Screening for hepatitis C raises ethical, cost issues

The CMS plans to start covering one-time universal hepatitis C testing for aging baby boomers. The controversial move will add billions of dollars to Medicare costs to identify asymptomatic people who carry a virus that may not need to be treated.

Until recently, hepatitis-C (HCV) screenings were recommended only for high-risk patients, such as users of injectable drugs, people on long-term kidney dialysis, or individuals who underwent blood transfusions before 1992. Left untreated, less than a quarter of people infected with HCV contract fibrosis, cirrhosis or cancer of the liver, usually many decades after exposure. Approximately 19,000 people die each year from HCV-associated disease.

In 2012, the Centers for Disease Control and Prevention recommended that all baby boomers be screened. Nearly a year later, the U.S. Preventive Services Task Force upgraded HCV screening to a grade B, meaning the test offers a moderate benefit for patients and payers should cover it.

However, treatments for HCV are limited and very expensive, costing about $84,000 for a full 12-course treatment of the latest drug, Gilead's Sovaldi. If all 300,000 Medicare patients projected to be diagnosed by 2015 were to seek treatment with the latest drug after being screened in the new program, the total expenditure could exceed $25 billion. That does not include the cost of screening, doctor visits and other fees.

Doctors administering the tests also face an ethical predicament. While they must tell asymptomatic patients they tested positive, most people will not develop serious illness from the infection. Moreover, the available treatments have severe side effects.

“There is currently no way of predicting which patients will develop liver disease and which will not,” said Dr. J. Mario Molina, president and CEO of Molina Healthcare, which operates managed care plans. “Screening … raises the question of what are you going to tell the patient,” he said.

Medicare's proposal to cover one-time HCV screening for all Medicare beneficiaries born between 1945 and 1965 was opened for comment on the agency website last week. A final rule is anticipated by June. Other payers, including Medicaid, are worried they will have to cover screenings as well.

Approximately 3.2 million people in the U.S. have chronic hepatitis C, but most have not been diagnosed. HCV is “primarily a disease of the baby boomer population,” wrote the authors of a PLOS journal study, which found that between 2007 and 2009, the population of people age 65 and older diagnosed with chronic HCV had increased to 1.19 million, accounting for 75% of all patients with the disease, and 83% of patients with advanced disease.

The mass screening campaign has already drawn criticism in a leading medical journal. “The desire to treat patients to prevent these consequences is great. But the treatments that we have had available are not very effective in clearing the infection, result in serious adverse effects including making patients feel sick during a prolonged treatment course, and are expensive,”

Dr. Mitchell Katz, director of the Los Angeles County Department of Health Services, wrote in a JAMA editorial published in February. “For these reasons, neither I nor my patients have been very enthusiastic about treatment.”

The call for mass screening comes just as drug companies are pushing to bring new medications to the market. Besides the Food and Drug Administration's approval in December of Gilead's combination antiviral treatment regimen Sovaldi, AbbVie announced positive results for its investigational therapy at the Conference on Retroviruses and Opportunistic Infections in Boston last week.

The company's pivotal phase III study showed that the therapy could cure 99% of hepatitis C infections in some patients. Bristol-Myers Squibb, Roche and Merck also are racing to develop drugs.

The CDC is also collaborating with test makers to develop diagnostics that will more accurately identify which drugs will work best for which HCV-positive patients. Last July, the CDC and Quest Diagnostics announced a research program in which they would share data about diagnostic, genotyping and viral load tests clinicians use to manage treatment.

Medicaid payers already are fretting about the costs. The latest drugs such as Sovaldi are too costly to treat every potential patient, they say. The issue is such a concern that several groups, including Molina Healthcare, sent letters to state Medicaid offices in January requesting “emergency guidance” on how to handle “extraordinarily expensive” treatments.

“Cost for much of the care is going to fall back on the taxpayers, and at a time when we're struggling just to get people insured, that is problematic,” Molina said. “You could probably insure 25 people per year, just with what it would cost to treat one person with that drug.”

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