HSE - PCRS

Application Details

HSE Application ID

HSE100044

HTA Number

25033

HTA Link

https://www.ncpe.ie/tislelizumab-tevimbra-hta-id-25033/

Drug

tislelizumab

Brand

Tevimbra®

Applicant

BeOne Medicines Ireland Limited

Indication Applied For

Tislelizumab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5%.

Application Date

08/05/2025

Marketing Authorisation Date

25/11/2024

Application Status

Proposal from Applicant Under Review

19/09/2025

Awaiting Proposal from Applicant

04/09/2025

Applicant Meeting Held with CPU

04/09/2025

Rapid Review Completed

09/06/2025

Rapid Review Commissioned

08/05/2025

Pricing and Reimbursement Application Complete

08/05/2025

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