Cost-effectiveness of hepatitis C treatment using generic direct-acting antivirals available in India

Abstract

Background & aims: Availability of directly-acting antivirals (DAAs) has changed the treatment landscape of hepatitis C virus (HCV) infection. The high price of DAAs has restricted their use in several countries. However, in some countries such as India, generic DAAs are available at much cheaper price. This study examined whether generic DAAs could be cost-saving and how long it would take for the treatment to become cost-saving/effective.

Methods: A previously-validated, mathematical model was adapted to the HCV-infected population in India to compare the outcomes of no treatment versus treatment with DAAs. Model parameters were estimated from published studies. Cost-effectiveness of HCV treatment using available DAAs was calculated, using a payer's perspective. We estimated quality-adjusted life years (QALYs), disability-adjusted life years (DALYs), total costs, and incremental cost-effectiveness ratio of DAAs versus no treatment. One-way and probabilistic sensitivity analyses were conducted.

Results: Compared with no treatment, the use of generic DAAs in Indian HCV patients would increase the life expectancy by 8.02 years, increase QALYs by 3.89, avert 19.07 DALYs, and reduce the lifetime healthcare costs by $1,309 per-person treated. Treatment became cost-effective within 2 years, and cost-saving within 10 years of its initiation overall and within 5 years in persons with cirrhosis. Treating 10,000 HCV-infected persons could prevent 3400-3850 decompensated cirrhosis, 1800-2500 HCC, and 4000-4550 liver-related deaths. The results were sensitive to the costs of DAAs, pre- and post-treatment diagnostic tests and management of cirrhosis, and quality of life after sustained virologic response.

Conclusions: Treatment with generic DAAs available in India will improve patient outcomes, provide a good value for money within 2 years, and be ultimately cost-saving. Therefore, in this and similar settings, HCV treatment should be a priority from a public health as well an economic perspective.

Fig 1. State-transition model schematic of showing the natural history of hepatitis C virus infection.

Abbreviations: DC = decompensated cirrhosis; HCC = hepatocellular carcinoma; HCV = hepatitis C virus; LRD = liver-related death; SVR = sustained virologic response. (Adapted from Chhatwal et al.[9])

Fig 2. Change in adverse clinical outcomes in patients with hepatitis C virus infection in India following treatment using regimens based on directly-acting antiviral drugs available there at low cost.

Abbreviations: DAA, direct-acting antivirals; DC, decompensated cirrhosis; HCC, hepatocellular carcinoma; LRD, liver-related deaths.

Fig 3. Cost-effectiveness of directly-acting antiviral drug-based treatment of persons with hepatitis C virus infection at various stages of liver fibrosis in India, depending on modelling time horizon.

Fig 4. Cost-effectiveness of direct-acting antiviral drug-based treatment of persons with hepatitis C virus infection, by age of starting treatment (years) and time horizon.

DAAs became cost-effective within 2 years of initiation of treatment irrespective of patient’s age; and DAAs became cost-saving for patients of age ≤50 around 10 years but never for patients at the age ≥60.

Fig 5. Tornado diagram for one-way sensitivity analysis of incremental cost-effectiveness ratio using (A) $ per additional quality-adjusted life-year, and (B) $ per disability-adjusted life-year averted.

Horizontal bars show the variation in incremental cost-effectiveness ratio (ICER; in $/QALY gained or $/DALY averted) with variation in the value of the parameter. In the parameter names, the prefix ‘c’ represents cost of a health-state, ‘q’ the quality-of-life weight and ‘p’ the transition probability from one state to the other. Values of ICER below 0 indicate that the treatment is cost-saving. Abbreviations: QALY = quality-adjusted life-year, DALY = disability-adjusted life-year.