Теоретико-прикладне обґрунтування соціально-економічної системи ціноутворення на лікарські засоби на засадах оцінки технологій охорони здоровʼя

Abstract

Дисертаційна робота присвячена розробці та обґрунтуванню теоретичних, методичних, науково-прикладних засад удосконалення системи ціноутворення на ЛЗ на основі ОТОЗ, що сприятиме підвищенню доступності та раціональному застосуванню ліків для населення України. Соціально-економічна значущість результатів дисертаційного дослідження полягає у тому, що запропоновані рекомендації, науково-методичні розробки, зокрема науково-методичні рекомендації, ухвалені ПК «Фармація» МОЗ та НАМН України, узгоджені МОЗ України, а також програмно-методичні матеріали упроваджені у практичну діяльність державних органів на національному та регіональному рівнях, у роботу закладів охорони здоровʼя та освітній процес фармацевтичних та медичних ЗВО

Диссертационная работа посвящена разработке и обоснованию теоретических, методических, научно-прикладных основ совершенствования системы ценообразования на ЛС на основе оценки технологий здравоохранения (НТA), что будет способствовать повышению доступности и рациональному применению лекарств для населения Украины. Социально-экономическая значимость результатов диссертационного исследования заключается в том, что предложенные рекомендации, научно-методические разработки, в частности научно-методические рекомендации, утвержденные ПК «Фармация» МЗ и НАМН Украины, согласованные в МОЗ Украины, а также программно-методические материалы внедрены в практическую деятельность государственных органов на национальном и региональном уровнях, в работу учреждений здравоохранения и учебный процесс фармацевтических и медицинских вузов.

The dissertation is devoted to the development and substantiation of theoretical, methodological, scientific and applied principles of improving the medicine pricing system on the basis of Health Technology Assessment (НTA), this will increase the availability and rational use of medicines for the population of Ukraine. Analysis and systematization of Ukrainian and European regulatory framework, WHO guidelines to ensure availability of medicines, including pricing, reimbursement, HTA and public procurement was carried out. Priority areas for improving state price regulation are identified: reference pricing, regulation of surcharges; tax benefits / discounts; application of the "cost plus" method, monitoring and registration of prices, impact on generic consumption, tenders and negotiations, joint procurement, value-based pricing and HTA. An analysis of the effectiveness of the current system of state regulation of drug prices in Ukraine is carried out. The main factors limiting the availability of drugs in Ukraine are identified: lack of compulsory health insurance and reimbursement, inadequate level of public funding for health care, non-transparency of pricing processes, low solvency of the population, irrational selection, prescription and use of drugs. Proven lack of effectiveness of the current system of state regulation of prices, due to the imperfection of the regulatory framework, frequent unjustified changes, lack of common methodological approaches to pricing and control of health care costs. Modern approaches to the formation of a system of socially effective drug prices were investigated, the methodological bases of application of reference pricing in different countries were generalized. The scientific and methodical recommendations on formation of model of reference pricing with use of the international experience are offered. Scientific and methodological approaches were developed to improve the provision of pharmaceutical care to patients in the implementation of pilot projects and government programs for reference pricing and reimbursement. The priority directions of implementation of pilot projects on state regulation of prices and reference pricing of drugs by the most common nosologies (cardiovascular diseases, diabetes mellitus, influenza and influenza-like diseases, etc.) are substantiated. Based on the results of a survey of medical and pharmaceutical workers, an assessment of the effectiveness and main problems of the Government reimbursement program "Available Medicines" was conducted. External monitoring of insulin prices revealed significant price overruns in Ukraine compared to Hungary, Romania, Moldova, Poland, Slovakia, Greece and other countries, which indicates the need to improve the current model of reference pricing and reimbursement of insulin therapy. A generalized model of reference pricing for insulin drugs was developed, which provides a justification for the choice of reference countries, criteria for dividing insulin drugs into groups, and an algorithm for calculating reference prices was proposed. The business process of forming the register of reimbursement prices and the standard operating procedure of pricing for insulin drugs were offered. Methods of calculating the cost of production in domestic and foreign practice were generalized and systematized. Scientific and methodological approaches to the formation of the cost of drugs of industrial and pharmaceutical production were substantiated. Approaches to the formation of prices for innovative drugs in the world and in Ukraine were studied. Theoretical and methodological provisions of the organization of HTA were developed, on the basis of which for the first time recommendations for the creation of an industry standard for HTA were developed, its structure and content were substantiated, in particular the main components of drug pricing and reimbursement. Conceptual bases on mechanisms of maintenance of realization of the program of introduction of HTA are offered. Materials of the conducted researches in the part of substantiation of theoretical and methodological bases of carrying out of an estimation of health care technologies used at preparation of the draft Resolution of the Cabinet of Ministers of Ukraine. Methodical approaches to price and pharmacoeconomic evaluation of new and existing technologies in pharmacotherapy of socially dangerous diseases are substantiated. The analysis of drug availability for CVD treatment using HTA methodology (clinical and economic analysis, ABC-VEN analysis, frequency analysis of prescriptions), as well as calculations and analysis of drug price indices, availability, liquidity and solvency adequacy. Theoretical and applied approaches to the development of a pricing model for essential medicines in the context of the implementation of НТА are substantiated. Firstly the international experience of training specialists in НТА in the historical aspect is analyzed and systematized. According to the results of the survey of health professionals, the state, problems and prospects of НTA implementation have been studied. The necessity of НTA introduction, capacity building and formation of professional environment is proved. The information needs and directions of development of professional training of specialists in this direction are revealed. The qualification characteristic of the expert on НТА is developed. The main competencies of a specialist, the structure and content of the educational program are substantiated. Results of scientific research are the basis of 7 guidelines, agreed in the MoH of Ukraine, 1 information letter, introduced into the work of state bodies, pharmacies, as well as in the educational process of pharmaceutical and medical institutions.