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Background: <p>Increasing prevalence of metabolic dysfunction–associated liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH) poses a growing healthcare burden. Noninvasive diagnostic tools to replace liver biopsy are urgently needed. We investigated the utility and cost-effectiveness of including multiparametric magnetic resonance imaging (mpMRI) to the management of adults with suspected MASLD multi-nationally.</p> Methods: <p>RADIcAL-1, a 1:1 randomised controlled trial (standard-of-care [SoC] <i>vs</i>. imaging arm [IA; SoC+mpMRI]) included 802 participants from Germany, Netherlands, Portugal and UK. Wilcoxon-rank tests were used to compare access to healthcare practitioners, patient assessments and proportion of patients with a diagnosis (%diagnosis). Liver fat and disease activity (corrected T1 [cT1]) were used to identify patients not requiring biopsy in the imaging arm. Primary endpoint was mpMRI cost-effectiveness and improvement in resource use (visits avoided) using mpMRI.</p> Results: <p>mpMRI is cost-effective with an ICER of €4968/QALY gained. 403 were randomised to IA and 399 to SoC. SoC has significantly more specialist appointments (<i>p</i> = 0.015) and patient assessments (<i>p</i> &lt; 0.001). Across all involved hospitals, %diagnosis is significantly higher in the imaging arm (<i>p</i> = 0.0012). cT1 correctly classifies 50% of patients without MASH with fibrosis and can avoid biopsy. Including all costs, the imaging arm incurs higher short-term per-patient healthcare expenditure compared to the SoC arm (€1,300 <i>vs</i>. €830).</p> Conclusion: <p>Adding mpMRI to SoC for the management of adults with suspected MASLD multi-nationally is cost-effective, enhances rate of diagnosis multi-nationally and increases rate of diagnosis without increasing other liver-related health care resource use. Due to the need for standardisation of SoC, widespread use can support optimisation of the MASLD clinical pathway and improve long-term patient management.</p>

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Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月18日

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  • Elizabeth Shumbayawonda,
  • Marika French,
  • Jane Elizabeth Carolan,
  • Cayden Beyer,
  • Paula Lorgelly,
  • Dimitar Tonev,
  • Rajarshi Banerjee,
  • Michael H. Miller,
  • Christopher D. Byrne,
  • Janisha Patel,
  • Saima Ajaz,
  • Kosh Agarwal,
  • Johanna Backhus,
  • Minneke J. Coenraad,
  • Jelte J. Schaapman,
  • Andrew Fraser,
  • Miguel Castelo Branco,
  • Stephen Barclay,
  • Matthias M. Dollinger,
  • Daniel J. Cuthbertson,
  • Daniel Forton,
  • Hildo J. Lamb

摘要

Background:

Increasing prevalence of metabolic dysfunction–associated liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH) poses a growing healthcare burden. Noninvasive diagnostic tools to replace liver biopsy are urgently needed. We investigated the utility and cost-effectiveness of including multiparametric magnetic resonance imaging (mpMRI) to the management of adults with suspected MASLD multi-nationally.

Methods:

RADIcAL-1, a 1:1 randomised controlled trial (standard-of-care [SoC] vs. imaging arm [IA; SoC+mpMRI]) included 802 participants from Germany, Netherlands, Portugal and UK. Wilcoxon-rank tests were used to compare access to healthcare practitioners, patient assessments and proportion of patients with a diagnosis (%diagnosis). Liver fat and disease activity (corrected T1 [cT1]) were used to identify patients not requiring biopsy in the imaging arm. Primary endpoint was mpMRI cost-effectiveness and improvement in resource use (visits avoided) using mpMRI.

Results:

mpMRI is cost-effective with an ICER of €4968/QALY gained. 403 were randomised to IA and 399 to SoC. SoC has significantly more specialist appointments (p = 0.015) and patient assessments (p < 0.001). Across all involved hospitals, %diagnosis is significantly higher in the imaging arm (p = 0.0012). cT1 correctly classifies 50% of patients without MASH with fibrosis and can avoid biopsy. Including all costs, the imaging arm incurs higher short-term per-patient healthcare expenditure compared to the SoC arm (€1,300 vs. €830).

Conclusion:

Adding mpMRI to SoC for the management of adults with suspected MASLD multi-nationally is cost-effective, enhances rate of diagnosis multi-nationally and increases rate of diagnosis without increasing other liver-related health care resource use. Due to the need for standardisation of SoC, widespread use can support optimisation of the MASLD clinical pathway and improve long-term patient management.