Bexagliflozine Medicine 08 June 2021 Extended indication Type 2 diabetes mellitus Therapeutic value Possible equal value Total cost € 6,650,000.00 Registration phase Clinical trials Product Active substance Bexagliflozine Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Diabetes Extended indication Type 2 diabetes mellitus Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Theracos Portfolio holder 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 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options SGLT2-remmers Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Op de komende American Diabetes Association bijeenkomst worden naar verwachting de volledige uitkomsten van de trial bekend gemaakt. Met de data die tot nu toe bekend is wordt er verwacht dat indien de bijwerkingen gunstig zijn het mogelijk hooguit een gelijke waarde zal hebben als de andere SGLT2-remmers. Duration of treatment Frequency of administration 1 times a day Dosage per administration 20mg References NCT02558296 Additional remarks Expected patient volume per year Patient volume < 19,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Stichting farmaceutische kerngetallen. Additional remarks De afgelopen jaren is er een sterke groei van SGLT-2 remmer gebruik. In 2018 maakten 19.000 diabetes patiënten gebruik van SGLT-2 remmers. Er wordt verwacht dat er mogelijk substitutie plaats zal vinden onder de SGLT-2 remmers. Expected cost per patient per year Cost € 350.00 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 GIP databank Additional remarks Vergelijkbare prijs met andere SGLT-2 remmers, zo'n €350 per patiënt per jaar. Potential total cost per year Total cost € 6,650,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Fase 2-3 studie bij hypertensie References AdisInsight Additional remarks Other information Additional remarks