OBJECTIVES: To characterize HTA implementation in decision-making process of selecting essential medicines in Ukraine.

METHODS: Analysis of legislative acts, normative documents, reports of Expert Committee on the Selection and Use of Essential Medicines (EC) with recommendations to Ministry of Health of Ukraine (MOH).

RESULTS: Implementation of HTA in Ukraine can be dated to 2016 when EC was formed by MOH. The key function of EC was to make evidence-based recommendations for medicines to be included in National list of essential medicines (NLEM) based on the requirements of “Provision on NLEM” (approved in 2016). In 2018 EC developed first Guideline on HTA that outlined recommendations for HTA submissions. Starting from its establishing, EC received 123 submissions for assessment and made the following decisions: 1 INN was recommended for reimbursement, 21 – for conditional reimbursement, 45 – not recommended, 21 – not recommended, but new submission is possible, 35 – rejected due to unsatisfied quality of submission. Assessment of submissions revealed fundamental challenges in Ukrainian healthcare system, such as need for HTA trainings of stakeholders, official registers of certain diseases, implementation of MEA, and HTA institutionalization.

In order to implement HTA roadmap in Ukraine in 2019 MOH established HTA Department at State Expert Center to provide HTA expertise for medicines. In January 2020 MOH released project “Provision on NLEM and Provision of Expert Committee in HTA” stating that Expert Committee will provide appraisal procedure of submissions expertized by HTA Department. In December 2020 Cabinet of Ministers adopted Decree “On the approval of state health technology assessment procedure”. In March 2021 MOH approved HTA Guideline “The state health technology assessment for medicines”.

CONCLUSIONS: There is comprehensive approach in the development of strong HTA function in the decision-making process in healthcare system in Ukraine based on the important experience since 2016 and stakeholders engagement.