Esketamine Medicine 09 January 2018 Extended indication Tinnitus Therapeutic value Possible added value Total cost Registration phase Clinical trials Product Active substance Esketamine Domain Neurological disorders Reason of inclusion Main indication Neurological disorders other Extended indication Tinnitus Current proprietary name Already available biosimilars / generics Proprietary name Keyzilen Manufacturer Auris Portfolio holder Mechanism of action Unknown Route of administration Auricular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks NMDA receptor antagonist ook gebruikt bij anaesthesie, depressie (en als partydrug). Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New therapeutical formulation ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Registatieproces: 'Fast Track Designation' in Amerika (FDA). Therapeutic value Current treatment options Geen andere behandelopties. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation http://www.renalandurologynews.com/drugs-in-the-pipeline/fda-fast-tracks-esketamine-gel-for-acute-inner-ear-tinnitus/article/510189/ Duration of treatment Frequency of administration 3 times every 4 days Dosage per administration 0.87 mg/ml References http://adisinsight.springer.com/drugs/800023242; https://www.sps.nhs.uk/medicines/esketamine/ Additional remarks Toedieningsfrequentie betreft 3x over 3-5 dagen. 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 Verwachting is dat het meerkosten gaat opleveren. Bij ontbreken andere opties zal er waarschijnlijk een hoge prijs gevraagd worden, vraag is hoe snel me-too preperaten beschikbaar komen omdat de basisstof niet vernieuwend is. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks