Masitinib Medicine 09 January 2018 Extended indication Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole. Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance Masitinib Domain Neurological disorders Reason of inclusion Main indication ALS Extended indication Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole. Current proprietary name Already available biosimilars / generics Proprietary name Alsitek 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 Normal trajectory Particularity New medicine ATMP Unknown Submission date September 2016 Expected Registration Orphan drug Yes Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Negatieve opinie CHMP april 2018. Herbeoordeling gestart in april 2018. Fabrikant heeft de aanvraag tot herbeoordeling ingetrokken in mei 2018. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 1,071 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks 1071 gebruikers riluzole (GIP databank 2016), maximaal volume. 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