Empagliflozine Medicine 06 June 2023 Extended indication Extension of indication for Jardiance to include treatment of children aged 10 years and above with type 2 diabetes. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Empagliflozine Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Extension of indication for Jardiance to include treatment of children aged 10 years and above with type 2 diabetes. Current proprietary name Already available biosimilars / generics Proprietary name Jardiance Manufacturer Boehringer Ingelheim Portfolio holder Boehringer Ingelheim Mechanism of action SGLT inhibitor 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 Unknown ATMP No Submission date January 2023 Expected Registration November 2023 Orphan drug No 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 Duration of treatment Frequency of administration 1 times a day Dosage per administration 10 - 25mg References NCT03429543 (DINAMO) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 383.00 - 898.00 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 Farmacotherapeutisch Kompas Additional remarks Op basis van het FK, zal de behandeling tussen de €383 en €898 per patiënt per jaar kosten 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