OBJECTIVES: The article №79¹ “Managed Entry Agreements (MEAs)” has been implemented to the Law of Ukraine № 2801-XII “On Principles of Ukrainian Health Care Legislation” since 17 March 2020. On 23 December 2020 the Cabinet of Ministers of Ukraine (CMU) approved the first Decree №1300 “On the approval of the procedure for the state health technology assessment (HTA)”. On 27 January 2021 CMU Decree №61 confirmed the negotiation procedure for MEAs, procedure for concluding, executing, amending and terminating MEAs, standard MEA form. This research aims to provide a review of MEA implementation based on HTA in Ukraine.

METHODS: All legislative acts concerning MEAs and HTA were identified and analyzed. We have also reviewed all published HTA conclusions to determine the number of recommendations to consider a MEA.

RESULTS: The perspective of providing HTA recommendations for MEA procedures is enshrined in all three legislative acts: the Law of Ukraine №2801-XII, CMU Decree №1300, CMU Decree №61. The simplified scheme of the process is the following: HTA conclusion prepared by an authorized body (the HTA Department of the State Expert Centre of the Ministry of Health (MoH) of Ukraine) – negotiation – agreement – monitoring – prolongation. As of mid-2022 the authorized body has published 21 HTA conclusions, 11 of which contain recommendations to consider the possibility of negotiating a MEA. Through the Order of the MoH №2882 of 12 November 2021 MoH has already addressed applicants with a proposal to negotiate a MEA for 5 medicines for oncology and rare diseases: brentuximab vedotin, pembrolizumab, venetoclax, cabozantinib, risdiplam.

CONCLUSIONS: The recently approved legislative acts for HTA and MEA in Ukraine are aimed at improving patients' access to innovative medicines at the expense of the state budget that meets best international practice and showed prospective implementation of use of these tools in practice.