Eryaspase (Asparaginase) Medicine 12 June 2018 Extended indication Acute lymphoblastic leukaemia (ALL), Philadelphia-negative Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Eryaspase (Asparaginase) Domain Oncology and Hematology Reason of inclusion Main indication Leukemia Extended indication Acute lymphoblastic leukaemia (ALL), Philadelphia-negative Current proprietary name Already available biosimilars / generics Proprietary name Graspa Manufacturer ERYtech 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 New medicine ATMP Unknown Submission date February 2018 Expected Registration March 2019 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 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 13 - 40 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Blinatumomab Additional remarks NKR 2016: 40 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Ca 30% krijgt een eerste recidief. Dit komt overeen met ca 13 patiënten per jaar. 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 No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks