Itacitinib Medicine 12 June 2018 Extended indication Grade II to IV acute graft-versus-host disease (aGvHD). Therapeutic value No judgement yet Total cost € 22,200,000.00 Registration phase Clinical trials Product Active substance Itacitinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Stem cell transplants Extended indication Grade II to IV acute graft-versus-host disease (aGvHD). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Incyte Portfolio holder Mechanism of action JAK tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Janus kinase 1 (JAK1)-inhibitor. Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Phase III gestart, GRAVITAS-301, JAK1 inhibitor icm corticosteroids. Therapeutic value Current treatment options Ciclosporin en corticosteroiden (en zodra geregistreerd ibrutinib) Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Nog geen valide uitspraak over te doen daar nog geen data bekend zijn van de GRAVITAS trial Duration of treatment Frequency of administration 1 times a day Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 300 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. Gezien 2L behandeling zal slechts een deel van deze patiënten in aanmerking komen voor Prochymal. Expected cost per patient per year Cost € 74,000.00 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 Medicijnkosten.nl Additional remarks Geschatte maximale kosten op basis van kosten en behandelschema ibrutinib is €74.000 per patiënt per jaar. Potential total cost per year Total cost € 22,200,000.00 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 Clinicaltrials.gov Additional remarks Er lopen wel meerdere studies voor andere aandoeningen maar nog niet in Fase 3. Other information Additional remarks