Upadacitinib Medicine 10 June 2020 Extended indication Extension of indication to include the treatment of active ankylosing spondylitis in adult patient for Rinvoq Therapeutic value No judgement Total cost € 4,009,600.00 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 the treatment of active ankylosing spondylitis in adult patient for Rinvoq 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 Na falen NSAID zijn TNFi of anti-IL17A geregistreerd voor deze indicatie. 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 ten opzichte van 26% in de placebo arm. De verwachting is dat patiënten die falen op anti-TNF medicatie eerst anti-IL17 therapie zullen ontvangen. Indien zij ook hier op falen zullen JAK-remmers worden ingezet, waaronder upadacitinib. 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 300 - 400 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. De verwachting is dat patiënten die falen op anti-TNF medicatie eerst anti-IL17 therapie zullen ontvangen en indien zij ook hier op falen upadacitinib ingezet zal worden. Dit zal neerkomen op zo'n 300-400 patiënten per jaar die in aanmerking komen voor upadacitinib. 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: 15mg. Additional remarks AIP 15mg: €879 per pack 28 tabletten, €11.456 per jaar Potential total cost per year Total cost € 4,009,600.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Atopic dermatitis; Crohn's disease; Giant cell arteritis; Ulcerative colitis; Vasculitis References Adisinsight. Additional remarks Lopende fase 3 studies. Other information Additional remarks