Lisocabtagene maraleucel Medicine 07 December 2022 Extended indication Extension of indication to include treatment of adult patients with Second-line (2L) Transplant Intended (TI) Large B-Cell Lymphoma (LBCL) for Breyanzi. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Lisocabtagene maraleucel Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Extension of indication to include treatment of adult patients with Second-line (2L) Transplant Intended (TI) Large B-Cell Lymphoma (LBCL) for Breyanzi. Current proprietary name Already available biosimilars / generics Proprietary name Breyanzi Manufacturer Celgene 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 Yes Submission date June 2022 Expected Registration July 2023 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 Dosage per administration References NCT03575351 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 € 390,504.00 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 Drugs.com Additional remarks De Nederlandse prijs is nog niet bekend. Op basis van de US-prijs zijn de kosten voor Breyanzi per behandeling: € 390.504. Dit middel is in de sluis geplaatst tot er een financieel arrangement overeengekomen is. 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