Nivolumab Medicine 07 December 2022 Extended indication Extension of indication to include adolescent patients aged 12 years and older in treatment of advanced (unresectable or metastatic) melanoma (nivolumab monotherapy), treatment of advanced (unresectable or metastatic) melanoma (nivolumab in combination with ipilimumab) and adjuvant treatment of melanoma (nivolumab monotherapy). Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Nivolumab Domain Oncology Reason of inclusion Indication extension IND Main indication Skin cancer Extended indication Extension of indication to include adolescent patients aged 12 years and older in treatment of advanced (unresectable or metastatic) melanoma (nivolumab monotherapy), treatment of advanced (unresectable or metastatic) melanoma (nivolumab in combination with ipilimumab) and adjuvant treatment of melanoma (nivolumab monotherapy). 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 September 2022 Expected Registration June 2023 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Handelsvergunning per 31 mei 2023. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie; Additional remarks Het betreft een indicatie-uitbreiding voor 12 tot 18 jaar. Op basis van een expertopinie wordt er verwacht dat er maximaal 5 patiënten in aanmerking zullen komen voor deze indicatie. Expected cost per patient per year Cost References G-standaard Additional remarks Nivolumab 10mg/ml flacon, 4 ml (40mg): €405,03; Nivolumab 10mg/ml flacon, 10ml (100mg): €1.012,56; Nivolumab 10mg/ml flacon, 24ml (240mg): €2.430,15; Z-index, 1 april 2021, exclusief btw. 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 (50 mg): €3.268,50; Ipilimumab 5mg/ml, flacon 40ml (200 mg): €13.074 Z-index, 1 april 2021, exclusief btw. 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