Research Article: Cost-effectiveness and budgetary impact of HCV treatment with direct-acting antivirals in India including the risk of reinfection

Date Published: June 6, 2019

Publisher: Public Library of Science

Author(s): Antoine Chaillon, Sanjay R. Mehta, Martin Hoenigl, Sunil S. Solomon, Peter Vickerman, Matthew Hickman, Britt Skaathun, Natasha K. Martin, Yury E. Khudyakov.


HCV direct-acting antivirals (DAAs) are produced in India at low cost. However, concerns surrounding reinfection and budgetary impact limit treatment scale-up in India. We evaluate the cost-effectiveness and budgetary impact of HCV treatment in India, including reinfection.

A closed cohort Markov model of HCV disease progression, treatment, and reinfection was parameterized. We compared treatment by fibrosis stage (F2-F4 or F0-F4) to no treatment from a health care payer perspective. Costs (2017 USD$, based on India-specific data) and health utilities (in quality-adjusted life years, QALYs) were attached to each health state. We assumed DAAs with 90% sustained viral response at $900/treatment and 1%/year reinfection, varied in the sensitivity analysis from 0.1–15%. We deemed the intervention cost-effective if the incremental cost-effectiveness ratio (ICER) fell below India’s per capita GDP ($1,709). We assessed the budgetary impact of treating all diagnosed individuals.

HCV treatment for diagnosed F2-F4 individuals was cost-saving (net costs -$2,881 and net QALYs 3.18/person treated; negative ICER) compared to no treatment. HCV treatment remained cost-saving with reinfection rates of 15%/year. Treating all diagnosed individuals was likely cost-effective compared to delay until F2 (mean ICER $1,586/QALY gained, 67% of simulations falling under the $1,709 threshold) with 1%/year reinfection. For all scenarios, annual retesting for reinfection was more cost-effective than the current policy (one-time retest). Treating all diagnosed individuals and reinfections results in net costs of $445–1,334 million over 5 years (<0.25% of total health care expenditure over 5 years), and cost-savings within 14 years. HCV treatment was highly cost-effective in India, despite reinfection. Annual retesting for reinfection was cost-effective, supporting a policy change towards more frequent retesting. A comprehensive HCV treatment scale-up plan is warranted in India.

Partial Text

An estimated 90% of the global burden of hepatitis C virus (HCV) falls within low to middle income countries (LMIC) [1]. India is one of the countries with the highest burden of HCV worldwide, with an estimated 6.1 million individuals chronically infected with HCV in 2016 [2, 3], roughly 8.5% of the global burden. Highly effective direct-acting antiviral treatments are now available, which are short duration (8–12 weeks), all-oral, highly tolerable, and can lead to cure in >90% of individuals. Yet in India and many LMICs, few are treated, despite advances in HCV treatment which have made HCV an easily curable infection [4]. Globally, it is estimated that only 7% of those diagnosed with HCV initiated treatment in 2015[5] and most LMIC settings have rates below these global estimates. Additionally, The World Health Organization (WHO) recently released a strategy to eliminate HCV as a public health threat, with targets to reduce HCV mortality by 65% and HCV incidence by 80% by 2030 [6]. Yet few LMIC have national strategies to reach this target [7].

Our analysis highlights that despite the risk of reinfection among the general population in India, HCV treatment for diagnosed individuals with moderate to severe liver disease (fibrosis F2 or greater) and annual monitoring for reinfection in India is cost-saving compared to no treatment. Additionally, a further expansion to treat all diagnosed (F0 or above) is likely cost-effective compared to treating those with moderate to severe liver disease. Together these results support the provision of HCV treatment among the general population in India, despite any potential additional associated costs related to retesting and retreatment due to reinfection. Our analysis additionally found that annual retesting for reinfection among those treated for HCV was more cost-effective than a onetime retest after sustained viral response. As current Indian guidelines only recommend a one-time retest at one year post SVR, our work supports a policy change towards annual retesting [36, 43]. Additionally, although we found that treating all diagnosed individuals in 2018 and their future reinfections would incur substantial costs to the government, at a net cost of $445–1,334 million over the next 5 years (<0.25% of total health expenditure over 5 years), it would become cost-saving within 14 years. As HCV is a slowly progressing disease, the economic benefits to the health payer occur over a longer time frame, but nevertheless can result in overall cost-savings within a moderate time frame. The enormous burden of HCV in India and the availability of highly effective and affordable HCV DAA therapies in India poses an enormous opportunity. HCV treatment and annual monitoring for reinfection among the general population in India is likely cost-effective and potentially cost-saving, despite the risk of reinfection. We found that annual retesting for reinfection among those treated for HCV was more cost-effective than a onetime retest after sustained viral response, supporting a policy change in India towards more frequent retesting. Although HCV treatment for all diagnosed individuals would result in a large budgetary impact, this investment would be offset within roughly 15 years due to averted HCV related health care costs. This evidence points towards the benefit and need for a comprehensive HCV treatment action plan in India.   Source: