METHODS: We developed a decision-analytic model to evaluate the performance of the Pathway on economic and health-related outcomes. The model simulated the natural history of NAFLD and imposed a multi-step testing and treatment pathway. We used data from a cohort of 501 T2DM patients to inform risk stratification and distribution of non-invasive test scores. We simulated the life course of 50-year-old T2DM patients under usual care versus the Clinical Care Pathway. Model outputs were used to perform cost-effectiveness analysis from the healthcare payer perspective.

RESULTS: Compared with usual care, the Clinical Care Pathway detected 34,305 additional cases of NAFLD with significant fibrosis and prevented 2,048 cases of decompensated cirrhosis, 943 cases of hepatocellular carcinoma, 3,403 liver-related deaths, and 946 non-liver-related deaths per 100,000 patients. The Pathway increased quality-adjusted life years (QALYs) by 0.28 and total costs by $14,375 per patient lifetime. With an incremental cost-effectiveness ratio of $50,777 per additional QALY, the Pathway is cost-effective. Furthermore, cost-effectiveness was not sensitive to the value of key input parameters.

CONCLUSIONS: The Clinical Care Pathway is cost-effective for the management of NAFLD in patients with T2DM. Widespread adoption of the Pathway in clinical practice could improve NAFLD-related outcomes.