Extended indication Extension of indication to include the treatment of type 2 diabetes in adolescents and children aged
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Exenatide
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
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
Proprietary name Bydureon
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2021
Expected Registration June 2022
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie verkregen in april 2022.

Therapeutic value

Therapeutic value No estimate possible yet
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.

Expected patient volume per year

References https://www.volksgezondheidenzorg.info/onderwerp/diabetes-mellitus/cijfers-context/huidige-situatie#node-aandeel-diabetes-type-i-totaal-naar-leeftijd-en-geslacht
Additional comments 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
References GIPdatabank
Additional comments In 2021 werd er per patiënt €1.000 vergoed voor exenatide.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.