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:
with ursodeoxycholic acid (UDCA), if UDCA alone has not worked well enough, or
alone, if UDCA cannot be tolerated.
Seladelpar can only be used if the company provides it according to the commercial arrangement.
Seladelpar must be funded in the NHS in England for the condition and population in the recommendation, if it is considered the most suitable treatment option. Seladelpar must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that seladelpar provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
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.