Pricing and Reimbursement Application Tracker
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mirikizumab (Omvoh®)
Application Details
HSE Application ID
HSE100084
HTA Number
25068
HTA Link
https://www.ncpe.ie/mirikizumab-omvoh-hta-id-25068/
Drug
mirikizumab
Brand
Omvoh®
Applicant
Eli Lilly
Indication Applied For
Indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
Application Date
18/12/2025
Marketing Authorisation Date
12/02/2025
Application Status
Awaiting Proposal from Applicant
19/03/2026
Applicant Meeting Held with CPU
19/03/2026
Rapid Review Completed
18/12/2025
Pricing and Reimbursement Application Complete
18/12/2025
Rapid Review Commissioned
01/12/2025
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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Application Withdrawn at the Request of Applicant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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