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Your role in hepatitis C treatment
While it’s encouraging that a new class of prescription medications can cure hepatitis C, the high prices of the drugs are creating a quandary for healthcare stakeholders. The first new drug, sofosbuvir, earned FDA approval in late 2013 and carried a price tag of $84,000 for a course of treatment.
“I wish drug companies would lower their prices. And they are starting to do that,” says Neil A. Capretto, DO, medical director of Gateway Behavioral Health, based in Pennsylvania. “But the cost of this is just in a league of its own.”
According to Centers for Disease Control and Prevention (CDC) estimates, there are as many as 7 million cases of chronic hepatitis C in the United States. Less than 25 percent of new cases clear on their own, and the other 75 percent or more become chronic and require treatment to help avoid liver disease.
Treatment centers
Treatment centers have a role to play because not only is the hepatitis C virus (HCV) prevalent among those with substance use disorder, it can also be contagious, generally spreading through needle-sharing. CDC recommends testing for anyone who is positive for human immunodeficiency virus (HIV) or any “current or former injection drug user, even if you injected only one time or many years ago.”
Mary DiOrio, MD, medical director for the Ohio Department of Health, says increasing awareness of the risk factors for HCV is important because oftentimes the infections are asymptomatic. Many individuals who have the virus don’t even realize it, especially within the baby boomer population.
“With the new drugs coming out, the pharmaceutical industry has helped with awareness campaigns on television and in print media, which may be helping to get the message across about hepatitis C and the need for testing,” DiOrio says.
Capretto says at Gateway, incoming patients are screened as part of a comprehensive health assessment, and they are referred for confirming diagnosis and treatment when appropriate. He says patients aren’t in the inpatient program quite long enough for Gateway to address HCV, but at the outpatient level of care, clinicians do follow-up to ensure they have appointments with providers who can treat the virus.
“For people who test negative, we tell them about the risk factors,” Capretto says. “They are retested in three months because there’s a chance it is too early to detect the HCV infection in the first screening.”
It only takes one experience of sharing one needle for the HCV infection to spread, he says. Needle exchange programs that aim to prevent the spread of blood-borne illness have helped reduce the incidence of HCV.
He says five years ago, charts he examined showed positive HCV tests in 80 percent to 90 percent of screenings for people who had used injected drugs a year or more. For those who used for six months, the positive screens came in at about 70 percent. Today, the prevalence of HCV in each category has been reduced by about 20 percent, he says.
“It’s still a big problem, but sterile needles and awareness has helped,” Capretto says.
He says the good news is that the newer drug treatments offer hope for patients to be cured of HCV, unlike a few years ago when the prevailing treatment was not as efficacious, “and it was torturous.” Centers should use motivational interviewing to shepherd patients toward seeking treatment for HCV, he says. Many will find that the recovery experience will also inspire them to work hard on their health overall.
Barriers to access
Even so, treatment for HCV with the newer class of medications isn’t quite as simple as writing a prescription. Clinicians are finding that payers—Medicaid programs in particular—have tight guidelines on who will and who won’t be approved for coverage.
In fact, research by the Harvard Center for Health Law and Policy Innovation shows that many Medicaid programs expect individuals to be fully abstinent for six, or even 12, months before they are eligible for coverage of the costly HCV treatments. Some stipulations also include enrollment in substance-use treatment programs. Spurring several consumer lawsuits, payers have also limited coverage authorizations only to those with advanced liver disease, citing medical necessity.
And the medications are in high demand because they offer shorter regimens, generally cutting the prevailing treatment time in half, while also reducing the serious, uncomfortable side effects that often had patients abandoning HCV medications in the past. According to experts, the new medications are also able to clear the virus effectively, providing a cure for hepatitis C.
“Given the unprecedented restrictions in coverage that we are seeing, I believe the treatment providers should become more actively engaged in advocacy to ensure the new curative therapies are accessible,” says Robert Greenwald, a professor and the Harvard Center for Health Law and Policy Innovation’s faculty director.
According to law, Medicaid programs must cover pharmaceuticals in way that is consistent with FDA labeling, he says. However, the most common restrictions currently placed on coverage for HCV drug treatments are inconsistent with labeling.
For example, there is no published data indicating that abstinence from alcohol and other drug substances is a clinical requirement for the use of the newer HCV treatments. And yet, many Medicaid programs have restrictions that require abstinence for six months or more before the patient is eligible for coverage.
“For substance-use treatment providers, it will be really important to educate state health officials that these barriers based on substance use are contrary to established health and legal conceptions of treatment access for substance users,” Greenwald says. “So it’s a terrible precedent that we’re seeing here.”
He says those who are excluded from treatment by the barriers are precisely the individuals who should be prioritized to receive the medications.
Greenwald believes there’s bias against those with HCV because they tend to be the population with SUD as well. No other category of healthcare experiences such exclusion, he says. Life-saving treatments for lung cancer, for example, are provided to individuals without the stipulation that they must be non-smokers. In fact, he says, if it were not the SUD population most in need of the HCV treatments, such intense restrictions might not be an issue.
“We need to get at the stigma associated with HCV,” he says. “ I don’t think we’ve ever seen any restrictions like this before.”
While Greenwald says behavioral health interventions are effective and should be part of comprehensive treatment when appropriate, in no way should access guidelines demand that behavioral health treatment be a requirement for someone to receive curative therapies.
“Not only is it the substance-use restrictions that are a problem, but other restrictions based on stage of liver disease that limit treatment to individuals with more advanced disease,” he says. “I’ve never seen any kind of restriction like that for any kind of cancer or any other health condition. In part, why we’re seeing that, I believe, is because of discriminatory practices related to perceptions about who people living with HCV are.”
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Costs drop
With the price of the medications coming in so high, it’s understandable that payers have to balance the cost equation. Even a patient with generous commercial insurance might be responsible for a 20 percent copayment that could break the bank.
Capretto says in an ideal world, there wouldn’t be limits on who gets access to treatment, but he understands that Medicaid programs especially don’t have unlimited budgets.
“I wish that wasn’t the case,” he says.
However, Greenwald says, the cost of the newer HCV medications has dropped dramatically over the past year because of increasing competition as similar products hit the market. In addition, while the manufacturers’ price might be $80,000 or $100,000, Medicaid wouldn’t be paying that much in actual costs because of guaranteed Medicaid discount pricing and supplemental rebates. Private payers also negotiate reduced prices.
Overall, between new competitive products and pricing structures, Greenwald believes the medication price has dropped about 50 percent in the past year.
“There are many other treatments that cost far more than this cure does,” Greeenwald says.
For example, many HIV drugs are covered for a patient’s entire life without additional restrictions, and those treatments might cost $20,000 a year, every year. And he says it’s important to note the HIV drugs are not cure, but a therapy to help prevent the progression of the virus leading to AIDS.
HIV parallel
It seems like déjà vu to Jeffrey H. Samet, MD, MA, MPH, chief of general internal medicine at Boston Medical Center. He says the sudden prevalence of HIV/AIDS in the 1980s can provide some history lessons for healthcare providers addressing HCV.
“We had a lot of people with HIV who were not getting into care,” Samet says. “And the place they were seen most often was in addiction treatment centers.”
Initially treatment was poor, but awareness and medical advances improved the prognosis for HIV, changing it from a progressively terminal condition to a survivable chronic condition as long as it was appropriately managed. Samet says approaching HCV with similar awareness and access to treatment is “a no-brainer.” Providers should take advantage of the new curative treatments and make a system shift toward universal screening and referral to specialized treatment.
Samet says individuals with HCV who seek addiction services will likely be motivated to make a fresh start and address all their health concerns. A creative effort among providers is needed to ensure care is coordinated because not everything can be addressed at a typical addiction treatment center, nor does it need to be, he says. The treatment center’s role is to screen patients and connect them to treatment.
“Fifteen years ago, the idea of a hepatitis C cure was not so bright; it was hard to pull off,” Samet says. “Today it’s not so hard.”
