OBJECTIVES: To analyze the correlation between new medicines inclusion in Positive Drug List (PDL), reference price per DDD (defined daily dose) and reimbursed cost for antihyperlipidemic medicines in Bulgaria.

METHODS: A retrospective and observational analysis of 10 International Nonproprietary Names (INNs), belonging to ATCC10AA, C10AB, and C10AX. The study evaluates changes in reference price (the lowest one within the same INN-International nonproprietary name), and number of medicinal products included in PDL during 2017-2019. The reimbursed costs are compared. Data was collected from the National Health Insurance Fund (NHIF) and NCPRMP (National council on pricing and reimbursement of medicinal products) official registers.

RESULTS: One new INN (ezetimibe) and high number generics, belonging to INN rosuvastatin are included in PDL. As a result reference price per DDD of rosuvastatin declines (from 0.19133 in 2017 to 0.15733 in 2019). On total number of generics within a group decrease (103 in 2017 to 94 in 2019). Generally, reference price per DDD remain unchanged or slightly decrease. NHIF spending on fenofibrate, evolocumab and ezetimibe increase. Despite decreasing spending on most products and decline in reference price per DDD, total NHIF expenditure rise (from 3328823 in 2017 to 4090236 BGN in 2019)

CONCLUSIONS: Generic competition favours medicines prices and leads to a reduction in the reference price per DDD. The final costs of NHIF are affected not only by the differences in the reference price per DDD. The increasing utilization of newer and expensive medicines also impact the overall expenditure and market share of the products.