Extended indication 1L non-squamous NSCLC (combi): In combination with pemetrexed and platinum-containing chemotherapy f
Therapeutic value Possible equal value
Registration phase Registration application pending

Product

Active substance Tislelizumab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication 1L non-squamous NSCLC (combi): In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations
Manufacturer Novartis
Portfolio holder Novartis
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Injection / infusion solution
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2022
Expected Registration June 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Chemo-Immuno
Therapeutic value Possible equal value
Substantiation Er wordt mogelijke substitutie met andere medicamenten verwacht.
Duration of treatment Median 10 month / months
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References RATIONALE 304 study

Expected patient volume per year

Patient volume

0 - 992

Market share is generally not included unless otherwise stated.

References NKR2020 (1); Pakketadvies Atezolizumab (2);
Additional comments Jaarlijks presenteren er ongeveer 5.027 patiënten per jaar met NSCLC stadium IV (1). Ongeveer 47% van deze patiënten heeft een niet-plaveiselcelcarcinoom 2.363 (2). Hiervan ontvangt 60% een eerstelijnsbehandeling 1.418 waarvan 70% chemotherapie 992 (2). Gezien de overige behandelopties met immuuntherapie in de eerste lijn zal er slechts een (zeer) klein deel van de patiënten voor deze behandeling in aanmerking komen.

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 comments De prijs in Nederland is nog niet bekend. In een kosteneffectiviteitstudie 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

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Verschillende klinische studies lopen binnen long kanker en gastro-intestinale tumortypes

Other information

There is currently no futher information available.