Upadacitinib Medicine 08 December 2020 Extended indication Moderately to Severely Active Ulcerative Colitis Therapeutic value No estimate possible yet Total cost € 3,436,800.00 Registration phase Clinical trials Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Moderately to Severely Active Ulcerative Colitis 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 2021 Expected Registration November 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in november 2022. Therapeutic value Current treatment options Biologicals, biosimilars, JAK inhibitors 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. De fase 3 studie (U-Accomplish) loopt nog. Indien upadacitinib effectief blijkt zal het waarschijnlijk gaan concurreren met tofacitinib en in de toekomst mogelijk met filgotinib. Het bijwerkingenprofiel van de geneesmiddelen zal moeten uitwijzen welk geneesmiddel de voorkeur krijgt. 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 z-index november: 15mg 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