Upadacitinib Medicine 03 December 2024 Extended indication Extension of indication to include treatment of giant cell arteritis (GCA) in adult patients Therapeutic value No estimate possible yet Total cost € 6,447,600.00 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 treatment of giant cell arteritis (GCA) in adult patients 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 July 2024 Expected Registration June 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Indiening juli 2024. Fabrikant verwacht registratie juni 2025. Therapeutic value Current treatment options Glucocorticosteroïden, MTX en tocilizumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De effectiviteit van upadactinib bij GCA zal nog moeten blijken. Het is wel de verwachting dat dit mogelijk een plek zal kunnen krijgen binnen de behandeling. Maar resultaten uit de studies dienen afgewacht te worden. Duration of treatment Frequency of administration Dosage per administration References NCT03725202 (SELECT-GCA, M16-852) Additional remarks Expected patient volume per year Patient volume < 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1:Expertopinie; Additional remarks Er wordt verwacht dat er mogelijk minder dan 600 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost € 10,746.00 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 Lijstprijs rinvoq 15mg op basis van G-standaard juli 2024 Additional remarks Potential total cost per year Total cost € 6,447,600.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks