Cost-Effectiveness Analysis of Boceprevir for the Treatment of Chronic Hepatitis C Virus Genotype 1 Infection in Portugal
The recent approval of two protease inhibitors, boceprevir and telaprevir, is likely to change the management of chronic hepatitis C virus (HCV) genotype 1 infection.
We evaluated the long-term clinical outcomes and the cost effectiveness of therapeutic strategies using boceprevir with peginterferon plus ribavirin (PR) in comparison with PR alone for treating HCV genotype 1 infection in Portugal.
A Markov model was developed to project the expected lifetime costs and quality-adjusted life-years (QALYs) associated with PR alone and the treatment strategies outlined by the European Medicines Agency in the boceprevir summary of product characteristics. The boceprevir-based therapeutic strategies differ according to whether or not the patient was previously treated and whether or not the patient had compensated cirrhosis. The model simulated the experience of a series of cohorts of chronically HCV-infected patients (each defined by age, sex, race and fibrosis score). All treatment-related inputs were obtained from boceprevir clinical trials – SPRINT-2, RESPOND-2 and PROVIDE. Estimates of the natural history parameters and health state utilities were based on published studies. Portugal-specific annual direct costs of HCV health states were estimated by convening a panel of experts to derive health state resource use and multiplying the results by national unit costs. The model was developed from a healthcare system perspective with a timeframe corresponding to the remaining duration of the patients’ lifetimes. Both future costs and QALYs were discounted at 5 %. To test the robustness of the conclusions, we conducted deterministic and probabilistic sensitivity analyses.
In comparison with the treatment with PR alone, boceprevir-based regimens were projected to reduce the lifetime incidence of advanced liver disease, liver transplantation, and liver-related death by 45–51 % and increase life expectancy by 2.3–4.3 years. Although the addition of BOC increased treatment costs by €13,300–€19,700, the reduction of disease burden resulted in a decrease of €5,400–€9,000 in discounted health state costs and an increase of 0.68–1.23 in discounted QALYs per patient. The incremental cost-effectiveness ratios of the boceprevir-based regimens compared with PR among previously untreated and previously treated patients were €11,600/QALY and €8,700/QALY, respectively. The results were most sensitive to variations in sustained virologic response rates, discount rates and age at treatment.
Adding boceprevir to PR was projected to reduce the number of liver complications and liver-related deaths, and to be cost effective in treating both previously untreated and treated patients.
The authors would like to thank Drs John R. Cook and Erik J. Dasbach (Merck) for providing helpful suggestions during model development and Jane Liao (Merck) for providing programming support in the analysis of data from SPRINT-2 and RESPOND-2 studies. The authors would also like to acknowledge the contribution of a panel of eight anonymous Portuguese clinical experts in estimating resource use. All panel members received compensation for their participation, and some members had received speaker’s and investigator’s fees from MSD Portugal in the past.
This study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. Dr. Chhatwal was a former employee of and has received consulting fees from Merck. Dr. El Khoury was a former employee and Drs Elbasha, Ferrante and Laires are current employees of Merck and all hold stocks and/or stock options.
E.H. Elbasha, J. Chhatwal, S.A. Ferrante and A.C. El Khoury developed the model. P.A. Laires contributed to data collection and analysis. All authors provided critical input to the draft. All authors reviewed the final draft and agree with its content. E.H. Elbasha is a guarantor for the overall content.
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