Nivolumab Medicine 03 December 2024 Extended indication Extension of indication to include a new indication for OPDIVO in combination with ipilimumab as first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC) based on study CA2099DW Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registration application pending Product Active substance Nivolumab Domain Oncology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Extension of indication to include a new indication for OPDIVO in combination with ipilimumab as first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC) based on study CA2099DW Current proprietary name Already available biosimilars / generics Proprietary name Opdivo Manufacturer BMS 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 Unknown ATMP No Submission date July 2024 Expected Registration May 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Primary completion (estimated): 30 september 2026. Therapeutic value Current treatment options Sorafenib, regorafenib Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation OS: 23.7 mo with NIVO + IPI versus 20.6 mo with LEN/SOR (HR, 0.79; 95% CI, 0.65–0.96) (1,2). Voldoet niet aan PASKWIL-criteria. Duration of treatment Frequency of administration Dosage per administration References NCT04039607 (CA2099DW) (1); Robert Galle et al. JCO. 2024 (2). Additional remarks Expected patient volume per year Patient volume < 324 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2024 (1). Additional remarks In 2022 werden er 324 patiënten met hepatocellulair carcinoom gediagnosticeerd, stadium III en IV (1). Expected cost per patient per year Cost References Additional remarks 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