Durvalumab Medicine 09 January 2018 Extended indication Non-small cell lung cancer (NSCLC) stage IIIB, unresectable. Therapeutic value No judgement Total cost € 61,850,000.00 Registration phase Unknown Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication Non-small cell lung cancer (NSCLC) stage IIIB, unresectable. Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date October 2017 Expected Registration August 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Nivolumab, Pembrolizumab 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 50 - 2,424 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Fabrikant Additional remarks NKR 2015: NSCLC stadium 3: 2424 diagnoses. Fabrikant: 50 patienten in 2019 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 Verwacht in lijn met andere immunotherapieën. €1098,16 voor nivolumab 10mg per ml fl 10 ml; €3355,96 voor pembrolizumab 25 mg per ml fl 4ml. Potential total cost per year Total cost € 61,850,000.00 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 Nog voor veel indicaties in ontwikkeling, monotherapie en in combinatie met tremelimumab. References Additional remarks Other information Additional remarks