The growth of public expenditure worldwide has set the priority on assessment of trends and establishment of factors which generate the most significant public costs. The goal of the current study is to review the tendencies in public healthcare expenditures in Bulgaria and to analyze the influence of the demographic, economic, and healthcare system capacity indicators on expenditures dynamics. A retrospective, top-down, financial analysis of the healthcare system expenditures was performed. Datasets of the National Statistical Institute (NSI), National Health Insurance Fund (NHIF), and National Center of Public Health and Analysis (NCPHA) were retrospectively reviewed from2014–2019 to collect the information in absolute units of healthcare expenditures, healthcare system performance, demographics, and economic indicators. The research showed that increasing GDP led to higher healthcare costs, and it was the main factor affecting the cost growth in Bulgaria. The number of hospitalized patients and citizens in retirement age remained constant, confirming that their impact on healthcare costs was negligible. In conclusion, the population aging, average life expectancy, patient morbidity, and hospitalization rate altogether impacted healthcare costs mainly due to the multimorbidity of older people and the rising need for outpatient hospital services and medications.

The aim of this study is to evaluate the effect of the introduction of biosimilars in Bulgaria on the prices and utilization of biologic disease modifying antirheumatic drugs (bDMARD). It is a combined qualitative and quantitative analysis of time of entry of biosimilars on the national market and the respective changes in the prices and utilization during 2015–2020. We found 58 biosimilars for 16 reference products authorized for sale on the European market by the end of 2019, but for 2 of the reference products biosimilars were not found on the national market. Only inflammatory joint disease had more than one biosimilar molecule indicated for therapy. Prices of the observed bDMARD decreased by 17% down to 48%. We noted significant price decreases upon biosimilar entrance onto the market. In total, the reimbursed expenditures for the whole therapeutic group steadily increased from 72 to 99 million BGN. Utilization changed from to 0.5868 to 2.7215 defined daily dose (DDD)/1000inh/day. Our study shows that the entrance of biosimilars in the country is relatively slow because only half of the biosimilars authorized in Europe are reimbursed nationally. Introduction of biosimilars decreases the prices and changes the utilization significantly but other factors might also contribute to this.

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), and positive drug lists for reimbursed medicines are among the variety of implemented cost-containment measures aimed at reducing and controlling the rising cost for pharmaceuticals. The aim of our study was to analyze the influence of a recently introduced measure in Bulgaria—budget capping in terms of overall budget expenditure. A secondary goal was to analyze current and extrapolate future trends in the healthcare and pharmaceutical budget based on data from 2016 to 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 the new 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 were extrapolated for the next 3 years. The Kruskal–Wallis test was applied to establish statistically significant differences between the groups. During 2016–2021, healthcare services and pharmaceutical spending increased permanently, observing a growth of 82 and 80%, respectively. The overall healthcare budget increased from European €1.8 billion to 3.3 billion. The subgroup analysis showed a similar trend for all three groups, with 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 European €1.8 billion to 3.3 billion) 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 European €34 billion to 59 billion during 2019–2021) reveals that the market environmental risk factors are not well foreseen and practically implemented.

Aim:Real-world data and real-world evidence (RWE) are becoming more important for healthcare decision making and health technology assessment. We aimed to propose solutions to overcome barriers preventing Central and Eastern European (CEE) countries from using RWE generated in Western Europe.Materials & methods:To achieve this, following a scoping review and a webinar, the most important barriers were selected through a survey. A workshop was held with CEE experts to discuss proposed solutions.Results:Based on survey results, we selected the nine most important barriers. Multiple solutions were proposed, for example, the need for a European consensus, and building trust in using RWE.Conclusion:Through collaboration with regional stakeholders, we proposed a list of solutions to overcome barriers on transferring RWE from Western Europe to CEE countries.

Health care systems worldwide are experiencing tremendous financial pressure because of the introduction of new targeted health technologies and medicines. This study aims to analyze and compare public and household healthcare expenditures in Bulgaria during the period 2015–2019, as well as present the major cost-containment measures implied by the government and their probable influence on the overall health care cost. Regulatory analysis of the endorsed cost-containment measures, budget analysis of public and household health care expenditures, and their extrapolations were performed. The regulatory analysis reveals that a large number of measures are introduced and valid until January 2021, considering pharmaceuticals, medical devices, and negotiations between the National Health Insurance Fund (NHIF) and Marketing authorization holders (MAHs). NHIF costs due to pharmaceuticals, food supplements, and medical devices are rising from 2015 to 2019. The overall health expenditures average per household and the average per person also grow in this period. The cost extrapolation reveals that an increase in 3-year periods is expected. Despite the implementation of variety of cost-containment measures in Bulgaria, such as HTA, ERP, discounts, and annual negotiations, The National Health Insurance Fund's (NHIF) spending on pharmaceuticals continues to rise in recent years, and further increases are expected in the next 3 years. The average expenditure per household and per person also increased, which confirms the global trend of rising medicine and outpatient services value.

Background: Type 2 diabetes is a chronic disease with high global prevalence and significant social and economic burden. The pandemic affected patients’ diagnostics and medicines dispensing. Diabetes was among the most-affected conditions during lockdown due to the limited resources and unaffordable medicines. The impact of the pandemic on utilisation and cost has not been thoroughly studied, which inspired us to conduct the current study. Objectives: The study explored cost dynamics, changes in antidiabetic medicines utilisation, and public expenditure of pharmacotherapy in three periods: pre-pandemic (2018–2019), during the pandemic (2020–2021), and post-pandemic (2022–2023). Methods: It is a retrospective, observational, macroeconomic analysis. Reimbursed cost and utilisation were analysed as a crude sum and as indexes of the average value. Results: The result shows that five new INNs have been included in the Positive Medicines List (PML), two of these being fixed dose combinations (FDCs). During the pandemic, a slow tendency of increase of the crude sum of public expenditure was observed, followed by a sharp increase in the post-pandemic period. The public spending increased more than twice, and we found a 30,018,982 Euro growth. The highest public spending is found for dapagliflozine in post-pandemic vs. pandemic period (index = 1.67), as well as empagliflozin/metformin and dapagliflozine in pandemic vs. pre-pandemic period (index = 0.21). Total utilisation increases from 58.16 to 71.78 DDD/1000 inh/day during 2018–2023. The most significant rise of utilisation is found for canagliflozin (index = 0.68) pandemic vs. pre-pandemic and dapagliflozin (index = 3.66) post-pandemic vs. pandemic. Conclusions: Analysis of the antidiabetic medicines market reveals the rising of reimbursed cost and utilisation in pre-, post-, and during the pandemic. In conclusion, organisation of the supply and financing of antidiabetic medicines was not affected during the pandemic.