Nivolumab Medicine 09 January 2018 Extended indication Mesothelioom (in combinatie met ipilimumab). Therapeutic value No judgement Total cost € 28,350,000.00 Registration phase Clinical trials Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Mesothelioma Extended indication Mesothelioom (in combinatie met ipilimumab). 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 PD-1 antilichaam. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date October 2019 Expected Registration August 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Alle PD1 en PDL1 remmers worden verwacht voor deze indicatie (pembrolizumab, atezolizumab) 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 Additional remarks Behandelduur is onbekend Expected patient volume per year Patient volume < 567 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2016 Additional remarks 567 diagnoses pleuramesothelioom. 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, januari 2019 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 is nog niet bekend, prijs ingeschat in lijn met andere indicaties. 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 € 28,350,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks