OBJECTIVES: The legal grounds for the procurement of medicines through the use of managed entry agreement (MEA) mechanism in Ukraine have been established since 2020. This research aims to provide a review of MEA implementation based on health technology assessment (HTA) in Ukraine.

METHODS: All publically available HTA conclusions up to 31 December 2022 were analyzed towards recommendations to consider a MEA and official publications on the Ministry of Health of Ukraine (MoH) website were reviewed regarding the first concluded contracts in Ukraine.

RESULTS: One of the main prerequisites for MEA conclusion is recommendation for the MoH to consider a MEA based on the results of HTA conducted by the HTA Department of the State Expert Centre of the MoH. As of the end of 2022 among 72 publically available HTA conclusions 23 (31.9%) contain recommendations to consider a MEA. Through the MoH Orders issued in 2021-2022 MoH addressed applicants with a proposal to negotiate a MEA for 22 medicines. Despite the challenging times caused by Russia’s full-scale invasion of Ukraine the first 10 MEAs were concluded at the end of 2022. So, henceforth patients in Ukraine will get an improved access to 10 medicines for rare diseases: risdiplam, plasma-derived C1-esterase inhibitor, factor VIII inhibitor bypassing activity, alglucosidase alfa, imiglucerase, velaglucerase alfa, elosulfase alfa, galsulfase, idursulfase, laronidase. For the first time in Ukraine the medicine for children with spinal muscular atrophy (SMA), namely risdiplam, will be procured centrally. 9 of these medicines have been already procured centrally but procurement under MEA resulted in savings of 10 million dollars and 10 million Ukrainian hryvnias in 2022 based on publicly available information on MoH website.

CONCLUSIONS: Conclusion of the first MEAs based on HTA is an effective tool to improve patients' access to innovative medicines and make efficient resource allocation for public payer expenditures in Ukraine.