Extended indication

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged

Therapeutic value

No estimate possible yet

Registration phase

Positive CHMP opinion

Product

Active substance

sofosbuvir / velpatasvir

Domain

Infectious diseases

Reason of inclusion

Indication extension

Main indication

Viral infections other

Extended indication

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 3 years of age and older.

Proprietary name

Epclusa

Manufacturer

Gilead

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Extramural (GVS)

Additional comments
Werkingsmechanisme: sofosbuvir (NS5B-remmer), velpastasvir (NS5A-remmer)

Registration

Registration route

Centralised (EMA)

Submission date

2021

Expected Registration

January 2022

Registration phase

Positive CHMP opinion

Additional comments
Positieve CHMP-opinie in november 2021.

Therapeutic value

Therapeutic value

No estimate possible yet

Substantiation

Betreft een uitbreiding voor kinderen.

Dosage per administration

400/100MG

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References
medicijnkosten.nl
Additional comments
Gemiddelde prijs betreft €321,16 inclusief btw en exclusief afleverkosten.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.