COST-EFFECTIVE ALTERNATIVES TO LIVER BIOPSY IN THE MANAGEMENT OF CHRONIC HEPATITIS C

Purpose: Chronic hepatitis C (HCV) is a serious liver disease affecting over 3 million Americans. Liver biopsy is the gold standard for assessing liver fibrosis and is used as a benchmark for initiating treatment, though it is expensive and carries serious risks of complications. FibroTest is a noninvasive biomarker assay for fibrosis, proposed as a screening alternative to biopsy. We assessed the cost-effectiveness of screening strategies for liver fibrosis and subsequent treatment of U.S. patients with chronic HCV.

Method: We estimated the health outcomes and costs associated with each of 6 screening strategies. For patients with chronic HCV, screening strategies to detect fibrosis employed FibroTest and liver biopsy either alone or sequentially followed by treatment (peginterferon alfa and ribavirin). Strategies included: FibroTest only; FibroTest with liver biopsy for ambiguous results; FibroTest followed by biopsy to rule in or rule out significant fibrosis (Metavir score stage 2+); Biopsy only (standard care); and Treatment without prior screening. For treatment of genotype 1 patients, early viral response (EVR) was assessed at 12 weeks, with further 36-week treatment reserved for those with EVR. For other genotypes, treatment was 24 weeks. We developed a Markov model of chronic HCV stratified by gender and genotype that tracks fibrosis progression towards decompensated cirrhosis, hepatocellular carcinoma, and death. Estimates of disease, population, cost, and utility parameters were derived from the published literature and expert opinion. Outcomes were expressed as expected lifetime costs (2009 USD), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER).

Result: Treatment of chronic HCV without screening is preferred for both men and women. For genotype 1, the ICER is $2,000/QALY compared to FibroTest only. For other genotypes, it is more effective and less costly than all alternatives. In clinical settings where testing is required prior to treatment, FibroTest only is more effective and less costly than liver biopsy, the current standard of care. Compared to FibroTest only, FibroTest with biopsy for ambiguous results has an ICER of $93,000/QALY for genotype 1 and $16,000/QALY for other genotypes. These results are robust to multi-way and probabilistic sensitivity analyses.

Conclusion: Early treatment of chronic HCV is superior to the other screening strategies considered. In clinical settings where testing is required prior to treatment, FibroTest screening is a cost-effective alternative to liver biopsy.