Upadacitinib Medicine 12 June 2019 Extended indication Atopische dermatitis Therapeutic value Possible equal value Total cost € 6,250,000.00 Registration phase Clinical trials Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Atopische dermatitis Current proprietary name Already available biosimilars / generics Proprietary name 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 JAK1 inhibitor. Vergelijkbaar met baricitinib en tofacitinib. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Dupilumab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Plaatsbepaling JAK-remmers versus biologicals is vooralsnog onduidelijk. Lijkt beter te werken dan baricitinib. Duration of treatment Frequency of administration 1 times a day Dosage per administration 15 mg -30 mg References fabrikant Additional remarks Expected patient volume per year Patient volume 200 - 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nav inschatting Dupilumab Additional remarks Het is te verwachten dat het aantal CE patiënten die in aanmerking komen voor JAK remmers vergelijkbaar is met de inschatting voor dupilumab. Deze inschatting is gemaakt o.b.v. orale immunosuppressiva gebruik in Nederland (maximaal 2046 patiënten). Aangezien de drempel wat lager wordt, verwacht de werkgroep een stijgend aantal CE patiënten die behandeld gaan worden met systemische middelen. De werkgroep verwacht dat uiteindelijk enkele honderden patiënten behandeld zullen worden met Baricitinib indien effectief. 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 Additional remarks Kosten inschatting op basis van andere JAK remmers. Potential total cost per year Total cost € 6,250,000.00 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 Phase III: Crohn's disease; Psoriatic arthritis; Ulcerative colitis References https://adisinsight.springer.com/drugs/800037410 Additional remarks Other information Additional remarks