Upadacitinib Medicine 04 December 2025 Extended indication Extension of indication to include the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older Therapeutic value No estimate possible yet Total cost € 490,000.00 Registration phase Registration application pending Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Extension of indication to include the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older Current proprietary name Already available biosimilars / generics Proprietary name Rinvoq Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action JAK tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date October 2025 Expected Registration November 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Broadly excluded 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 NCT03725007 (M15-340) 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 Isala.nl; Expertopinie Additional remarks In Nederland komt JIA voor bij ongeveer 1 op de 1.000 kinderen, wat overeenkomt met een prevalentie van 80 tot 90 per 100.000 kinderen. Dit resulteert in een totaal van ongeveer 2.000 tot 3.000 kinderen met JIA in Nederland. De doelgroep (op anti-TNF falende kinderen met JIA die een behandeling nodig hebben) zal niet meer zijn dan 300 patiënten, waarvan het meerendeel behandeld kan worden met abatacept of tocilizumab, of met de al beschikbaar JAK-remmers. Mogelijk zullen er 50 patiënten per jaar in aanmerking komen voor dit middel. Expected cost per patient per year Cost € < 9,800.00 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 Een tablet Rinvoq 15mg kost €29,14 (inclusief BTW) (1). Een jaarbehandeling zou €9.764,31 (exclusief BTW) per patiënt per jaar kosten (€29,14/1,09*365,24). Potential total cost per year Total cost € 490,000.00 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