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 Registered Product Active substance Tislelizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Stomach cancer 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 ATMP No Submission date January 2024 Expected Registration January 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks 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 en dus mogelijk een derde PD1 behandeloptie wordt. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References Yoon et al. 2022 (1); NCT03783442 (RATIONALE-306; BGB-A317-306) (2) Additional remarks 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 3 en 4 slokdarmkanker gediagnosticeerd. Expected cost per patient per year Cost € 30,000.00 - 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 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. Gegeven de prijs van andere PD1-remmers binnen dit indicatiegebied is de verwachting dat de kosten €30.000 tot €60.000 per patiënt per jaar zullen bedragen. 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