Durvalumab Medicine 12 June 2018 Extended indication Non-small cell lung cancer (NSCLC), 1L monotherapy Therapeutic value No judgement Total cost € 48,459,960.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication Non-small cell lung cancer (NSCLC), 1L monotherapy 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 Unknown Particularity Indication extension ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant: "Imfinzi plus tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy. The MYSTIC trial continues as planned to assess the additional primary endpoints of overall survival for Imfinzi monotherapy and for the Imfinzi plus tremelimumab combination." Therapeutic value Current treatment options Platinum doublet chemotherapie / pembrolizumab voor PD-L1 > 50%. 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 NCT02453282 Additional remarks Expected patient volume per year Patient volume 198 - 988 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References De fabrikant geeft aan dat ze verwachten dat er 988 patiënten binnen de indicatie zullen vallen waarvan 198 mogelijk daadwerkelijk behandeld zullen worden. Additional remarks Expected cost per patient per year Cost € 81,720.00 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; Pakketadvies pembrolizumab (Keytruda®) 2016 Zorginstituut Nederland Diemen Additional remarks Naar verwachting is de maandelijkse kostprijs vergelijkbaar met maandelijkse kostprijs van pembrolizumab (€6.810). Potential total cost per year Total cost € 48,459,960.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks