Seladelpar
Treatment of primary biliary cholangitis in patients with inadequate response to ursodeoxycholic acid (UDCA) or intolerance to UDCA.
Decisions on record
- Meeting Dec 2025 Recommended Primary biliary cholangitis (PBC) no PSD
- Meeting Jul 2025 Deferred Primary biliary cholangitis inadequately responsive to or intolerant to ursodeoxycholic acid
Access path
- Dec 2025Recommended · restricted
vs best supportive care, obeticholic acid, elafibranor
- Dec 2025Recommended · restricted
- PBS listing · Authority Required
From the public summary
7.1 The PBAC deferred making a recommendation for the listing of seladelpar for the treatment of primary biliary cholangitis (PBC). The PBAC was of a mind to recommend seladelpar, pending advice from the TGA Delegate. The PBAC considered that seladelpar was non-inferior in terms of effectiveness and safety compared to obeticholic acid (OCA) and therefore, considered that a cost-minimisation approach versus OCA was appropriate.PSD · Jul 2025
7.2 The PBAC acknowledged the input from the Liver Foundation supporting the submission. The PBAC also noted the input provided during the Sponsor hearing, which highlighted the need for alternative treatments for patients who do not respond to first-line treatment with ursodeoxycholic acid (UDCA).PSD · Jul 2025
6.57 The submission presented cost utility analyses comparing seladelpar ± UDCA with BSC ± UDCA and OCA ± UDCA. Given that (i) the ESC considered that seladelpar was non- inferior compared to both OCA and elafibranor in terms of efficacy and safety, (ii) elafibranor was recommended by the PBAC in March 2025 on the basis of a cost- minimisation approach versus OCA (see paragraph 2.2) and (iii) elafibranor was not yet listed on the PBS, the ESC considered …PSD · Jul 2025
The ESC considered that a similar approach could be applied to the cost minimisation between seladelpar and OCA. Cost utility analysis versus BSC (± UDCA) and OCA (± UDCA)PSD · Jul 2025
Table 2: Trials and associated reports presented in the submission Trial ID Protocol title/ Publication title Publication citation Seladelpar RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to RESPONSE Evaluate the Efficacy and Safety of Seladelpar in Patients with PrimaryPSD · Jul 2025
30 November 2023 NCT04620733 Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) Hirschfield GM, Bowlus CL, Mayo MJ, et al. A Phase 3 Trial of Seladelpar NEJM. 2024; 390(9):783-94 in Primary Biliary Cholangitis OCA POISE NCT01473524 Nevens F, Andreone P, Mazzella G, et al. A Placebo-controlled trial of NEJM. 2016; 375(7):631- EUCTR2011- obeticholic acid in primary biliary cholangitis. 43.PSD · Jul 2025
6.3 The PBAC noted and welcomed the input from one organisation, the Liver Foundation via the Consumer Comments facility on the PBS website. The comment supported the listing of seladelpar on the PBS.PSD · Jul 2025
6.4 The comments described the significant impact of PBC on quality of life, particularly chronic fatigue and severe itching, which can be debilitating, relentless and indescribable, with no effective relief.PSD · Jul 2025
Cost-effectiveness
The submission proposed a placeholder DPMQ with no published or effective price for seladelpar. The ICER was deliberately overestimated due to confidential special pricing arrangements for the comparator (OCA).
The PBAC considered that a price premium for elafibranor would be reasonable given the potential reduction in PBC-related pruritus compared to OCA. PBAC · 2025
Decision context
PopulationPatients aged 18 years or older with primary biliary cholangitis who have had an inadequate response to UDCA (despite at least 52 weeks of treatment) or are intolerant to UDCA, and have elevated ALP (≥1.67x ULN) or elevated total bilirubin (1-2x ULN).
Risk sharingThe PBAC considered that seladelpar should join the risk sharing arrangement for OCA.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2025 | Recommended · restricted | best supportive care, obeticholic acid, elafibranor | — | RCT · Surrogate |
| Dec 2025 | Recommended · restricted | best supportive care, obeticholic acid, elafibranor | — | RCT · Surrogate |
Consumer voice
The Liver Foundation submitted consumer input supporting PBS listing of seladelpar, highlighting the significant impact of PBC on quality of life, particularly chronic fatigue and severe itching that can be debilitating and relentless with no effective relief.
The comments described the significant impact of PBC on quality of life, particularly chronic fatigue and severe itching, which can be debilitating, relentless and indescribable, with no effective relief. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to inadequate response or intolerance to UDCA after ≥52 weeks; TGA label includes all primary biliary cholangitis patients.