Upadacitinib Medicine 10 June 2020 Extended indication Ankylosing Spondylitis Therapeutic value No judgement 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 Ankylosing Spondylitis 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 Verschillende TNF blokkers na falen NSAID of anti-IL17A Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Een recente publicatie van de fase 2/3 placebo gecontroleerde trial laat 52% ASAS40 respons zien vs 26% in placebo arm. Verdere studieresultaten worden nog afgewacht om te bepalen of dit geneesmiddel een therapeutische meerwaarde heeft Duration of treatment Frequency of administration Dosage per administration References NCT04169373; Lancet. 2019 Dec 7;394(10214):2108-2117. Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Ixekizumab record Additional remarks Axiale spondyloartritis komt voor bij ongeveer 1 op de 400 mensen, dit zijn in Nederland ongeveer 42.500 mensen. De inschatting is dat ongeveer 3.000-4.000 patiënten anti-TNF medicatie krijgen. 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