Upadacitinib Medicine 08 December 2020 Extended indication Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Therapeutic value No estimate possible yet Total cost € 3,436,800.00 Registration phase Registered and reimbursed Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 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 Unknown Submission date 2022 Expected Registration July 2022 Orphan drug Unknown Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in 2022. Positieve CHMP opinie ontvangen in mei 2022. Therapeutic value Current treatment options Biologicals, biosimilars, JAK remmers. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 2 studie (U-Achieve) zijn de klinische eindpunten behaald. In een fase 3 studie (U-Accomplish) werd resultaat ten opzichte van placebo gevonden. Upadacitinib zal waarschijnlijk gaan concurreren met tofacitinib en in de toekomst mogelijk met filgotinib. De verwachting op basis van resultaten in andere ziektebeelden is dat upadacitinib de voorkeur zal krijgen ten opzichte van deze andere JAK-remmers. Duration of treatment Frequency of administration 1 times a day Dosage per administration 15 mg References NCT03653026; U-Accomplish (NCT03653026) Additional remarks Expected patient volume per year Patient volume 200 - 400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Crohn-colitis.nl; Horizonscan Alicaforsen; Additional remarks Colitis ulcerosa komt steeds vaker voor met name in de westerse landen. Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft colitis. In 2017 werd vedolizumab voorgeschreven aan 1.658 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 800 Colitis Ulcerosa. Indien upadacitinib effectief blijkt zullen er mogelijk 200-400 patiënten voor in aanmerking komen in Nederland. 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 G-standaard; Additional remarks AIP 15mg : €879 per pack 28 tabletten, €11.456 per jaar. Potential total cost per year Total cost € 3,436,800.00 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 Ankylosing spondylitis; Atopic dermatitis; Crohn's disease; Giant cell arteritis; Vasculitis References adisinsight Additional remarks Lopende fase 3 studies Other information Additional remarks