Ferric carboxymaltose Medicine 04 June 2024 Extended indication Treatment of patients in heart failure with a reduced ejection fraction and with iron deficiency Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ferric carboxymaltose Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Treatment of patients in heart failure with a reduced ejection fraction and with iron deficiency Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer American Regent Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options SGLT2-remmers Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is geen meerwaarde met betrekking tot de harde eindpunten in de studie. Er is wel een verbetering op kwaliteit van leven en klachten. Duration of treatment Frequency of administration 1 times every 6 months Dosage per administration 15mg/kg References NCT03037931 Additional remarks 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1.500mg - repeated every 6 months as indicated by the results of iron indices. Expected patient volume per year Patient volume > 5,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Inschatting Dapagliflozine Additional remarks In 2018 waren er 5.533 gebruikers van Entresto, inschatting: minimaal 5.500 gebruikers per jaar die in aanmerking kunnen komen voor Dapagliflozine. Echter, net als bij de andere SGLT2-remmers is de verwachting dat dit geneesmiddel breder zal worden ingezet, dit gezien de nieuwe inzichten over de therapeutische waarde. De verwachting is dat het gebruik van SGLT2-remmers bij de huidige indicaties flink toe zal gaan nemen (verwachting: een stijging naar ruim 100.000 patiënten bij diabetes mellitus 2 op een relatief korte termijn). Ook is de verwachting dat het gebruik van SGLT2-remmers bij patiënten met hartfalen zonder diabetes mellitus breed zal worden ingezet (verwachting: mogelijk gaat dat om zo’n 250.000 tot 500.000 patiënten). Expected cost per patient per year Cost References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks