Durvalumab Medicine 09 January 2018 Extended indication Non-small cell lung cancer (NSCLC) stage III, unresectable. Therapeutic value No judgement Total cost € 66,830,000.00 Registration phase Registration application pending Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication Non-small cell lung cancer (NSCLC) stage III, 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 PD-L1 remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date October 2017 Expected Registration November 2018 Orphan drug No Registration phase Registration application pending 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 1 times every 2 weeks Dosage per administration 10 mg/kg References Fabrikant; Antonia et al. N Engl J Med 2017;377:1919-29. Additional remarks Expected patient volume per year Patient volume 815 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: realistisch volume bedraagt 815 patienten in 2019. Expected cost per patient per year Cost € 82,000.00 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 Fabrikant Additional remarks Verwacht in lijn met andere immunotherapieën. Naar verwachting is de maandelijkse kostprijs vergelijkbaar met maandelijkse kostprijs van pembrolizumab (€6.810). Potential total cost per year Total cost € 66,830,000.00 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