OBJECTIVES : The health technology assessment (HTA) is carried out by independent expert bodies in most EU countries, the ultimate goal of which is to support evidence-based decision making. In January 2019, the HTA Department at the State Expert Center of the Ministry of Health of Ukraine (MoH) was established. The study aimed to provide review of new legislation for HTA function in Ukraine.

METHODS : Comprehensive review of the new legislation for HTA in 2020.

RESULTS : On 23 December, 2020 the Cabinet of Ministers of Ukraine has approved the Decree №1300 “On the approval of the procedure for the state health technology assessment”. The Decree defined measures needed to establish an independent body for state HTA in the form of a state commercial unitary enterprise till January 1, 2022. The Decree concerns HTA for new medicines aimed for inclusion on the regulatory lists such as National List of Essential Medicines, central procurement programs and consequently requires approval of corresponding HTA guidelines. It is stated that HTA for medical devices will be introduced from January 1, 2022. The Decree provides the procedure of primary and specialized expertise of the dossier submitted by the pharmaceutical company with the development of conclusion with recommendations including options for managed entry agreements that will last up to 110 days. Decision-making criteria for selection of new medicines by MoH are defined in the legislation: results of comparative clinical efficacy (effectiveness), safety, cost-effectiveness and budget impact analysis, quality of evidence, organizational criteria, epidemiological indicators for a particular disease in Ukraine.

CONCLUSIONS : The new Decree comprises the main developments and basis for update of HTA roadmap in Ukraine that will support the process and empower the transition of the HTA Department to the independent body with the aim of broadening patients' access to medicines and to improve allocative efficiency of spendings.