Правила формирования перечней лекарственных препаратов для медицинского применения на федеральном уровне: текущее состояние и перспективы развития

Abstract

The paper discusses the issues of normative and legal regulation for creation of drug lists (List of Vital and Essential Medicines, List of Medical Drugs for Certain Categories of Citizens, List of High-Cost Medical Drugs (Seven Nosologies list). It also considers historical aspects, current state and planned changes of these rules. The stages of expertise, evaluation criteria, and rules of decision making in the process of inclusion of medical drugs (MD) into the lists according to the RF Government Decree no. 871 on 28 August 2014 and the project on the amendment of this decree are thoroughly considered. The proposed changes address the terms of submission of proposals for the inclusion and exclusion of MDs into the lists, and the terms of expert procedures. Changes in expert procedures (complex evaluation) of MD are proposed; a new stage (analysis of methodological quality of pharmacoeconomic studies and budget impact analysis) is introduced. Integral scales of clinical and pharmacoeconomic evaluation of MD are substituted with complex evaluation scales. The requirements for ethodological quality of pharmacoeconomic studies and budget impact analysis are created. A further stage of the development of the rules for creating the lists can be the performance of complex evaluation within a single expert body with the participation of expert organizations and leading specialists.