OBJECTIVES: To analyse the influence of budget cap with pay back managed entry agreement (MEA) as cost-containment measure in Bulgaria on public spending for rheumatology medicines.

METHODS: Retrospective, observational, macroeconomic analysis of National Health Insurance Fund (NHIF) spending for reimbursed rheumatology products during 2019 – 2021 after the introduction of budget cap with pay back MEA. On total 17 medicines (INNs) are selected from the official registers of NHIF. Their reimbursed spending were calculated as per three main groups of MEAs (group A, B, C) and the differences were statistically tested. Costs are presented in national currency BGN (ex-change rate 1BGN=0.95Euro).

RESULTS: The total reimbursed budget for rheumatology products increased from 100.5 to 102 million of BGN during 2019–2021 (p>0.05). Group A (prescribed after a consultation with committee from 3 specialists) includes 13 biological and 1 JAK inhibitor and their budget share is more than 99%. Only upadacitinib decreased its reimbursed budget in 2021.We also noted an increase in utilization and reimbursed amount of new biosimilar products. Group B (all other medicines out of group A) include methotrexate and NSADs with budget of 25 thousand BGN. Group C (oncology and life-saving medicines) include only dexamethasone with budget of 105 thousand of BGN. Reimbursed budget for group B and C declined<0.05).

CONCLUSIONS: The result of introduced budget cap with pay back MEA as cost-containment measures is not visible yet three years after its introduction. Only the budget for NSADs and non-biological products decreased. On opposite budget for biologicals increased but their prescribing increased which shows that most patients can benefit.