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 Registered 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 ATMP No Submission date July 2024 Expected Registration March 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Out of the sluice Additional remarks EC decision 31/01/2025. Het financiële arrangement voor nivolumab, een geneesmiddel voor kankerbehandeling, is verlengd tot 1 januari 2027. Europees besluit van 31 januari 2025. Therapeutic value Current treatment options Atezolizumab + bevacizumab, sorafenib en lenvatinib. Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Totale overleving: 23,7 maanden met NIVO + IPI versus 20,6 maanden met LEN/SOR (HR, 0,79; 95% BI, 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 G-standaard Additional remarks Nivolumab 10mg/ml flacon, 4ml (40mg): €405,03; Nivolumab 10mg/ml flacon, 10ml (100mg): €1.012,56; Nivolumab 10mg/ml flacon, 24ml (240mg): €2.430,15; Z-index, 1 mei 2025, exclusief btw. De prijs is ingeschat in lijn met andere indicaties. Voor alle indicaties van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis lopend tot 1 januari 2027. Ipilimumab 5mg/ml, flacon 10ml (50mg): €3.268,50; Ipilimumab 5mg/ml, flacon 40ml (200mg): €13.074 Z-index, 1 mei 2025, exclusief btw. 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