Regulatoire T-cellen (TREGS) Medicine 07 December 2022 Extended indication Behandeling van type 1 diabetes. Therapeutic value No estimate possible yet Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer PolTREG Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise 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) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 80,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Gipdatabank (1); DitabetesFonds (2); 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). Expected cost per patient per year Cost References Additional remarks 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