Insulin icodec / semaglutide Medicine 03 December 2024 Extended indication Treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Insulin icodec / semaglutide Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Diabetes Extended indication Treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists Current proprietary name Already available biosimilars / generics Proprietary name IcoSema Manufacturer Novo Nordisk Portfolio holder Mechanism of action Insulin preparation Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date November 2024 Expected Registration December 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van gemiddelde doorlooptijd van 13 maanden voor nieuw middel. Therapeutic value Current treatment options 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 a week Dosage per administration References NCT05352815 (COMBINE 1); NCT05259033 (COMBINE 2); NCT05013229 (COMBINE 3) Additional remarks IcoSema is een fixed-ratio combinatie van wekelijks basaal insuline icodec en wekelijks semaglutide (700U/2 mg/ml). IcoSema wordt op dezelfde manier getitreerd als insuline, met een maximale wekelijkse dosering van 350 doseringsstappen (i.e., 350 U insuline icodec/1 mg semaglutide). Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank (1) Additional remarks In Nederland zijn er ongeveer 195.000 gebruikers van langwerkende insulines (1). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks 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