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Seladelpar for previously treated primary biliary cholangitis

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1 Recommendations

1.1

Seladelpar should not be used to treat primary biliary cholangitis, including pruritus, in adults:

  • with ursodeoxycholic acid (UDCA), if the primary biliary cholangitis has not responded well enough to UDCA, or

  • alone, if UDCA cannot be tolerated.

1.2

This recommendation is not intended to affect treatment with seladelpar that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

Seladelpar is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because the available evidence does not suggest that seladelpar offers value for money in this population.

Why the committee made these recommendations

Usual treatment in NHS practice for primary biliary cholangitis is UDCA. If UDCA does not work well enough, licensed add-on treatments include obeticholic acid or elafibranor. People who cannot tolerate UDCA may also have obeticholic acid or elafibranor. But there are uncertainties about the treatment pathway.

Clinical trial evidence shows that seladelpar reduces liver enzymes, which are raised in primary biliary cholangitis, more than placebo. This suggests that seladelpar could delay the condition getting worse. Clinical trial evidence also shows that seladelpar reduces pruritus (itch) compared with placebo.

Seladelpar has not been compared in a clinical trial with obeticholic acid or elafibranor. The results of an indirect comparison are highly uncertain. It is unclear whether seladelpar reduces liver enzymes compared with obeticholic acid or elafibranor. But there may be a reduced itch with seladelpar compared with obeticholic acid.

It is not clear if the company's economic model fully reflects the effect of itching and other aspects of primary biliary cholangitis on quality of life. The cost-effectiveness estimates are uncertain and are above the range that NICE considers an acceptable use of NHS resources. So, seladelpar should not be used.