Economic Burden and Current Managed Care Challenges Associated With Hepatitis C

Infection with hepatitis C virus (HCV) is associated with significant morbidity, mortality, and costs related to treatment.^1,2 However, HCV infection is severely underdiagnosed and undertreated.³ Newer therapies have the potential to improve the virological and liver-related outcomes associated with HCV, but at an increased cost of treatment.4,5 Despite the barriers to treatment, the economic burden of HCV extends beyond treatment costs, and clinicians, patients, and managed care professionals must understand the full impact of cost-effective HCV treatment.6 This article will review the economic burden associated with HCV and current challenges in the managed care setting, determine cost-effectiveness of HCV therapies, highlight issues surrounding adherence, and address challenges to managed care organizations.

Economic Burden of HCV

A study evaluated UnitedHealth Group–affiliated health plan claims from 1997 to 1999 for patients tested for HCV.6 In that study, 0.7% of members were tested during the study period, and 6.7% of the population was diagnosed with chronic HCV. Treatment was given to 33.6% of male patients and 25.2% of female patients diagnosed with chronic HCV. Depending on the regimen used, 64.8% to 75.8% of patients completed the standard treatment course. Of the treated patients, 64.5% had a baseline HCV RNA test and 32.5% had a follow-up HCV RNA test within 6 months.6 These findings highlight the barriers to treatment, including lack of diagnosis, undertreatment, poor adherence, and incomplete follow-up and monitoring.^3,6 Another study of inpatient data from the Healthcare Cost and Utilization Project, outpatient data from the National Ambulatory Medical Care Survey, and medication data from the Verispan Source Prescription Audit evaluated data from 1994 to 2001 in patients with chronic HCV.⁷ In the 8 years of the study, there were 3- to 4-fold increases in the costs of care associated with an aging population and an increase in the number of patients with the disease. The increase in hospitalizations, charges, hospital days, and physician visits was 25% to 30% per year during the study, primarily in patients aged 40 to 60 years. From 1994 to 2001, patients aged 40 to 49 years had increased liver-related hospital days (from 32.3% to 37.6%), and patients aged 50 to 59 years had increased liver-related hospital days (from 17% to 30.1%). For every $100,000 in nationwide charges for all hospitalizations, liverrelated HCV hospitalizations increased from $145 in 1994 to $427 in 2001. For every $100,000 in new prescriptions, ribavirin-interferon costs rose from $78 in 1998 to $259 in 2001. Prior to 1998, spending was focused on interferon monotherapy. During the same period, patients coinfected with human immunodeficiency virus (HIV) and HCV had 7.5 times as many hospitalizations in 2001 as patients with HIV alone, and 2.9 times the charges in 1994.⁷ Data from this resource utilization study demonstrated that direct expenditures for HCV-related morbidity increased significantly over time, largely due to an aging, undertreated population experiencing worsening of disease.7 Estimates from 2010 to 2019 indicated that the direct costs of HCV-related disease in the United States would be $6.5 to $13.6 billion in 1999-adjusted dollars.⁸

The current estimate for HCV-related mortality in the United States is 8000 to 10,000 deaths per year.⁹ US estimates predict 160,000 to 196,000 HCV-related deaths from 2005 to 2025, and from 2010 to 2019, the costs of premature mortality are expected to be $54.2 billion.^8,9 Lost productivity, due to disability from decompensated cirrhosis and hepatocellular carcinoma, is expected to contribute an additional $21.3 billion in costs. It is likely that these costs will increase, because the mortality rate for HCV is expected to peak in 2030 with an estimated death rate of 12,900 in the United States.¹ Recent evidence suggests that declining treatment rates will result in suboptimal prevention of liverrelated deaths between 2002 and 2030, with only approximately 14.5% of deaths prevented.¹⁰ These results highlight the costs associated with HCV and indicate that the direct costs are substantially less than the indirect costs, suggesting that therapy might be cost-effective if it could be delivered effectively, and that therapy could prevent HCV-related morbidity and mortality.

Strategies for Determining the Cost-effectiveness of Therapy

In 1998, the direct costs of HCV infection in the United States were estimated to be over $1 billion. Pharmacoeconomic analyses take into consideration both disease costs and treatment costs. Thus, cost-effectiveness studies must consider the treatment costs (direct costs) in the context of disease costs (direct and indirect costs) and societal costs, such as lost productivity (indirect costs).¹¹ A study published in 1999 suggested a $400 reduction in lifetime cost of care, and a 1.5-year increase in life expectancy with interferon therapy.¹² These data suggest that interferon was cost-effective because it was cost-saving, despite marginal efficacy. In an analysis of 9 studies of interferon taken from a societal perspective, nearly all studies identified an incremental cost-effectiveness ratio (ICER) of less than $5000 (1995 values) per quality-adjusted life-year (QALY) for 6 to 12 months of interferon monotherapy compared with no antiviral therapy.11 For relapsed patients, 6 months of interferon and ribavirin combination therapy cost $280 more than interferon monotherapy retreatment, and had an ICER of $140 per QALY gained (1999 values).¹¹ For treatmentnaïve patients, interferon plus ribavirin compared with interferon (with interferon plus ribavirin for patients experiencing relapse) had an ICER of $7500 per QALY gained. ICERs less than $50,000 to $100,000 per QALY gained are generally considered cost-effective.¹¹