Glecaprevir / pibrentasvir Medicine 04 June 2026 Extended indication Maviret is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Glecaprevir / pibrentasvir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Maviret is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older Current proprietary name Already available biosimilars / generics Proprietary name Maviret Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date December 2025 Expected Registration July 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit middel mocht al worden gebruikt voor acute hepatitis C infectie, dus deze indicatieuitbreiding zal geen invloed hebben op de behandeling. Duration of treatment Frequency of administration Dosage per administration References NCT04903626; Expertopinie Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 24,000.00 - 72,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Medicijnkosten.nl Additional remarks Afhankelijk van de duur van de kuur (8 tot 24 weken), kan een behandeling Maviret tussen de €24.000 en €72.000 kosten. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks