Nofazinlimab Medicine 03 December 2024 Extended indication Nofazinlimab in combination with lenvatinib for first line treatment of unresectable advanced hepatocellular carcinoma in adults and elderly who are ineligible for surgery and/or locoregional therapy. Therapeutic value No estimate possible yet Total cost € 7,500,000.00 Registration phase Clinical trials Product Active substance Nofazinlimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Liver cancer Extended indication Nofazinlimab in combination with lenvatinib for first line treatment of unresectable advanced hepatocellular carcinoma in adults and elderly who are ineligible for surgery and/or locoregional therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer CStone Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor 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 December 2025 Expected Registration January 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Gebaseerd op een primary completion datum in juni 2025 kan een indieningsdatum in september 2025 en een verwachte registratie in oktober 2026 geschat worden. Therapeutic value Current treatment options Atezolizumab en bevacizumab, tremelimumab en durvalumab of TKI-remmers. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn al relatief veel verschillende behandelopties in de eerste lijn van deze indicatie. Er is daarnaast geen head-to-head studie om een mogelijke meerwaarde mee aan te tonen ten opzichte van deze producten. Duration of treatment Frequency of administration Dosage per administration References NCT04194775 (CS1003-305) Additional remarks Expected patient volume per year Patient volume < 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1). Additional remarks In 2021 waren er 787 diagnoses hepatocellulair carcinoom, waarvan 200 in stadium IV (1). Er wordt op basis van een expert opinie verwacht dat er uiteindelijk maximaal 150 patiënten in aanmerking zullen komen. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Prijs in lijn verwacht met andere PD-1(L)-receptor antagonisten. Potential total cost per year Total cost € 7,500,000.00 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