Tislelizumab Medicine 03 June 2025 Extended indication Extension of indication for Tevimbra in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable NSCLC. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tislelizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication for Tevimbra in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable NSCLC. Current proprietary name Already available biosimilars / generics Proprietary name Tevimbra 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 2025 Expected Registration July 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice 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 Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Rationale-315 is gepubliceerd in de Lanncet resp med 2025;13:119. Het betreft een volledig Chinese studie peri-operatief. EFS mediaan niet bereikt: HR 0.56 (95% CI 0.40-.79) pCR 41% vs 6% Duration of treatment Frequency of administration Dosage per administration References NCT04379635 (BGB-A317-315) 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 2022 Additional remarks In 2022 waren er 2.006 patiënten met niet-kleincellig longcarcinoom die chirurgie ondergingen. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks