Nivolumab Medicine 12 June 2018 Extended indication Gastric cancer 3/4e lijn Therapeutic value No judgement Total cost € 332,500.00 Registration phase Registration application pending Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Main indication Stomach cancer Extended indication Gastric cancer 3/4e lijn 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 PD-1 antilichaam. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date August 2017 Expected Registration September 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Nivolumab heeft in de sluis gezeten, de afspraken die gedurende die periode zijn gemaakt t.a.v. de vergoeding gelden ook voor deze indicatie-uitbreiding. Therapeutic value Current treatment options BSC Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 1.92 month / months Frequency of administration 1 times every 2 weeks Dosage per administration 3 mg/kg References Kang et al. Lancet. 2017 Dec 2;390(10111):2461-2471 Additional remarks Toedieningsfrequentie 1 maal per 2 weken. Mediane behandelduur 1,92 maanden. Expected patient volume per year Patient volume 26 - 44 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; NKR Additional remarks In 2016 waren er 400 diagnoses stadium IV maagcarcinoom. Gezien de verwachte plaats in de behandeling zal het patiëntvolume niet erg hoog zijn. De fabrikant geeft aan dat het 26-44 patiënten verwacht binnen deze indicatie. Expected cost per patient per year Cost € 9,000.00 - 10,000.00 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 Fabrikant Additional remarks €1.036 voor 10 ml van 10 mg/ml en €414,30 voor 4 ml van 10 mg/ml. Voor een behandelduur van 1,92 maanden voor een patiënt van 70 kg komt dit neer op 9 flacons en dus €9.324. Potential total cost per year Total cost € 332,500.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Diverse References Clinicaltrial.gov Additional remarks Other information Additional remarks