Cost-Effectiveness Assessment of Telaprevir Combination Treatment Compared to Pegylated-Interferon+Ribavirin Alone in the Management of Chronic Hepatitis C in Treatment-naïve Patients

Abstract

Purpose: The addition of telaprevir (T) to the combination of peginterferon alfa-2a/ribavirin (PR) for the treatment of genotype 1 chronic HCV in treatment-naïve patients substantially increased SVR compared to PR alone in the Phase 3 pivotal study ADVANCE. Based on this improvement in SVR rates, an Excel®-based decision-analytic model was developed to explore the potential long-term clinical and economic consequences of telaprevir combination treatment in treatment-naïve patients. Methods: A two-part (Treatment; Post-treatment) model was developed to project incremental clinical and economic consequences of T/PR versus PR alone treatment options. For Treatment, parallel hypothetical cohorts of 1,000 patients were generated and assigned to one of the treatment options. Based on intention-to-treat SVR rates from the ADVANCE trial, a proportion of each cohort was deemed to achieve SVR. Cohorts were directed into the Post-treatment part where long-term treatment consequences and associated economic implications were estimated for remaining lifetimes using a cyclic Markov process. In any cycle, patients could remain in or transition among health states: absence of cirrhosis, cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and death. Baseline patient characteristics and SVR rates by baseline fibrosis scores were based on ADVANCE data. Age- and gender-specific health state transition probabilities, which varied with achievement of SVR, mortality, health state utilities, and cost data were obtained from published sources. The perspective of the analysis was that of a third-party payor. Results: The model projected an improvement in life expectancy and qualityadjusted life-years (QALYs) with T/PR treatment versus PR over the lifetime of the patient mainly due to reductions in HCV-related complications (20.1 LYs and 17.2 QALYs versus 19.3 LYs and 16.0 QALYs, respectively). While T/PR treatment was estimated to increase the treatment costs, most of this increase was offset by a reduction in the costs of the management of long-term complications: additional per patient cost associated with T/PR was ˜$16,000 over the patient's lifetime compared to PR alone. Estimated incremental cost-effectiveness ratios in this patient population were $13,500/QALYs and ˜$19,500/LYsgained. Conclusion: Modeling results suggested that telaprevir combination treatment is a cost-effective treatment strategy compared to peginterferon alfa-2a/ribavirin alone in treatment-naïve patients. The cost-effectiveness of telaprevir combination treatment was well within the limits of conventional willingness-to-pay thresholds in the U.S. Disclosure: Mr Deniz is an employee and stock holder of Vertex Pharmaceuticals, Dr. Brogan, Mr. Miller, Ms. Talbird and Mr. Thompson are employees of RTI Health Solutions. This research was performed by RTI Health Solutions and funded by Vertex Pharmaceuticals Incorporated.