OBJECTIVES : Access to innovative medicines is limited in low-income countries. We analysed the list of innovative medicines which have been registered in the Ukrainian market during the last 5 years and have been added to the main drug markers purchased for budget funds and medical assistance standards. We studied the market access to innovative medicines and identified opportunities for improving them.

METHODS : We used the official data of MoH on drug registrations, statistical observation method.

RESULTS : We established the list of 8 innovative medicines (emitsizumab, adalimumab, trastuzumab, apixaban, pablociclib, pemrolizumab, emiglucerase, tammiglucerase alfa), which have been registered in the Ukrainian market for 2014-2018 and included in national medical protocols. There are two lists which regulate the possibility of procurement medicines for budget funds the National Essential Medicines List (NEML) and the list of medicines which included into National State Programs.The NEML was approved in 2017 and included 427 INNs, mainly for basic therapy, based on the WHO 19-th list. According to the current legislation, drugs that are not included in the NEML can’t be purchased for budget funds and their access to the market is limited. Of the drugs that were selected for statistical analysis, only one recommended by the Expert Committee prior to inclusion in NEML was emicizumab. We analysed of 39 National Programs and all of the innovative drugs which were included. Statistical analysis showed that only 4 Inns - adalimumab, trastuzumab, emiglucerase, and tamiglucerase alpha were included in these National Programs. Managed Entry Agreements -MEA used for faster access to innovative medicines in EU countries.

CONCLUSIONS : Access to innovative medicines is significantly limited in Ukraine. It is need to implement the MEA methods for the rational use of bugdet funds based on HTA data for procurement and pricing for National state programs.