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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 comments 
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 comments 
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 comments 
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.