Exenatide Medicine 07 December 2021 Extended indication Extension of indication to include the treatment of type 2 diabetes in adolescents and children aged 10 years and above Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Exenatide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Extension of indication to include the treatment of type 2 diabetes in adolescents and children aged 10 years and above Current proprietary name Already available biosimilars / generics Proprietary name Bydureon Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Unknown 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 August 2021 Expected Registration May 2022 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie verkregen in april 2022. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Exenatide wordt vrijwel niet gebruikt als GLP-1 receptor agonist in verband met beperkte effectiviteit ten opzichte van het bijwerkingenprofiel. Er wordt ook in deze patiëntpopulatie geen groot verbruik verwacht. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.volksgezondheidenzorg.info/onderwerp/diabetes-mellitus/cijfers-context/huidige-situatie#node-aandeel-diabetes-type-i-totaal-naar-leeftijd-en-geslacht Additional remarks Aantal kinderen met diabetes mellitus type 2 is zeer beperkt, verwachting dat toepassing in deze populatie minimaal is. Informatie over prevalentie van diabetes bij kinderen en jongeren is schaars. Expected cost per patient per year Cost € < 1,000.00 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 GIPdatabank Additional remarks In 2021 werd er per patiënt €1.000 vergoed voor exenatide. 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