Regulatoire T-cellen (TREGS)

Extended indication	Behandeling van type 1 diabetes.
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Regulatoire T-cellen (TREGS)
Domain	Metabolism and Endocrinology
Reason of inclusion	New medicine (specialité)
Main indication	Diabetes
Extended indication	Behandeling van type 1 diabetes.
Manufacturer	PolTREG
Budgetting framework	Intermural (MSZ)
Additional remarks	'T1D is an example of autoimmune disease which frequency is contineously increasing in pediatric population in Europe. Yet, there is no commonly accepted treatment which could be administered to stop the progression of disease and all afected subjects develop full onset T1D. It is therefore important to go through formal path of registration and start offering the treatment which has some efficacy in this disease.'

Registration

Registration route	Centralised (EMA)
ATMP	Yes
Submission date	2025
Expected Registration	2026
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	Er wordt veel van dit product verwacht, echter zullen de bijwerkingen niet gering zijn. Op dit moment worden de resultaten uit de klinische studies nog afgewacht.

Expected patient volume per year

Patient volume	< 80,000 Market share is generally not included unless otherwise stated.
References	Gipdatabank (1); DitabetesFonds (2); expertopinie (3)
Additional remarks	Totaal aantal gebruikers van diabetesmiddelen in 2016 was 814.714 (1). 10% hiervan heeft diabetes type 1 dus het aantal patiënten in Nederland bedraagt ongeveer 80.000 (2). De behandelindicatie zou liggen bij nieuw ontdekte DM1, dat zullen er enkele duizenden per jaar zijn (3).

Patient volume

< 80,000

Market share is generally not included unless otherwise stated.

References

Gipdatabank (1); DitabetesFonds (2); expertopinie (3)

Additional remarks

Totaal aantal gebruikers van diabetesmiddelen in 2016 was 814.714 (1). 10% hiervan heeft diabetes type 1 dus het aantal patiënten in Nederland bedraagt ongeveer 80.000 (2). De behandelindicatie zou liggen bij nieuw ontdekte DM1, dat zullen er enkele duizenden per jaar zijn (3).

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.