Aflibercept Medicine 07 December 2021 Extended indication Retinopathy of prematurity Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Aflibercept Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Eye disorders Extended indication Retinopathy of prematurity Current proprietary name Already available biosimilars / generics Proprietary name Eylea Manufacturer Bayer Portfolio holder Mechanism of action Angiogenesis inhibitor Route of administration Intravitreal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date November 2021 Expected Registration September 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Anti-VEGF (bevacizumab en ranibizumab), laser en cryo-therapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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 Frequency of administration Dosage per administration 0,4 mg References NCT04004208 Additional remarks 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. Maximum patient volume for sluice 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. Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Fabrikant Additional remarks Other information Additional remarks