Upadacitinib Medicine 12 June 2019 Extended indication Upadacitinib is indicated for the treatment of moderate to severe atopic dermatitis in patients who have failed to respond to conventional (topical) therapies. Therapeutic value No judgement Total cost € 6,250,000.00 Registration phase Clinical trials Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Upadacitinib is indicated for the treatment of moderate to severe atopic dermatitis in patients who have failed to respond to conventional (topical) therapies. 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 October 2020 Expected Registration September 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in mei 2021. Therapeutic value Current treatment options Ciclosporine, dupilumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation De plaatsbepaling van JAK-remmers versus biologicals is vooralsnog onduidelijk. Duration of treatment Frequency of administration 1 times a day Dosage per administration 15 mg -30 mg References fabrikant Additional remarks Expected patient volume per year Patient volume 200 - 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nav 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 uiteindelijk enkele honderden patiënten behandeld zullen worden met upadacitinib indien effectief. Expected cost per patient per year Cost € 10,000.00 - 15,000.00 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 fabrikant; G-standaard, Z-index mei 2020 Additional remarks Gelijke kosten verwacht vergeleken met de andere JAK remmers en met een aantal andere biologische behandelingen; meerkosten vergeleken met sommige al wat oudere biologicals. AIP van €878,82 per pak met 28 tabletjes; €10.546 per jaar. Potential total cost per year Total cost € 6,250,000.00 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 III: Crohn's disease; Psoriatic arthritis; Ulcerative colitis References https://adisinsight.springer.com/drugs/800037410 Additional remarks Other information Additional remarks