Upadacitinib Medicine 07 June 2022 Extended indication RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Therapeutic value Possible added value Total cost € 2,864,000.00 Registration phase Registered and reimbursed Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). 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 Unknown ATMP No Submission date January 2022 Expected Registration August 2022 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen op juni 2022. Therapeutic value Current treatment options Na falen NSAID zijn TNFi of anti-IL17A geregistreerd voor deze indicatie Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Dit geneesmiddel zal waarschijnlijk ingezet worden na falen op anti-TNF of anti-IL17 therapie. Upadacitinib is reeds geïndiceerd voor axiale SPA. Ook in de fase 3 studie voor non-radiographische axial SPA werden in vergelijking met placebo significante resultaten gevonden. Duration of treatment Frequency of administration 1 times a day Dosage per administration References Additional remarks NCT04169373 Expected patient volume per year Patient volume < 250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Landewé en Van der Heijde. Ned Tijdschr Geneeskd. 2011(1); Expert opinie(2); Additional remarks De prevalentie van nrSpA wordt ingeschat tussen de 0,3%-0,4% (1). Ongeveer 50% van de patiënten wordt behandeld met een biological (2) . De inschatting is dat het met name gebruikt gaat worden na falen op een TNF-blokker en dat er ongeveer 450 patiënten voor in aanmerking zullen komen. Expected cost per patient per year Cost € 11,456.00 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 G-standaard Additional remarks Gebaseerd op kosten van andere behandelingen met Rinvoq. AIP 15mg : €879 per pack 28 tabletten, €11.456 per jaar Potential total cost per year Total cost € 2,864,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Crohn's disease; Ulcerative colitis; Hidradenitis suppurativa References Additional remarks Other information Additional remarks