Transient Elastography and Controlled Attenuation Parameter for Diagnosing Liver Fibrosis and Steatosis in Ontario: An Economic Analysis.

BACKGROUND Liver fibrosis is characterized by a buildup of connective tissue due to chronic liver damage. Steatosis is the collection of excessive amounts of fat inside liver cells. Liver biopsy remains the gold standard for the diagnosis of liver fibrosis and steatosis, but its use as a diagnostic tool is limited by its invasive nature and high cost. OBJECTIVES To evaluate the cost-effectiveness and budget impact of transient elastography (TE) with and without controlled attenuation parameter (CAP) for the diagnosis of liver fibrosis or steatosis in patients with hepatitis B, hepatitis C, alcoholic liver disease, and nonalcoholic fatty liver disease. DATA SOURCES An economic literature search was performed using computerized databases. For primary economic and budget impact analyses, we obtained data from various sources, such as the Health Quality Ontario evidence-based analysis, published literature, and the Institute for Clinical Evaluative Sciences. REVIEW METHODS A systematic review of existing TE cost-effectiveness studies was conducted, and a primary economic evaluation was undertaken from the perspective of the Ontario Ministry of Health and Long-Term Care. Decision analytic models were used to compare short-term costs and outcomes of TE compared to liver biopsy. Outcomes were expressed as incremental cost per correctly diagnosed cases gained. A budget impact analysis was also conducted. RESULTS We included 10 relevant studies that evaluated the cost-effectiveness of TE compared to other noninvasive tests and to liver biopsy; no cost-effectiveness studies of TE with CAP were identified. All studies showed that TE was less expensive but associated with a decrease in the number of correctly diagnosed cases. TE also improved quality-adjusted life-years in patients with hepatitis B and hepatitis C. Our primary economic analysis suggested that TE led to cost savings but was less effective than liver biopsy in the diagnosis of liver fibrosis. TE became more economically attractive with a higher degree of liver fibrosis. TE with CAP was also less expensive and less accurate than liver biopsy. LIMITATIONS The model did not take into account long-term costs and consequences associated with TE and liver biopsy and did not include costs to patients and their families, or patient preferences related to diagnostic information. CONCLUSIONS TE showed potential cost savings compared to liver biopsy. Further investigation is needed to determine the long-term impacts of TE on morbidity and mortality in Canada and the optimal diagnostic modality for liver fibrosis and steatosis.