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Eptacog beta (activated)

Cevenfacta

Extended indication CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of b
Therapeutic value Possible equal value
Total cost 342,000.00
Registration phase Registered

Product

Active substance Eptacog beta (activated)
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Hemostasis promoting medication
Extended indication CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: - in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ≥5 Bethesda Units (BU)); - in patients with congenital haemophilia with low titre inhibitors (BU <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.
Proprietary name Cevenfacta
Manufacturer rEVO
Mechanism of action Coagulant
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
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 Normal trajectory
Submission date February 2021
Expected Registration July 2022
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP opinie ontvangen in mei 2022.

Therapeutic value

Current treatment options Eptacog alfa, emicizumab, protrombinecomplexen
Therapeutic value Possible equal value
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 geproduceerde eptacog alfa. Echter klinische vergelijking tussen deze twee ontbreekt. Betreft dan dus grotendeels substitutie. Een beperking is dat eptacog beta niet voor kinderen <12 jaar wordt geregistreerd.
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.
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
References Medicijnkosten.nl
Additional remarks De verwachting is dat de prijs vergelijkbaar zal zijn met eptacog alfa (€820 voor een spuit van 1mg). Per toediening zal er gemiddeld 7mg 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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.