Yes. Esketamine nasal spray (Spravato) is reimbursed by Italy's national health service (SSN) as a Classe H hospital medicine for treatment-resistant depression — no response to at least two antidepressants at adequate dose and duration in the current moderate-to-severe episode. For patients who meet those criteria, the medicine and its administration are covered as hospital care, delivered at regionally authorized psychiatric centers with each patient entered in an AIFA monitoring registry. This page covers exactly who qualifies, how the hospital route works, what you pay, and what to do if you fall outside the criteria; the eligibility decision itself always sits with a clinician, and you can begin orienting yourself with our eligibility check.
What is covered
Since May 2022, esketamine nasal spray is reimbursed as a Classe H medicine — the hospital class — under AIFA Determina n. 334/2022, published in the Gazzetta Ufficiale on 18 May 2022. The reimbursed indication is treatment-resistant major depression in adults, treated with esketamine in combination with an SSRI or SNRI. Classe H shapes everything practical: the medicine is not something you collect at a pharmacy — it is dispensed, administered and monitored inside accredited hospital psychiatric units, including the supervised administration and post-dose observation.
One nuance is worth knowing up front: esketamine's separate psychiatric-emergency indication — rapid short-term reduction of depressive symptoms in an acute situation — was classified by AIFA in Classe C in 2024 and is not reimbursed by the SSN. The funded pathway is the treatment-resistant depression indication.
Who qualifies
The reimbursed criteria under Determina 334/2022:
- An adult with a moderate-to-severe depressive episode;
- No response to at least two different antidepressants taken at adequate dose and duration in the current episode — "adequate" means sufficient dose for sufficient duration, so a week on a starting dose usually does not count;
- Esketamine is used in combination with an SSRI or SNRI.
The practical currency is a written treatment history: every antidepressant tried in the current episode, with substance, dose, duration and outcome. The AIFA registry entry is built from exactly this record, so assembling it before the first appointment does more than anything else to shorten the process.
Who decides and how to apply
The route runs through a psychiatrist — in a public mental-health service (CSM) or hospital clinic — who refers you to a regionally authorized center. After the national decision, Italian regions issued implementing decrees naming which hospitals may prescribe and administer Spravato, so which center you attend depends on where you live; your psychiatrist will know the authorized center for your area. Prescribers enter every patient into the AIFA monitoring registry: your eligibility is documented there before treatment starts and your course is tracked in it. For the full picture of every legal route in the country, see our Italy access guide; to see who is listed near you, browse providers in Italy.
What it costs you
For patients who meet the criteria, the medicine and its administration are covered by the SSN as hospital care — you do not buy the spray at a pharmacy, and administration happens within the hospital. If a hospital uses esketamine in an emergency context, that use falls under the Classe C indication and sits outside national reimbursement, so if cost matters — and it usually does — make sure your case is assessed under the treatment-resistant depression pathway. Off-label psychiatric ketamine at private clinics is not reimbursed by the SSN and is self-pay from the first appointment.
If you do not qualify
Italy has no named exceptional or individual-case reimbursement mechanism for esketamine — the standard Classe H criteria govern, and the honest fallbacks are:
- Private ketamine. Off-label ketamine for depression is legal under physician responsibility, but the Italian market is very small — Florence's Istituto di Neuroscienze is the main listed provider, with no published fee schedule, entirely self-pay. Ask for a written cost breakdown and a full screening first — see our clinic-choice guide.
- Clinical trials are free by definition. Two ketamine and esketamine studies are recruiting in Italy — in Milan and at university sites in Brescia, Cagliari, Naples and Turin; see the trials guide for how to search.
Frequently asked questions
Is Spravato reimbursed in Italy?
Yes — the SSN reimburses it as a Classe H hospital medicine since May 2022 for treatment-resistant depression, defined as at least two failed antidepressants at adequate dose and duration in the current moderate-to-severe episode. Treatment happens at regionally authorized psychiatric centers under an AIFA monitoring registry.
Do I pick the spray up at a pharmacy?
No. Classe H means the medicine is dispensed, administered and monitored inside accredited hospital psychiatric units — this is a hospital-financed system, unlike Germany's office-based model. The Europe-wide reimbursement map shows how the models compare.
Does it matter which region I live in?
Yes, in one specific way: regions authorize the hospital centers that may deliver Spravato, so availability and waiting differ by region. Being treated outside your region is sometimes possible within the SSN, but ask the receiving center first.
Why is the psychiatric-emergency use of esketamine not covered?
AIFA classified that separate indication in Classe C in 2024, which excludes it from SSN reimbursement. The funded pathway is the treatment-resistant depression indication under Determina 334/2022.
Sources
- Gazzetta Ufficiale — AIFA Determina n. 334/2022 (Spravato, Classe H)
- AIFA — monitoring registries for supervised medicines
- Regione Veneto — implementing decree identifying authorized Spravato centers
- Blossom: Medical access in Italy
- EMA: Spravato (esketamine) EPAR
- Reimbursement Pathways for Psychedelic Therapies in Europe — Magnetar Access × Blossom (2025)
This guide is for general information only and is not medical advice, a diagnosis, or a recommendation of any treatment. Regulations and reimbursement rules change; always verify current requirements with your insurer and discuss your options with a licensed clinician who knows your history. If you are in crisis, contact your local emergency number or a crisis line immediately.
This guide awaits review by a licensed medical professional.