LONG-TERM EFFECTIVENESS AND COST EFFECTIVENESS OF DIFFERENT ANTIVIRAL TREATMENTS FOR CHRONIC GENOTYPE-1 HCV INFECTION IN GERMANY INCLUDING OMBITASVIR/PARITAPREVIR/RITONAVIR AND DASABUVIR

Purpose:

Chronic hepatitis C (CHC) imposes considerable clinical and economic burden. Direct-acting antiviral drugs show improved sustained virologic response rates (SVR) compared to standard treatments, but associated high drug costs are an ongoing debate in Germany. We systematically evaluated long-term clinical effectiveness and cost effectiveness of different antiviral treatments for treatment-naïve and -experienced patients with genotype 1 (GT1) CHC with or without compensated cirrhosis in Germany.

Method(s):

We developed and applied a Markov state-transition model for the German health care context to evaluate different antiviral treatment regimens: ombitasvir/paritaprevir/ritonavir+dasabuvir± ribavirin (OBV/PTV/r+DSV±R), peginterferon+R (PR), telaprevir+PR (TVR+PR), boceprevir+PR (BOC+PR), sofosbuvir+PR (SOF+PR), simeprevir+PR (SIM+PR), SOF+ledipasvir (SOF/LDV). The model considers German epidemiological, health-related quality-of-life (HRQoL) and economic data from literature and databases. Antiviral treatment was modelled according to German drug labels. Treatment-related SVR, adverse events, discontinuation and HRQoL changes were based on international clinical trials. We adopted the perspective of the patient community insured by the German Statutory Sickness Funds. Cost and effects were discounted at 3% per year. Outcomes included reduction in lifetime risk for decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC) and liver transplantation (LT), lifetime costs, quality-adjusted life years (QALY), and incremental cost-effectiveness ratios (ICER; in Euro/QALY). We applied the IQWiG efficiency frontier approach to assess and visualize incremental cost effectiveness. Comprehensive sensitivity analyses were performed.

Result(s): In the base-case analysis, OBV/PTV/r+DSV±R achieved the highest effectiveness based on patient-relevant outcomes including lifetime risk reductions of 91% (DCC), 82% (HCC) and 85% (LT) in treatment-naïve and 91%, 75%, 81% in treatment-experienced GT1 CHC patients when compared to no treatment. Based on the efficiency frontier, OBV/PTV/r+DSV±R was cost effective with an ICER of 26,423 Euro/QALY (vs. SIM+P+R as the next best non-dominated strategy) in treatment-naïve, and 16,893 Euro/QALY (vs. no treatment) in treatment-experienced GT1 CHC-patients. Results remain robust in most sensitivity analyses. The parameters SVR, discount rate, progression to more advanced liver disease and the relative utility for being HCV-RNA positive had the greatest influence on the ICER.

Conclusion(s):

Based on our analyses, antiviral treatment with OBV/PTV/r+DSV±R achieves the highest benefit in terms of life expectancy, QALY and reduction in DCC, HCC, and LT. Based on our modeling analyses, OBV/PTV/r+DSV±R is considered cost effective for the treatment of patients with GT1 CHC with or without compensated cirrhosis in Germany.