Bevacizumab-vikg Medicine 08 June 2021 Extended indication Wet age-related macular degeneration Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Bevacizumab-vikg Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Wet age-related macular degeneration Current proprietary name Already available biosimilars / generics Proprietary name Lytenava Manufacturer Outlook Therapeutics 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 New therapeutical formulation ATMP No Submission date December 2022 Expected Registration February 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Dit product is als nieuw middel ingediend bij de EMA (gegeven de nieuwe toedieningsvorm). Negatieve CHMP opinie ontvangen in november 2021. Herindiening december 2022. Therapeutic value Current treatment options Ranibizumab, aflibercept, brolucizumab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Dit betreft een geregistreerde versie van de doorgeleverde bereiding van bevacizumab ooginjecties. Duration of treatment Frequency of administration Dosage per administration 1,25mg References NORSE studies Additional remarks Expected patient volume per year Patient volume > 50,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Opendisdata; Additional remarks Dit betreft een intravitreale versie van de nu de doorgeleverde bereiding van bevacizumab ooginjecties. In 2019 zijn er bij ongeveer 50.000 patiënten met AMD bevacizumab injecties toegediend. Dit aantal neemt echter jaarlijks toe. Expected cost per patient per year Cost References medicijnkosten.nl; Additional remarks De kosten zijn mogelijk vergelijkbaar met ranibizumab. Lucentis, 0,23ml injectievloeistof 10mg/ml €726,50. De kosten zullen hoger uitvallen dan de doorgeleverde bereiding van bevacizumab ooginjecties. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Branch retinal vein occlusion; Diabetic macular oedema. References Adis Insight Additional remarks Other information Additional remarks