Tislelizumab Medicine 03 December 2024 Extended indication Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. 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 Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. Current proprietary name Already available biosimilars / generics Proprietary name Tevimbra Manufacturer BeiGene Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor 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 November 2024 Expected Registration May 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks Positieve CHMP-opinie in maart 2025. Tevimba is in 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 Atezolizumab Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Op basis van het primaire eindpunt lijkt tislelizumab qua effectiviteit vergelijkbaar aan atezolizumab. Het is echter enkel getest in klinische studies in China. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References NCT04005716 (BGB-A317-312) 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 (1). Additional remarks Jaarlijks presenteren er ongeveer 1.150 patiënten per jaar met SCLC stadium 4(1). 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