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Sofosbuvir / velpatasvir / voxilaprevi

Vosevi

Extended indication Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Sofosbuvir / velpatasvir / voxilaprevi
Domain Infectious diseases
Reason of inclusion Indication extension
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.
Proprietary name Vosevi
Manufacturer Gilead
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Werkingsmechanisme: sofosbuvir (NS5B-remmer), velpastasvir (NS5A-remmer), voxilaprevir (NS3/4A remmer).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration September 2021
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie in juli 2021.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation betreft een uitbreiding voor kinderen.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Adis Insight

Other information

There is currently no futher information available.