Durvalumab Medicine 05 December 2023 Extended indication Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Therapeutic value No estimate possible yet Total cost € 23,490,000.00 Registration phase Registered Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor 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 ATMP No Submission date 2023 Expected Registration December 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks Positieve CHMP-opinie oktober 2023, registratie in november 2023. Therapeutic value Current treatment options Durvalumab in combinatie met tremelimumab, atezolizumab-bevacizumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het studiedesign is ingewikkeld. Op dit moment wordt de combinatie van atezolizumab/bevacizumab veel gegeven aan deze patiënten. Het is niet duidelijk welke behandeling effectiever is. Duration of treatment Frequency of administration Dosage per administration 1500mg References NCT03298451 Additional remarks Expected patient volume per year Patient volume < 348 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) NKR 2021 Additional remarks Totaal aantal nieuwe HCC-patiënten in 2021 per jaar 787 patiënten. Hiervan bevonden zich er 169 in stadium 2 en 179 in stadium 3 (1). Expected cost per patient per year Cost € 45,000.00 - 90,000.00 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 Andere indicaties voor Durvalumab Additional remarks De mediane behandelduur in de studie was 5,5 maand. https://pmc.ncbi.nlm.nih.gov/articles/PMC9396100/ https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.TPS4144 https://www.annalsofoncology.org/article/S0923-7534(24)00049-8/fulltext Dosering conform SMPC is 1.500 elke vier weken tot aan progressie. 1 flacio durva is 500ml dus per cycle 3 flacons = €5.550. Voor 5.5 maand is dat €33.069. Potential total cost per year Total cost € 23,490,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks