Pembrolizumab Medicine 09 January 2018 Extended indication 1st line non-squamous NSCLC in combination with platinum-pemetrexed. Therapeutic value No judgement Total cost € 27,050,000.00 Registration phase Unknown Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication 1st line non-squamous NSCLC in combination with platinum-pemetrexed. 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 October 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Aanvraag ingetrokken in november 2017, verwacht: nieuwe indiening. 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 270 - 811 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2016: 7728 diagnoses NSCLC, stadium 3 en 4. 35% niet-plaveiselcel. 60% onvangt eerstelijnsbehandeling, waarvan 50% chemotherapie. Dit komt neer op een totaal van 811 patienten. Realistisch volume: marktaandeel delen met nivolumab en atezolizumab: 33,3%; 270 patiënten. 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 van 4 ml, 25 mg/ml. Potential total cost per year Total cost € 27,050,000.00 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