Tislelizumab Medicine 07 December 2022 Extended indication Extension of indication to include in combination with platinum-based chemotherapy the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tislelizumab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Extension of indication to include in combination with platinum-based chemotherapy the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BeiGene Portfolio holder BeiGene 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date January 2024 Expected Registration November 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Nog niet ingediend bij EMA. Dit geneesmiddel is de sluis geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen met uitzondering van de toepassing als monotherapie voor de behandeling van volwassen patiënten met niet-resectabel, lokaal gevorderd of gemetastaseerd plaveiselcelcarcinoom van de slokdarm na eerdere platina-bevattende chemotherapie. 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 De mediane algehele overleving was 17,2 maanden met tislelizumab plus chemotherapie en 10,6 maanden met enkel chemotherapie (HR= 0,66; P<.0001). De cieBOM heeft in mei 2022 pembrolizumab + chemotherapie studie (KEYNOTE-590-studie) goedgekeurd voor de eerstelijn. De verwachting is dat tislelizumab vergelijkbaar zal zijn en de concurrentie zal aangaan met deze pd-l1 remmer. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1 References Yoon et al. 2022 Additional remarks Betreft klinische studie RATIONALE-306 Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 Additional remarks In 2021 zijn in Nederland 1.787 patiënten met stadium III en IV slokdarmkanker gediagnosticeerd. 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 kosteneffectiviteit studie 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