Tremelimumab Medicine 03 June 2025 Extended indication Tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC) (EMERALD-3). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tremelimumab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Liver cancer Extended indication Tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC) (EMERALD-3). Current proprietary name Already available biosimilars / generics Proprietary name Imjudo Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action CTLA-4 antibody 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 No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Included in the sluice Additional remarks Fabrikant verwacht registratie in het eerste kwartaal van 2027. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten uit de EMERALD-3 bekend. Er zijn al twee andere positieve studies. De verwachting is wel dat trans arteriële chemo-embolisatie (TACE) mogelijk steeds meer vervangen zal worden door trans arteriële radio-embolisatie (TARE). Duration of treatment Frequency of administration Dosage per administration References NCT05301842 (EMERALD-3) 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 De verwachting is dat het aantal patiënten beperkt zal zijn. Het aantal patiënten dat jaarlijks TACE krijgt in Nederland is beperkt. Er wordt steeds meer radio-embolisatie met Yttrium-90' en 'Holmium-166 toegepast. Expected cost per patient per year Cost € 45,000.00 - 90,000.00 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 Afhankelijk van de behandelduur zal tremelimumab tussen de €45.000 en €90.000 kosten voor deze indicatie. Potential total cost per year Total cost 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