Reimbursed Care Access in Netherlands

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. National drug scheduling and the Opiumwet framework place hard restrictions on substances listed under Lijst I of the Opiumwet; possession, production and distribution outside authorised research are illegal #.

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. MDMA is controlled within the Opiumwet regime; any therapeutic access would be limited to formal clinical trials and authorised research programmes under national and EU rules #.

Esketamine nasal spray (Spravato) holds a centralised marketing authorisation in the European Union for adults with treatment‑resistant major depressive disorder and is available in the EU with restricted supervised administration conditions; the EMA product assessment and authorisation are documented in the Spravato EPAR. The EMA decision: opinion adopted 17 Oct 2019, marketing authorisation issued 18 Dec 2019 #.

In the Netherlands the pathway to reimbursement from the statutory basic health insurance (basispakket) is managed by Zorginstituut Nederland (the National Health Care Institute). Zorginstituut Nederland is currently involved in evaluating evidence for broader use of esketamine formulations: in particular a nationally funded ‘‘Veelbelovende zorg’’ (promising care) research project is studying oral esketamine for severe, non‑psychotic, treatment‑resistant depression (project start 1 September 2020; results to be submitted around January 2026). The Institute will use those data to assess whether oral esketamine can be included in the basic insurance package and under what conditions #.

Practical access and reimbursement status: Spravato (esketamine nasal spray) as an authorised medicine is subject to local implementation (hospital/clinic procurement and supervised administration) and to the Dutch procedures for inclusion in the Geneesmiddelenvergoedingssysteem (GVS). Whether a given esketamine product is reimbursed from the basic package depends on the formal package advice and any price/usage negotiations; Zorginstituut Nederland advises the minister and negotiates reimbursement conditions per established GVS processes. Patients currently access Spravato via authorised clinical services under the EMA label and local arrangements while national reimbursement decisions for expanded formulations (e.g., oral esketamine) remain under evaluation # #.

Ketamine is an authorised medicinal product in the Netherlands as an anaesthetic and analgesic (marketing‑authorised clinical uses under national/European frameworks) and is routinely available via clinical services; product dossiers and registrations for ketamine are held/managed via the national competent authority (CBG‑MEB). For example, regulatory documents for ketamine formulations are included in CBG documentation on marketed authorisations. See CBG product documentation for ketamine preparations/authorisations. #.

Psychiatric use: ketamine is used off‑label in specialised psychiatric settings (e.g., intravenous or intranasal ketamine for rapid antidepressant effect in treatment‑resistant depression) but such uses are considered off‑label and are handled locally by hospitals and insurers. Reimbursement for off‑label psychiatric ketamine depends on local hospital policy, individual insurer decisions, and whether care is provided under an approved care pathway; the Zorginstituut has a formal route to evaluate off‑label or repurposed medicines and to advise the Minister on inclusion in the basic package when there is robust evidence or negotiated arrangements. The Dutch health‑system pathway for determining whether an off‑label use is reimbursed involves Zorginstituut Nederland appraisal and inclusion in the GVS where applicable # #.

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. DMT and DMT‑containing preparations are regulated under the Opiumwet framework; access is limited to authorised clinical trials and research under national and EU rules #.

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. 5‑MeO‑DMT is subject to the Opiumwet regulatory restrictions and may only be present in authorised research contexts in the Netherlands #.

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. Ibogaine and related preparations are controlled under the Opiumwet regime; clinical or therapeutic use would be restricted to formally authorised studies. #.

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. Although ayahuasca is a traditional plant brew containing DMT, the presence of DMT places ayahuasca preparations under the Opiumwet restrictions in the Netherlands; any religious or ceremonial exceptions do not alter the national criminal/health regulatory controls outside tightly regulated research. #.

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. Mescaline and mescaline‑containing cacti are controlled under the Opiumwet; authorised medical access is limited to clinical studies. #.

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. The family of 2C phenethylamines (e.g., 2C‑B, 2C‑I and related analogues) are subject to strong regulatory controls under the Opiumwet and may only be used in authorised research contexts. #.