following a resubmission assessed under the orphan equivalent medicine process:
seladelpar (Livdelzi®) is not recommended for use within NHSScotland.
Indication under review: for the treatment of primary biliary cholangitis (PBC), including pruritus, in adults in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
In a randomised, double-blind, phase III study, there was a significantly higher composite biochemical response at month 12 to seladelpar compared with placebo in patients with PBC who have had an inadequate response or intolerance to UCDA.
The company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- seladelpar (Livdelzi)
- SMC ID:
- SMC2899
- Indication:
Treatment of primary biliary cholangitis (PBC), including pruritus, in adults in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
- Pharmaceutical company
- Gilead Sciences Ltd
- BNF chapter
- Gastro-intestinal system
- Submission type
- Resubmission
- Status
- Not recommended
- Date advice published
- 09 March 2026