Moxetumomab pasudotox Medicine 13 December 2018 Extended indication Hairy cell lymfoma, third line Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Moxetumomab pasudotox Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Leukemia Extended indication Hairy cell lymfoma, third line Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti-CD22 recombinant immunotoxin Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Goedgekeurd door de FDA, de fabrikant geeft aan dat het nog niet bekend is of dit product in Europa wordt ingediend voor registratie. Therapeutic value Current treatment options Cladribine 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 NCT01829711 Additional remarks Patients will receive Moxetumomab Pasudotox IV over 30 minutes on days 1, 3, 5 of each 28 day cycle for a maximum of 6 cycles. Expected patient volume per year Patient volume 1 - 2 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nederlandse Vereniging voor Hematologie Additional remarks Per jaar krijgen ongeveer 40 mensen de diagnose HCL. Levensverwachting is hoog en vaak is er geen behandeling nodig. Gezien de derdelijns behandeling zal het aantal patiënten gering zijn. Experts verwachten 1-2 patiënten per jaar bij wie ook als alternatief een BRAF remmer gegeven kan worden bij klassieke HCL. 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 ALL, CLL References Clinicaltrials.gov Additional remarks Momenteel in fase II Other information Additional remarks