Delayed Access to Innovative Medicines in Romania: A Comprehensive Analysis of the Reimbursement Processes (2015-2024)

OBJECTIVES: The legal framework in Romania imposes multiple steps for innovative drugs to become reimbursed unconditionally: HTA, inclusion in the reimbursement list, and publication of the prescription protocols. Additional procedures are required for conditional reimbursements, involving cost-volume and cost-volume-result agreements with a separate budget. Considerable delays in reimbursement accumulated over recent years. This study aims to assess the delays and identify their main causes to inform updates to the reimbursement framework.

METHODS: We processed all publicly available HTA reports published between January 2015 and June 2024, identifying the dates when drugs and their indications were included in the reimbursement list and therapeutic protocols. The duration between HTA decision and reimbursement was calculated in days. For drugs still awaiting reimbursement, June 25, 2024 was the cut-off date.

RESULTS: We identified 496 HTA reports corresponding to 523 indications approved for reimbursement. The percentage of conditional decisions increased from 41% in 2015 to 63% in 2023. Only 361 (69%) indications were reimbursed, the duration from HTA decision to reimbursement for 2021 submissions reaching 470 days (95% CI: 385, 556) for conditional, 250 days (95% CI: 214, 286) more compared to unconditional. In June 2024, 109 indications were still waiting for reimbursement (80.7% conditional) starting from 2021: 9.7% of 2021 submissions, 58% - 2022, 84.3% - 2023 and 100% - 2024. For drugs awaiting reimbursement, average waiting time since HTA decision was 327 days (95% CI: 291, 362), highest being 690 days.

CONCLUSIONS: The reimbursement process in Romania became increasingly dysfunctional in the last 3 years. Despite more drugs receiving HTA approval, faster, reimbursement is less and less likely. Coupled with insufficient funding, the current framework for conditional reimbursement is restrictive, administratively burdensome, and inefficient in addressing the financial uncertainty of new drugs. More flexible and effective managed entry agreements are required to ensure patients get timely access to innovative medicines.