HSE - PCRS

Application Details

HSE Application ID

HSE100083

HTA Number

25070

HTA Link

https://www.ncpe.ie/tislelizumab-tevimbra-hta-id-25070/

Drug

tislelizumab

Brand

Tevimbra®

Applicant

BeOne Medicines Ireland Limited

Indication Applied For

Tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy, indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5%.

Application Date

05/12/2025

Marketing Authorisation Date

25/11/2024

Application Status

Awaiting Proposal from Applicant

19/03/2026

Applicant Meeting Held with CPU

19/03/2026

Rapid Review Completed

18/12/2025

Rapid Review Commissioned

11/12/2025

Pricing and Reimbursement Application Complete

05/12/2025

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