Ivarmacitinib Medicine 03 June 2025 Extended indication Ivarmacitinib monotherapy for treatment of moderately to severely active ulcerative colitis in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ivarmacitinib Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Bowel diseases Extended indication Ivarmacitinib monotherapy for treatment of moderately to severely active ulcerative colitis in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Arcutis 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date October 2025 Expected Registration November 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options DMARDs, andere JAK-remmers zoals tofacitinib en upadacitinib. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn al meerdere JAK-remmers op de markt. De inzet van ivarmacitinib zal daarom afhangen van de tolereerbaarheid en de prijs. Duration of treatment Frequency of administration Dosage per administration References NCT05181137 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Crohn-colitis.nl; Horizonscan Alicaforsen; Additional remarks Colitis ulcerosa komt steeds vaker voor met name in de Westerse landen. Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft colitis. 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