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.