Insulin glargine

Active substance Insulin glargine
Domain Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen Indication extension
Main indication Diabetes
Extended indication Extension of indication to include new population for Toujeo (i.e. adolescents and children from the age of 6 years).

Product

Proprietary name Toujeo
Manufacturer Sanofi
Mechanism of action Receptor agonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional comments Insulin receptor agonists

Registration

Registration route Centralised (EMA)
Submission date April 2019
Expected Registration January 2020
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie in oktober 2019.

Therapeutic value

Therapeutic value No judgement
Substantiation De data bij volwassenen wijzen uit dat het geneesmiddel een meerwaarde heeft. De glucosewaarden zijn stabieler en er is een beter afgifte patroon waardoor het werkingsmechanisme langer is. Echter, is de data bij kinderen nog beperkt en lopen de trials nog op dit moment.
Duration of treatment Not found
Frequency of administration 1 times a day
Dosage per administration 300 U/ml
References farmacotherapeutisch kompas

Expected patient volume per year

References https://www.volksgezondheidenzorg.info/onderwerp/diabetes-mellitus/cijfers-context/huidige-situatie#node-prevalentie-diabetes-bij-kinderen-en-jongeren
Additional comments Aantal kinderen met diabetes mellitus 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 360.00
References GIP databank
Additional comments Huidige kosten per patiënt per jaar voor insuline glargine betreffen zo'n €360.

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.