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.