Eptacog beta (activated)

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	Registration application pending

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.
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	March 2022
Orphan drug	No
Registration phase	Registration application pending

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.
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.

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 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 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.

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.