Less than a third of insured hepatitis C patients get timely treatment, study shows

By Neeraj G. Patel, CNN

There’s a highly effective and often curative treatment for people with hepatitis C, but less than a third of insured patients get it within a year of diagnosis, according to a new study.

The researchers on the study, published Tuesday by the US Centers for Disease Control and Prevention, found that among about 48,000 people who tested positive for the potentially life-threatening disease from early 2019 to late 2020, the percentage who started treatment within a year was 35% with private insurance, 28% with Medicare and 23% with Medicaid.

Hepatitis C is caused by a virus that spreads through contact with blood from an infected person, such as by using a shared needle when injecting a drug. Without treatment, it can become a lifelong infection that can increase the risk of liver disease, cancer and death.

The CDC estimates that there were over 2 million people in the US living with hepatitis C infection from 2013 to 2016, and it was listed as a cause of death for 14,242 people in 2019.

“Nearly a decade after a highly effective cure has become available, we’re still seeing very large gaps in hepatitis C treatment — tremendous missed opportunities to not only improve health and prevent cancer and save lives but even prevent ongoing transmission,” Dr. Carolyn Wester, director of the CDC’s Division of Viral Hepatitis and co-author of the new study, told CNN.

High costs and insurance restrictions

The US Food and Drug Administration approved the first of a series of new hepatitis C treatments called interferon-free direct-acting antiviral agents in December 2013.

Experts estimate that the treatment, which typically involves tablets taken by mouth over two to three months, cures over 95% of people who get it, but many have had trouble accessing it in part due to its high price.

Wester said that when the treatment became available, the cost for a two- to three-month regimen was roughly $90,000 per person. That cost has come down due to factors like increased competition from other drug manufacturers, but it’s still a barrier to access.

She added that in order to contain their own costs, insurers put restrictions on who could receive coverage for the treatment, and people who qualify for coverage may still have to pay out-of-pocket costs.

Some insurers have limited coverage to certain groups of patients such as those who have evidence of liver damage, have abstained from drug and alcohol use for over a month, or have been prescribed the treatment by a specialist physician. This is despite clinical guidelines recommending that everyone with hepatitis C be treated, with rare exceptions such as children younger than 3.

“I think there’s an unfortunate, really terrible stigma against people who inject drugs, sort of this idea that treatment is futile in a way because if they continue injecting drugs, they might just get reinfected,” said Dr. Alysse Wurcel, an assistant professor and physician at Tufts Medical Center, who was not involved in the study. “There’s lots of studies that came out that these medicines are safe and efficacious in people who inject drugs.”

The researchers on the new study found that people whose Medicaid program enacted at least one of these restrictions were 23% less likely to access treatment within a year of diagnosis compared with those whose Medicaid program did not enact a restriction.

Accessing treatment soon after diagnosis is important.

“Otherwise, people often fall out of care, or because hepatitis C can remain asymptomatic for years, people forget or are unaware of their diagnosis,” Wester said. “And what ends up happening is, they don’t get linked to the treatment that they need, and then they show up much later in the health system with advanced disease and complications that are much harder and much more costly to treat. In addition, we’ve lost years of opportunity to prevent transmission.”

The study was published in the CDC’s Morbidity and Mortality Weekly Report, which is not peer-reviewed, meaning it has not been validated by independent experts.

Years of declining treatment rates

The study had some limitations, including that the findings are not generalizable to people who do not have health insurance or who have disruptions in their coverage. It also did not include information about patients who are incarcerated.

The researchers looked at “patients who are diagnosed and have insurance coverage, so in many ways [these] are the individuals who are set up to have the best access to care and treatment,” Wester said on a media call Tuesday.

Additionally, the data was not specific enough to describe why each person did not receive treatment. Because the study period overlapped with the Covid-19 pandemic, many people may have been less likely than normal to seek and receive treatment due to disruptions to care. Still, hepatitis C treatment rates have been declining annually since 2015, the CDC said in an email.

“It is likely that COVID-19 disruptions played a role in the low treatment numbers in this analysis; however, other longer-standing barriers are also at play to prevent access to treatment. These include state Medicaid restrictions on what types of providers can prescribe treatment, patient eligibility restrictions, and prior authorization requirements before treatment can begin,” the CDC added. Prior authorization is a process by which insurers review whether a treatment is medically necessary before it agrees to cover a drug.

A key to ending the epidemic

“Health care providers, insurers, and policymakers and public health professionals all need to work towards removing those eligibility restrictions,” Wester said. She added that treatment should be made available in more settings, like primary care offices, and that more testing needs to be done to identify people who could benefit from treatment.

Wurcel said she remembers the day the new treatments were approved. She had made a list of patients whom she would try to get onto the new therapy. What followed was nearly a decade of a “rollercoaster” as patients have had to navigate obstacles to access.

“The only way to end the hepatitis C epidemic is to treat more, and one of the key multilevel strategies is decreasing the price of hepatitis C meds. That has to be part of the strategy aimed at eradicating hepatitis C,” she said.

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