Presentation (CTI)

OBJECTIVES: Findings from EFPIA Patients W.A.I.T. Indicator 2025 Survey, assessing access to innovative medicines across EU, highlighted substantial cross-country variation in time to reimbursement. This analysis aims to evaluate the average time from European Commission (EC) Decision to official reimbursement for innovative medicines in Greece in 2024-2025 and to identify the key process steps contributing to delays in patient access.
METHODS: A retrospective review of publicly accessible databases was performed applying predefined criteria. Innovative medicines were defined as products authorized in Greece under legal basis 8(3) that received EC Decision between 2022-2025, included in one Price Bulletin between 2023-2025 and granted initial reimbursement in 2025. Medicines’ new indications and vaccines were excluded. The analysis was conducted using official data sourced from Price Bulletins, Positive Reimbursement Lists, and Ministerial Decisions for reimbursement inclusion, published on the official websites of the Greek Ministry of Health and DIAVGEIA transparency portal. In addition, an equivalent analysis was conducted for 2024, enabling a comparison of temporal changes in reimbursement timelines between the two years.
RESULTS: A total of 17 innovative medicines were identified in 2025 and 17 in 2024. The mean interval from EC decision to official reimbursement was reduced from 723 days in 2024 to 696 days in 2025. The price approval remained the longest component of the process, accounting for 412 days (57%) in 2024 and 363 days (52%) in 2025. The overall decline in timelines was most pronounced for orphan medicines, decreased from 693 days in 2024 to 536 days in 2025—approximately a 5‑month improvement.
CONCLUSIONS: While not directly comparable to the EFPIA survey, these findings are consistent with survey’s results, highlighting an improvement in access timelines in 2025 compared with 2024. However, pricing procedures remain the main bottleneck. Further research is needed to assess delays and support targeted policy actions.