Inolimomab Medicine 12 June 2019 Extended indication Severe steroid-resistant acute graft versus host disease (GvHD). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Inolimomab Domain 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 Leukotac 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 2022 Expected Registration 2023 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 References EudraCT Number: 2007-005009-24. Additional remarks Momenteel alleen fase 3 klinische studies in Europa. Expected patient volume per year Patient volume 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References EBMT database. Additional remarks Jaarlijks worden in Nederland circa 600 allogene stamceltransplantaties uitgevoerd. In naar schatting de helft van de gevallen (=300) treedt enige vorm van Graft-versus-Host-ziekte op welke behandeld wordt met steroïden. Hiervan is naar schatting 50% steroïd refractair, wat maakt dat jaarlijks in totaal 150 patiënten theoretisch in aanmerking zouden komen voor behandeling met dit geneesmiddel. 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 No Indication extensions References Adisinsight Additional remarks Other information Additional remarks