Time to Access Orphan Medicines in Greece

OBJECTIVES: Timely access to orphan drugs remains an ongoing challenge in most European countries. The purpose of the present study was to compare the time elapsed from market authorization to reimbursement of new medicinal products (MPs) with or without orphan designation, in the current year in Greece.

METHODS: Data were obtained from the Greek Health Technology Assessment (HTA) Committee’s database and other publicly available sources for MPs containing new active substances that were included in the national Positive Reimbursement List in February 2023. Median time intervals were computed in calendar days.

RESULTS: The national Positive Reimbursement List in February 2023 encompassed a total of 53 newly approved for reimbursement MPs containing new active substances, among which 13 had an orphan designation. The median time (25th-75th percentiles) between market authorization and HTA dossier application was 420 days (260-856) for non-orphan MPs, and 457 days (360-832) for orphan MPs. On the other hand, the median time from completion of HTA to reimbursement was 228 days (200-442) for non-orphan MPs and 417 days (376-570) for orphan MPs.

CONCLUSIONS: Longer time to access orphan (vs. non-orphan) drugs was attributed to delays both in the dossier application for HTA and in the time from HTA to reimbursement. Orphan MPs are a priority of the new European HTA regulation to facilitate timely access across the EU.