Presentation (CTI)

OBJECTIVES: In Romania, the conditional reimbursement framework has remained unchanged since 2015: it requires declaring eligible patient populations and negotiating cost-volume agreements that await available budget for initiation. With reimbursement delays accumulating, we aim to measure durations between steps, explore underlying causes, and propose solutions to enable faster access for patients.
METHODS: Public data from the National Drug Agency (HTA dossiers), National Health Insurance House (eligible populations, negotiation sums, prioritization list), and state budget laws were analyzed. Reimbursement statuses were confirmed through the Reimbursement List and Therapeutic Protocols. Mean durations with 95% confidence intervals were calculated in days for conditional HTA dossiers submitted from January 1, 2020, until the June 15, 2025 cut-off.
RESULTS: 207 conditional HTA decisions were identified. Annual decisions increased from 29 in 2020 to 48 in 2024. The time from eligible population publication to reimbursement grew dramatically, from 136 days (95% CI: 60-211) in 2021 to 489 days (95% CI: 433-544) in 2024. The yearly negotiation budget was 4.3 billion RON between 2020-2024, increasing to 6.2 billion RON in 2025. In 2024, over 80% of the negotiation cap was reached mid-year. Due to a growing backlog, in November 2024 the authorities decided to prioritize drugs with budget savings (versus their comparator) over drugs without therapeutic alternatives. As of June 15, 2025, no prioritized new drug was reimbursed; 114 decisions (55.1%) remained pending reimbursement, with 50.8% of these lacking therapeutic alternatives.
CONCLUSIONS: Romania’s conditional reimbursement system cannot adequately accommodate the growing number of conditional HTA decisions. The constrained budget, used primarily for renewing existing agreements, directly contributes to prolonged delays. Reimbursement of drugs without therapeutic alternatives is hindered by prioritization based on budget impact. Increased funding and a more nuanced decision-making framework, such as multi-criteria decision analysis, could ensure patients timely access to essential treatments.