Esketamine Medicine 13 December 2018 Extended indication Major Depressive Disorder with imminent risk of suicide Therapeutic value Possible added value Total cost Registration phase Clinical trials Product Active substance Esketamine Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Psychiatry Extended indication Major Depressive Disorder with imminent risk of suicide Current proprietary name Already available biosimilars / generics Proprietary name Spravato Manufacturer Janssen Portfolio holder Mechanism of action Unknown Route of administration Nasal Therapeutical formulation Nose spray Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Esketamine is een glutamaat receptor modulator. Esketamine grijpt aan op de NMDA en opioïd receptoren waardoor er uiteindelijk meer glutamaat vrijkomt wat uiteindelijk leidt tot een verbeterde synaptische connectiviteit. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date February 2020 Expected Registration December 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Er zijn geen specifieke middelen die suïcidaal gedrag verminderen of een suïcide kunnen voorkomen. Er is geen afdoende bewijs dat antidepressiva, antipsychotica, stemmingsstabilisatoren, anxiolytica en ECT helpen om suïcidaal gedrag te verminderen. Met andere woorden: momenteel is er geen adequate behandeloptie voor deze patiënten. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Klinische studies Duration of treatment Average 4 week / weeks Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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 Yes Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions No Indication extensions References Fabrikant Additional remarks Other information Additional remarks