Elbasvir / grazoprevir Medicine 08 June 2021 Extended indication Extension of indication to include treatment of chronic hepatitis C (CHC) in paediatric patients 12 years of age and older who weigh at least 30kg for Zepatier. Therapeutic value No estimate possible yet Total cost € 136,144.00 Registration phase Registered and reimbursed Product Active substance Elbasvir / grazoprevir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Extension of indication to include treatment of chronic hepatitis C (CHC) in paediatric patients 12 years of age and older who weigh at least 30kg for Zepatier. Current proprietary name Already available biosimilars / generics Proprietary name Zepatier Manufacturer MSD Portfolio holder Mechanism of action Virus inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date March 2021 Expected Registration October 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie (september 2021). Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 5 - 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Er wordt beperkt gebruik van 5 á 10 patiënten per jaar verwacht. Dit is voor bepaalde subtypes hepatitis C. Expected cost per patient per year Cost € < 17,018.00 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 GIPdatabank Additional remarks Pediatrische indicatie, kosten zijn afhankelijk van dosering. Voor volwassenen met dezelfde indicatie zijn de kosten €17.018 per patiënt per jaar. Potential total cost per year Total cost € 136,144.00 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