Upadacitinib Medicine 10 June 2020 Extended indication Patients With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD). Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Patients With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD). 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2020 Expected Registration May 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in mei 2021. Therapeutic value Current treatment options adalimumab, golimumab, ixekizumab, secukinumab infliximab, certolizumab pegol, etanercept, tofacitinib, ustekinumab, apremilast, abatacept. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat upadacitinib de concurrentie aan zal gaan met de andere JAK remmers. Upadacitnib is even effectief als tofacitinib en baricitnib, maar heeft mogelijk minder nadelige bijwerkingen zoals het ontstaan van trombose. Hierdoor zal waarschijnlijk eerder upadacitnib voorgeschreven worden. Duration of treatment Frequency of administration Dosage per administration References NCT03104374 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IQVIA Additional remarks Naar schatting zijn er ongeveer 18.544 mensen in Nederland met psoriatrische artritis die in ziekenhuizen behandeld worden. Hiervan wordt ~26% met een biological behandeld (4.914). 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. Prijzen vergelijkbaar met huidige behandeling (baricitinib en tofacitinib). AIP van €878,82 per pak met 28 tabletten. Potential total cost per year Total cost 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