Cost-Effectiveness Modelling of Sofosbuvir-Containing Regimens for Chronic Genotype 5 Hepatitis C Virus Infection in South Africa

Abstract

Background

The recently launched nucleotide polymerase inhibitor sofosbuvir represents a significant turn in the treatment paradigm of chronic hepatitis C. While effective, sofosbuvir is also associated with a considerable cost.

Objective

The objective of this study was to evaluate the cost effectiveness of sofosbuvir-containing regimens in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 5 (HCV-G5) mono-infection in South Africa (SA).

Design

We constructed a lifetime horizon decision-analytic Markov model of the natural history of HCV infection to evaluate the cost effectiveness of sofosbuvir–ledipasvir (SOF/LDV) monotherapy against sofosbuvir triple therapy (SOF-TT) (sofosbuvir + pegylated interferon and ribavirin [peg-INF/RBV]) and the current standard of care (SOC) (peg-INF/RBV) for patients with chronic HCV-G5 in the South African context. The model was populated with data from published literature, expert opinion and South African private sector cost data. The price modelled for sofosbuvir was the predicted South African private sector price of 82,129.32 South African rand (R) (US$7000) for 12 weeks. The analysis was conducted from a third-party payer perspective.

Outcome Measures

The outcome measures were discounted and undiscounted costs (in 2015 South African rand and US dollars) and quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).

Results

Outcomes from the cost-effectiveness model show that SOF/LDV yields the most favourable future health economic outcomes compared with SOF-TT and the current SOC in SA. Findings relating to the lifetime incremental cost per QALY gained for patients infected with HCV-G5 indicate that SOF/LDV dominated both SOF-TT and SOC, i.e. SOF/LDV is less costly and more effective.

Conclusion

Outcomes from this analysis suggest that at a price of R123,190 ($US10,500) for 12 weeks of SOF/LDV might be cost effective for South African patients infected with HCV-G5.

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Notes

  1. 1.

    US$1 = R11.73276 [11].

  2. 2.

    The METAVIR scoring system is a scoring method used for measuring the degree of liver inflammation and staging of fibrosis in patients with hepatitis C. It uses a grading and a staging system where the grade indicates the amount of inflammation and the stage represents the amount of fibrosis or scarring. The grade is usually scored from 0 to 4 (0 = no activity and 3 or 4 = severe activity). The fibrosis score is also assigned a number from 0 to 4 (0 = no scarring; 1 = minimal scarring; 2 = scarring extending outside the areas in the liver that contains blood vessels; 3 = bridging fibrosis, spreading and connecting to other areas that contain fibrosis; and 4 = cirrhosis or advanced scarring of the liver) [41].

  3. 3.

    In SA, medicine prices are regulated (Medicines and Related Substances Act, SA, 2014) and consist of a regulated SEP, VAT and a professional fee charged by the dispensing pharmacist, which makes discounting of any sort illegal [48].

  4. 4.

    SA does not have a WTP threshold. We thus assumed an ICER of three times the gross domestic product (GDP)/capita as cost effective [57].

  5. 5.

    Utility value for SOF/LDV for 24 weeks = 0.741 [37].

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Author contributions

Ilanca Fraser and Tienie Stander conceived the design of the study. Ilanca Fraser was responsible for model construction, data collection, data analysis and interpretation of results. Johanita Burger supervised the study concept and writing of the manuscript. Mark Sonderup and Tienie Stander co-supervised the study concept, evaluated the model for clinical/technical accuracy and assisted with data collection. Johanita Burger, Martie Lubbe and George Dranitsaris reviewed the manuscript carefully for final approval.

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Correspondence to Johanita Burger.

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Funding

This study was financially supported by the North-West University, under number 20098871 and Gilead Sciences Inc., under number PO # 801097865.

Conflict of interest

Ilanca Fraser does not report competing interests. Johanita Burger does not report competing interests. Martie Lubbe does not report competing interests. George Dranitsaris does not report competing interests. As a potential competing interest, Mark Sonderup reports that he has consulted to Gilead Sciences Inc. in the past five years. As a potential competing interest, TS reports that, as an employer of HEXOR (Pty) Ltd., he has consulted to Gilead Sciences, Inc. in the past five years.

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Fraser, I., Burger, J., Lubbe, M. et al. Cost-Effectiveness Modelling of Sofosbuvir-Containing Regimens for Chronic Genotype 5 Hepatitis C Virus Infection in South Africa. PharmacoEconomics 34, 403–417 (2016). https://doi.org/10.1007/s40273-015-0356-x

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Keywords

  • Sustained Virologic Response
  • Sustained Virologic Response Rate
  • Sofosbuvir
  • Early Virologic Response
  • Annual Transition Probability