Dapagliflozine Medicine 09 January 2018 Extended indication Type 1 diabetes Therapeutic value No judgement Total cost € 9,600,000.00 Registration phase Unknown Product Active substance Dapagliflozine Domain Metabolism and Endocrinology Reason of inclusion Main indication Diabetes Extended indication Type 1 diabetes Current proprietary name Already available biosimilars / generics Proprietary name Forxiga Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Dit middel wordt voor type 2 diabetes patiënten reeds vergoed. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Insuline Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Hier is nog geen uitspraak over te doen. Fase 3 trials zijn nog niet afgerond. Fase 2 laat mogelijk een beperkte HbA1c daling zien met gelijk/minder hypo’s maar vaker optreden van ketoacidose. Het is de vraag of de firma’s een registratieaanvraag voor de indicatie type 1 diabetes zullen indienen, of die zal worden verleend en of er een vergoedingsstatus komt. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 16,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 10 tot 20% van de patiënten met type 1 diabetes, in totaal zijn er 80.000 patienten met type 1 diabetes in NL. Expected cost per patient per year Cost € < 600.00 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 Additional remarks De prijs van het middel dat nu al op de markt is voor type 2 diabetes. Potential total cost per year Total cost € 9,600,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks