Tislelizumab Medicine 07 December 2022 Extended indication 1L locally advanced or metastatic gastric carcinoma Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tislelizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication 1L locally advanced or metastatic gastric carcinoma Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novartis Portfolio holder Novartis Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Precieze indicatie nog onbekend Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in 2024. Therapeutic value Current treatment options Chemotherapie en PD-1/PD-L1 inhibitors plus chemotherapie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Nivolumab plus chemotherapie is al geregistreerd voor de eerstelijn. Tislelizumab zal mogelijk de concurrentie aangaan. In de studie van Xu et al. 2020 werd veiligheid aangetoond. Duration of treatment Frequency of administration 1 times a day Dosage per administration 200mg References Xu et al 2020 Additional remarks Betreft klinische studie RATIONALE-305 Expected patient volume per year Patient volume < 510 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2020 (1); Additional remarks De incidentie van maagcarcinoom betrof 1.063 (1) patiënten, waarbij 48% procent sprake is van palliatief stadium. Er wordt vooralsnog uitgegaan dat dit uitsluitend adenocarcinoom omvat. In de studie zijn ook patiënten met GEJ geïncludeerd, maar een accurate inschatting van de omvang van deze groep is lastig te maken. Di is echter signifcant lager dan het gedeelte met maagcarcinoom Expected cost per patient per year Cost References Cost-effectiveness analysis of tislelizumab, nivolumab and docetaxel as second- and third-line for advanced or metastatic non-small cell lung cancer in China. Front Pharmacol. 2022 Aug 25. Additional remarks De prijs in Nederland is nog niet bekend. In een kosteneffectiviteitstudie bij longkanker lijkt de prijs per patiënt wel lager uit te vallen dan bij bijvoorbeeld de PD-L1 remmer nivolumab. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Verschillende klinische studies lopen binnen longkanker en gastro-intestinale tumortypes References Additional remarks Other information Additional remarks