Ritlecitinib Medicine 04 December 2025 Extended indication Treatment of patients with non-segmental vitiligo. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ritlecitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Treatment of patients with non-segmental vitiligo. Current proprietary name Already available biosimilars / generics Proprietary name Litfulo Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Selectieve JAK3/TEC kinase remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2026 Expected Registration December 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de TRANQUILLO en TRANQUILLO 2 fase 3 studies wordt ritlecitinib vergeleken met placebo. Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration 1 times a day Dosage per administration 50mg of 100mg References NCT05583526 (TRANQUILLO); NCT06072183 (TRANQUILLO 2); NCT06163326 (TRANQUILLO LTE) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.huidmedischcentrum.nl/ Additional remarks In Nederland hebben naar schatting circa 150.000 mensen vitiligo. Hiervan heeft ongeveer 80 tot 90% de non-segmentale vorm (NSV), wat neerkomt op 120.000 tot 135.000 mensen. Expected cost per patient per year Cost € 7,000.00 - 8,000.00 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 Additional remarks De apotheek inkoopprijs is €640,30 (exclusief BTW) per verpakking van 30 stuks in de dosering van 50mg. Uitgaande van de eenmaal daagse dosering 365 dagen per jaar, zouden de totale kosten per patiënt per jaar ongeveer €7.790,32 bedragen. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks