Vilobelimab Medicine 05 December 2023 Extended indication Gohibic is indicated for the treatment of adult patients with SARS‑CoV2‑induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of Standard of Care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Vilobelimab Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication Gohibic is indicated for the treatment of adult patients with SARS‑CoV2‑induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of Standard of Care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). 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 January 2025 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie november 2024 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 dat het complementsysteem remt. Dit zou moeten zorgen voor een lagere mortaliteit bij de eindstadia van COVID-19. Hierdoor is dit geneesmiddel is in principe variantonafhankelijk. Er is op dit moment echter nog niet genoeg bewijs om een plaatsbepaling te doen (2). Duration of treatment Frequency of administration Dosage per administration 800 mg References NCT04333420 (PANAMO) (1); Expertopinie (2). Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Coronadashboard. Rijksoverheid (1); Expertopinie (2). Additional remarks In 2023 waren er 857 intensive care opnames van COVID patiënten (1). Er wordt verwacht dat er mogelijk 100 patiënten behandeld zullen worden met vilobelimab (2). Expected cost per patient per year Cost References Drugs.com Additional remarks De prijs voor Vilobelimab intraveneuze oplossing (10mg/mL) is $6,350 voor 80ml. 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