Pricing and Reimbursement Application Tracker
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pembrolizumab (Keytruda®)
Application Details
HSE Application ID
HSE100103
HTA Number
26004
HTA Link
https://www.ncpe.ie/subcutaneous-pembrolizumab-keytruda-hta-id-26004/
Drug
pembrolizumab
Brand
Keytruda®
Applicant
Merck Sharp & Dohme B.V.
Indication Applied For
Subcutaneous pembrolizumab (Keytruda®) for all previously approved adult indications where pembrolizumab is authorised for intravenous infusion.
Application Date
18/02/2026
Marketing Authorisation Date
17/11/2025
Application Status
Rapid Review Completed
21/04/2026
Pricing and Reimbursement Application Complete
18/02/2026
Rapid Review Commissioned
05/02/2026
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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Application Withdrawn at the Request of Applicant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
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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