ODEVIXIBAT
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Bylvay®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- IPSEN PTY LTD
- Condition/indication:
(therapeutic use) -
- Alagille syndrome (ALGS)
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- Change to existing listing (Category 1)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
PBAC outcome published: - Not Recommended (see PBAC Outcomes)
-
5Lodgement of required documentation:
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC did not recommend odevixibat for the treatment of cholestatic pruritus (severe itching caused by bile build up) in Alagille syndrome (ALGS) in patients aged six months and older.
The PBAC noted that ALGS is a rare condition with severe impacts on quality of life, including sleep, comfort, and wellbeing. The PBAC acknowledged the input from consumers, healthcare professionals and organisations describing the substantial burden of cholestatic pruritus in ALGS in this vulnerable population, noting that persistent and severe pruritus may significantly impair sleep, schooling, development, family functioning and mental health. The PBAC considered that there is a clear need for better treatments for this condition.
The PBAC considered that there was evidence showing that odevixibat can reduce itching more than current treatments for some patients with ALGS. However, the PBAC noted that no evidence was presented to support any benefit for odevixibat in slowing ALGS progression, helping patients with ALGS to keep their own liver for longer, or improving overall survival. Additionally, the long‑term benefits remain uncertain.
The PBAC considered that the economic model used to estimate value for money was not reliable due to unsupported assumptions, and the PBAC could not be confident that the benefits justify the requested price. Further, the estimates of the total cost to government were uncertain due to unsupported assumptions about how many people would be eligible for, and receive, treatment.