Upadacitinib Medicine 12 June 2019 Extended indication Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Therapeutic value No estimate possible yet Total cost € 17,184,000.00 Registration phase Registered and reimbursed Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Rinvoq Manufacturer Abbvie Portfolio holder Mechanism of action JAK tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks JAK1 inhibitor. Vergelijkbaar met baricitinib en tofacitinib. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2020 Expected Registration August 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juni 2021. Therapeutic value Current treatment options Ciclosporine, dupilumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat upadacitnib ook de concurrentie aan zal gaan met de JAK-remmers baricitinib en abrocitinib. De keuze tussen een JAK-remmer of dupilumab zal gemaakt worden op basis van de voorkeur in toedieningsvorm en bijwerkingen voor de patiënt. Duration of treatment Frequency of administration 1 times a day Dosage per administration 15 mg References fabrikant Additional remarks Expected patient volume per year Patient volume < 1,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Naar aanleiding van inschatting Dupilumab Additional remarks Het is te verwachten dat het aantal CE patiënten die in aanmerking komen voor JAK-remmers vergelijkbaar is met de inschatting voor dupilumab. Deze inschatting is gemaakt op basis van orale immunosuppressiva gebruik in Nederland (maximaal 2.046 patiënten). Aangezien de drempel wat lager wordt, verwacht de werkgroep een stijgend aantal CE patiënten die behandeld gaan worden met systemische middelen. De werkgroep verwacht dat er uiteindelijk 1.500 patiënten behandeld zullen worden met JAK-remmers. Dit aantal zal verdeeld worden over de drie JAK-Remmers. 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 z-index november: AIP 15mg Additional remarks AIP 15mg : €879 per pack 28 tabletten, €11.456 per jaar Potential total cost per year Total cost € 17,184,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Phase 3: Crohn's disease; Psoriatic arthritis; Ulcerative colitis References https://adisinsight.springer.com/drugs/800037410 Additional remarks Other information Additional remarks