Pricing and Reimbursement Application Tracker
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Guselkumab (Tremfya®)
Application Details
HSE Application ID
HSE100066
HTA Number
25050
HTA Link
https://www.ncpe.ie/guselkumab-tremfya-hta-id-25050/
Drug
Guselkumab
Brand
Tremfya®
Applicant
Johnson & Johnson Innovative Medicine (J&J IM)
Indication Applied For
Indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
Application Date
27/08/2025
Marketing Authorisation Date
02/05/2025
Application Status
Rapid Review Completed
11/09/2025
Pricing and Reimbursement Application Complete
27/08/2025
Rapid Review Commissioned
05/08/2025
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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Application Withdrawn at the Request of Applicant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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