March 16, 2014

The Cost of Treatment Failure

Journal of Viral Hepatitis

Resource Use and Costs Incurred by Hepatitis C Virus Genotype 1-Infected Patients Who Do or Do Not Achieve Sustained Virological Response to Therapy

M. Backx, A. Lewszuk, J. R. White, J. Cole, A. Sreedharan, S. van Sanden, J. Diels, A. Lawson, K. R. Neal, M. J. Wiselka, T. Ito, W. L. Irving

J Viral Hepat. 2014;21(3):208-215

Abstract and Introduction

Abstract

Chronic hepatitis C virus (HCV) infection places a considerable economic burden on health services. Cost-effectiveness analyses of antiviral treatment for patients with chronic HCV infection are dependent on assumptions about cost reductions following sustained virological response (SVR) to therapy. This study quantified the medium-term difference in health resource usage and costs depending on treatment outcome. Retrospective chart review of patients with HCV genotype 1 infection who had received at least 2 months pegylated interferon and ribavirin therapy, with known treatment outcome was conducted. Disease status was categorized as chronic hepatitis, cirrhosis or decompensated liver disease. Health resource use was documented for each patient in each disease state. Unit costs were from the NHS 'Payment by Results' database and the British National Formulary. One hundred and ninety three patients (108 SVR, 85 non-SVR) with mean follow-up of 3.5 (SVR) and 4.9 (non-SVR) years were enrolled. No SVR patient progressed to a more severe liver disease state. Annual transition rates for non-SVR patients were 7.4% (chronic hepatitis to cirrhosis) and 4.9% (cirrhosis to decompensated liver disease). By extrapolation of modelled data over a 5-year post-treatment period, failure of patients with chronic hepatitis to achieve SVR was associated with a 13-fold increase (roughly £2300) in costs, whilst for patients who were retreated, the increase was 56-fold, equating to more than £10 000. Achievement of an SVR has significant effects on health service usage and costs. This work provides real-life data for future cost-effectiveness analyses related to the treatment for chronic HCV infection.

Introduction

An estimated 130–170 million people worldwide are chronically infected with hepatitis C virus (HCV), with around 216 000 living in the United Kingdom (UK).[1] Chronic infection may result in progressive liver damage, leading to cirrhosis and its sequelae in at least 20–30% of individuals.[2] Both hospital admissions and deaths related to chronic HCV infection are rising in the UK,[1] and end-stage liver disease resulting from chronic HCV infection is now a leading indication for liver transplantation.[3] It is estimated that by 2020, nearly 16 000 individuals will be living with HCV-related cirrhosis or hepatocellular carcinoma in England if left untreated.[4] Estimates of direct medical expenses related to HCV infection in the USA predict a rise in total expenditure to over $10 billion in the next decade.[5] The management of chronic HCV infection thus places a significant health and economic burden on national health services worldwide.

Until recently, the standard of care (SoC) for chronic HCV infection involved combination therapy with pegylated interferon and ribavirin. For genotype 1 disease, this resulted in a sustained viral response (SVR) in approximately 40–50% of patients,[6] which in turn results in lower rates of liver-related morbidity and mortality.[7] Recent advances in the understanding of HCV biology have led to the development of directly acting antiviral (DAA) agents. Two of these therapies, telaprevir and boceprevir, act on the viral NS3/4a protease and, in combination with pegylated interferon and ribavirin, have been shown to significantly improve SVR both in treatment-naïve and in treatment-experienced patients with genotype 1 disease. In the USA, triple therapy is now considered the new standard of care for patients with genotype 1 infection.[8] In England and Wales, the National Institute for Health and Clinical Excellence (NICE) has recommended the use of telaprevir or boceprevir, each in combination with pegylated interferon and ribavirin, as treatment options for genotype 1 chronic HCV infection in adults with compensated liver disease for both treatment-naïve and treatment-experienced patients.[9,10]

As treatment options for genotype 1 chronic HCV infection expand, it will be important to understand the cost reductions associated with achievement of an SVR, in addition to the obvious clinical benefits to an individual patient. Previous cost-effectiveness analyses of antiviral therapy have made assumptions that achieving an SVR reduces costs.[11–13] Prior to this study, no previous paper has contrasted the resource use and costs of genotype 1 patients with and without SVR to assess the relative value of successful antiviral treatment in terms of offsetting morbidity costs.

This study aimed to compare disease progression, use of health services and costs to the UK National Health Service (NHS) between patients with genotype 1 infection who achieved an SVR following pegylated interferon and ribavirin therapy vs those who did not, using real-world data representative of routine NHS practice in the UK.

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