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 Registration phase Positive CHMP opinion 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 Unknown ATMP Unknown Submission date 2023 Expected Registration December 2023 Orphan drug Unknown Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Posititve CHMP-opinie oktober 2023 Therapeutic value Current treatment options Therapeutic value No estimate possible yet 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 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks