Atezolizumab Medicine 03 June 2025 Extended indication Atezolizumab in combination with lenvatinib for second line treatment of locally advanced or metastatic and/or unresectable hepatocellular carcinoma in adults and elderly who have progressed on prior systemic treatment with atezolizumab plus bevacizumab. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Atezolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Atezolizumab in combination with lenvatinib for second line treatment of locally advanced or metastatic and/or unresectable hepatocellular carcinoma in adults and elderly who have progressed on prior systemic treatment with atezolizumab plus bevacizumab. Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche 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 September 2026 Expected Registration April 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Out of the sluice Additional remarks Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2026). Zie publicatie in de Staatscourant van 6 november 2023. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog geen data beschikbaar. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1.200mg References NCT04770896 (IMbrave251) Additional remarks 1.200mg op dag een van elke cyclus van 21 dagen totdat er sprake is van onacceptabele toxiciteit of verlies van klinisch voordeel, zoals bepaald door de onderzoeker. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1) Additional remarks In 2021 waren er 351 diagnoses hepatocellulair carcinoom, stadium II en III (1). 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 Op basis van lijstprijs per vial (1.200mg atezolizumab) van €4.145. Kosten per patiënt per jaar zijn een inschatting in verband met onbekende behandelduur. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2026). Potential total cost per year Total cost 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