Tislelizumab Medicine 03 June 2025 Extended indication Tislelizumab monotherapy for third line, salvage treatment of relapsed or refractory classical Hodgkin lymphoma in adults and elderly. Therapeutic value Possible equal value Total cost € 1,170,000.00 Registration phase Clinical trials Product Active substance Tislelizumab Domain Hematology Reason of inclusion Indication extension IND Main indication Hodgkin's lymphoma Extended indication Tislelizumab monotherapy for third line, salvage treatment of relapsed or refractory classical Hodgkin lymphoma in adults and elderly. 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 ATMP No Submission date 2027 Expected Registration 2030 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Pembrolizumab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation De fase 3-studie loopt nog (1). Aan de hand van de fase 2-studie kan gezegd worden dat er ten opzichte van pembrolizumab een iets hogere ORR (87 versus 66) en CR rate (67 versus 25) en langere mPFS (32 versus 13) en DOR (31 versus 21 maanden), in een groep die iets meer voorbehandeling heeft gehad (3 versus 2). Er is wel iets meer toxiciteit (TRAE 31 versus 21%) (2). Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200mg References NCT04486391 (RATIONALE 314) (1); Song et al. Leukemia. 2020 (2) Additional remarks Expected patient volume per year Patient volume < 26 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1); GIPdatabank (2). Additional remarks In 2021 waren er 441 diagnoses klassiek hodgkinlymfoom (1). In 2021 waren er 26 gebruikers van pembrolizumab in dezelfde setting (recidief of therapieresistent klassiek HL, derde lijn) (2). 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(L)-1 remmer nivolumab. Gegeven de prijs van andere PD(L)1-remmers is de verwachting dat de kosten €30.000 tot €60.000 per patiënt per jaar zullen bedragen. Potential total cost per year Total cost € 1,170,000.00 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