Presentation (CTI)

OBJECTIVES: Ukraine has the lowest government spending per capita among East Europe countries. In 2023 in Ukraine government covers only 13,3% of pharmaceuticals. According to data 2020 availability to innovative drugs in Ukraine is less than 10% and original drugs share in state procurement is less than 20%, which are the lowest rates in region. In 2020 HTA process was introduced in national legislation in Ukraine. For inclusion drugs in lists for public procurement it is obligatory for company to submit dossier with an economic model. It concerns centralized procedure by MOH, National essential list for health care facilities procurement and for regional programs.
METHODS: Review of Pfizer’s products experience in HTA process in Ukraine.
RESULTS: During 2021-2024 nine Pfizer’s products passed HTA, two by short procedure. Average time of national HTA was ~ 200 days. One drug received a negative response twice: first time due to an incorrectly selected comparator, second due to high ICER and budget impact. Palbociclib at first also got negative recommendations due to lack of OS data. Ceftazidime/avibactam and apixaban - were included in the national list according to the HTA results, and apixaban was recommended for the reimbursement program in 2022, but hasn’t been included yet. Four drugs, including palbociclib, received conclusions with recommendations for the MEA. One was signed and two started. Among the problematic issues of the HTA for innovations are outdated statistics and clinical protocols, absence of patient registers in the case of orphan diseases, non-provision by the state the previous line of treatment; low ICER threshold ~ $9500 for all drugs.
CONCLUSIONS: Ukraine is on implementation stage of instruments for access to innovative therapies. Along with HTA institutionalization it is necessary to review budgets procurements, develop a single positive list, introduce patient co-payments, and implement MCDA.