Sofosbuvir / velpatasvir / voxilaprevi Medicine 07 December 2021 Extended indication Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Sofosbuvir / velpatasvir / voxilaprevi Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg. Current proprietary name Already available biosimilars / generics Proprietary name Vosevi Manufacturer Gilead Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: sofosbuvir (NS5B-remmer), velpastasvir (NS5A-remmer), voxilaprevir (NS3/4A remmer). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2021 Expected Registration September 2021 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juli 2021. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation betreft een uitbreiding voor kinderen. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Medicijnkosten.nl, GIP databank Additional remarks Prijs per tablet betreft €545 exclusief afleverkosten en inclusief BTW. Huidige vergoeding per gebruiker in 2020 betrof €37.412. 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 No Indication extensions References Adis Insight Additional remarks Other information Additional remarks