Eptacog beta (activated) Medicine 12 June 2018 Extended indication Haemophilia A and B; in patients with inhibitory antibodies to factor VIII or IX. Therapeutic value Possible equal value Total cost € 342,000.00 Registration phase Clinical trials Product Active substance Eptacog beta (activated) Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Hemostasis promoting medication Extended indication Haemophilia A and B; in patients with inhibitory antibodies to factor VIII or IX. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer rEVO Portfolio holder Mechanism of action Coagulant Route of administration Unknown Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Meer informatie over de werking van het product: "A transgenically produced recombinant form of human factor VIIa." Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Eptacog alfa, emicizumab, protrombinecomplexen Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Het verschil tussen eptacog alfa in tegenstelling tot eptacog beta is dat het geproduceerd is op transgene wijze. Daardoor zou het een stabielere / natuurlijkere glycosylering hebben dan het recombinant geproduceerd eptacog alfa. Echter klinische vergelijking tussen deze twee ontbreekt. Betreft dan dus grotendeels substitutie. Duration of treatment Frequency of administration Dosage per administration References NCT02548143 Additional remarks PERSEPT 1: "Intravenous 75 μg/kg or 225 μg/kg initial doses with 75 μg/kg subsequent doses by schedule were administered until clinical response." Expected patient volume per year Patient volume < 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NVHB Additional remarks Aantallen patiënten hemofilie A met remmers wordt door de behandelaren (NVHB) ingeschat op maximaal totaal 30 patiënten. Expected cost per patient per year Cost € 5,700.00 - 17,100.00 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.nl Additional remarks De verwachting is dat de prijs vergelijkbaar zal zijn met eptacog alfa (€820 voor een spuit van 1 mg). Per toediening zal er gemiddeld 7 mg moeten worden toegediend (€5.700). Bij bloedingen 1-3 toedieningen (maximaal €17.100), bij profylaxe meermaals. Potential total cost per year Total cost € 342,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks