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How will the changes adopted in the latest edition of RF Government Resolution № 871 affect the procedure for including drugs in the lists of vital and essential drugs and high-cost nosologies drug lists: the view of a practicing researcher
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.
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Bibliography link:
Yagudina R.I., Kulikov A.Yu., Serpik V.G. How will the changes adopted in the latest edition of RF Government Resolution № 871 affect the procedure for including drugs in the lists of vital and essential drugs and high-cost nosologies drug lists: the view of a practicing researcher // Pharmacoeconomics: theory and practice. - 2025. - Vol.13, №2. P. 25-35 DOI: https://doi.org/10.30809/phe.3.2025.3







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