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 Registered and reimbursed

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 Registered and reimbursed
Additional comments Positieve CHMP-opinie in november 2021.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Betreft een uitbreiding voor kinderen. Indien de veiligheid van Sofosbuvir / velpatasvir / voxilaprevi aangetoond wordt in de studie is het de verwachting dat er voor deze optie gekozen wordt.
Dosage per administration 400/100MG

Expected patient volume per year

Patient volume

5

Market share is generally not included unless otherwise stated.

References RIVM(1); CBS (2); Expertopinie(3)
Additional comments Jaarlijks zijn er tussen de 600 en 700 meldingen van hepatitis C (1). In 2019 besloeg de bevolkingsgroep van 3-12 jaar 8,8% van de totale bevolking. Hepatitis komt in Nederland zeer zelden voor bij kinderen. Het is de verwachting dat er 5 kinderen per jaar in aanmerking zullen komen voor deze indicatie (3).

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.