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).

1. 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

2. 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.

3. 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

4. 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.

5. Expected cost per patient per year

Cost
360
References
GIP databank
Additional comments
Huidige kosten per patiënt per jaar voor insuline glargine betreffen zo'n €360.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.