Insulin efsitora alfa Medicine 04 December 2025 Extended indication Treatment of type 2 diabetes mellitus. Therapeutic value No estimate possible yet Total cost € 76,500,000.00 Registration phase Registration application pending Product Active substance Insulin efsitora alfa Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Diabetes Extended indication Treatment of type 2 diabetes mellitus. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Eli Lilly Portfolio holder Mechanism of action Insulin preparation Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Insuline efsitora alfa (LY-3209590) is een eenmaal per week toe te dienen basale insuline die bestaat uit een insulinevariant die is gefuseerd met humaan immunoglobuline en die is ontworpen om een langwerkend basaal insulineprofiel te bieden voor patiënten met diabetes. Het is een selectieve insuline-receptoragonist (IR). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date August 2025 Expected Registration September 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Leefstijlinterventies, metformine, sulfonylureumderivaten, SGLT2-remmers, GLP-1-receptoragonisten en (zo nodig) dagelijkse insuline. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de QWINT-1 studie was het risico op ernstige hypoʼs 40% lager dan bij insuline glargine. Er is een verbeterde time in range. patiënten hebben de voorkeur voor minder injecties. Duration of treatment Frequency of administration 1 times a week Dosage per administration References NCT05662332 (QWINT-1); NCT05362058 (QWINT-2); NCT05275400 (QWINT-3); NCT05462756 (QWINT-4) Additional remarks Expected patient volume per year Patient volume < 170,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata; Expertopinie Additional remarks Er zijn ongeveer 200.000 gebruikers van langwerkende insuline. Ongeveer 30.000 daarvan zijn mensen met type 1 diabetes. Expected cost per patient per year Cost € 400.00 - 500.00 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 GIPdatabank Additional remarks De gemiddelde vergoeding per gebruiker van insulines en analogen ligt tussen de €400 en €500. Potential total cost per year Total cost € 76,500,000.00 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