Nivolumab Medicine 12 June 2018 Extended indication Advanced hepatocellular carcinoma (HCC) - first-line. Therapeutic value No judgement Total cost € 7,900,000.00 Registration phase Clinical trials Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Advanced hepatocellular carcinoma (HCC) - first-line. Current proprietary name Already available biosimilars / generics Proprietary name Opdivo Manufacturer BMS Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks A fully human IgG4 monoclonal antibody targeting the programmed cell death-1 receptor (PD-1). Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date November 2019 Expected Registration August 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options sorafenib, regorafenib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT02576509 Additional remarks Expected patient volume per year Patient volume < 158 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Totaal aantal patiënten in 2016 met hepatocellulair carcinoom stadium 4 betreft 158. 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 G-standaard Additional remarks nivolumab 10 mg/ml flacon, 4 ml (40 mg): € 405,03; nivolumab 10 mg/ml flacon, 10 ml (100 mg): € 1.012,56; nivolumab 10 mg/ml flacon, 24 ml (240 mg): € 2.430,15; Z-index, 1 augustus 2018, excl. BTW. Gemiddeld aantal toedieningen nog niet bekend, prijs ingeschat in lijn met andere indicaties van nivolumab. Voor alle indicatie van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019). Potential total cost per year Total cost € 7,900,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Er lopen meerdere PhIII studies, o.a. Recurrent glioblastoma - second-line monotherapy, Advanced renal cell carcinoma - first-line in combination with ipilimumab. References Clinicaltrials.gov; SPS. Additional remarks Other information Additional remarks