AUTHOR=Mitkova Zornitsa , Dimitrova Maria , Doneva Miglena , Tachkov Konstantin , Kamusheva Maria , Marinov Lyubomir , Gerasimov Nikolay , Tcharaktchiev Dimitar , Petrova Guenka TITLE=Budget cap and pay-back model to control spending on medicines: A case study of Bulgaria JOURNAL=Frontiers in Public Health VOLUME=Volume 10 - 2022 YEAR=2022 URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.1011928 DOI=10.3389/fpubh.2022.1011928 ISSN=2296-2565 ABSTRACT=Central and Eastern European countries (CEEC) have among the highest rates of increase in healthcare expenditure. External reference pricing, generics and biologics price capping, regressive scale for price setting, health technology assessment (HTA), Positive Drug Lists for reimbursed of medicines are among the variety of implemented cost-containment measures aimed at reducing controlling the rising cost for pharmaceuticals. The aim of our study is to analyse the influence of a recently introduced measure in Bulgaria - budget capping in terms of overall budget expenditure. A secondary goal was to analyse current and extrapolate future trends in the healthcare and pharmaceuticals budget based on data from 2016-2021. The study is a retrospective, observational and prognostic, macroeconomic analysis of the National Health Insurance Fund’s (NHIF) budget before (2016-2018) and after (2019-2021) the introduction of thenew budget cap model. Subgroups analysis for each of the three new budget groups of medicines (group A: medicines for outpatient treatment, prescribed after approval by a committee of 3 specialists; group B: all other medicines out of group A; and group C: oncology and life-saving medicines out of group A) was also performed, and the data was extrapolated for the next three years. The Kruskal-Wallis’s test was applied to establish statistically significant differences between the groups. During 2016-2021, the healthcare services and pharmaceuticals spending increased permanently, observing a growth of 82% and 80%, respectively. The overall healthcare budget increased from 1.8 bln to 3.3 bln Euro. The subgroup analysis showed a similar trend for all three groups, with a similar growth between them. The highest spending was observed in group C, which outpaced the others mainly due to the particular antineoplastic (chemotherapy) medicines included in it. The rising overall healthcare cost in Bulgaria (from 1.8 bln to 3.3 bln Euro) reveals that implementation of a mechanism for budget predictability and sustainability is needed. The introduced budget cap is a relatively effective measure but the high level of overspending and pay back amount (from 34 to 59 bln Euro during 2019 - 2021) reveals that the market environmental risk factors are not well foreseen and practically implemented.