Reimbursed Care Access in Belgium

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorised medical use outside of approved clinical research. Clinical research may be possible in Belgium under the standard clinical trial approval pathway administered by the Federal Agency for Medicines and Health Products (FAMHP) and ethics committees; participation in clinical trials must follow CTIS/FAMHP procedures. # #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorised medical use outside of approved clinical research. Clinical development or investigator‑led studies may be initiated only via the FAMHP clinical trials process (CTIS) and subject to national regulatory and ethics approvals. # #

Esketamine (Spravato® nasal spray) is authorised in Belgium for treatment‑resistant depression in combination with an SSRI or SNRI and is managed under the national medicines regulatory pathway; the FAMHP maintains public documentation on the product and its approved indication. #

Regulatory/administrative context: the FAMHP lists Spravato® with the EMA‑aligned indication (major depressive disorder, treatment‑resistant) and has records of compassionate‑use/medical‑need programme documents and approval correspondence pertaining to esketamine use in Belgium. These FAMHP documents describe the authorised indication and programmatic context for access. #

Reimbursement/access: access is primarily via the authorised medicinal product pathway and hospital/ambulatory settings that follow the product label and FAMHP guidance. Public reimbursement (RIZIV/INAMI) for innovative medicines in Belgium follows national assessment and reimbursement procedures administered by INAMI/RIZIV; Belgium has recently updated accelerated pathways for early access and temporary reimbursement of innovative medicines (EEFA / Early Temporary Reimbursement) which may be applicable to high‑need medicines — decisions about RIZIV/INAMI reimbursement status for a specific product are made by those authorities. For information on national reimbursement procedures and early access frameworks see INAMI/RIZIV guidance pages. #

Practical implications: clinicians and hospital pharmacies should follow FAMHP product documentation and national reimbursement guidance to determine whether a given patient’s treatment with esketamine will be covered by the compulsory health insurance or require private payment or ad hoc arrangements. #

Ketamine is an authorised medicinal product in Belgium for anaesthesia and pain indications and is widely used in clinical practice in hospital and perioperative settings; its off‑label use for psychiatric indications (e.g., rapid‑acting antidepressant effects via IV infusions) may be prescribed by clinicians outside the registered antidepressant indications but remains an off‑label practice governed by professional responsibility and national guidance on off‑label prescribing. Belgian guidance documents on off‑label prescribing and psychotropic drug use emphasise clinician responsibility, informed consent and multidisciplinary oversight for off‑label psychotropic uses. # #

Reimbursement: routine public reimbursement for ketamine when used as an anaesthetic or in standard hospital procedures follows normal hospital/ambulatory reimbursement rules; when used off‑label for depression, reimbursement depends on the care setting, coding and whether the treatment can be justified under existing hospital/medical tariffs — there is no specific, nationwide automatic reimbursement entitlement for off‑label ketamine infusions for depression outside standard negotiated hospital funding pathways. Clinicians considering off‑label ketamine for psychiatric use should verify local hospital policies and RIZIV/INAMI billing rules. #

Research/clinical trials: investigational uses of ketamine for psychiatric indications should be run as clinical trials under FAMHP/CTIS oversight when intended to generate generalisable evidence. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorised medical use outside of approved clinical research. Clinical research may be possible under FAMHP/CTIS clinical trial approval processes. # #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorised medical use outside of approved clinical research. Any clinical research must be authorised by FAMHP and follow CTIS procedures. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorised medical use outside of approved clinical research. Use outside trials is not authorised and would be subject to criminal and regulatory controls; clinical research requires FAMHP/CTIS approval. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorised medical use outside of approved clinical research. Ritual or private use remains outside legal medical frameworks; any clinical research in Belgium must follow FAMHP/CTIS approval routes. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorised medical use outside of approved clinical research. Clinical research requires standard FAMHP approvals. #

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorised medical use outside of approved clinical research. There is no authorised therapeutic framework for 2C‑series compounds in Belgium; any research would require FAMHP clinical trial approval. #