Remibrutinib Medicine 05 December 2023 Extended indication Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Remibrutinib Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment. Current proprietary name Already available biosimilars / generics Proprietary name Rhapsido Manufacturer Novartis Portfolio holder Novartis Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise UMCU, EMC, AMC (UCARE centres) Additional remarks Zeer specifieke remmer van Bruton-tyrosinekinase. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date March 2025 Expected Registration April 2026 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in februari 2026 Therapeutic value Current treatment options Antihistaminica van de tweede generatie (eerstelijn), omalizumab (tweedelijn), ciclosporine (derdelijn). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De gerandomiseerde klinische studie NCT06042478 vergelijkt remibrutinib met omalizumab en zal medio 2027 worden afgerond. In de tweede behandellijn zal een keuze gemaakt kunnen worden tussen remibrutinib en omalizumab. Duration of treatment Frequency of administration 2 times a day Dosage per administration 25 mg References NCT05030311 (REMIX-I) ; NCT05032157 (REMIX-II) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fricke J, Avila G, Keller T et al. Epidemiology of chronic urticaria in children and adults; A systematic review. Allergy 2020;75(2):423-32 Zuberbier T, et al. The EAACI/GA2LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria. Allergy 2022;77(3):734-66 https://richtlijnen.nhg.org/behandelrichtlijnen/urticaria-en-angio-oedeem Additional remarks De incidentie van urticaria is 5,2 per 1.000 patiënten per jaar. Ongeveer 1,8% van de bevolking heeft minstens één keer in zijn leven chronische urticaria (zo'n 300.000 personen). Dat betekent dat de klachten langer dan zes weken duren. Echter, bij 90% van de patiënten verdwijnen de klachten binnen drie maanden, 66 tot 93% van de patiënten heeft chronische spontane urticaria. Expected cost per patient per year Cost € 25,000.00 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 IHSI Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van de ATC klasse (L04AA) in Nederland Potential total cost per year Total cost Total cost for sluice Additional remarks Unknown Off label use Off label use No Indications off label use References Additional remarks middel is nog niet op de markt Indication extension Indication extensions Yes Indication extensions pediatric CSU, CIndU, MS, HS, voedselallergie References Additional remarks Deze indicaties zijn in onderzoek en het is nog onduidelijk of deze geregistreerd gaan worden. pediatric CSU en CIndU mogelijke registratie tweede helft 2027, de overige indicaties later dan 2027. Other information Additional remarks