Pricing and Reimbursement Application Tracker
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bimekizumab (Bimzelx®)
Application Details
HSE Application ID
HSE100024
HTA Number
25018
HTA Link
https://www.ncpe.ie/bimekizumab-bimzelx-hta-id-25018/
Drug
bimekizumab
Brand
Bimzelx®
Applicant
UCB Pharma S.A.
Indication Applied For
Indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hidradenitis suppurativa therapy.
Application Date
06/03/2025
Marketing Authorisation Date
19/04/2024
Application Status
Rapid Review Completed
02/04/2025
Pricing and Reimbursement Application Complete
06/03/2025
Rapid Review Commissioned
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Application Withdrawn at the Request of Applicant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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