Vilobelimab Medicine 05 December 2023 Extended indication COVID-19 pneumonia Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Vilobelimab Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication COVID-19 pneumonia Current proprietary name Already available biosimilars / generics Proprietary name Gohibic Manufacturer Inflarx Portfolio holder Inflarx Mechanism of action Complement inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date August 2023 Expected Registration September 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Het geneesmiddel heeft een fast track registratie in de Verenigde Staten. Therapeutic value Current treatment options Tocilizumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is een anti-c5a monoklonaal antilichaam. Er is een publicatie met meerwaarde in mechanisch geventileerde patiënten. Dit geneesmiddel is in principe variant afhankelijk. Er is op dit moment nog niet genoeg bewijs om een plaatsbepaling te doen. Duration of treatment Frequency of administration Dosage per administration 800mg References NCT04333420 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) https://coronadashboard.rijksoverheid.nl/; (2) Expert opinie; Additional remarks In 2023 waren er 857 intensive care opnames van COVID patiënten. Er wordt verwacht dat er mogelijk 100 patiënten behandeld zullen worden met vilobelimab. Expected cost per patient per year Cost References Drugs.com Additional remarks De prijs voor Vilobelimab intraveneuze oplossing (10mg/mL) is $6,350 voor 80 milliliters. De prijs in de Verenigde Staten is vaak hoger dan in Nederland. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks