Upadacitinib Medicine 03 June 2025 Extended indication Moderate to severe Hidradenitis suppurativa in adolescents, adults and elderly who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication Moderate to severe Hidradenitis suppurativa in adolescents, adults and elderly who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. 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 2027 Expected Registration 2028 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Tijdslijnen zijn onzeker Therapeutic value Current treatment options Eerste keuze: adalimumab/infliximab/ustekinumab. Verder ook secukinumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Aan de fase 2 studie zaten 47 patiënten op upadacitinib en 21 op placebo. De duur was 48 weken. Op week 12 werd er een significant verschil van upadacitinib versus placebo gevonden met een goede veiligheid. Op week 48 werd er een goed effect gezien met een 30 en 15mg dosis en een goede veiligheid. De fase 3 studie loopt nog. Duration of treatment Frequency of administration Dosage per administration References NCT05889182 (Step-Up-HS); Expertopinie Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) Richtlijn FMS Hidradenitis suppurativa (HS) Additional remarks Er wordt geschat dat hidradenitis suppurativa (HS) bij circa één procent van de bevolking voorkomt. Dit percentage omvat zowel zeer lichte vormen als de ernstige varianten van HS. Het is niet bekend hoeveel patiënten er zijn met zeer ernstige HS (1). Expected cost per patient per year Cost € < 9,700.00 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 €28,94 (inclusief BTW) (1). Een jaarbehandeling zou €9.697,29 (exclusief BTW) per patiënt per jaar kosten (€28,94/1,09*365,24). Potential total cost per year Total cost 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