Hepatitis C: Pharmacoeconomic and Ethical Concerns

Raymond S. Koff, MD, Chairman, Department of medicine, Metro West Medical Center, Framingham, Massachusetts
Raymond S. Koff, MD

Dr. Raymond S. Koff is a graduate of the Albert Einstein College of Medicine in New York. He undertook residency training in Internal Medicine on the Ward Medical Service of Barnes Hospital, Washington University School of Medicine in St. Louis. His research and clinical interest in viral hepatitis and liver disease began with his service as an Epidemic Intelligence Service Officer of the National Communicable Disease Center (now the Center for Disease Control and prevention). Subsequently, he became Clinical and Research Fellow in the Gastrointestinal Unit of the Massachusetts General Hospital. He later joined the Boston Veterans Administration Hospital as a Clinical Investigator, and was appointed to the faculty of the Boston University School of Medicine, rising to the rank of professor of Medicine and Chief of the Hepatology Section. In 1986, he became Chairman of the Department of Medicine of MetroWest Medical Center and Chief of its Hepatology Section. At present, he is Professor of Medicine at the University of Massachusetts Medical School. Dr. Koff has written or edited three books, over 120 journal articles, and scores of book chapters. He has served as an associate editor, and member of the editorial board for a number of subspecialty journals, and is a reviewer for several journals in his field of interest. He has served on many committees for the FDA, NIH, Veterans Administration, and national digestive disease organizations. His research interests continue to be focused on viral hepatitis.

Hepatitis C virus (HCV) is a common bloodborne infection that predisposes patients to cirrhosis and hepatocellular carcinoma and results in about 10,000 deaths annually in the US. The healthcare costs associated with the treatment of HCV infection and its associated conditions are considerable, in particular those for hepatocellular carcinoma and liver transplantation. For example, the cost associated with liver transplantation can vary from $90,000 to more than $200,000, and are even higher ($150,000 to > $300,000) with surgical complications. It is estimated that the costs associated with treatment of HCV and its morbidities and the costs from work loss (decreased productivity) are more than $600 million annually in the US.

Although often perceived as an asymptomatic disease, HCV infection reduces quality of life in affected individuals. A number of studies have reported that quality of life is significantly lower in HCV infected patients compared with healthy controls, with HCV patients reporting substantial reductions in measures of somatic symptoms (e.g. energy/fatigue and body pain). Moreover, interferon treatment itself impairs health-related quality of life; indeed, many interferon-treated patients experience mood alterations suggesting that therapy may actually make patients feel worse compared with no therapy. Health-related quality of life does improve in sustained virological responders. Thus, HCV infection has important public health, financial and quality-of-life implications.

Standard interferon treatment is expensive, inconvenient to administer and achieves sustained virological response rates of about 10 to 20% in patients with chronic HCV infection. Because of this low rate of response, as well as the high cost of interferon, a number of economic concerns exist surrounding this treatment. Pharmacoeconomic studies have been conducted to assess the cost-effectiveness of standard interferon therapy in patients with HCV infection. These studies used clinical trial data to develop models to determine clinical outcomes and costs in hypothetical cohorts of patients. Despite the less-than-optimal clinical efficacy of standard Interferon, cost-effectiveness ratios for interferon treatment versus no treatment compared favorably with well-accepted medical interventions, such as treatment of hypertension, pneumococcal vaccination and screening for colorectal or breast cancer (table). In another study, the number of years of life gained in patients aged 20, 30, 40 and 50 years at initiation of interferon therapy was higher in those treated for 18 months (4, 4, 2.8, 1.6 and 0.8, respectively) than in those treated for 6 months (2.0, 1.2, 0.7 and 0.4, respectively). Interferon treatment of HCV infection is likely to slow progression to hepatocellular carcinoma and death.

The cost-effectiveness ratios attained in pharmacoeconomic studies of interferon therapy in patients with HCV were particularly sensitive to treatment response rates and to rates of disease progression (which are influenced by response rates).

Overall, these results suggest that despite low sustained response rates, interferon treatment of HCV is warranted from clinical, economic and probably ethical viewpoints.

Table
 Intervention
Cost per year-of-life gained 
Interferon for mild chronic HCV 
     20-year-old patient              $500 
     30-year-old patient             $1900 
     50-year-old patient           $19,000 

Treatment of hypertension 
     40-year-old patient           $88,000 

     70-year-old patient            $5,300 
Pneumococcal vaccination            $9,400

Screening for breast cancer         $43,400 ­ 79,800 
Screening for colorectal cancer     $86,300

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