Masitinib Medicine 09 January 2018 Extended indication Gastro Intestinale Stroma Tumor (GIST) Therapeutic value No judgement Total cost Registration phase No registration expected Product Active substance Masitinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Stomach cancer Extended indication Gastro Intestinale Stroma Tumor (GIST) Current proprietary name Already available biosimilars / generics Proprietary name Masican Manufacturer AB Science Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Deze indicatie is niet meer terug te vinden in de pipeline van de de fabrikant. 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 0 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 waren er 50 diagnoses van GIST stadium IV. De kans op een plek in de richtlijn lijkt klein. 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 Er lopen meerdere fase 3 studies. References Additional remarks Other information Additional remarks