Problems of assessing economic effectiveness of antimicrobial agents: an experience of the Russian Federation

Objective. To assess the actual practice of conducting clinical and economic studies of antimicrobial medicines included in the federal drug restrictive lists in the period from 2017 to the present. Materials and Methods. As part of the study, the lists of Vital and Essential Drugs in the period from 2017 to 2021 were analyzed for the identification of newly included Class J medicines «Antimicrobial drugs for systemic use» followed by a search for available clinical and economic studies. Results. Data were obtained on 8 clinical and economic studies for 6 drugs used for systemic antimicrobial therapy. The evaluation of available methodological approaches to the assessment of the economic effectiveness of antimicrobial drugs was carried out. Sensitivity analysis was used to test the stability of the results to changes in the effectiveness of strategies over time. Information about the effectiveness was based on international, more often pre-registration randomized clinical trials and their meta-analyses, without taking into account the epidemiological situation in the Russian Federation. For chronic infections, the indicator of the degree of patients’ adherence to therapy remains not taken into account. In the vast majority of studies, only direct medical costs are taken into account. Conclusions. Evaluation of the economic effectiveness of the use of antimicrobial drugs requires, on the one hand, an expansion of the set of technical tools, taking into account the specific features of this group: the problem of bacterial resistance, epidemiological features of the spread of diseases, the importance of antibacterial therapy and prevention in the introduction of other medical technologies, on the other hand, a systematic analysis of the results of studies to assess the compliance of forecasts with the real economic effects of the introduction of medical technology.