Ustekinumab Medicine 05 December 2023 Extended indication Moderately to severely active Ulcerative Colitis Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Ustekinumab Domain Chronic immune diseases Reason of inclusion Generic G Main indication Bowel diseases Extended indication Moderately to severely active Ulcerative Colitis Current proprietary name Stelara Already available biosimilars / generics Proprietary name Manufacturer Janssen Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks IL12/23 remmer. 130 mg IV als inductie, daarna 90 mg SC als onderhoud elke 12 weken of elke 8 weken voor de patiënten die dat nodig hebben. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date December 2022 Expected Registration January 2024 Orphan drug Unknown Registration phase Registration application pending 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 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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