OBJECTIVES: Our research is aimed to determine the Health Technology Assessment (HTA) requirements for financing new therapies in Central and Eastern European (CEE) countries.

METHODS: The interviews among HTA and Marker Access experts from CEE countries: Albania, Bosnia and Hercegovina, Bulgaria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Moldova, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia, Slovenia, and Ukraine were conducted. The requirements for reimbursement application and implications of HTA were examined and compared among all specified countries.

RESULTS: In most of the CEE countries, reimbursement decisions are based on budget impact (BI) and cost-effectiveness (CE) analyses. In some countries, only BI is required. Usually, there is a need for local data. Areas, where discrepancies across countries were found, include medical evidence requirements. Some countries model their reimbursement decision-making policy on HTA documentation used in other countries, while others require the preparation of all HTA analysis de novo taking into account local HTA requirements and local data.

CONCLUSIONS: HTA evaluations are commonly used in considered countries, but the scope varies. General pricing and reimbursement requirements are quite similar in all the regions.