Ianalumab Medicine 03 June 2025 Extended indication Treatment of Sjögren’s disease in adults Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Ianalumab Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication Treatment of Sjögren’s disease in adults Current proprietary name Already available biosimilars / generics Proprietary name nog niet bekend Manufacturer Novartis Portfolio holder Novartis Mechanism of action Receptor antagonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise UMCG, EMC Additional remarks anti-BAFF-R mAb Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2026 Expected Registration March 2027 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Algemene immunosuppressiva (e.g., corticosteroïden) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 300mg References NCT05350072 (NEPTUNUS-1); NCT05349214 (NEPTUNUS-2) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Ramos-Casals M, Brito-Zerón P, Bombardieri S, et al.; EULAR-Sjögren Syndrome Task Force Group. EULAR recommendations for the management of Sjögrenʼs syndrome with topical and systemic therapies. Ann Rheum Dis. 2020 Jan;79(1):3-18. FMS richtlijn: https://richtlijnendatabase.nl/richtlijn/topicale_en_systemische_behandeling_van_de_ziekte_van_sj_gren/startpagina_-_topicale_en_systemische_behandeling_van_de_ziekte_van_sj_gren_sjd.html Additional remarks De ziekte van Sjögren komt voor bij 1 tot 23 personen per 10.000 inwoners in Europese landen. De fabrikant geeft aan dat wellicht maar een fractie van de patiënten met orgaanbetrokkenheid in aanmerking zal komen. Expected cost per patient per year Cost € 30,000.00 - 80,000.00 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 Prijs op basis van vergelijkbare prijzen van auto‑immuun biologicals (bijv. rituximab / belimumab. 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