1Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.
Introduction: In registration trials, triple therapy with telaprevir (TVR), pegylated-interferon (IFN), and ribavirin (RBV) achieved sustained virological response (SVR) rates between 64-75%, but the clinical effectiveness and economic burdens of this treatment in real-world practice remain to be determined.
Methods: Records of 147 patients who initiated TVR-based triple therapy at the Mount Sinai Medical Center (5/2011-12/2011) were reviewed. Direct medical costs for pre-treatment, on-treatment, and post-treatment care were calculated using data from Medicare reimbursement databases, RED Book, and Healthcare Cost and Utilization Project database. Costs are presented in 2012 US dollars. SVR (undetectable HCV RNA 24 weeks after the end-of-treatment) was determined on an intention-to-treat basis. Cost-per-SVR was calculated by dividing the median cost by the SVR rate.
Results: Median age of the 147 patients was 56 years [interquartile range (IQR) = 51 - 61], 68% were male, 19% were black, 11% had HIV/HCV co-infection, 36% had advanced fibrosis/cirrhosis (FIB-4 scores ≥ 3.25), 44% achieved an SVR. The total cost of care was $11.56 million. Median cost of care was $83,721 per patient (IQR=$66,652- $98,102). The median cost-per-SVR was $189,338 (IQR=$150,735 - $221,860). Total costs were TVR (61%), IFN (24%), RBV (4%), adverse event management (8%), professional fees (2%), and laboratory tests (1%).
Conclusions: TVR and IFN accounted for 85% of costs. Pharmaceutical prices and the low (44%) SVR rate, in this real-world study, were major contributors to the high cost-per-SVR.