OBJECTIVES: To provide a structured overview of the company submissions - dossiers for state HTA and conclusions made by HTA Department of State Expert Center (SEC) of MOH of Ukraine to define impact for the healthcare system.

METHODS: We performed descriptive analysis to identify distribution of dossiers and published HTA conclusions by nosologies, diseases and targeted lists with the help of pivot tables.

RESULTS: The approval of the Decree of Cabinet of Ministers of Ukraine (CMU) №1300 on the approval of state HTA dated 23 December, 2020 and HTA guideline for medicines in Ukraine provided the procedure for pharmaceutical companies that allowed to submit dossiers to the SEC with the aim of potential inclusion on the National list of essential medicines (NEML) and/or the nomenclature. As of December 2021, 27 dossiers were submitted to the HTA Department of SEC and 14 conclusions with recommendations for MOH were developed in 2021. The majority of accepted dossiers concerned treatment of oncologic diseases (59,3%) followed by respiratory diseases (11,1%) and cardiovascular diseases (7,4%). Other nosologies include diabetes mellitus, mental illness, hepatitis, orphan, infectious and hormonal diseases. Most of the dossiers aimed for inclusion of medicines to the nomenclature (59,3%), followed by either of the lists (22,2%) and only NLEM (18,5%). 3 medicines were recommended for listing on the NEML or nomenclature (empagliflozin, tiotropium bromide, triptorelin) and 8 medicines were recommended for MEA, others - not recommended. 5 medicines are currently under the negotiation process by the MOH for a possible MEA agreement.

CONCLUSIONS: As a result of the work done in the context of state HTA by full procedure, the total of 14 conclusions with recommendations were developed, 8 medicines were recommended for MEA and 2 medicines (empagliflozin, tiotropium bromide) were listed in the NEML due to CMU Decree №1431 dated 31 December, 2021.