Pricing and Reimbursement Application Tracker
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tislelizumab (Tevimbra®)
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
Rapid Review Completed
18/12/2025
Rapid Review Commissioned
11/12/2025
Pricing and Reimbursement Application Complete
05/12/2025
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Status
Pricing and Reimbursement Application Complete
Rapid Review Commissioned
Rapid Review Completed
Applicant Meeting Held with CPU
Awaiting Proposal from Applicant
Proposal from Applicant Under Review
Full Health Technology Assessment Commissioned by HSE
NCPE Assessment Completed
HSE Drugs Group Review Pending
Reviewed by HSE Drugs Group
HSE Rare Disease Technology Review Committee - Review Requested
HSE Rare Disease Technology Review Committee - Review Received
Further Information Requested by HSE Drugs Group
Reviewed by HSE Senior Leadership Team
Managed Access Protocol (MAP) Commissioned
Proposed HSE Decision Issued to Applicant
Applicant Representations Received
HSE Decision Issued to Applicant
Application On Hold at the Request of Applicant
Application Withdrawn at the Request of Applicant
Application on Hold as Agreed by HSE and Applicant
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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