Bulevirtide Medicine 04 June 2024 Extended indication Extension of indication to include treatment of chronic hepatitis delta virus (HDV) infection in paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease for Hepcludex. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Bulevirtide Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Unknown Extended indication Extension of indication to include treatment of chronic hepatitis delta virus (HDV) infection in paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease for Hepcludex. Current proprietary name Already available biosimilars / generics Proprietary name Hepcludex Manufacturer Gilead Portfolio holder Gilead Mechanism of action Virus inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date November 2023 Expected Registration September 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks 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