Tislelizumab Medicine 07 December 2022 Extended indication Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Tislelizumab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC Current proprietary name Already available biosimilars / generics Proprietary name Tizveni 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 March 2022 Expected Registration April 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie februari 2024. 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 Chemo-immuno Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 8 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References RATIONALE 307 studie (NCT03594747) Additional remarks Voor behandelduur vooralsnog mPFS gebruikt Expected patient volume per year Patient volume 0 - 497 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies (en Horizonscan) atezolizumab. Additional remarks Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. Van deze groep heeft ongeveer 35% plaveiselcelcarcinoom (1.575). Hiervan ontvangt ongeveer 60% een eerstelijnsbehandeling (945) waarvan 52,6% chemotherapie (497). Deze patiënten komen in aanmerking voor een behandeling met immuuntherapie en/of chemotherapie (immunotherapie) in de eerste lijn. Slechts een (zeer) klein deel van de in aanmerking komende patiënten zal behandeld worden met tislelizumab. Expected cost per patient per year Cost References Additional remarks Nog onbekend 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