Authors' objectives: This report aims to identify and summarise evidence that addresses the following research question: What is the clinical and cost effectiveness of the Enhanced Liver Fibrosis (ELF) test in the diagnosis of advanced liver fibrosis in metabolic dysfunction-associated steatotic liver disease (MASLD) using a cut-off of 9.8? Evidence was summarised for ELF with a cut-off of 9.8 as a stand-alone test and also as a second-line test in a two-step diagnostic pathway, using the Fibrosis-4 (FIB-4) index as the first-line test.

Authors' results and conclusions: Two systematic reviews and meta-analyses that examined the ability of the ELF test to identify advanced fibrosis in MASLD were identified. The meta-analyses included 20 observational studies that evaluated diagnostic accuracy of the ELF test at multiple different cut-offs. Six full-text studies that were included in the reviews examined a cut-off of 9.8. A further ten additional full-text observational studies that examined the diagnostic accuracy of the ELF test at 9.8 and/or evaluated sequential two-step FIB-4 -> ELF pathways. This made a total of 16 relevant full-text studies. The majority of studies were secondary analyses using data from clinical trials or MASLD registeries. One study, examining a FIB-4 -> ELF pathway was a real-world non-randomised comparative study in primary care. Studies reported wide ranges for sensitivity and specificity of the ELF test at 9.8 and for FIB-4 -> ELF pathways with various cut-offs used for FIB-4. Compared with an ELF cut-off of 10.51, a cut-off of 9.8 was found to be cost-effective. Evidence that use of a two-step FIB-4 -> ELF diagnostic pathway reduced unnecessary referrals whilst increasing detection rates for advanced liver fibrosis was promising. HTW developed a cost-utility analysis from the NHS Wales perspective to estimate the cost effectiveness of reducing the ELF test cut-off from 10.51 to 9.8 in a one-step diagnostic pathway.

Authors' recommendations: The evidence supports the routine adoption of a change to the Enhanced Liver Fibrosis (ELF) test score cut-off from 10.51 to 9.8 to diagnose advanced fibrosis (AF) in people with metabolic dysfunction-associated steatotic liver disease (MASLD) in any healthcare setting. Evidence for use of a two-step pathway using the Fibrosis-4 (FIB-4) index, followed by an ELF test for people with an indeterminate FIB-4 score in primary care, is promising, but insufficient to support routine adoption. Evidence exists for the diagnostic accuracy of the ELF test at a cut-off of 9.8 to diagnose AF in people with MASLD. Use of a two-step pathway may reduce unnecessary referrals to secondary care. Health economic assessment estimates that reducing the ELF test cut-off from 10.51 to 9.8 is likely to be cost effective, with an incremental cost-effectiveness ratio of £14,842 per quality-adjusted life year gained. Cost effectiveness remained in a scenario reducing the ELF test cut-off in a two-step pathway following an indeterminate FIB-4.

Authors' methods: The Evidence Appraisal Report is based on a literature search (strategy available on request) for published clinical and economic evidence on the health technology of interest. It is not a full systematic review but aims to identify the best available evidence on the health technology of interest. Researchers critically evaluate and synthesise this evidence. We include the following clinical evidence in order of priority: systematic reviews; randomised trials; non-randomised trials. We only include evidence for “lower priority” evidence where outcomes are not reported by a “higher priority” source. We also search for economic evaluations or original research that can form the basis of an assessment of costs/cost comparison. We carry out various levels of economic evaluation, according to the evidence that is available to inform this.

Authors' identified further research: No research recommendations made. The Appraisal Panel discussed that the ELF test is not routinely used in primary care in Wales and there is no standard care pathway for the diagnosis of advanced fibrosis in patients with MASLD.

Project Status: Completed

Year Published: 2024

URL for published report: https://healthtechnology.wales/reports-guidance/elf-test-enhanced-liver-fibrosis/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Wales, United Kingdom

Organisation Name: Health Technology Wales

Contact Address: c/o Digital Health Care Wales, 21 Cowbridge Road East Cardiff CF11 9AD

Contact Name: Susan Myles, PhD

Contact Email: healthtechnology@wales.nhs.uk