Economic value and clinical association of a supervised lifestyle-improving program for MASLD

Metabolic dysfunction-associated steatotic liver disease (MASLD) is both common and, in some cases, a progressive condition. Emerging pharmacological options have shown promise in select patient sub-groups (e.g., resmetirom for MASH with fibrosis; GLP-1 receptor agonists for obesity/diabetes with metabolic benefits), but structured lifestyle programs remain foundational in routine care.

This study evaluates the cost-utility analysis of a multidisciplinary, kinesiology-supervised lifestyle-improving program for patients with MASLD, supported by clinical evidence.

We analyzed 27 adults with MASLD, a cohort established from an initial group of 43 subjects, who participated in a structured program of supervised exercise and dietary counseling. Health-related quality of life (SF-36 mapped to EQ-5D) and associated clinical markers, including hepatic steatosis (ultrasound), blood pressure, and serum aminotransferases, were evaluated at baseline and after the program. A cost-utility analysis was conducted from the healthcare system's perspective, estimating the incremental cost-effectiveness ratios (ICERs and €/QALY) with deterministic and probabilistic sensitivity analyses. Pharmaceutical expenditures and projected disease progression costs were also explored using administrative data and literature-based models.

Health-related quality of life improved after the program, with a quality-adjusted life year (QALY) gain of 0.081 (95% CI: 0.001-0.161). The base-case ICER was €17,778/QALY. The probability of cost-effectiveness was 71% at €25,000/QALY, 84% at €30,000/QALY, and 95% at €40,000/QALY. Ultrasound steatosis showed a distributional shift toward lower grades with an unchanged median (Wilcoxon p = 0.007). Systolic/diastolic blood pressure decreased by -5.6/-3.7 mmHg (p = 0.05 and p = 0.03), and AST/ALT declined (both p < 0.01). At the 2-year follow-up, 55.6% of patients reported maintaining regular physical activity. Outpatient pharmaceutical expenditures showed a decline from €74 to €50 per patient/year between 2018 and 2021, with reduced variability across patients. However, this trend did not reach statistical significance in mixed-effects analyses (p = 0.06).

In this pre-post observational study, the supervised program was associated with favorable cost-utility outcomes and distributional improvements in selected clinical markers. These findings support the program's potential value in routine care and warrant confirmation in controlled studies.

https://clinicaltrials.gov/expert-search?term, identifier NCT06026293.