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Cost-Effectiveness Analysis of Early Treatment of Chronic HCV with Sofosbuvir/Velpatasvir in Italy

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Abstract

Background

Chronic Hepatitis C virus (cHCV) is a major health issue worldwide. New effective direct-acting anti-viral (DAA) drugs such as the combination sofosbuvir/velpatasvir, represent an important turning point, given the high sustained virologic response (SVR) rates associated with their use.

Objectives

To estimate the cost and effects of two different treatment strategies based on sofosbuvir/velpatasvir. Strategy 1: treating all patients, including those in the early stages of fibrosis; Strategy 2: reserving treatments for patients at more advanced stages of disease (≥ F3). The analysis compares the incremental cost-effectiveness ratio (ICER) of Strategy 1 versus Strategy 2 in a cohort of HCV-infected patients and a cohort of hepatitis C virus (HCV)-human immunodeficiency virus (HIV) patients.

Methods

A Markov model simulating the natural history of the disease was built considering a 60-year time horizon and two cohorts of 1000 patients aged ≥ 35 years. Disease morbidity was classified according to the METAVIR classification. The robustness of the model was tested using deterministic and probabilistic sensitivity analyses (PSA).

Results

In both cohorts, Strategy 1 results in higher resource consumption and a greater number of quality-adjusted life-years (QALYs) compared with Strategy 2. The ICERs for the cohort of HCV patients and the cohort of co-infected HCV/HIV patients ranged between €15,555–74,804/QALY and €10,708–55,138/QALY, respectively, depending on the assumed cost of the treatment. In the PSA, the ICER distribution remained below the threshold of €30,000/QALY in 96 and 97% of the scenarios in the cohorts of HCV and HCV/HIV patients, respectively.

Conclusions

Extending the treatment of HCV to patients at an early stage of HCV infection is estimated to be cost effective from the perspective of the Italian Healthcare System.

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Notes

  1. Concerning the patients with genotype 3 affected by compensated cirrhosis, the addition of RBV might be considered [Source: Epclusa Product Characteristics Summary].

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Author information

Authors and Affiliations

  1. Catholic University of Sacred Heart, Rome, Italy

    Matteo Ruggeri, Federica Romano, Michele Basile, Silvia Coretti, Francesca Romana Rolli & Americo Cicchetti

  2. “Nicolò Cusano” University, Rome, Italy

    Carlo Drago

Authors
  1. Matteo Ruggeri
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  2. Federica Romano
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  3. Michele Basile
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  4. Silvia Coretti
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  5. Francesca Romana Rolli
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  6. Carlo Drago
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  7. Americo Cicchetti
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Contributions

All authors made a substantial contribution to the conception, design, acquisition of data and related analysis and interpretation and participated in drafting the article and revising it critically and according to its important intellectual content.

Corresponding author

Correspondence to Michele Basile.

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Data availability statement

All data generated or analyzed during this study are included in this published article (and its supplementary information files).

Funding

This study was funded by Gilead Sciences Srl. The views expressed here are those of the authors and not necessarily those of the funders.

Conflict of interest

None of the authors (Dr. Ruggeri, Drs. Romano F, Dr. Basile, Drs. Coretti, Drs. Rolli, Dr. Drago and Dr. Cicchetti) has any potential conflict of interest related to this manuscript.

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Ruggeri, M., Romano, F., Basile, M. et al. Cost-Effectiveness Analysis of Early Treatment of Chronic HCV with Sofosbuvir/Velpatasvir in Italy. Appl Health Econ Health Policy 16, 711–722 (2018). https://doi.org/10.1007/s40258-018-0410-x

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