Eptacog beta (activated) Medicine 12 June 2018 Extended indication Haemophilia A and B; in pts with inhibitory antibodies to factor VIII or IX. Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Eptacog beta (activated) Domain Cardiovascular diseases Reason of inclusion Main indication Hemostasis promoting medication Extended indication Haemophilia A and B; in pts with inhibitory antibodies to factor VIII or IX. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer rEVO Portfolio holder Mechanism of action Unknown 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 New medicine ATMP Unknown Submission date 2018 Expected Registration 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Eptacog alfa en in de toekomst Emicizumab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References 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 15 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks De verwachte patiëntaantallen komen naar verwachting overeen met de aantallen bij emicuzumab bij de indicatie "Prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adults and children with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors". Respectievelijk 100 patiënten maximaal en het aantal dat daadwerkelijk behandeld zal worden op 15, wellicht oplopend tot 50. Eptacog beta kan ook bij hemofilie B met remmende antistoffen worden toegepast, maar dat is verwaarloosbaar want komt zelden voor bij hemofilie B. 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 No Indication extensions References Additional remarks Other information Additional remarks