Lisocabtagene maraleucel Medicine 04 December 2025 Extended indication Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Therapeutic value Possible added value Total cost € 9,318,000.00 Registration phase Registered Product Active substance Lisocabtagene maraleucel Domain Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Current proprietary name Already available biosimilars / generics Proprietary name Breyanzi Manufacturer BMS Portfolio holder BMS 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 Normal trajectory Particularity ATMP Yes Submission date April 2025 Expected Registration December 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks Besluit Europese Commissie - 21 november 2025 Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat er meerwaarde zal zijn ten opzichte van de standaard behandeling. Voor Brexucabtagene autoleucel werd in de Scholar-2 (PMID: 36257914) een mediane overall survival van 14,6 maanden gevonden, voor Lisocabtagene maraleucel was de mediane PFS 15,7 maanden (PMID: 38072625). Brexucabtagene autoleucel is vergelijkbaar met Lisocabtagene maraleucel qua uitkomsten. Echter lijkt de toxiciteit voor lisocel beduidend minder. Duration of treatment Frequency of administration Dosage per administration References NCT02631044 (TRANSCEND-NHL-001) Additional remarks Expected patient volume per year Patient volume 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expert opinie Additional remarks Er wordt op basis van een expertopinie een patiëntaantal van rond de dertig verwacht. 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 jan 2026. Additional remarks Wordt eenmalig toegediend. Potential total cost per year Total cost € 9,318,000.00 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