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 € 13,629,000.00 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 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 Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 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 € 413,000.00 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 Horizonscan emicizumab Additional remarks De verwachting is dat de prijs competitief zal zijn aan emicizumab bij dezelfde indicatie. Redenatie bij emicizumab: Bij een dosering van 1,5 mg/kg per week en een gewicht van 70 kg, is de benodigde emicuzimab 105 mg per week. Flacon a 105 mg bedraagt €7.950,00. De kosten per jaar, voor een patiënt van 70 kg bedragen €7.950,00 *52 = €413.400,00. De variatie van de prijs is daardoor afhankelijk van het gewicht van de patiënt. Potential total cost per year Total cost € 13,629,000.00 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