Lisocabtagene maraleucel Medicine 03 June 2025 Extended indication Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory Marginal zone lymphoma in adults and elderly previously treated with systemic therapies including anti-CD20 and alkylating agent or relapsed after haematopoietic stem cell transplant. Therapeutic value No estimate possible yet Total cost € 4,659,000.00 Registration phase Registration application pending Product Active substance Lisocabtagene maraleucel Domain Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory Marginal zone lymphoma in adults and elderly previously treated with systemic therapies including anti-CD20 and alkylating agent or relapsed after haematopoietic stem cell transplant. Current proprietary name Already available biosimilars / generics Proprietary name Breyanzi Manufacturer BMS Portfolio holder Mechanism of action Autologous modified cell therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CD19-directed genetically modified autologous cellular immunotherapy. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Yes Submission date May 2026 Expected Registration December 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Broadly excluded 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 NCT04245839 Additional remarks Expected patient volume per year Patient volume 15 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: NKR2022 Additional remarks In 2022 waren er 347 patiënten in Nederland met Marginalezonelymfoom (1). Op basis van expert opinie wordt er verwacht dat er ongeveer vijftien van deze patiënten per jaar in aanmerking zullen komen. Expected cost per patient per year Cost € 310,600.00 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 Z-index, 1 mei 2025. Additional remarks De apothekersinkoopprijs van liso-cel is € 310.650. Dit geneesmiddel is breed in de sluis geplaatst. Potential total cost per year Total cost € 4,659,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks