HSE - PCRS

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

Proposal from Applicant Under Review

26/05/2026

Awaiting Proposal from Applicant

07/05/2026

Applicant Meeting Held with CPU

07/05/2026

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