Ustekinumab Medicine 04 December 2025 Extended indication Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Therapeutic value No estimate possible yet Total cost € 500,000.00 Registration phase Registered Product Active substance Ustekinumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Stelara 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date August 2025 Expected Registration April 2026 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Positieve CHMP-opinie in februari 2026, EC registratie in april 2026. 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 NCT04673357 (CNTO1275CRD3004) Additional remarks Expected patient volume per year Patient volume < 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Informatiepagina Crohn. Crohn & Colitis. 2024 (1). Additional remarks In Nederland hebben ruim 100.000 mensen een chronische darmontsteking. Dit is ongeveer 1 op de 170 mensen. Hiervan heeft iets minder dan de helft de ziekte van Crohn (1). Er wordt verwacht dat het patiëntvolume laag zal uitvallen door de concurrentie op deze indicatie en het lagere aandeel van patiënten 2 tot 18 jaar. 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 € 500,000.00 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