Masitinib Medicine 09 January 2018 Extended indication Crohn's disease. Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Masitinib Domain Chronic immune diseases Reason of inclusion Main indication Bowel diseases Extended indication Crohn's disease. Current proprietary name Already available biosimilars / generics Proprietary name Masipro Manufacturer AB Science Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Al als diergeneesmiddel op de markt sinds 2009 voor behandeling van mast-cel tumoren (Masivet). Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Patienten die niet reageren op bestaand anti-TNF en vedolizumab worden omgezet naar dit middel. Duration of treatment 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Ook in ontwikkeling voor veel andere indicaties, waaronder oncologie, MS etc. In 2018 verwacht voor astma. Marktregistratie voor de indicatie mastocytosis is afgewezen door de CHMP in september 2017. References Additional remarks Other information Additional remarks