification of effective and problematic aspects of the existing system of preferential medicines provision, allowing to regulate the optimality of its functioning. Aims to identify regional epidemiological features and key aspects of drug provision for patients with ankylosing spondylitis (AS) in Moscow in dynamics for the period 20172020. To identify the trend of changes and their specifics in order to optimize further preferential drug provision (DLO) for patients with AS in Moscow. Materials and methods. The sources of the study were the data of LLO of patients with AS within the outpatient care, registered in Moscow in 20172020. The researchers analyzed the number of patients with AS who are entitled to free and preferential drug provision, who received drugs as an outpatient link in the period 20172020. The age structure of beneficiaries with AS and their ratio by gender has been determined. A tendency was revealed in the distribution of patients according to the main drug therapy regimens, according to the drugs they received during the reporting period. The structure of LLO of patients with AS was revealed by international non-proprietary names of drugs, their dosage form, quantities, cost minus payment by patients. Results. A retrospective analysis of real-world data showed that the population with AS in Moscow increased by 1.5 times from 2017 to 2020, as well as the cost of expenses for LLO of these patients, excluding patient payments, also increased by 1.5 times. The average age of patients was 5014 years in 2017, and in 2018, 2019, and 2020. This indicator increased to 5111 years. The ratio of patients by sex was 2:1 male and female, respectively, in all periods studied. The maximum proportion of patients fell on the age group 4059 years, which was about 50% of the entire population of patients with AS during the entire study period. The second place was occupied by the age group 6079 years, which accounted for 28.10% of all patients with AS in 2017 and by 2020 decreased by 3.38%, already amounting to 24.72% of patients, the third place in the number of patients belongs to the age group 3039 years, which accounted for about 1718% of the entire population with AS during the entire study period. The analysis of the polypharmacy indicator indicates a low drug load of most patients since a small proportion of patients from 1.54% (20 people) to 2.71% (49 people) had more than 10 items for international nonproprietary names per year. The leading position was occupied by the therapeutic scheme of monotherapy NSAIDs in 2017, since 2018 the first place belongs to the scheme of therapy with one iTNF-. Conclusions. The increase in costs for the relief of adverse reactions and the treatment of concomitant diseases indicates a shift in the approach to the treatment of diseases of the musculoskeletal system, as pathologies accompanied by a wide variety of comorbid and polymorbid conditions. Despite the positive changes in the regional system of LLO of Moscow, it is possible to improve the indicators of the provision of patients with AS when evaluating its effectiveness, taking into account clinical indicators and the results of the assessment of the quality of life reported by patients.

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