Psilocybine Medicine 04 December 2025 Extended indication Psilocybine monotherapy for treatment of treatment-resistant Major depression in adults and elderly without psychotic features. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Psilocybine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Depression Extended indication Psilocybine monotherapy for treatment of treatment-resistant Major depression in adults and elderly without psychotic features. Current proprietary name Already available biosimilars / generics Proprietary name COMP360 Manufacturer Compass Pathways Portfolio holder Compass Pathways Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 10mg tot 25mg References NCT05624268; NCT05711940 Additional remarks Expected patient volume per year Patient volume 2,694 - 11,713 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Budget impactanalyse van esketamine (Spravato®) - in combinatie met een SSRI of een SNRI - voor de behandeling van volwassenen met een therapieresistente depressieve stoornis. Zorginstituut Nederland. 2020. Additional remarks In een budget impactanalyse op basis van declaratiegegevens werden er minimaal 2.694 patiënten en maximaal 11.713 patiënten geschat die in aanmerking kwamen voor Spravato. Mogelijk is dit ongeveer dezelfde groep patiënten die in de toekomst in aanmerking komt voor deze behandeling. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks