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Estimating future hepatitis C morbidity, mortality, and costs in the United States
  This study estimated future morbidity, mortality, and costs resulting from hepatitis C virus (HCV). We used a computer cohort simulation of the natural history of HCV in the US population.
From the year 2010 through 2019, our model projected 165,900 deaths from chronic liver disease, 27,200 deaths from hepatocellular carcinoma, and $10.7 billion in direct medical expenditures for HCV. During this period, HCV may lead to 720,700 years of decompensated cirrhosis and hepatocellular carcinoma and to the loss of 1.83 million years of life in those younger than 65 at a societal cost of $21.3 and $54.2 billion, respectively. In sensitivity analysis, these estimates depended on (1) whether patients with HCV and normal transaminase levels develop progressive liver disease, (2) the extent of alcohol ingestion, and (3) the likelihood of dying from other causes related to the route of HCV acquisition.
Our projections for hepatitis C likely underestimated the long-term costs be-cause they did not include future expenses related to periodic liver biopsy, screening for hepatocellular carcinoma, and treatment costs. Moreover, our estimates applied variable costs (the additional cost to treat 1 more patient) and not charges (retail price) or total costs (including fixed costs or overhead). The latter are typically 2 to 3 times higher. For example, in this analysis, liver transplantation cost $108,659 for the first year and $18, 976 per year subsequently (in 1999 dollars), but other studies that used charge data reported transplantation costs of $200,000 or higher for the surgery and $25,000 per year for medications.
Our estimates did not consider the possibility of accelerated HCV progression in older individuals or those co-infected with hepatitis B or HIV, who are more likely to develop hepatic complications.
Based on the 2 million individuals who had detectable viral RNA for HCV and who presumably had elevated liver transaminases in 1991, our model predicted that annual HCV-related liver deaths for the years 2010 to 2019 would increase 2-fold when compared with the 8000 deaths in 1991. HCV-related chronic liver disease mortality would be 181,300 over this 10-year period, with another 27,200 deaths from HCV-related hepatocellular carcinoma. The highest proportion of deaths related to hepatitis C would occur 10 to 20 years from now, peaking in 2014. The need for liver transplants would rise until 2015. Because of the higher risk for decompensated liver disease and the relatively low risk of cancer assumed for this analysis, new cases of hepatocellular carcinoma would rise only until 2008 but would remain relatively stable throughout the next 20 years, varying by at most several hundred. Figure 3 shows the estimated annual direct medical care costs. For the 10-year period from 2010 to 2019, direct medical expenditures would be $10.7 billion.
Our results confirm prior Centers for Disease Control and Prevention projections and suggest that HCV may lead to a substantial health and economic burden over the next 10 to 20 years.
Our results suggested that despite the remarkable decline in the incidence of hepatitis C, mortality related to existing cases of hepatitis C in 1991 will likely continue to increase over the next 10 to 20 years, and our results confirmed that hepatitis C may be an awakening giant. Although screening tests and treatments are available, waiting times for new patient appointments to see a hepatologist for evaluation of hepatitis C in some parts of the United States have increased to several months, emphasizing the need to train clinicians in the management of hepatitis C. There is some urgency for action because hepatitis C is frequently asymptomatic until cirrhosis develops, at which time treatment is less effective. Once hepatic decompensation occurs, treatment is limited by the shortage of donor transplant organs. Additional research regarding the cost-effectiveness of screening for hepatitis C and indications for treatment should be pursued to help formu-late public health policy in this area. Continued research on the natural history of he-patitis C and the development of new treatments should remain priorities for the nationŐs health.
American Journal of Public Health, Vol 90, Issue 10 1562-1569
JB Wong, GM McQuillan, JG McHutchison and T Poynard
Department of Medicine, New England Medical Center, Tupper Research Institute,
Tufts University School of Medicine, Boston, Mass., USA.
AASLD, Nov 2002
Peginterferon alfa-2b and ribavirin have the highest sustained response rates for chronic hepatitis C but published drug cost estimates usually assume full dosing for 48 weeks. These estimates neglect dose reductions and discontinuations that occur during treatment as well as clinical management algorithms that lead to drug stoppage in those unlikely to benefit from further therapy.
The aim of this study is to estimate the antiviral drug costs associated with peginterferon alfa-2b+ribavirin. We analyzed actual drug dosing for 511 patients who were intended to receive 800 mg of ribavirin daily and 1.5 mcg/kg peginterferon alfa-2b weekly (PegR8) for 48 weeks and for the subset receiving >10.6 mg/kg of ribavirin (PegRW) (Manns Lancet). Based on ribavirin capsules and peginterferon vials used in this trial, we determined the drug costs for 1) full dosing (Full), 2) intent to treat with reductions and discontinuations as occurred in the trial (ITT), 3) discontinuing therapy in those who were HCV RNA-positive after 24 weeks (Stop24), 4) criteria in Stop24 and also limiting therapy in those with genotype 2/3 to 24 weeks (Stop2/3), and 5) criteria in Stop2/3 and also discontinuing therapy in those viral positive or with <2 log drop in viral load in non-genotype 2/3 patients after 12 weeks (Stop12). Any missing PCR values were assumed to be positive.
The table shows the drug costs for both regimens and shows that these management algorithms result in substantial reductions in likely drug costs. Checking a qualitative PCR at week 24 would allow discontinuation in the 31-36% of patients who are unlikely to respond with further therapy. If the duration of therapy is also limited to 24 weeks for those with genotype 2/3, in all, 60-61% may stop therapy after 24 weeks. Checking a qualitative and a quantitative PCR at week 12 and discontinuing therapy for those PCR positive with <2 log decrease in viral load would allow stopping therapy for 23-24% of patients at week12. Because most genotype 2/3 patients respond by 12 weeks, also applying the same Stop12 rule for those with genotype 2/3 would only increase drug stoppage at week 12 to 24-26% of all patients. Although the goal was 48 weeks of treatment, the overall observed ITT mean duration of therapy was 42 weeks. Alternative management algorithms would decrease the overall mean duration of therapy for all patients to 37 weeks with Stop24, 31 weeks with Stop2/3 and 29 weeks with Stop12. For the 61-62% of patients affected by these treatment management algorithms, the observed mean 40 week therapy duration with ITT would be reduced to 31-32 weeks with Stop24, 21 weeks with Stop2/3 and 18-19 weeks with Stop12.
Our results suggest that treatment management algorithms substantially reduce antiviral drug costs and the duration of therapy. Drug costs should be weighed against the cost and likelihood of complications from hepatitis C and should consider therapeutic effectiveness. Individual decisions to continue ribavirin and peginterferon alfa-2b should also consider the potential clinical benefits for specific patient characteristics, such as advanced fibrosis.
John B Wong, Tufts-New England Medical Center, Boston, MA; Gary L Davis, Baylor University Medical Center, Dallas, TX; John G McHutchison, Scripps Clinic, La Jolla, CA; Michael P Manns, Medizinische Hochschule Hannover, Hannover, Germany; Janice K Albrecht, Schering-Plough Research Institute, Kenilworth, NJ
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