Remibrutinib Medicine 05 December 2023 Extended indication Chronic spontaneous urticaria Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Remibrutinib Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Chronic spontaneous urticaria Current proprietary name Already available biosimilars / generics Proprietary name 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 (UCARE centres) Additional remarks Highly specific inhibitor of Bruton's tyrosine kinase Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2024 Expected Registration October 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options 2nd generation antihistamines (1st line), omalizumab (2nd line), cyclosporin (3rd line) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 25 mg References NCT05032157 Additional remarks De eerste keuze is omalizumab. Remibrutinib (een BTK remmer) zal waarschijnlijk ingezet worden na falen omalizumab. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References European Journal of Dermatology. Treatment of chronic spontaneous urticaria with an inadequate response to H1-antihistamines: an expert opinion. Volume 27, numéro 1, January-February 2017.; Urticaria Farmacotherapeutische richtlijn; 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 References Additional remarks Unknown Potential total cost per year Total cost Total cost for sluice Additional remarks Unknown Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks