Implementation of health technology assessment at the stage of market access for pharmaceuticals in Ukraine

Abstract

Market access for pharmaceuticals is a set of strategies, activities and processes developed by pharmaceutical companies to provide affordable medicines at appropriate fair prices in a particular health care system. Access to the pharmaceutical market covers main areas of stages, including the health technology assessment (HTA).
 The aim of the work was to analyze the stages of market access for pharmaceuticals in particular the implementation of HTA based on regulatory review, tasks and activities of the HTA Department of the State Expert Center of the Ministry of Health and the Expert Committee for Selection and Use of Essential Medicines and directions of HTA use in the health care system in Ukraine.
 Materials: legislation governing the conduction of HTA in Ukraine, international publications on the subject of the study. Research methods: system and content analysis, data synthesis and generalization of information, extrapolation, retrospective analysis.
 We have generalized the legislation for the introduction of HTA in Ukraine, the stages of institutionalization of the direction, the HTA roadmap, current state of financing of medicines using several regulatory lists from the perspective of state payer, including: National list of essential medicines, nomenclature of central procurement, insulin reimbursement. The mechanisms of selection of new medicines and evaluation with the use of HTA methods for inclusion on the regulatory lists, is in particular only for the National list, by criteria are presented: morbidity, disease prevalence and mortality; evidence of comparative efficacy (effectiveness), safety and cost-effectiveness; demand; the results of the budget impact analysis; pharmacokinetic properties of drugs; WHO recommendations on the use of essential medicines. In order to inform decisions on the rational allocation and use of financial resources in the health care system in January 2019, the HTA Department in Ukraine was established at SE "State Expert Center of the Ministry of Health of Ukraine" to conduct HTA and examination of applications for inclusion of medicines on National list.
 It is substantiated that the institutionalization of the direction with the establishment of the HTA Department is an important step in ensuring the ecosystem of decision-making based on HTA in the Ukrainian health care system. The developed methodological support, in particular the first HTA guidelines, the model of multicriteria decision analysis, experience in assessment of applications for inclusion of medicines on the National list indicate the feasibility of further expanding the use of HTA for other regulatory lists, including the list of central procurement programs and development of single positive list of medicines for public funding in Ukraine.