Ustekinumab Medicine 04 June 2026 Extended indication Extension of indication to include treatment of ulcerative colitis in paediatric patients from the age of 2 years and older. Therapeutic value No estimate possible yet Total cost € 1,160,000.00 Registration phase Registration application pending Product Active substance Ustekinumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Extension of indication to include treatment of ulcerative colitis in paediatric patients from the age of 2 years and older. Current proprietary name Already available biosimilars / generics Proprietary name Stelara Manufacturer Janssen Portfolio holder Janssen Mechanism of action Interleukin inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Intraveneuze inductiebehandeling gevolgd door subcutane onderhoudsbehandeling met ustekinumab. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP No Submission date December 2025 Expected Registration July 2026 Orphan drug No 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 NCT04630028 Additional remarks Expected patient volume per year Patient volume < 116 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References UMCG (1); Declaratiedata (2) Additional remarks In Nederland krijgen elk jaar ongeveer 150 kinderen onder de 18 jaar de diagnose colitis ulcerosa (1). In 2024 waren er 116 gebruikers van Stelara voor colitis ulcerosa onder de 18 jaar (2). Expected cost per patient per year Cost € 8,000.00 - 12,000.00 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; posologie onderhoudsdosering bij volwassenen Additional remarks 90 mg wegwerpspuit kost €1.659,59. Voor de behandeling van een patiënt betekent dit doorgaans 5 tot 7 spuiten per jaar. Potential total cost per year Total cost € 1,160,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks