Presentation (CTI)

OBJECTIVES: To compare the time to reimbursement for the spinal muscular atrophy (SMA) treatment Evrysdi (risdiplam) in Turkiye with that in the five largest European markets (EURO5: France, Germany, Italy, Spain, and the UK), and draw implications for patient access.
METHODS: The marketing authorization and first reimbursement dates of Evrysdi 0.75mg/mL (80mL) in the EURO-5 markets were extracted from GlobalData’s POLI database. For Turkiye, the marketing authorization date for Evrysdi was obtained from the official Turkish Medicines and Medical Devices Agency (TITCK) database, and the first reimbursement date from the Social Security Institution’s (SGK) Health Implementation Communiqué. Time to reimbursement was defined as the period (in days) between the marketing authorization date and the official national reimbursement decision by the respective authority (SGK for Turkiye, HAS for France, G-BA for Germany, CIPM for Spain, AIFA for Italy, and NICE for the UK).
RESULTS: Across the six markets, the time to reimbursement ranged from 36 to 646 days. Germany was the first country in the EURO-5 to grant reimbursement to Evrysdi only 36 days after first approval, followed by France (102 days), Turkiye (191 days), the UK (210 days), Italy (319 days), and Spain (646 days). Despite Turkiye overtaking three of the EURO-5 markets in time to reimbursement for Evrysdi, the drug was granted marketing authorization only recently on October 18, 2024 compared to early-mid 2021 in the EURO-5.
CONCLUSIONS: Preliminary observations suggest that Evrysdi not only experienced delayed market entry by almost three years but also late reimbursement in Turkiye compared to the EURO-5 markets. This is mainly due to the SGK’s strict criteria relating to the reimbursement of high-cost therapies. Despite this, the quicker time to reimbursement in Turkiye than three top EU markets is a sign that orphan drugs are being prioritized for reimbursement to improve patient access.