Dapagliflozine Medicine 08 December 2020 Extended indication Extension of indication for Forxiga / Edistride to include treatment of children aged 10 years and adolescents with T2DM based on the results from studies Therapeutic value No estimate possible yet Total cost € 37,000.00 Registration phase Positive CHMP opinion Product Active substance Dapagliflozine Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Extension of indication for Forxiga / Edistride to include treatment of children aged 10 years and adolescents with T2DM based on the results from studies Current proprietary name Already available biosimilars / generics Proprietary name Forxiga Manufacturer AstraZeneca Portfolio holder Mechanism of action SGLT inhibitor Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2020 Expected Registration December 2021 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in het vierde kwartaal van 2021. Positieve CHMP opinie ontvangen oktober 2021. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment zijn er niet veel patiënten in Nederland in deze leeftijdsgroep die in aanmerking zullen komen voor dapagliflozine. Duration of treatment Frequency of administration 1 times a day Dosage per administration 5mg References NCT03199053 Additional remarks Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Baan CA, Poos MJJC. Hoe vaak komt diabetes mellitus voor en hoeveel mensen sterven eraan? In: Volksgezondheid Toekomst Verkenning, Nationaal Kompas Volksgezondheid. Bilthoven: RIVM, 2013.; Diabetes vereniging Nederland; Additional remarks Het overgrote deel (ongeveer 98%) van de kinderen heeft DM type 1. Het aantal kinderen met DM type 2 is de laatste jaren toegenomen. Ongeveer 12.000 kinderen en jongvolwassenen hebben diabetes. Dit betekent dat er maximaal 240 patiënten in Nederland DM type 2 hebben. Naar verwachting zal deze behandeling bij maximaal 100 patiënten ingezet worden. Expected cost per patient per year Cost € 370.00 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 medicijnkosten; Additional remarks Forxiga tablet filmomhuld 5mg 1x per dag dus 365,25*€1,014= €370,36 Potential total cost per year Total cost € 37,000.00 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 Renal failure References adisinsight Additional remarks Lopende fase 3 studie Other information Additional remarks