Nivolumab Medicine 09 January 2018 Extended indication Adjuvant melanoma stage III - post-resection adjuvant therapy in high-risk patients. Therapeutic value No judgement Total cost € 17,500,000.00 Registration phase Registration application pending Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Main indication Skin cancer Extended indication Adjuvant melanoma stage III - post-resection adjuvant therapy in high-risk patients. 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 remmer. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date October 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 Ipilimumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 12 month / months Frequency of administration 1 times every 2 weeks Dosage per administration 3 mg/kg References Weber et al. N Engl J Med. 2017 Nov 9;377(19):1824-1835 Additional remarks Maximaal 1 jaar behandelduur. Expected patient volume per year Patient volume 350 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Oncoline; Fabrikant Additional remarks NKR 2015: 427 diagnoses melanoom stadium 3. Oncoline: momenteel wordt er niet geadviseerd om patiënten met melanoom buiten onderzoeksverband systemisch adjuvante behandeling te geven. Fabrikant geeft een realistisch patiëntenvolume aan van 350. 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 €1.036 voor 10 ml van 10 mg/ml en €414,30 voor 4 ml van 10 mg/ml. Maximum uitgaande van 12 maanden behandeling van een volwassene van 70 kg. Potential total cost per year Total cost € 17,500,000.00 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 Diverse References Fabrikant Additional remarks Other information Additional remarks