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

Background 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. Methods 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. Results 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. Conclusions 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.

[1]  R. Aggarwal,et al.  Burden of hepatitis C virus infection in India: A systematic review and meta‐analysis , 2018, Journal of gastroenterology and hepatology.

[2]  Josephine G. Walker,et al.  Curbing the hepatitis C virus epidemic in Pakistan: the impact of scaling up treatment and prevention for achieving elimination , 2018, International journal of epidemiology.

[3]  J. Chhatwal,et al.  Systematic review: cost‐effectiveness of direct‐acting antivirals for treatment of hepatitis C genotypes 2‐6 , 2017, Alimentary pharmacology & therapeutics.

[4]  J. Chhatwal,et al.  Direct‐Acting Antiviral Agents for Patients With Hepatitis C Virus Genotype 1 Infection Are Cost‐Saving , 2017, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[5]  R. Aggarwal,et al.  Cost-effectiveness of hepatitis C treatment using generic direct-acting antivirals available in India , 2017, PloS one.

[6]  R. Kamel AASLD 2016 Recommendations for Testing, Managing, and Treating Hepatitis C , 2017 .

[7]  P. Gustafson,et al.  Incidence, risk factors, and prevention of hepatitis C reinfection: a population-based cohort study. , 2017, The lancet. Gastroenterology & hepatology.

[8]  A. Petruzziello,et al.  Global epidemiology of hepatitis C virus infection: An up-date of the distribution and circulation of hepatitis C virus genotypes , 2016, World journal of gastroenterology.

[9]  Reza Assadi,et al.  The global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013 , 2016, The Lancet.

[10]  Sanjay Hadigal Comments: Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy against HCV Infection: Update 2016. , 2016, Journal of Clinical and Experimental Hepatology.

[11]  R. Riley,et al.  Risk of Late Relapse or Reinfection With Hepatitis C Virus After Achieving a Sustained Virological Response: A Systematic Review and Meta-analysis , 2016, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[12]  J. Chhatwal,et al.  Systematic Review of Modelling Approaches for the Cost Effectiveness of Hepatitis C Treatment with Direct-Acting Antivirals , 2016, PharmacoEconomics.

[13]  S. Nagral,et al.  Liver Transplantation in India: At the Crossroads. , 2015, Journal of clinical and experimental hepatology.

[14]  V. Mattoo,et al.  Direct Medical Cost Associated With The Diagnosis and Treatment of Patients With Chronic Hepatitis-B In Three Large Metropolitan Cities In India - A Pilot Study. , 2015, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[15]  F. Ermiş,et al.  New treatment strategies for hepatitis C infection. , 2015, World journal of hepatology.

[16]  C. Bickerstaff The cost–effectiveness of novel direct acting antiviral agent therapies for the treatment of chronic hepatitis C , 2015, Expert review of pharmacoeconomics & outcomes research.

[17]  J. Ward,et al.  Cost‐effectiveness of hepatitis C treatment for patients in early stages of liver disease , 2015, Hepatology.

[18]  M. Leshno,et al.  The present and future disease burden of hepatitis C virus (HCV) infections with today's treatment paradigm – volume 2 , 2015, Journal of viral hepatitis.

[19]  C. Bickerstaff The cost-effectiveness of novel direct acting antiviral agent therapies for the treatment of chronic hepatitis C. , 2015, Expert review of pharmacoeconomics & outcomes research.

[20]  Y. Chawla,et al.  Indian National Association for Study of the Liver , 2015, Indian Journal of Gastroenterology.

[21]  H. Razavi,et al.  Global epidemiology and genotype distribution of the hepatitis C virus infection. , 2014, Journal of hepatology.

[22]  M. Abdel-hamid,et al.  Effect of preventive and curative interventions on hepatitis C virus transmission in Egypt (ANRS 1211): a modelling study. , 2014, The Lancet. Global health.

[23]  Y. Yazdanpanah,et al.  Should we await IFN-free regimens to treat HCV genotype 1 treatment-naive patients? A cost-effectiveness analysis (ANRS 95141). , 2014, Journal of hepatology.

[24]  R. Aggarwal,et al.  Consensus Statement of HCV Task Force of the Indian National Association for Study of the Liver (INASL). Part II: INASL Recommendations for Management of HCV in India. , 2014, Journal of clinical and experimental hepatology.

[25]  R. Aggarwal,et al.  Consensus Statement of HCV Task Force of the Indian National Association for Study of the Liver (INASL). Part I: Status Report of HCV Infection in India. , 2014, Journal of clinical and experimental hepatology.

[26]  G. Esmat,et al.  The present and future disease burden of hepatitis C virus (HCV) infection with today's treatment paradigm , 2014, Journal of viral hepatitis.

[27]  M. Kumar,et al.  Indian National Association for Study of the Liver , 2016, Indian Journal of Gastroenterology.

[28]  M. Hellard,et al.  Hepatitis C virus treatment for prevention among people who inject drugs: Modeling treatment scale-up in the age of direct-acting antivirals , 2013, Hepatology.

[29]  M. Hellard,et al.  Assessing the cost‐effectiveness of treating chronic hepatitis C virus in people who inject drugs in Australia , 2013, Journal of gastroenterology and hepatology.

[30]  A. Flaxman,et al.  Global epidemiology of hepatitis C virus infection: New estimates of age‐specific antibody to HCV seroprevalence , 2013, Hepatology.

[31]  S. Reid Estimating the Burden of Disease from Unsafe Injections in India: A Cost–benefit Assessment of the Auto-disable Syringe in a Country with Low Blood-borne Virus Prevalence , 2012, Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine.

[32]  N. Arora Injection practices in India , 2012, WHO South-East Asia Journal of Public Health.

[33]  R. Kim,et al.  Structural frameworks and key model parameters in cost-effectiveness analyses for current and future treatments of chronic hepatitis C. , 2011, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[34]  K. Shanmugam Discount Rate for Health Benefits and the Value of Life in India , 2011 .

[35]  F. Sanai,et al.  A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt , 2011, Liver international : official journal of the International Association for the Study of the Liver.

[36]  S. Hassan,et al.  A comparison of four fibrosis indexes in chronic HCV: Development of new fibrosis-cirrhosis index (FCI) , 2011, BMC gastroenterology.

[37]  L. Abu-Raddad,et al.  Evidence of intense ongoing endemic transmission of hepatitis C virus in Egypt , 2010, Proceedings of the National Academy of Sciences.

[38]  A. Mukhopadhya,et al.  Hepatitis C in India , 2008, Journal of Biosciences.

[39]  M. Murhekar,et al.  Assessment of injection-related practices in a tribal community of Andaman and Nicobar Islands, India. , 2005, Public Health.

[40]  K. Namasivayam,et al.  Injection practices in southern part of India. , 2003, Public health.

[41]  A. Santra,et al.  Hepatitis C virus infection in the general population: A community‐based study in West Bengal, India , 2003, Hepatology.

[42]  R. Aggarwal,et al.  Assessment of cost-effectiveness of universal hepatitis B immunization in a low-income country with intermediate endemicity using a Markov model. , 2003, Journal of hepatology.

[43]  P. Bedossa,et al.  An algorithm for the grading of activity in chronic hepatitis C , 1996, Hepatology.