Durvalumab Medicine 08 June 2021 Extended indication In combination with tremelimumab in patients with HCC not eligible for locoregional therapy (1L). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication In combination with tremelimumab in patients with HCC not eligible for locoregional therapy (1L). 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 PD-L1 mAb + CTLA-4 mAB. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in het tweede kwartaal van 2022 en registratie in het tweede kwartaal van 2023. Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties. Therapeutic value Current treatment options Sorafenib, lenvatinib. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten van de fase 2 studie waren positief. De fase 3 studie (HIMALAYA) loopt nog op dit moment. De verwachting is dat er substitutie plaats zal vinden voor sorafenib en lenvatinib. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 1500 mg durvalumab + 300 mg tremelimumab 1x References HIMALAYA (NCT03298451). Additional remarks Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Expected patient volume per year Patient volume < 65 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 waren er 110 stadium II en 132 stadium III patiënten met een hepatocellulair carcinoom. In totaal zullen er maximaal 142 patiënten in aanmerking komen voor behandeling. De verwachting is dat patiënten die op dit moment sorafenib/lenvatinib ontvangen mogelijk zullen overstappen. In 2019 waren er 65 patiënten die met sorafenib/lenvatinib behandeld werden. Expected cost per patient per year Cost References Fabrikant Additional remarks Tremelimumab prijs is onbekend. Imfinzi kost €2.328 per 500mg. De prijs per mg is dus €4,66. De kosten van een 1.500mg dosis zijn dus €6.984. 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