July 13, 2015
In an era of breakthrough drugs for hepatitis C (HCV), it is easy to forget that effective screening is just as important as lifesaving medication. In the U.S., the $84,000 price tag of the direct acting antiviral sofosbuvir (Sovaldi) prompted a nationwide discussion on equity and access for those who need treatment. Yet, if more Americans were routinely screened and retained for follow-up, the virus could be eradicated from the U.S. by 2030 with only a modest increase in treatment, according to a recent analysis by Nancy Reau, M.D., associate professor of medicine at the University of Chicago. Reau presented her findings at Digestive Disease Week 2015, in Washington, D.C.
Much of the conversation around HCV has focused on the extremely high prices of lifesaving medications, forcing payer systems to prioritize treatment to the sickest patients. Yet Reau's analysis is pragmatic and optimistic, as she clearly identifies modest changes to screening and treatment policies that would make total eradication possible by the year 2030.
HCV is the most common bloodborne chronic viral infection in the U.S., according to the Centers for Disease Control and Prevention (CDC). In 2007, HCV surpassed HIV as a leading cause of death, among bloodborne infections.
HCV is a silent disease. Many patients don't know they're infected, and continue to transmit the virus for several years without showing any symptoms. In 2012, the CDC published new guidelines recommending universal screening for everyone born from 1945 to 1965. In many ways, the baby-boomer guidelines were an easy-to-follow rule that boosted screening rates in a high-risk population, said Reau. However, she added, "We have to remind people that you can't just go by birthday."
With the birth cohort rule, health care providers might neglect other high-risk categories, Reau cautioned. For example, tattoos are a major risk factor for HCV, and tattoos are popular among young people. Another at-risk group is men who have sex with men. Many of these younger patients fall outside the birth cohort, and are not being screened even if they have risk factors, Reau explained.
The first step toward disease eradication is disease identification. Among health care providers, there is a big push for universal screening, or a one-time test for all Americans, much like the guidelines for HIV. The next step after proper screening is ensuring proper follow-up, Reau said, noting in her presentation that one third of the patients who receive an initial positive test result never receive a confirmation test. Primary care providers have an extremely important role to play in ensuring patients living with HCV are referred to a specialist. A primary care doctor often has the opportunity to intervene before a patient's disease progresses to cirrhosis and other complications arise.
The last major step in disease eradication is proper treatment. There are now drugs and drug cocktails that make HCV undetectable in most patients. These drugs, including sofosbuvir, ledipasvir/sofosbuvir (Harvoni) and dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira Pak), are vastly superior to peginterferon plus ribavirin, yet they come at a high price.
If every single eligible patient were to receive treatment in the next five years, payers would need $136 billion to cover the cost of drugs, according to Reau's presentation. These new medications may be cost-effective (worth the high price because of the number of lives saved), but that doesn't mean private and public payers have room in their budget to cover every single infected patient, Reau said.
Today, public and private payers prioritize treatment to the sickest patients. "The concept allows patients at highest risk to be treated first, and when your budget allows you, you can liberalize patients who have less [severe] disease," Reau said. The health care system does not need to start treating every patient now to cure the entire population by 2030, she asserted.
Back in the days of peginterferon plus ribavirin, 2004 to 2005 represented years of "peak treatment," in which more than 120,000 patients were being treated in the U.S. Starting in 2005 to 2006, doctors started warehousing in anticipation of the new drugs. Treatment rates with direct acting antivirals over the last few months have been difficult to capture, but not as many patients are being treated today as they were in 2005 to 2006, Reau said. For the 2030 prediction to be fulfilled, the number of patients being treated with direct acting antivirals will have to surpass that 2005 to 2006 peak, which is "very do-able," according to Reau.
Modeling suggests that if we increase our screening, and effectively reevaluate the rules of prioritization so that we liberalize our coverage policies to capture as many patients as we can, HCV can be eradicated by 2030, Reau said.
Sony Salzman is a freelance journalist reporting on health care and medicine, who has won awards in both narrative writing and radio journalism. Follow Salzman on Twitter: @sonysalz.
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