Pricing and Reimbursement Application Tracker
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odevixibat (Kayfanda®)
Application Details
HSE Application ID
HSE100089
HTA Number
26005
HTA Link
https://www.ncpe.ie/odevixibat-kayfanda-hta-id-26005/
Drug
odevixibat
Brand
Kayfanda®
Applicant
Ipsen Pharma
Indication Applied For
Indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older.
Application Date
11/02/2026
Marketing Authorisation Date
19/09/2024
Application Status
Full Health Technology Assessment Commissioned by HSE
31/03/2026
Rapid Review Completed
26/02/2026
Rapid Review Commissioned
11/02/2026
Pricing and Reimbursement Application Complete
11/02/2026
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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Application Withdrawn at the Request of Applicant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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