Pricing and Reimbursement Application Tracker
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infliximab (Remsima®)
Application Details
HSE Application ID
HSE100104
HTA Number
26017
HTA Link
https://www.ncpe.ie/infliximab-remsima-sc-induction-phase-of-treatment-in-patients-with-rheumatoid-arthritis-hta-id-26017/
Drug
infliximab
Brand
Remsima®
Applicant
Celltrion Healthcare
Indication Applied For
Subcutaneous infliximab induction phase of treatment in patients with rheumatoid arthritis. In combination with methotrexate for the reduction of signs and symptoms as well as the improvement in physical function in: • Adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. • Adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Application Date
08/04/2026
Marketing Authorisation Date
30/04/2021
Application Status
Rapid Review Completed
24/04/2026
Rapid Review Commissioned
08/04/2026
Pricing and Reimbursement Application Complete
08/04/2026
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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Application Withdrawn at the Request of Applicant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
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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