NICE(UK) positive for Livdelzi (seladelpar) for previously treated primary biliary cholangitis – Gilead

NICE(UK): Seladelpar can be used, within its marketing authorisation, as an option to treat primary biliary cholangitis, including associated pruritus, in adults.

It can be used: i) with ursodeoxycholic acid (UDCA), if UDCA alone has not worked well enough, or ii) alone, if UDCA cannot be tolerated. Seladelpar can only be used if the company provides it according to the commercial arrangement.

Why the committee made this recommendation: Usual treatment for primary biliary cholangitis is UDCA. If this does not work well enough, or is not tolerated, add-on treatments include obeticholic acid or elafibranor. Clinical trial evidence shows that seladelpar improves indicators of liver function, such as alkaline phosphatase (ALP), more than placebo. This suggests that seladelpar could delay the condition getting worse. The evidence also shows that seladelpar reduces pruritus (itch) compared with placebo. Seladelpar has not been directly compared in a clinical trial with obeticholic acid or elafibranor.

But the results of indirect comparisons suggest that seladelpar may reduce itch more than obeticholic acid. And it may improve ALP-related outcomes more than obeticholic acid or elafibranor. The cost-effectiveness estimates are below what NICE considers an acceptable use of NHS resources. So, seladelpar can be used.