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melphalan flufenamide (Pepaxti®)
Application Details
HSE Application ID
HSE100037
HTA Number
25028
HTA Link
https://www.ncpe.ie/melphalan-flufenamide-pepaxti-hta-id-25028/
Drug
melphalan flufenamide
Brand
Pepaxti®
Applicant
Oncopeptides AB (publ)
Indication Applied For
Indicated in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least three years from transplantation
Application Date
21/02/2025
Marketing Authorisation Date
17/08/2022
Application Status
Rapid Review Completed
09/05/2025
Rapid Review Commissioned
01/04/2025
Pricing and Reimbursement Application Complete
21/02/2025
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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Application Withdrawn at the Request of Applicant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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