Resource impact summary report

Resource impact summary report

This summary report is based on the NICE assumptions used in the resource impact template. Users can amend the 'Population and treatments' and 'Unit costs' worksheets in the template to reflect local data and assumptions.

Financial and capacity resource impact

The key drivers of resource impact are that:

  • Seladelpar and the comparator treatments are oral treatments.

  • Seladelpar has not been directly compared in a clinical trial with obeticholic acid (OCA) or elafibranor. But the results of indirect comparisons suggest that seladelpar may reduce itch more than obeticholic acid, and it may reduce liver enzymes more than obeticholic acid or elafibranor.

  • As regional variations in population and standard care exist, the impact should be reviewed locally.

The company has a commercial arrangement. This makes seladelpar available to the NHS at a discount.

Users can input the confidential price of seladelpar and amend other variables in the resource impact template.

The payment mechanism for the technology is determined by the responsible commissioner and depends on whether the technology is classified as high cost.

For further analysis or to calculate the financial and capacity impact from a commissioner (national) and provider (local) perspective, see the resource impact template.

Eligible population for seladelpar

Table 1 shows the population who are eligible for seladelpar in England. The figures below are based on the ONS population, these figures will be higher if QOF population is selected.

Table 1 Population expected to be eligible for seladelpar in England
Eligibility criteria Proportion (%) Eligible population Source

Prevalence of primary biliary cholangitis (PBC)

16,487

UK-PBC webpage on epidemiology of PBC

Proportion of people with a diagnosis of PBC who initiated treatment with ursodeoxycholic acid (UDCA)

87.70

14,459

Abbas et al. 2023

Proportion of people who have an incomplete response to UDCA

40.00

5,784

Bernal et al. 2023

Portion who will go onto receive a second line treatment

51.09

2,955

Abbas et al. 2023

Eligible population

2,955

Evidence suggests that PBC is significantly more common in some areas and adherence to the guidance has regional variations.

Because of the regional variations in population and standard care, we encourage users to review the assumed populations and alter any assumptions that do not reflect their local circumstances in the resource impact template. Users will also need to input the market shares of the treatments in cells D49 to G54 of the 'Population and treatments' worksheet.

Treatment options for the eligible population

The comparator treatments for the eligible population are elafibranor with or with without UDCA, or OCA with or without UDCA.

For more information about the treatments, such as dose and average treatment duration, see the resource impact template.

Key information

Table 2 Key information

Time from publication to routine commissioning funding

90 days

Programme budgeting category

13C, Problems of the gastrointestinal system - Hepatobiliary

Commissioner(s)

NHS England

Provider(s)

NHS hospital trusts

Pathway position

Second line. Recommendation states that seladelpar can be used:

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

  • alone, if UDCA cannot be tolerated.

About this resource impact summary report

This resource impact summary report accompanies the NICE technology appraisal guidance on seladelpar for previously treated primary biliary cholangitis and should be read with it.

ISBN: 978-1-4731-9576-9

This page was last updated: