Deucravacitinib Medicine 04 December 2025 Extended indication Sotyktu, alone or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy. Therapeutic value No estimate possible yet Total cost € 7,350,000.00 Registration phase Registration application pending Product Active substance Deucravacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Sotyktu, alone or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy. Current proprietary name Already available biosimilars / generics Proprietary name Sotyktu Manufacturer BMS Portfolio holder BMS Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Orale selectieve tyrosinekinase 2 (TYK2) remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2025 Expected Registration February 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options NSAIDs, DMARDs, targeted synthetische DMARDs, biologicals Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het fase 2-onderzoek liet een ACR20-respons van 53–63% zien, wat duidt op duidelijke werkzaamheid. Momenteel lopen twee fase 3-studies: één bij biological-naïeve patiënten met verwachte voltooiing in juni 2027, en één bij zowel biological-naïeve patiënten als bij patiënten die onvoldoende reageerden op TNF-remmers, met voltooiing in november 2026. De effectiviteit op gewrichtssymptomen lijkt daarmee aannemelijk, maar het is nog onduidelijk of het middel even goed werkt op de huid. Duration of treatment Frequency of administration 1 times a day Dosage per administration 6 mg References NCT04908202 (POETYK PsA-1); NCT04908189 (POETYK PsA-2); Expertopinie Additional remarks Expected patient volume per year Patient volume 500 - 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Onderzoekmetmensen.nl; Richtlijnendatabase.nl; Expertopinie Additional remarks In Nederland hebben naar schatting 6.000 tot 20.500 volwassenen psoriatische artritis (PsA) Van hen reageert ongeveer 30 tot 40% onvoldoende op of is intolerant voor conventionele synthetische DMARD-therapie. Bovendien is dit substitutie voor andere DMARDs en targeted synthetics DMARDs, waardoor het volume mogelijk tussen de 500-1000 patiënten zal liggen. Expected cost per patient per year Cost € 9,800.00 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, 1 juli 2025 Additional remarks De prijs in Nederland is €746,92 per verpakking met 28 tabletten. Kosten per patiënt per jaar zijn €746,92÷28x365,25=€9.743,30. Potential total cost per year Total cost € 7,350,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks