Tremelimumab Medicine 08 June 2021 Extended indication Durvalumab in combinatie met tremelimumab als eerste lijnsbehandeling bij unresectable HCC. Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Tremelimumab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Liver cancer Extended indication Durvalumab in combinatie met tremelimumab als eerste lijnsbehandeling bij unresectable HCC. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action CTLA-4 antibody 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 No Submission date July 2022 Expected Registration July 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in juli 2022. Therapeutic value Current treatment options Immunotherapie en doelgerichte therapie Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt verwacht dat deze behandeling mogelijk standaardzorg zal worden en de markt verdeeld zal worden over deze therapie en de atezolizumab/bevacizumab combinatie therapie. Duration of treatment Frequency of administration Dosage per administration References NCT03298451 Additional remarks Behandelduur tot progressie. Expected patient volume per year Patient volume < 158 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2016: 158 patiënten met HCC stadium 4. De werkgroep verwacht dat er substitutie plaats zal vinden en hiervan 50-75 patiënten voor deze behandeling in aanmerking komen. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Nog niet bepaald. 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