Version 5

Tislelizumab

Medicine

Extended indication Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell c
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Tislelizumab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.
Proprietary name Tevimbra
Manufacturer BeiGene
Portfolio holder BeiGene
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date March 2022
Expected Registration September 2023
Orphan drug No
Registration phase Registered

Therapeutic value

Current treatment options Chemotherapie en overige PD/PDL-1 remmers
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation De fase 3 (RATIONALE 302) vergelijkt chemotherapie met tislelizumab. Dit zorgde voor een significante verbetering van de mediane overall survival (8,6 maanden versus 6,3 maanden; HR=0.70; P= .0001). Het is de verwachting dat dit niet genoeg zal zijn om de paskwil-criteria te halen.
Duration of treatment Median 84 day / days
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References Shen et al 2022: Randomized phase III study of second-line tislelizumab versus chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302)
Additional remarks Rationale 302 studie

Expected patient volume per year

Patient volume < 290

Market share is generally not included unless otherwise stated.
References 1. NKR2021 2. VEKTIS
Additional remarks 1. In 2021 zijn in Nederland 1.787 patiënten met stadium III en IV slokdarmkanker gediagnosticeerd. 2. Het aantal patiënten in stadium III en IV die in de tweede lijn een PD-PDL1 inhibitor krijgt, is 290. Dit middel is in juli 2023 als sluis kandidaat geadviseerd in verband met verwachte indicatie uitbreidingen waardoor het maximale kostenbeslag meer is dan €20.000.000 per jaar.

Expected cost per patient 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.

Potential total cost per year

Off label use

Off label use No

Indication extension

Indication extensions Yes
Indication extensions Verschillende klinische studies lopen binnen longkanker en gastro-intestinale tumortypes

Other information