Delayed access to innovative medicines in Romania: a comprehensive analysis of the reimbursement processes (2015–2024)

Despite some efficiency gains in the HTA evaluation stage, Romania's conditional reimbursement pathway remains hampered by tight budgets and administrative hurdles, prolonging patient inaccessibility-particularly in oncology, where timely treatment is critical. Strengthening administrative capacity, diversifying Managed Entry Agreement (MEA) models, and integrating new digital tools could help address these bottlenecks. Without substantial reforms, the backlog will continue growing, limiting patients' timely access to innovative therapies.