Dapagliflozine Medicine 08 December 2020 Extended indication Treatment of hospitalized adult patients with COVID-19 to prevent organ damage and to improve survival. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Dapagliflozine Domain Infectious diseases Reason of inclusion Indication extension IND Main indication COVID-19 Extended indication Treatment of hospitalized adult patients with COVID-19 to prevent organ damage and to improve survival. 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 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De trial heeft de primaire eindpunten niet gehaald. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De trial heeft de primaire eindpunten niet gehaald. Duration of treatment Average 30 day / days Frequency of administration 1 times a day Dosage per administration 10mg References NCT04350593 (DARE-19); https://www.astrazeneca.com/media-centre/press-releases/2021/update-on-farxiga-covid-19-dare-19-phase-iii-trial.html 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 Zie actuele informatie hierover bij het RIVM: https://www.rivm.nl/coronavirus-covid-19/actueel Expected cost per patient per year Cost € 44.00 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 G-standaard Additional remarks Uitgaande van 100% therapietrouw en tabletten van 10mg en de prijs in de G-Standaard (€1,47 per tablet) 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 Yes Indication extensions Renal failure References adisinsght Additional remarks Lopende fase 3 studie Other information Additional remarks