Sofosbuvir / velpatasvir Medicine 07 December 2021 Extended indication Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 3 years of age and older. Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Sofosbuvir / velpatasvir Domain Infectious diseases Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Epclusa Manufacturer Gilead Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: sofosbuvir (NS5B-remmer), velpastasvir (NS5A-remmer) Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration January 2022 Orphan drug Unknown Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in november 2021. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration Dosage per administration 400/100MG References Additional remarks Expected patient volume per year Patient volume 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References RIVM(1); CBS (2); Expertopinie(3) Additional remarks 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 Cost References medicijnkosten.nl Additional remarks Gemiddelde prijs betreft €321,16 inclusief btw en exclusief afleverkosten. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks