Tislelizumab Medicine 04 June 2024 Extended indication Locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen. Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registered Product Active substance Tislelizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen. Current proprietary name Already available biosimilars / generics Proprietary name Tevimbra Manufacturer BeiGene Portfolio holder Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date April 2024 Expected Registration July 2024 Orphan drug No Registration phase Registered Reimbursement Advice Healthcare Institute Medicine sluice Broadly excluded Additional remarks Zorginstituut Nederland heeft de minister van Volksgezondheid, Welzijn en Sport (VWS) in februari 2026 geadviseerd om tislelizumab (Tevimbra®) na prijsonderhandelingen te vergoeden uit het basispakket van de zorgverzekering. Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Deze indicatieuitbreiding in de tweedelijn zal waarschijnlijk niet relevant zijn voor de Nederlandse praktijk, omdat immunotherapie in de eerstelijn wordt ingezet (4,5). Duration of treatment Frequency of administration Dosage per administration References NCT03358875 (1); NCT03663205 (2); NCT03594747 (RATIONALE) (3); Richtlijn niet-kleincellig longcarcinoom. FMS. 2024 (4); Expertopinie (5). Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Zie therapeutische waarde. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks