Pricing and Reimbursement Application Tracker
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cemiplimab (Libtayo®)
Application Details
HSE Application ID
HSE100123
HTA Number
HTA Link
Drug
cemiplimab
Brand
Libtayo®
Applicant
Regeneron Ireland Designated Activity Company (DAC)
Indication Applied For
In combination with platinum-based chemotherapy for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: • locally advanced NSCLC who are not candidates for definitive chemoradiation, or • metastatic NSCLC.
Application Date
14/07/2026
Marketing Authorisation Date
24/03/2023
Application Status
Pricing and Reimbursement Application Complete
14/07/2026
Rapid Review Commissioned
10/07/2026
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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Application Withdrawn at the Request of Applicant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
Rapid Review Completed: On the basis of current evidence, the NCPE recommends that the product not be considered for reimbursement.
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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