Extended indication Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) dif
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Axicabtagene ciloleucel
Domain Hematology
Reason of inclusion Indication extension
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)
Proprietary name Yescarta
Manufacturer Gilead
Mechanism of action CAR-T therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date December 2021
Expected Registration October 2022
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment one-off
Frequency of administration 1 times a day

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

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 comments 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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.