Dapagliflozine Medicine 13 December 2018 Extended indication Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) Therapeutic value Possible added value Total cost € 1,611,000.00 Registration phase Clinical trials Product Active substance Dapagliflozine Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other medication for cardiovascular diseases Extended indication Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) 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 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De fabrikant geeft aan dat de verwachte registratie in 2021 zal plaatsvinden. Therapeutic value Current treatment options SGLT2-remmers Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Het wordt steeds duidelijker dat deze compounds CV events voorkomen bij diabeten met gekend atherosclerotisch vaatlijden en de rol van deze compounds bij HF is nu focus van veel onderzoek. De verwachting is dat SGLT2-remmers een grote impact gaan hebben bij HFrEF. Duration of treatment Frequency of administration 1 times a day Dosage per administration 5-10 mg References NCT03036124;NCT03030235 Additional remarks Expected patient volume per year Patient volume 3,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank 2017 Additional remarks 2.754 gebruikers van Entresto in 2017, inschatting: zo'n 3.000 gebruikers per jaar die in aanmerking kunnen komen voor Dapagliflozine. Expected cost per patient per year Cost € 537.00 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 Z-index Additional remarks Uitgaande van 100% therapietrouw en tabletten van 10 mg en de Z-index prijs (€1,47 per tablet), zijn de kosten €537 per patiënt per jaar. Potential total cost per year Total cost € 1,611,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks