Pharmacoeconomics: theory and practice
№3, 2025, Vol.13

In this article, the authors analyse the amendments adopted in 2024 to Russian Federation Government Resolution № 871 of August 28, 2014 (as amended on July 25, 2024) “On Approval of the Rules for Forming Lists of Medicinal Products for Medical Use and the Minimum Range of Medicinal Products Required to Provide Medical Care” that affect the pharmacoeconomic assessment of drugs when they are included in the lists. We highlight three important innovations: formalization and increased role of the assessment of the methodological quality of pharmacoeconomic studies by the Center for Expertise and Quality Control of Medical Care of the Ministry of Health of Russia; the introduction of a willingness-to-pay threshold parameter when interpreting the results of an incremental cost-effectiveness analysis (clinical-economic analysis); and the emergence of powers for the commission established by the Ministry of Health of the Russian Federation for the formation of lists of drugs and the minimum range of medicinal products to request data on consumption (number of patients) of the drugs in question from the executive authorities in the field of healthcare of the constituent entities of the Russian Federation. A detailed analysis of key changes revealed that the innovation regarding the analysis of the methodological quality of pharmacoeconomic studies is an unnecessary barrier, not always feasible, is not used in international practice as a scoring system, and requires clarification, as it carries the risk of loss of access to drugs for patients due to refusal to include them in the list based on the low methodological quality of the pharmacoeconomic assessment. The Commission’s mandated right to request epidemiological and pharmacoepidemiological data from constituent entities of the Russian Federation could become a powerful auxiliary tool for conducting relevant pharmacoeconomic assessments; however, this requires the data collected by the Commission to be publicly available to researchers, among other things. The introduction of a willingness-to-pay threshold equivalent for incremental cost-effectiveness analysis is a step closer to international approaches in the domestic pharmacoeconomic analysis methodology and will facilitate more balanced pharmacoeconomic conclusions.

The purpose of the study was to analyze and design an automated system for planning the provision of medical property to geographically distributed medical and pharmaceutical organizations in order to optimize resource management at various levels of departmental healthcare. The study used system, structural-functional and problem analysis, sociological research methods (content analysis, expert survey, observation), comparison and description methods, logical research method, structural analysis and design methods, modeling methods, object-oriented programming methods and other research methods. When developing software, functional and object-oriented approaches were used: SADT and UML. The high-level programming language Python was used as a development tool. Data storage on the server part is implemented using the PostgreSQL database management system. The article presents the results of the analysis of the subject area of planning the provision of medical property. In addition, the main requirements for the automated system for planning the provision of medical property are substantiated and developed. In particular, a description is provided of: the intended purpose of the software product; the main stakeholders; the functional and operational purpose; the expected levels of use; the main users of the program; reliability and safety requirements; scalability requirements; operating conditions. At the analysis and design stage, taking into account the results of the sociological study, a functional model of the automated system for planning the provision of medical property according to the IDEF0 standard was substantiated and developed. As part of the use of an object-oriented approach to analysis and design for modeling the dynamic structure of the automated system according to the UML standard, an activity diagram and a sequence diagram were selected. Based on the analysis of the initial data and requirements for the automated system for planning the provision of medical property, the architecture of the PostgreSQL database was developed. The study also substantiated the main areas of implementation and deployment of the automated system for planning the provision of medical property. Based on the results of the study, further refinement and expansion of the functionality in accordance with the stated requirements is expected, as well as the organization of a number of events to scale and implement the automated system for planning the provision of medical property in the practical activities of departmental healthcare.

The study substantiates a methodological approach to integrating administrative databases for comprehensive analysis of factors determining costs in the Preferential Drug Provision System for children with type 1 diabetes mellitus during the period from 2022 to 2024. The research analyzed data from 22.8 thousand prescriptions for drugs and medical devices for a total of 163.7 million rubles. It was found that the greatest impact on costs is exerted by the use of modern medical technologies: application of continuous glucose monitoring systems (+402.0%) and insulin pump therapy (+131.0%). The smallest (+25.2%) but stable influence on costs was demonstrated in the presence of complications. The developed multivariate regression model explains 59.1% of cost variability, confirming the necessity of considering patients’ clinical characteristics and applied medical technologies when planning healthcare system resources.