Advice

following a full submission:

elafibranor (Iqirvo®) is accepted for use within NHSScotland.

Indication under review: for the treatment of primary biliary cholangitis (PBC) in
combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to
UDCA, or as monotherapy in adults unable to tolerate UDCA.

In a randomised, double-blind, phase III study, there was a significantly higher cholestasis
response at 52 weeks to elafibranor compared with placebo in patients with primary biliary
cholangitis who have had an inadequate response or intolerance to UDCA.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was
based, or a PAS/ list price that is equivalent or lower.

Medicine details

Medicine name:
elafibranor (Iqirvo)
SMC ID:
SMC2714
Indication:

Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

Pharmaceutical company
Ipsen Ltd
BNF chapter
Gastro-intestinal system
Submission type
Full
Status
Accepted
Date advice published
07 April 2025