Durvalumab Medicine 08 June 2021 Extended indication Extension of indication to include IMFINZI in combination with tremelimumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC). Therapeutic value No estimate possible yet Total cost € 4,387,500.00 Registration phase Registration application pending Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Extension of indication to include IMFINZI in combination with tremelimumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC). 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 April 2022 Expected Registration April 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 € 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 Additional remarks De dosis durvalumab is 1.500mg elke 4 weken tot ziekteprogressie. Prijs per toediening is dan (3 x €2.328)=€6.984. Voor 6 maanden is dit 26/4 x €6.984 = €45.396; voor 52 weken is dit 52/4x €6.984 = €90.792. In de studie wordt durvalumab onderzocht als monotherapie en in combinatie met tremelimumab. Afhankelijk van de behandelduur zal de prijs per jaar tussen de €45.000-€90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab. Potential total cost per year Total cost € 4,387,500.00 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