Dasatinib Medicine 12 June 2018 Extended indication Extension of Indication to include a paediatric indication for Philadelphia chromosome positive acute lymphoblastic leukaemia for Sprycel. Therapeutic value No judgement Total cost € 281,672.00 Registration phase Registration application pending Product Active substance Dasatinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Leukemia Extended indication Extension of Indication to include a paediatric indication for Philadelphia chromosome positive acute lymphoblastic leukaemia for Sprycel. Current proprietary name Already available biosimilars / generics Proprietary name Sprycel Manufacturer BMS Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tyrosine kinase inhibitor. Dit product is onderdeel van het gezamenlijk inkoop verband dure geneesmiddelen NVZ/NFU/ZN. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2017 Expected Registration February 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Overige TKIs, nilotinib, imatinib en bozutinib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Wordt momenteel off-label voor deze indicatie verstrekt. Zal bij registratie verplaatsen naar on-label. Duration of treatment Frequency of administration 1 times a day Dosage per administration 140 mg References Farmacotherapeutisch Kompas Additional remarks Expected patient volume per year Patient volume 11 - 20 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Maximaal zo rond de 20 patiënten die in aanmerking zouden komen voor de behandeling. Cijfersoverkanker.nl laat zien een voorlopige schatting voor 2017 zien van 11 kinderen met B-ALL met specifieke cytogenetische afwijkingen. Expected cost per patient per year Cost € 11,736.00 - 23,473.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Fabrikant; G-standaard Additional remarks €64,31 per tablet conform G-standaard mei 2018. Inmiddels onderdeel van nationaal inkoopinitiatief. Potential total cost per year Total cost € 281,672.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks