WASHINGTON -- Hepatitis C virus (HCV) patients, and particularly those on Medicare and Medicaid, continue to battle for access to curative treatments and coverage of those therapies, according to participants at a briefing on Capitol Hill on Tuesday.
The briefing was sponsored by The AIDS Institute, a nonprofit that advocates for patients with HIV and HCV. The session was billed as "An Update on Hepatitis C In the United States," and speakers included a CDC official, a representative of the the Centers for Medicare and Medicaid Services (CMS), and others.
HCV is the leading cause of liver disease, liver cancer, and liver transplants. About 3.5 million people in the U.S. have HCV, and around half of these individuals don't know they are infected, according to the CDC.
The issue of of the cost of obtaining HCV treatment was a major topic of discussion. In 2013, Gilead Sciences gained FDA approval for the anti-HCV drug sofosbuvir (Sovaldi), but the initial price tag of nearly $1,000 a pill shocked consumers and insurers.
While a 2015 study reported that HCV drugs, such as sofosbuvir-ledipasvir combo (Harvoni), were cost-effective for treating HCV at all stages, a Medicaid official still predicted that such pricey treatment would lead to a "Death Star scenario" and cause Medicaid budgets to "explode."
U.S. states currently have restrictions on which HCV patients can receive covered treatment. "Ideally, every [U.S.] state would want to provide coverage to any patient who needs it, but when the prices were set, they had to prioritize in terms of patients who they thought were at the most risk for death or cancer and that's why those [restrictions] were created," explained John Coster, PHD, RPh, director of the Division of Pharmacy for the Centers for Medicaid and CHIP Services at CMS to MedPage Today.
HCV drug prices have begun to drop because of competition and insurance rebates, so states began to drop some of those restrictions, Coster noted, but these changes will not happen overnight.
In determining what drugs and patients are covered, states used "management tools" such as prior authorization, drug utilization review, preferred drug lists (formularies), and quantity limits. All of these are reasonable mechanisms, but together they can serve as "de facto coverage restrictions," Coster explained.
Severity of HCV is measured on a scale of F0-F4, where a score of F0/F1 indicates mild or minimal scarring (fibrosis) and F3 indicates cirrhosis.
Certain states restrict coverage to patients with F3 hepatitis C or higher. But they may also require patients to have a liver biopsy or to be drug-free for over a year, or they may limit the type of clinician who can prescribe the medications, such as hepatologists only.
Restrictions may be applied in such a way that they prevent patients who need access to these medications from getting treatment, he said.
Historically, most people with the virus have been Baby Boomers -- individuals born from 1945 to 1965 -- who were infected at a time when blood for transfusion was not screened; drug use and other unsafe healthcare practices contributed to its spread, explained John Ward, MD, director of the Division of Viral Hepatitis at the the CDC in Atlanta.
More recently, the CDC has seen a significant jump in acute cases of HCV, with infection rates doubling from 2010 to 2014 to 2,194 cases, mainly among whites who use injectable drugs, and live mostly in rural and suburban parts of the East and Midwest, according to a CDC press release.
Ward noted that the social environments where HCV is most prevalent are "ripe" for transmission of HIV. "Where HCV is happening, HIV can follow," he said.
The CDC has recommended HCV testing for those born from 1945-1965; for anyone who has injected drugs; and for children born to those whose mothers have HCV or HIV.
Another area of concern is drug diversion.
Back in May, Matt Salo, executive director of the National Association of Medicaid Directors, told MedPage Today that "One of my members said, 'Look we are taking someone who has no money, potentially no home, might have an IV drug use problem. We're handing them a bottle of pills that might cost as much as a boat every month for 3 months. Does anyone see what might go wrong, here?'"
"Anytime you have a drug this expensive, there's possible diversion," Coster concurred. However, he said he's seen more issues with diversion with HIV drugs than HCV treatments.
In May, Washington state's Medicaid program was ordered to drop its restrictions on expensive HCV C treatments after state residents filed a lawsuit arguing that the therapies were medically necessary, according to STAT. And in June, Gilead Sciences and Massachusetts negotiated an agreement on rebates for some patients with the disease, the website reported.
Asked whether CMS will target specific states for failing to provide access to HCV treatments, Coster said he had a list of states in mind. For example, Illinois restricts coverage to patients at the stage F4, which he characterized as "close to death."
One strategy President Obama has floated is the concept of pooled purchasing. While Medicaid can't control launch prices, if federal payers, or at least the agencies within CMS, banded together, "we would get a better price," Coster said.
The AIDS Institute receives funding from the pharmaceutical industry, including companies that market HCV and HIV drugs, as well as from nonprofits such as the Elton John AIDS Foundation.
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