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nivolumab in combination with ipilimumab (Opdivo® in combination with Yervoy®)
Application Details
HSE Application ID
HSE100097
HTA Number
26011
HTA Link
https://www.ncpe.ie/nivolumab-opdivo-in-combination-with-ipilimumab-yervoy-hta-id-26011/
Drug
nivolumab in combination with ipilimumab
Brand
Opdivo® in combination with Yervoy®
Applicant
Bristol Myers Squibb
Indication Applied For
Nivolumab in combination with ipilimumab indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
Application Date
19/03/2026
Marketing Authorisation Date
28/02/2025
Application Status
Proposal from Applicant Under Review
24/06/2026
Awaiting Proposal from Applicant
10/06/2026
Applicant Meeting Held with CPU
10/06/2026
Rapid Review Completed
16/04/2026
Pricing and Reimbursement Application Complete
19/03/2026
Rapid Review Commissioned
12/03/2026
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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Application Withdrawn at the Request of Applicant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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