Lisocabtagene maraleucel Medicine 03 December 2024 Extended indication Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory follicular lymphoma in adults and elderly who have received 2 or more prior lines of systemic therapy 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 Indolent non-Hodgkin’s lymphoma Extended indication Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory follicular lymphoma in adults and elderly who have received 2 or more prior lines of systemic therapy 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 Unknown ATMP Yes Submission date August 2024 Expected Registration March 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options De huidige standaardbehandeling voor patiënten met FL met een recidief na eerstelijns behandeling bestaat uit een aantal immunochemotherapie opties, radiotherapie of radio-labeled antilichaam, rituximab monotherapie of in combinatie met lenalidomide, en idelalisib (in rituximab refractaire patiënten). In de derde of latere lijns behandeling kunnen dezelfde opties gebruikt worden voor zover deze nog niet gebruikt zijn, of kan er gekozen worden voor een op PECC (etoposide, chlorambucil, lomustine, prednisolon) of DHAP (dexamethason, cisplatin, cytarabine) gebaseerd chemotherapie schema. De behandelkeuze hangt af van de eerder gegeven behandelingen en de responsduur. 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 (TRANSCEND FL) Additional remarks For follicular lymphoma (FL), the dose is 90 to 110 x 10^6 CAR-positive viable T cells. A single dose of BREYANZI consists of 1:1 CAR-positive viable T cells of the CD8 and CD4 components, with each component supplied separately in one to four single-dose 5 mL vials. Each mL contains ≥1.5 × 10^6 to 70 × 10^6 CAR-positive viable T cells. 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 € 345,000.00 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 Zorginstituut Nederland. Advies - vergoed lisocabtagene maraleucel (Breyanzi®) voor de behandeling van lymfeklierkanker. 2024. Additional remarks De AIP van liso-cel is € 345.000. Dit geneesmiddel is breed in de sluis geplaatst. 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