Cost-Utility Analysis of Direct-Acting Antiviral Agents in Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype 1 Infection

Abstract

Abstract Background: The new regimens for hepatitis C authorized in Norway have increased sustained virologic response, give no side effects, resulting in lower transmission rate, reduced mortality and higher quality of life for the most vulnerable categories of people. But the new treatment is also connected with extremely high costs. Aim: To compare cost-utility of two types of treatment of treatment-naïve genotype 1 HCV mono-infected patients: newly invented direct-acting antiviral agents (DAAs) Elbasvir/Grazoprevir and Ledipasvir/Sofosbuvir with old standard treatment with Pegylated-Interferon alfa 2a/Ribavirin. The analysis will be made from payer perspective. Methods: A Markov model was developed to simulate the disease progression with quality-adjusted life years (QALY) gains and costs per QALY as an outcome derived from treatment with DAAs over a lifetime time horizon. The target population was the treatment-naïve patients infected with chronic HCV genotype 1, baseline virus RNA ≤6 million IU/mL and absence of NS5A resistance. The primary outcome was the ICUR (incremental cost-utility ratio) for LDV/SOF and EBR/GRZ versus PEG-IFN/RBV treatment. Costs are considered from the payer perspective. The study includes deterministic analysis. Sensitivity analysis is performed to check the robustness of the model. Transition probabilities, utilities and costs were obtained from the literature. To catch the possible uncertainty of the model, a probabilistic sensitivity analysis was conducted. The expected value of perfect information (EVPI) is to be calculated. The results will be analyzed from the point of view of the budget impact analysis (BIA). Results: The incremental cost per patient of EBR/GRZ is 786 207 NOK, cost of LDV/SOF – 920 785 NOK. The incremental effect for EBR/GRZ – 1.098 QALYs, for LDV/SOF – 1.094 QALYs. The incremental cost-utility ratio (ICUR) of 716 158 NOK – for EBR/GRZ and 841 727 NOK – for LDV/SOF per additional QALY gained basing on the old prices before rebate. EVPI and BIA demonstrated even more favorable results Conclusion: The treatment strategies with Zepatier (GRZ/EBR) and Harvoni (LDV/SOF) are cost-effective if willingness-to-pay (WTP) threshold is assumed to be 700 000 NOK and higher. The rebated prices will improve the cost-effectiveness of new regimens. Though, additional research is still required to diminish the uncertainties of the results.