Scientific methodology and practical use of managed entry agreements for innovative medicines in system of health technology assessment in Ukraine

In the Health Technology Assessment (HTA) system, it is advisable to use a mini-HTA to save budget funds at the hospital level, taking into account real world data on drug consumption for a rational use of resources at the local level. HTA include Managed Entry Agreements (MEA), which is being actively implemented in Europe to ensure the availability of innovative medicines for the treatment of oncological, hematological, rare diseases, assisted reproductive technologies (ART), and government funding programs. The aim of this study was to analyze the use of the mini-HTA approach for the evaluation of innovative drugs, in particular with ART. Theoretically and practically substantiate the «Managed Entry Agreement» methodology for innovative drugs for rapid availability to new medicines based on evidence-based medicine and pharmacoeconomics for implementation at the state (local) level and rational use of budget funds. Research methods – systematic analysis of data of reports, publications about the mini-HTA and the «Managed Entry Agreement» in the leading countries of Europe. The main objects were articles, reviews of pharmacoeconomists of ISPOR, LSE, which are leading in the HTA field in the world. The statistical data on innovative drugs, included in the legislatively regulated by the MEA in the EU, Central and Eastern Europe countries, using the methods of generalization, systematic analysis were studied. We summarized the HTA data include in mini-HTA reports in EU countries, which were legally regulated and included innovative drugs for the treatment of cancer, hematological and rare diseases. We established that using 6 main MEA methods, regulated by law in the EU countries. There is necessary to create a recommendation on mini-HTA and MEA to improve the regulatory framework and activities of the HTA Department of State Expert Centre, MoH of Ukraine in order to implementation of the State strategy for implementing the State policy of providing the population with medicines for the period up to 2025. We formulated the term «mini-HTA» as a systematic process of evaluating indicators of effectiveness, safety, quality of life, social and ethical aspects in relation to the costs for innovative drugs to save budget resources at the local level. There is advisable to use the MEA methods to estimate the cost for treatment regimens, including drugs for ART, which will ensure the rational use of funds for state programs, in particular, for the treatment of infertility, and public health resources.