Esketamine nasal spray (SPRAVATO®) holds an EU marketing authorisation (authorisation issued 18 December 2019) for adults with treatment‑resistant major depressive disorder in combination with an SSRI or SNRI; the product is distributed in EU member states and must be administered under supervision in a healthcare setting per the EMA product information. #.
Regulatory framework and payer position in Croatia: because Spravato is authorised at the EU level it may be supplied in Croatia through the standard national medicines regulatory and distribution channels, and clinical use must follow the EMA/SmPC restrictions (psychiatric prescriber, supervised administration, monitoring of blood pressure). However, national reimbursement (Hrvatski zavod za zdravstveno osiguranje, HZZO) inclusion is determined by HZZO's reimbursement/listing procedures; public reporting indicates that esketamine was considered for placement onto national drug lists and procurement/pricing discussions have been reported to HZZO (reporting of placement decisions appeared in Croatian press reporting HZZO's annual list updates). Where Spravato is not included on the HZZO reimbursed medicines list, access is possible through private payment or individual reimbursement/exceptional funding requests to HZZO, subject to national rules and local hospital/clinic policies. # #.
Practical implications for clinicians and patients: initiation should be by a psychiatrist in a facility equipped for supervised dosing and vital‑sign monitoring (as specified in the SmPC); if public reimbursement is required, clinicians or institutions must follow HZZO procedures for adding high‑cost specialty medicines or submit case‑by‑case funding applications. If you need an authoritative, up‑to‑date statement on whether SPRAVATO® is formally listed on HZZO's reimbursed medicines list (and any reimbursement criteria), I can check HZZO's current medicinal reimbursement lists and the official HZZO decisions and provide direct citations.