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Health Economic Evaluations of Sofosbuvir for Treatment of Chronic Hepatitis C: a Systematic Review

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Abstract

Background and Objective

The approval of sofosbuvir offers new therapeutic options for patients suffering from chronic hepatitis C. In phase III trials, it has demonstrated significantly greater efficacy and safety in comparison with the old standard of care. In addition, it provides the first interferon-free regimen allowing treatment of patients without previous therapeutic options. A current debate regarding pricing and affordability can be attributed to high treatment costs. The objective of this review was to compare health economic evaluations of sofosbuvir for the treatment of chronic hepatitis C in terms of models, patient populations, interventions and results.

Methods

A systematic review was conducted using the data sources Medline (1946–09/2015), Embase (1974–09/2015), the Health Technology Assessment Database (September 2015) and the UK National Health Service Economic Evaluation Database (September 2015). We included health economic evaluations that measured the cost-effectiveness of sofosbuvir-based regimens compared with regimens without sofosbuvir for the treatment of adult patients infected with chronic hepatitis C. The articles were then critically appraised regarding the effectiveness data, cost data and models utilised.

Results

Fourteen studies were included, which analysed the cost-effectiveness of sofosbuvir in seven different countries. Differences in study characteristics were found regarding study populations, modelling and willingness-to-pay thresholds. The study results demonstrated the cost-effectiveness of the treatment combination of sofosbuvir with pegylated interferon and ribavirin in comparison with the old standard of care. Dual therapy with sofosbuvir and ribavirin was considered cost effective only in comparison with no therapy.

Conclusion

Despite high costs, the included studies indicate that sofosbuvir-based regimens are cost effective in most patients. While the results are unequivocal with regard to sofosbuvir-based triple therapy, the cost-effectiveness of sofosbuvir-based dual therapy heavily depends on country-specific willingness to pay. Although interferon-containing triple therapy has now been replaced by newly approved direct-acting antivirals in most middle- and high-income countries, the availability of these oral treatment combinations is poor in low-income countries. Therefore, the findings of our review are still of relevance.

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Acknowledgments

Miriam Luhnen and Gloria Hanke independently screened the records identified through the literature search, extracted study information from the included articles and drafted the manuscript.

Siw Waffenschmidt developed the search strategy and provided the results of the literature search.

Andreas Gerber-Grote gave support during the whole preparation of the review and commented on the manuscript. We thank Consuela Jacobi-Yniguez for proofreading the article.

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Correspondence to Miriam Luhnen.

Ethics declarations

The preparation of this review was supported by the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]). All authors were employees of IQWiG when the review was prepared. No further funding was received.

Miriam Luhnen, Siw Waffenschmidt, Andreas Gerber-Grote and Gloria Hanke have no conflicts of interest that are relevant to the content of this review.

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A. Gerber-Grote and G. Hanke share senior authorship of this article.

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Luhnen, M., Waffenschmidt, S., Gerber-Grote, A. et al. Health Economic Evaluations of Sofosbuvir for Treatment of Chronic Hepatitis C: a Systematic Review. Appl Health Econ Health Policy 14, 527–543 (2016). https://doi.org/10.1007/s40258-016-0253-2

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