Purpose:
Recently, the German HTA agency IQWiG published new guidelines on health-economic evaluations within the German statutory health care system. The goals of this pilot study commissioned by IQWiG in Germany were (1) to apply IQWiG’s new guidelines to the economic evaluation of combination therapy with peginterferon plus ribavirin (PegIFN+RBV) for chronic hepatitis C (CHC) and (2) to assess the feasibility of the efficiency frontier (EF) approach in this case example.Method:
IQWiG’s EF approach assesses the cost-effectiveness of a new treatment within the specific disease area by comparing the new treatment’s incremental cost-effectiveness ratio (ICER) to ICERs of established treatments. We used IQWiG’s EF approach to assess the cost-effectiveness of PegIFN+RBV within the area of CHC comparing against other antiviral treatment regimes. We used a Markov model with a lifelong time horizon to determine health outcomes and costs of all treatment options. Health outcomes included sustained virological response (SVR), lifetime risk of decompensated cirrhosis and quality-adjusted life years (QALY). Model parameters were derived from the published literature and German databases. We adopted the perspective of the community of citizens insured through the statutory health insurance.Result: The ICERs of PegIFN+RBV compared to interferon plus ribavirin (IFN+RBV) were EUR 15,000 EUR per SVR avoided, EUR 42,000 per decompensated cirrhosis avoided, and EUR 4,000 per QALY gained. These ICERs are substantially lower than those of the last segments of the respective EFs (i.e., ICER of IFN+RBV vs. IFN monotherapy) indicating cost-effectiveness of PegIFN+RBV.
The introduction of new genotype-specific treatment guidelines led to cost-savings when compared to IFN+RBV. The EF approach was feasible in the case of CHC treatment, because (1) IQWiG suggests several types of health outcomes, including response rates, prognostic implications, and quality-of-life scores, which can be generated in CHC (i.e., SVR, cirrhosis risk, QALY) and (2) sufficient treatments and evidence existed to generate the EF.Conclusion: PegIFN+RBV is cost-effective when compared to other established treatments in CHC. The EF approach should be feasible for HTAs in the area of CHC. However, several issues remain to be solved and conclusions derived from HTAs based on IQWiG’s framework may substantially differ from HTAs assuming uniform willingness-to-pay thresholds across the entire health care system. The foundation of IQWiG’s approach, that is, deriving disease-specific ICER thresholds, remains challenged.