Tislelizumab Medicine 07 December 2022 Extended indication 1L non-squamous NSCLC (combi): In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Tislelizumab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication 1L non-squamous NSCLC (combi): In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2022 Expected Registration June 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemo-Immuno Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt mogelijke substitutie met andere medicamenten verwacht. Duration of treatment Median 10 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References RATIONALE 304 study Additional remarks Expected patient volume per year Patient volume 0 - 992 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2020 (1); Pakketadvies Atezolizumab (2); Additional remarks Jaarlijks presenteren er ongeveer 5.027 patiënten per jaar met NSCLC stadium IV (1). Ongeveer 47% van deze patiënten heeft een niet-plaveiselcelcarcinoom 2.363 (2). Hiervan ontvangt 60% een eerstelijnsbehandeling 1.418 waarvan 70% chemotherapie 992 (2). Gezien de overige behandelopties met immuuntherapie in de eerste lijn zal er slechts een (zeer) klein deel van de patiënten voor deze behandeling in aanmerking komen. 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 long kanker en gastro-intestinale tumortypes References Additional remarks Other information Additional remarks