AIMS: Telaprevir (T) in combination with peginterferon alfa-2a/ribavirin (PR) for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection substantially increased sustained virologic response (SVR) compared with PR alone in the multinational phase 3 studies ADVANCE (in treatment-naïve patients) and REALIZE (in prior relapsers, partial responders, and null responders to a previous course of PR therapy). A decision-analytic model was developed to explore the potential long-term clinical and economic consequences of T/PR compared with PR alone from a Canadian Ministry of Health perspective.
METHODS: A lifetime two-phase (treatment; post-treatment) Microsoft Excel model was developed to follow parallel hypothetical cohorts treated with T/PR or PR alone. Patients first moved through the 72-week decision-tree treatment phase of the model and then entered the cyclic Markov post-treatment phase. In any 1-year cycle, patients could remain in or transition among the following health states: four pre-cirrhosis health states, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, HCV-related death and non-HCV-related death. Clinical data, including patient characteristics and SVR attainment rates, were obtained from ADVANCE and REALIZE. Drug costs were obtained from public sources for each province and averaged. Health state transition probabilities (which varied by SVR status, age, and gender), other costs, utilities, and mortality were obtained from the trials and published sources. All costs were in 2011 Canadian dollars; all outcomes except HCV-related complications were discounted at 5% per year; and sensitivity analyses were conducted.
RESULTS: In treatment-naïve patients and treatment-experienced patients (prior relapsers, partial responders and null responders), the lifetime model projected that T/PR reduced HCV-related complications by 20% to 80% and increased life expectancy (0.4 to 1.2 more years) and quality-adjusted life expectancy (0.7 to 1.7 more quality-adjusted life years [QALYs]) compared with PR alone. Increased treatment costs with T/PR over PR alone were partially offset by lower other medical costs, yielding incremental cost-effectiveness ratios between $1,467 and $36,255 per QALY gained.
CONCLUSIONS: Using traditional benchmarks for acceptable cost-effectiveness, results from this model suggest that T combination therapy is a cost-effective treatment strategy in Canada compared with PR alone in treatment-naïve and previously treated patients.