Tenofovir alafenamide Medicine 07 December 2022 Extended indication Extension of indication to include treatment of chronic hepatitis B-infected children from 6 years and older and weighing at least 25 kilograms for Vemlidy, based on the interim results from Week 24 clinical study report (CSR). Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tenofovir alafenamide 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 B-infected children from 6 years and older and weighing at least 25 kilograms for Vemlidy, based on the interim results from Week 24 clinical study report (CSR). Current proprietary name Already available biosimilars / generics Proprietary name Vemlidy Manufacturer Gilead Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2022 Expected Registration July 2023 Orphan drug No 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 De kosten voor tenofovir alafenamide oraal tablet 300 mg is rond de $106 voor een voorraad van 20 tabletten in de VS. De prijs in Nederland is nog niet bekend. 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