Nivolumab Medicine 09 January 2018 Extended indication Metastatic colorectal carcinoma with mismatch-repair deficient (dMMR) microsatellite instability–high (MSI-H). Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Main indication Colon cancer Extended indication Metastatic colorectal carcinoma with mismatch-repair deficient (dMMR) microsatellite instability–high (MSI-H). 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 Financieel arrangement van toepassing op alle indicaties. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2017 Expected Registration April 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Therapeutic value Current treatment options Concurrentie van Pembrolizumab en ander PD1 en PDL-1 remmers 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 Expected patient volume per year Patient volume < 156 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Zoran et al. Familial Cancer 15 (2016): 405–412. Additional remarks 3115 patienten met CRC stadium 4 (NKR 2015). 15% van de CRC patienten heeft MSI-H (Zoran et al. Familial Cancer 15 (2016): 405–412.). Expertopinie: 5% MSI-H is realistisch. Expected cost per patient per year Cost References Additional remarks 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