Pembrolizumab Medicine 09 January 2018 Extended indication Breast cancer, metastatic triple negative. Therapeutic value No judgement Total cost € 5,000,000.00 Registration phase Unknown Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Main indication Breast cancer Extended indication Breast cancer, metastatic triple negative. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder Mechanism of action Unknown 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 Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration December 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Therapeutic value Current treatment options 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 < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2015: 100 diagnoses mammacarcinoom HR-, HER-, stadium 4 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 Medicijnkosten.nl Additional remarks € 3.355,96 per injectieflacon 25MG/ML FL 4ML (oplossing). € 1677,98 per injectieflacon 50MG FL (poeder) Potential total cost per year Total cost € 5,000,000.00 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