Inebilizumab Medicine 10 June 2020 Extended indication Adult patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. Therapeutic value Possible added value Total cost Registration phase Clinical trials Product Active substance Inebilizumab Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Neurological disorders other Extended indication Adult patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Viela Bio Portfolio holder Mechanism of action Other Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti-Human CD19 Therapeutic Antibody Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Methylprednisolon vooral aanvalsbehandeling gegeven, net als plasmaferese en eventueel IVIG. Satralizumab en eculizumab bedoeld ter preventie van volgende relapse. Daar wordt nu azathioprine (naast orale taper prednison) voor gegeven of rituximab of mycofenolaat mofetil. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Inebilizumab en satralizumab hebben waarschijnlijk minder risico's qua bijwerkingsprofiel dan eculizumab, waarbij een verhoogde kans op meningitis werd geconstateerd. Inebilizumab en satralizumab hebben een vergelijkbare effectiviteit en veiligheidsprofiel. Er is weinig evidence voor de werking van azathioprine en rituximab. Daardoor zal inebelizumab in de toekomst de voorkeur krijgen boven deze geneesmiddelen. Duration of treatment Frequency of administration 1 times every 6 months Dosage per administration 300 mg References NCT02200770; L.A. McNamara. High Risk for Invasive Meningococcal Disease Among Patients Receiving Eculizumab (Soliris) Despite Receipt of Meningococcal Vaccine. 2017; Additional remarks Expected patient volume per year Patient volume < 250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Marrie and Gryba. Int J MS Care. 2013 Fall; 15(3): 113–118; Tackley et al. Mult Scler Relat Disord. 2016 May;7:21-5 Additional remarks De incidentie van NMO ligt rond de 0,4 per 100.000 inwoners, dit betekent voor Nederland een incidentie van 70 patiënten per jaar. Na een aantal jaar zal dit kunnen leiden tot maximaal 250 patiënten die gebruik maken van inbelizumab. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks