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 and reimbursed

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 and reimbursed
Additional comments Positieve CHMP-opinie in juli 2021.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Betreft een uitbreiding voor kinderen. Indien veiligheid van dit middel (triple therapie) is aangetoond is de verwachting dat dit middel de voorkeur geniet boven Sofosbuvir / velpatasvir (dubbel therapie).

Expected patient volume per year

Patient volume

5

Market share is generally not included unless otherwise stated.

References RIVM (1); CBS (2); Expert opinie (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 (2). De verwachting is dat hepatitis C slechts zeer zelden voor zal komen bij kinderen. Naar schatting ongeveer 5 kinderen per jaar (3).

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.