Lifileucel Medicine 12 June 2018 Extended indication Maliganant melanoma, advanced melanoma. Therapeutic value No estimate possible yet Total cost € 260,400,000.00 Registration phase Clinical trials Product Active substance Lifileucel Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Maliganant melanoma, advanced melanoma. Current proprietary name Already available biosimilars / generics Proprietary name Contego Manufacturer Iovance 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 Autologe T cell therapie die gebruik maakt van tumor infiltrating lymphocytes (TILs) die uit de tumor van de patiënt zijn geïsoleerd. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials 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 Maligne melanoma is een erg competitief veld. Er worden veel cellulaire producten ontwikkeld voor dezelfde indicatie. Duration of treatment Frequency of administration Dosage per administration References NCT02360579 Additional remarks Expected patient volume per year Patient volume < 744 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Melanoom van de huid betreft 6.729 patiënten in 2018, hiervan zijn er 541 patiënten met stadium 3 en 203 patiënten met stadium 4 (maximaal 744 patiënten die in aanmerking komen voor deze behandeling.) Expected cost per patient per year Cost € 300,000.00 - 400,000.00 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 Additional remarks Indien de resultaten van de studie positief zijn is de prijs voor een behandeling hoog. Mogelijk vergelijkbaar met CAR-T therapieën (ongeveer €300.000-€400.000). Potential total cost per year Total cost € 260,400,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks