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 Registered 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 Kyinsu 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 ATMP No Submission date November 2024 Expected Registration November 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Eventueel biedt deze combinatie een voordeel in toedieningsgemak. Insuline voor wekelijkse toediening wordt in Nederland echter bijna niet gebruikt. Duration of treatment Frequency of administration 1 times a week Dosage per administration References NCT05352815 (COMBINE 1); NCT05259033 (COMBINE 2); NCT05013229 (COMBINE 3); Expertopinie 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 (dat wil zeggen 350U insuline icodec/1mg semaglutide). Expected patient volume per year Patient volume < 1,249 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank (1) Additional remarks Xultophy is een dagelijks toe te dienen combinatiepreparaat van liraglutide en semaglutide, in 2023 waren er 1.249 gebruikers van dit product (1). Waarschijnlijk zal het aantal gebruikers van IcoSema hierop lijken. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks