Axicabtagene ciloleucel Medicine 07 June 2022 Extended indication Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Axicabtagene ciloleucel Domain Hematology Reason of inclusion Indication extension IND Main indication Unknown Extended indication Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) Current proprietary name Already available biosimilars / generics Proprietary name Yescarta Manufacturer Gilead Portfolio holder Mechanism of action CAR-T therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date December 2021 Expected Registration October 2022 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 1 times a day 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 Fabrikant; Pakketadvies sluisgeneesmiddel axicabtagene ciloleucel (Yescarta®) voor volwassenen met recidiverend of refractair DLBCL en PMBCL na 2 of meer lijnen systemische therapie, ZIN 2019. medicijnkosten.nl Additional remarks De kosten van een eenmalige infusie van axi-cel zijn voor deze indicatie nog niet vastgesteld. De kosten kunnen mogelijk vergelijkbaar zijn met de indicatie waar reeds een uitspraak over gedaan is door middel van een pakketadvies. Yescarta inf dispersie zak 68ml Axicabtagen ciloleucel (incl. BTW): € 356.430,00 per stuk. 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