Pricing and Reimbursement Application Tracker
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bimekizumab (Bimzelx®)
Application Details
HSE Application ID
HSE100025
HTA Number
25019
HTA Link
https://www.ncpe.ie/bimekizumab-bimzelx-hta-id-25019/
Drug
bimekizumab
Brand
Bimzelx®
Applicant
UCB Pharma S.A.
Indication Applied For
Non-radiographic axial spondyloarthritis (nr-axSpA): Bimekizumab is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis): Bimekizumab is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
Application Date
06/03/2025
Marketing Authorisation Date
05/06/2023
Application Status
Rapid Review Completed
03/04/2025
Rapid Review Commissioned
06/03/2025
Pricing and Reimbursement Application Complete
06/03/2025
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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Application Withdrawn at the Request of Applicant
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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