Cost-effectiveness of Telaprevir combination therapy for chronic hepatitis C

Abstract

Objective: To explore the expected long-term health and economic outcomes of telaprevir (TVR) plus peginterferon alfa-2a and ribavirin (PR), a regimen that demonstrated substantially increased sustained virologic response (SVR) compared with PR alone in adults with chronic genotype 1 hepatitis C virus (HCV) and compensated liver disease in the Phase III studies ADVANCE (treatment-naïve patients) and REALIZE (relapsers, partial responders, and null responders to previous PR treatment).

Study design: A decision-analytic model was developed to assess the cost-effectiveness of TVR+PR vs. PR in the United States (US).

Methods: Patients first moved through the 72-week decision-tree treatment phase of the model and then entered the cyclic Markov post-treatment phase. Clinical data (patient characteristics, SVR rates, and adverse event rates and durations) were obtained from ADVANCE and REALIZE. Health-state transition probabilities, drug and other costs (in 2012/2013 US dollars), and utility values were obtained from the trials, published studies, and publicly available sources. Outcomes were discounted at 3% per year.

Results: Regardless of treatment history, patients receiving TVR+PR were projected to experience fewer liver-disease complications, more life-years, and more quality-adjusted life-years (QALYs) than patients receiving PR. In prior relapsers, TVR+PR was dominant, with lower total medical costs and more QALYs. For the other patient subgroups, incremental costs per QALY gained were between $16,778 (treatment-naïve patients) and $34,279 (prior null responders). Extensive sensitivity analyses confirmed robust model results.

Conclusions: At standard willingness-to-pay thresholds, TVR+PR represents a cost-effective treatment option compared with PR alone for patients with chronic genotype 1 HCV and compensated liver disease in the US. Future analyses are needed to compare TVR+PR with all existing HCV treatment options.

Figure 1. Overview of the Cost-effectiveness Model Structure: Treatment Phase and Post-treatment Phase.

DCC indicates decompensated cirrhosis; eRVR, extended rapid virologic response; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; PR, pegylated interferon alfa-2a plus ribavirin; RGT, response-guided therapy; SVR, sustained virologic response; TVR, telaprevir. a Treatment-naïve patients received no prior therapy for HCV, including interferon or peginterferon monotherapy; prior relapsers had HCV RNA undetectable at the end of treatment with peginterferon alfa and ribavirin but HCV RNA detectable within 24 weeks of treatment follow-up; prior partial responders had greater than or equal to a 2-log10 reduction in HCV RNA at week 12, but did not achieve HCV RNA undetectable at the end of treatment with peginterferon alfa and ribavirin; prior null responders had less than a 2-log10 reduction in HCV RNA at week 12 of treatment with peginterferon alfa and ribavirin. b Although not eligible for RGT in REALIZE, prior relapsers were eligible for RGT in the model (i.e., they could discontinue treatment early if eRVR was achieved), per the TVR prescribing information (INCIVEK, 2012) . c Transition probabilities between health states differed depending on achievement of SVR. Specifically, patients with SVR and with no or mild fibrosis (F0–F2) experienced no further liver deterioration. Patients with SVR and with advanced fibrosis (F3–F4) were at continuing risk of liver deterioration, but at lower probabilities than patients without SVR. ^d HCV-related death could occur only from health states DCC, HCC, and liver transplant.