Crisantaspase Medicine 12 June 2018 Extended indication Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase Therapeutic value No estimate possible yet Total cost € 901,800.00 Registration phase Registered Product Active substance Crisantaspase Domain Hematology Reason of inclusion New medicine (specialité) Main indication ALL Extended indication Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase Current proprietary name Already available biosimilars / generics Proprietary name Enrylaze Manufacturer Jazz Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks L-Asparaginase encapsulated inside donor-derived red blood cells. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date April 2023 Expected Registration September 2023 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juli 2023 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 150 IU/kg References NCT01518517 Additional remarks Minimaal 2 en maximaal 10 toedieningen om de 3 dagen in combinatie met standaard chemotherapie (COOPRALL). Expected patient volume per year Patient volume 26 - 81 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2020; Blinatumomab Additional remarks Er zijn jaarlijks 81 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Circa 30% van de patiënten krijgt een eerste recidief. Dit komt overeen met ongeveer 26 patiënten per jaar. Expected cost per patient per year Cost € > 16,700.00 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 GIPdatabank Additional remarks De prijs zal mogelijk vergelijkbaar zijn met andere vormen van crisantaspase die al op de markt zijn. Vergoeding per gebruiker in 2023 was €16.661,59 Potential total cost per year Total cost € 901,800.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks