Inolimomab Medicine 12 June 2019 Extended indication Severe steroid-resistant acute graft versus host disease (GvHD) Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Inolimomab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Stem cell transplants Extended indication Severe steroid-resistant acute graft versus host disease (GvHD) Current proprietary name Already available biosimilars / generics Proprietary name Leucotac Manufacturer Elsalys Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoklonaal antilichaam gericht tegen de alpha chain van de interleukine-2 receptor (IL-2). Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase Clinical trials 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 References EudraCT Number: 2007-005009-24 Additional remarks Momenteel alleen fase III klinische studies in de EU. Expected patient volume per year Patient volume 75 - 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Xhaard et al. Biol Blood Marrow Transplant. 2012 Mar;18(3):406-13. Additional remarks 400-500 allogene stamceltransplantaties per jaar. 50% kans op acute GvHD (250). 30-60% van de patiënten wordt steroïderesistent (75-150). 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 Unknown Indication extensions References Additional remarks Other information Additional remarks