Durvalumab / Tremelimumab Medicine 09 January 2018 Extended indication Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab, 1L. Therapeutic value No judgement Total cost € 14,800,000.00 Registration phase Clinical trials Product Active substance Durvalumab / Tremelimumab Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab, 1L. Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi / Tremelimumab 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 Anti PD-L1 + anti CTLA-4. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date 2018 Expected Registration 2019 Orphan drug No Registration phase Clinical trials 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 / 1 mg/kg References Fabrikant; NCT02453282 Additional remarks Toedingsfrequentie: Durvalumab 1 maal per 2 weken; Tremelimumab 1 maal per 4 weken met een maximum van 4 doses. Expected patient volume per year Patient volume 296 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Fabrikant Additional remarks NKR 2015: 5.304 diagnoses niet-kleincellig longcarcinoom stadium 4. Fabrikant: realistisch volume bedraagt 296 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 Additional remarks Verwacht in lijn met andere immunotherapieën. €1.098,16 voor nivolumab 10mg per ml fl 10 ml; €3.355,96 voor pembrolizumab 25 mg per ml fl 4ml. Berekening gebasseerd op EPAR. Potential total cost per year Total cost € 14,800,000.00 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. Meerdere studies teruggetrokken, 1 PhIII studie loopt nog: Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy. References Additional remarks Other information Additional remarks