Guselkumab Medicine 03 December 2024 Extended indication Extension of indication to include treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Therapeutic value No estimate possible yet Total cost € 2,023,050.00 Registration phase Registration application pending Product Active substance Guselkumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Extension of indication to include treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Tremfya Manufacturer Janssen Portfolio holder Janssen 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 Unknown ATMP No Submission date February 2025 Expected Registration April 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van inschatting fabrikant. Therapeutic value Current treatment options Ustekinumab, etanercept, adalimumab, ixekizumab, secukinumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 0 continuous Frequency of administration 1 times every 8 weeks Dosage per administration 50 tot100mg References NCT03451851 (CNTO1959PSO3011) Additional remarks Participants will receive subcutaneous injection of CNTO 1959 50(mg) and placebo 100mg at Week 0,4 and then every 8 weeks thereafter. Expected patient volume per year Patient volume 100 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NHG-Standaard Psoriasis Additional remarks Bij jonge kinderen is de prevalentie laag (ongeveer 0,4 per 1.000 patiënten per jaar). In Nederland zijn er 1,5 miljoen kinderen in de leeftijd van 6 tot 12 jaar. Dit betekent naar schatting 600 kinderen met deze indicatie. Het huidige aantal kinderen op een biological zal mogelijk rond de 50 liggen. Er wordt verwacht dat dit aantal de komende jaren zal groeien naar 100 tot 200. Hoe de verdeling van de markt over deze biologicals eruit zal zien is nog niet duidelijk. Een gedeelte van de patiënten zal mogelijk overstappen op deze behandeling. Expected cost per patient per year Cost € 13,487.00 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 Additional remarks 100mg pen/wegwerpspuit kost €2.075. Voor de behandeling van een patiënt betekent dit 6,5 spuiten per jaar. Potential total cost per year Total cost € 2,023,050.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks