Azacitidine Medicine 12 June 2019 Extended indication AML post-intensive chemotherapy maintenance Therapeutic value No judgement yet Total cost Registration phase Clinical trials Product Active substance Azacitidine Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication AML / MDS Extended indication AML post-intensive chemotherapy maintenance Current proprietary name Already available biosimilars / generics Proprietary name Onureg Manufacturer Celgene Portfolio holder Mechanism of action Cytostatic Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks DNA Methyltranserase inhibitor, ook bekend als CC-486 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 150 mg / 200 mg / 300 mg References NCT01835587 Additional remarks Dosering van 150 mg, 200 mg of 300 mg eenmaal daags (QD) gedurende 7, 10 of 14 dagen van elke 28-daagse cyclus. Start 42-84 dagen na transplantatie. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 774 nieuwe patiënten per jaar (2017, NKR). Expected cost per patient per year Cost € 40,000.00 - 190,000.00 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 medicijnkosten.nl Additional remarks € 374,49 per azacitidine poeder voor suspensie voor injectie 100 mg flacon. Uitgaande van het behandelschema zoals hierboven beschreven en de prijs van poeder voor injectie zou dat indien de behandeling een jaar zou duren, 70 - 170 behandeldagen, minimaal €40.000 kosten voor een dosis van 150 mg per dag en maximaal €190.000 kosten voor een dosis van 300 mg per dag. 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