Ustekinumab Medicine 03 December 2024 Extended indication Extension of indication to include treatment of moderately to severely active Crohn's disease in paediatric patients weighing at least 40kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy or have medical contraindications to such therapies for STELARA Therapeutic value No estimate possible yet Total cost 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 moderately to severely active Crohn's disease in paediatric patients weighing at least 40kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy or have medical contraindications to such therapies for STELARA 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 IL12/23-remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2024 Expected Registration May 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Primary completion (estimated): 24 juli 2025. Therapeutic value Current treatment options IL-23-remmers (risankizumab, vedolizumab) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De huidige behandelopties werken goed voor een grote groep van de pediatrische patiënten. Dit middel zal gaan concurreren met IL-23 remmers risankizumab (reeds geregistreerd voor Crohn) en guselkumab (nog niet geregistreerd voor IBD). Mirikizumab is ook in ontwikkeling. Ustekinumab is daarbij snel beschikbaar als biosimilar en zal dan zeer waarschijnlijk veel goedkoper zijn. Duration of treatment Frequency of administration Dosage per administration References NCT04673357 (CNTO1275CRD3004); Ziekte van Crohn. Farmacotherapeutisch kompas. 2024. Additional remarks Expected patient volume per year Patient volume 50 - 1 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 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