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Tislelizumab

Tevimbra

Extended indication Locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease
Therapeutic value Possibly no place in the treatment regimen
Registration phase Registration application pending

Product

Active substance Tislelizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.
Proprietary name Tevimbra
Manufacturer BeiGene
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2024
Expected Registration February 2025
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen
Substantiation Deze indicatieuitbreiding in de tweede lijn zal waarschijnlijk niet relevant zijn voor de Nederlandse praktijk, omdat immunotherapie in de eerste lijn wordt ingezet (4,5).
References NCT03358875 (1); NCT03663205 (2); NCT03594747 (RATIONALE) (3); Richtlijn niet-kleincellig longcarcinoom. FMS. 2024 (4); Expertopinie (5).

Expected patient volume per year

Additional remarks Zie therapeutische waarde.

Expected cost per patient per year

Cost 30,000.00 - 60,000.00
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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.