OBJECTIVES: The study explores and analyzes the impact of market protection expiration and generics entrance on public expenditures and medicines prices in the Bulgarian healthcare sector.

METHODS: The study is retrospective, observational analysis of differences in public expenditure and prices of originators before and after generics entry on the Bulgarian market. The generic prices are also compared. The official database of National Council of prices and reimbursement was reviewed and price differences were compared during the year: from January 2022 to February 2023. The price changes are presented in %.

RESULTS: A total of 6 INNs with the first generics approved (abiraterone, pazopanib, dasatinib, sitagliptin/metformin, cabazitaxel, sitagliptin) are found in the Positive Drug List. Within a year, the prices of the originators and generics decreased significantly after the first generic approval. The abiraterone price decreasing is 69 %, while the pazopanib is 29 %, found as the lowest during the period. Reference prices per DDD also decreased, which is the main prerequisite for declining public expenditure. The introduction of new cheaper alternatives leads to a significant decrease in the costs of the payer National Health Insurance Fund (NHIF). The average decreasing rate considering INNs is about 55 %. The findings reveal that public expenditure decreasing is significant for abiraterone 75.16% for a year, followed by dasatinib 53.28%, sitagliptin/ metformin 53.12%, and Pazopanib 40%.

CONCLUSIONS: The study confirms the correlation between price decreasing due to first and subsequent generics entrance and public expenditure. А substantial reduction in public spending was found, which highlighted the generics important role in public expenditure and potential for cost saving. Assessment in the long-term is necessary in order to find real market impact and the overall consequences on public spending.