Jennifer M. Stephens1, John Carter1, Xin Gao1, Seema Haider2, Vinod K. Rustgi3
1. Pharmerit North America LLC, Bethesda, MD, United States. 2. Pfizer Inc, New London, CT, United States. 3. Georgetown University Medical Center, Washington, DC, United States.
It is anticipated that the current standard of care (SOC: PEGIFN/RBV for 48 weeks) for the treatment of hepatitis C (HCV) will shift to a triple therapy approach. The first class of agents to be added to SOC is the protease inhibitors for triple therapy (PITT). Although the viral load reduction associated with protease inhibitors (PIs) is well documented, no study of the impact on costs related to PITT has been performed; particularly, those associated to adverse events (AEs). Our objective was to describe the incremental AE costs of PITT over SOC. METHODS: A comprehensive literature search of the past 5 years was conducted to identify clinical trial studies for PITT and SOC. We developed an economic analysis of the incremental costs of treating AEs in PITT (24-48 weeks) vs. SOC (48 weeks) based on AE incidence rates in PITT and SOC arms within PITT clinical trials. Medical interventions for AEs were drawn from SOC and PITT trials. Medication prices to treat AEs were based on 2009 US dollars (AWP-Redbook), and medical fees were based on standard 50th percentile costs for CPT codes from the 2009 National Fee Analyzer (Ingenix).RESULTS: A total of 5 SOC and 7 PITT trials were identified. Of the PITT trials, 3 (2 telaprevir; 1 boceprevir) contained a 48-wk SOC comparison arm. Average costs to manage an AE episode were estimated at up to $4825 for anemia (assuming epo use rate of 22%), $2837 for depression, $566 for diarrhea, and $633 for rash. The relative weighted AE incidence (w/ weighted avg total AE cost per patient) for SOC, telaprevir-based, and boceprevir-based PITT respectively are shown in the table below. The incremental cost to treat PITT-related AEs averaged >30% higher than SOC (range 8-60%). CONCLUSIONS: PITT may be associated with greater costs to manage AEs compared with SOC. Future studies should incorporate the economic burden of the AE profile, the total cost and value of treatment based on long term outcomes, and the effect of treatment-related AEs on the ability to achieve sustained viral response.