Filgotinib Medicine 03 December 2024 Extended indication Treatment of axial spondyloarthritis in adult patients with active radiographic axial spondyloarthritis (r-axSpA) and with active non-radiographic axial spondyloarthritis (nr-axSpA). Therapeutic value No estimate possible yet Total cost € 2,850,000.00 Registration phase Registration application pending Product Active substance Filgotinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Treatment of axial spondyloarthritis in adult patients with active radiographic axial spondyloarthritis (r-axSpA) and with active non-radiographic axial spondyloarthritis (nr-axSpA). Current proprietary name Already available biosimilars / generics Proprietary name Jyseleca Manufacturer Alfasigma Portfolio holder Alfasigma Mechanism of action JAK tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2026 Expected Registration September 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Na falen NSAID zijn TNFi, anti-IL17A en JAK-remmers (upadacitinib) beschikbaar. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fase 2 studie (N=116) toont in patiënten met axiale SPA die falen op NSAID therapie en biological naïef zijn een klinisch significante verschil ten opzichte van placebo. De fase 3 studie loopt nu naar respons in patiënten die gefaald hebben op biological DMARD therapie. De resultaten uit de fase 3 studie dienen afgewacht te worden om te bepalen of het geneesmiddel enigszins gelijkwaardig is aan upadacitib. Duration of treatment Frequency of administration 1 times a day Dosage per administration 200 mg References NCT05785611 (OLINGUITO); Expertopinie Additional remarks Expected patient volume per year Patient volume 150 - 450 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Axiale spondyloartritis. ReumaNederland. 2024 (1). Landewé en Van der Heijde. Ned Tijdschr Geneeskd. 2011(1); Expert opinie(2); Additional remarks Axiale spondylartritis komt bij ongeveer 1 op de 200 mensen voor (1). Er zal substitutie plaatsvinden van DMARD therapie. De verwachting is dat er maximaal 450 patiënten voor in aanmerking zullen komen. Expected cost per patient per year Cost € 9,000.00 - 10,000.00 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 Medicijnkosten.nl; Farmacotherapeutisch Kompas. Additional remarks Confidential discounts are offered at the level of the hospital, bringing the actual cost of treatment at substantially lower levels. Potential total cost per year Total cost € 2,850,000.00 Total cost for sluice Additional remarks Jyseleca wordt de derde optie in de JAKi-klasse, wat de marktpenetratie zal beïnvloeden. Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks