Ertugliflozin Medicine 04 June 2026 Extended indication Ertugliflozin in combination with metformin with or without insulin for treatment of Type 2 diabetes mellitus in children over 10 years of age and adolescents. Therapeutic value No estimate possible yet Total cost € 2,250.00 Registration phase Registration application pending Product Active substance Ertugliflozin Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Ertugliflozin in combination with metformin with or without insulin for treatment of Type 2 diabetes mellitus in children over 10 years of age and adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Steglatro Manufacturer MSD Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date March 2026 Expected Registration October 2026 Orphan drug Registration phase Registration application pending 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 zijn nog geen resultaten uit de studie bekend. Duration of treatment Frequency of administration Dosage per administration References NCT04029480 (MK-8835-059) Additional remarks Expected patient volume per year Patient volume < 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata Additional remarks Er zijn tussen de tien en twintig gebruikers van Steglatro voor volwassenen. Met deze indicatieuitbreiding naar kinderen zullen er een paar patiënten bij komen. Expected cost per patient per year Cost € 400.00 - 500.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Declaratiedata Additional remarks Er wordt tussen de 400 en 500 euro per gebruiker Steglatro vergoed. Potential total cost per year Total cost € 2,250.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks