OBJECTIVES: The objective of this research is to present the outcomes of the Financial-Based Managed Entry Agreements (FBMEA) in Romania performed during 8 years of implementation.

METHODS: The authors studied the evolution of the legislation on FBMEA looking for the hurdles and the legislative updates to overcome these hurdles. They performed an analysis of the existing FBMEA in Romania looking on public data sources from 2015 to 2022, measuring the outcomes of FBMEA development in terms of no. of drugs reimbursed, therapeutic areas covered, treated patients and the resources allocated.

RESULTS: In Romania the MEA are performed as Cost-Volume contracts (financial-based contracts with discounts based on market share or FBMEA) or Cost-Volume-Result contracts (outcome-based contracts with discounts based on market share).The number of drugs having a conditional reimbursement via CV contracts (FBMEA) increased yearly from four in 2015 to 73 in 2022. Their distribution in regards to therapeutically areas were (in 2022): 36.5% Oncology, 13.5% Neurology, 12.2% Rare Disease, 10.8% Endocrinology, 8.1% Cardiology, 5.4% Dermatology, 4.1% Ophthalmology, 2.7% Gastroenterology, 2.7% Hematology, 2.7% Rheumatology, 1.4% Nephrology. The number of patients treated via CV contracts (FBMEA) evolved from 932 in 2015 to 247,418 in 2022. The budget allocated to conclude these contracts evolved from 5.3 mil. Euro in 2015 to around 426 mil. Euro in 2022, which represents 13.3% of 3.2 billion Euro of total drugs with public reimbursement in 2022 (from 0.29% in 2015).

CONCLUSIONS: In Romania, the FBMEA are now the main pathway to public reimbursement of new drugs, especially in areas like Oncology and Neurology. There are still some problems for adjustment, but the FBMEA proved to be a solid ground for the reimbursement of new drugs. The future steps for FBMEA are already envisaged in terms of Paying for Performance mechanisms, which could bring additional benefits for the health care system.