Extended indication Retinopathy of prematurity
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Aflibercept
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Eye disorders
Extended indication Retinopathy of prematurity
Proprietary name Eylea
Manufacturer Bayer
Mechanism of action Angiogenesis inhibitor
Route of administration Intravitreal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2021
Expected Registration September 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Anti-VEGF (bevacizumab en ranibizumab), laser en cryo-therapie
Therapeutic value No estimate possible yet
Substantiation Naar verwachting zal laserbehandeling de eerste keuze van behandeling bij ernstige ROP blijven. Anti-VEGF kan aanvullend zinvol zijn, of als laser niet mogelijk is. Tevens zijn de lange termijn effecten niet bekend voor anti-VEGF in de ogen bij prematuren. Er wordt daarom voorzichtiger met anti-VEGF behandeld. Ook bevacizumab en ranibizumab zijn al geregistreerd voor deze indicatie.
Duration of treatment one-off
Dosage per administration 0,4 mg
References NCT04004208
Additional comments Subjects randomized to aflibercept will receive a intravitreal (IVT) injection of aflibercept per eligible eye at baseline and, if needed, up to a defined number of additional injections in each eye.

Expected patient volume per year

Patient volume

4 - 5

Market share is generally not included unless otherwise stated.

References Ludwig et al. Ophthalmic Surg Lasers Imaging Retina. 2017 Jul 1;48(7):553-562; Perinatale Zorg in Nederland 2016. Perined, 2018. Horizonscan ranibizumab ROP.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension No
References Fabrikant

Other information

There is currently no futher information available.