Pricing and Reimbursement Application Tracker
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serplulimab (Hetronifly®)
Application Details
HSE Application ID
HSE100122
HTA Number
26035
HTA Link
https://www.ncpe.ie/serplulimab-hetronifly-hta-id-26035/
Drug
serplulimab
Brand
Hetronifly®
Applicant
Accord Healthcare Ireland Ltd
Indication Applied For
Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: • locally advanced NSCLC who are not candidates for surgery or radiotherapy, or • metastatic NSCLC.
Application Date
09/07/2026
Marketing Authorisation Date
30/04/2026
Application Status
Rapid Review Completed
14/08/2026
Rapid Review Commissioned
10/07/2026
Pricing and Reimbursement Application Complete
09/07/2026
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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Application Withdrawn at the Request of Applicant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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