Coverage for a one-time hepatitis C screening may soon be available for all Medicare
beneficiaries born between 1945 and 1965.
But new recommendations are already raising ethical and financial issues in the healthcare community over what to do with the millions who could be diagnosed. HCV treatments are limited, and those that are available are very expensive. Doctors must tell asymptomatic patients they tested positive, but face the ethical dilemma of deciding whether to treat them.
Until recently, hepatitis C (HCV) screenings were recommended only for high-risk patients, such as users of injection drugs, people on long-term kidney dialysis, or individuals who had undergone blood transfusions before 1992. However, in August 2012 the Centers for Disease Control and Prevention
issued recommendations saying all baby boomers should be screened.
Nearly a year later, the U.S. Preventive Services Task Force extended its recommendations to do the same, upgrading screening for HCV to a grade B category
, which says there is moderate benefit for patients.
The CMS is the latest to follow suit. A representative from Medicare says this is the first time the program will include an HCV screening benefit. The agency's proposed recommendations for Medicare beneficiaries
were posted Tuesday, and will be open for comment for 30 days. A final recommendation is anticipated by June.
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 study
, which found that between 2007 and 2009, the population of people age 65 and over 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.
Because many people are asymptomatic, they look and feel fine, they remain undiagnosed. Over time, however, some—though not all—people with HCV can develop serious health problems, such as liver damage and liver cancer. By 2015, more than 300,000 may be diagnosed, the PLOS study projected.
“The issue with screening is that it raises the question of what are you going to tell the patient,” said Dr. J. Mario Molina, president and CEO of Molina Healthcare, a group that helps several states manage pharmacy benefits for Medicaid
enrollees. Though screening is indeed warranted, Molina noted, “there is currently no way of predicting which patient will develop liver disease and which will not.” Deciding whether to give a patient treatment has become an ethical predicament for many clinicians.
“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.”
Drug companies have been racing to bring new medications to the market, with several announcements of potential treatments and research opportunities being made in the past few months.
In December, the FDA approved Gilead's combination antiviral treatment regimen Sovaldi
as a breakthrough therapy for treating chronic hepatitis C infections for four genotypes of the disease.
This week, during the Conference on Retroviruses and Opportunistic Infections in Boston, AbbVie—formerly a part of Abbot Laboratories—announced early results of an investigational therapy tested in its pivotal phase III study, PEARL-III, which claimed their therapy could cure 99% of hepatitis C infections in patients with genotype 1 of the disease.
Bristol-Myers Squibb, Roche and Merck are among several other pharmaceutical companies reported to be researching treatments. And this past July, the CDC announced a new collaboration with Quest Diagnostics
on a hepatitis C research program in which they will share access to data about diagnostic, genotyping and viral load tests used by clinicians to manage treatment.
In the meantime, treatment for the population that will need HCV medication in the future remains uncertain, causing insurers and physicians additional worry. The available drugs might be too costly, they say, to try to treat every potential patient. The issue was 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.
The letters note, for example, that it costs about $84,000 a patient to administer the full 12 course treatment of Gilead's Sovaldi. At that price, if all 300,000 Medicare patients projected to be diagnosed by 2015 were to seek treatment with the drug, the total expenditure could exceed $25 billion, and that's not including drug tests, doctor visits and other fees. The price tag for the drug, Molina said, is not sustainable.
“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,” he told Modern Healthcare. “You could probably insure 25 people per year, just with what it would cost to treat one person with that drug.”Follow Sabriya Rice on Twitter: @MHSrice