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R.I. Medicaid limits supply of Hepatitis C drug due to cost

Policy will only cover treatment for patients with late-stage liver failure who are drug-free

Rhode Island’s Medicaid program decided in September to ration the delivery of Sovaldi, a prescription drug approved by the U.S. Food and Drug Administration last year to cure chronic Hepatitis C, due to the drug’s high cost and the relatively high prevalence of the virus among Medicaid enrollees in the state.

The state’s Medicaid policy stipulates that payment for treatment be approved only for patients with late-stage liver failure, as opposed to younger Hepatitis C patients who became infected as a result of drug use amidst the opioid addiction crisis in southern New England. Patients looking to have the treatment covered by Medicaid must be substance abuse-free for at least six months or actively involved in rehabilitation.

Hepatitis C is the “poster child for health disparities,” but treating all those infected by the virus would bankrupt the state, said Lynn Taylor, assistant professor of medicine, director of Miriam Hospital’s HIV/Viral Hepatitis Coinfection Program and the recipient of a grant from the Rhode Island Foundation to develop a strategic plan to address Hepatitis C.

Only discovered in 1989, Hepatitis C is a blood-borne illness that results in chronic inflammation of the liver. The United States did not begin screening blood transfusions for the virus until 1992, so anyone who had a blood transfusion before then could carry the virus, said Kristin Gourlay, a health reporter for Rhode Island Public Radio who has been working on a series this fall, “At the Crossroads: The Rise of Hepatitis C and the Fight to Stop It.”

The Centers for Disease Control estimates that 3.2 million people in the United States are infected with the virus, though most are unaware they have it. The CDC estimates that there were 16,000 reported incidents of acute Hepatitis C, which is a short-term illness that occurs within the first six months of infection, in the United States in 2009. Seventy-five to 85 percent of those who show symptoms of acute Hepatitis C end up with chronic Hepatitis C, according to the CDC.

It can be difficult to track the disease because it can remain dormant with virtually no symptoms for decades. As a result, the consequences of Hepatitis C infections are only coming to the surface now. Due to the length of time it takes for the disease to have a noticeable effect on the liver, patients infected prior to 1992 are presenting symptoms now, Taylor said.

More recently, there has also been a second wave of diagnosed infections from younger populations infected, who largely have a history of injection drug use, Gourlay said.

Opioid addiction has become a problem for Rhode Island in recent years — drug overdose is now the most common cause of accidental death in the state. Many addicted to prescription painkillers such as oxycontin and fentanyl turn to heroin because it is more widely available and less expensive, The Herald previously reported.

Hepatitis C disproportionately affects vulnerable populations, including seniors, veterans, injection drug users and prisoners, Gourlay said. Baby boomers are at greater risk of carrying the virus because they are more likely to have received a blood transfusion before the Hepatitis C screening began in 1992, she said. And veterans are more likely than civilians to have received a blood transfusion, which increases the likelihood they were infected with Hepatitis C, she added.

Injection drug users face increased risk of becoming infected with Hepatitis C through used, contaminated needles.

This also fuels the high rates of Hepatitis C infection in the prison population. Many prisoners have a past or present history of drug use, but because of socioeconomic factors frequently lack the resources to seek rehabilitation for addiction.

“The most common denominator for prisoners is poverty,” Gourlay said.

Most people with chronic Hepatitis C develop chronic liver disease, such as cirrhosis and liver cancer. Between 1 and 5 percent of people infected with Hepatitis C will die of liver cancer or liver failure. Hepatitis C now kills more people than does HIV in the United States.

But the discovery and approval of a new drug to treat chronic Hepatitis C by the FDA last year promised better outcomes for patients. Sovaldi, the first drug approved by the FDA to cure chronic Hepatitis C, is a daily pill taken for 12 or 24 weeks. Studies show that it cures between 84 and 96 percent of those who take the drug. In October, the FDA also approved a different daily pill, Harvoni, as a cure for a specific type of Hepatitis C.

The current standard of care for Hepatitis C patients is a year-long regimen of weekly injections of interferon, a drug also used to treat certain types of cancer. But interferon has a cure rate of less than 50 percent. A daily pill, such as Sovaldi, which is taken with another drug called Ribavarin, has fewer and less severe side effects than interferon injections and a shorter protocol, RIPR reported.

But these new treatments come with a hefty price tag compared to previous treatments. Sovaldi costs $84,000 for a 12-week course and Harvoni costs $94,000 for a full course, as compared to an annual supply of interferon, which costs about $30,000, RIPR reported.

Sovaldi “is projected to be among the best-selling drugs of all time,” Bloomberg News reported.

Sovaldi’s costs are a problem because much of the population affected by the disease — many of whom are Medicaid beneficiaries — cannot pay for the treatments out-of-pocket and is unable to receive the medications because of Medicaid’s policy.

Sovaldi’s costs are a problem because of the number of beneficiaries that are affected by the disease. Because of the state's Medicaid policy, many beneficiaries are unable to receive coverage for the cost of the drug, and are unable to pay for the treatment out of pocket.

“These are public dollars that we’re going to have to pay for treatments. But the pockets aren’t very deep here. That’s especially true here in Rhode Island,” Gourlay said.

It is much less expensive to cure the disease now than it is to pay for the later consequences of chronic Hepatitis C, such as a liver transplant, which can cost upwards of $500,000, Taylor said.

The number of services Medicaid is mandated to provide increased under the Affordable Care Act of 2010, as did the number of enrollees. As a result, state officials projected that Medicaid costs would exceed the original budget by $52 million, WPRI reported.

Taylor said she thinks Medicaid is “wasting money,” by refusing to provide Sovaldi to people abusing substances. “I think the Medicaid policy should eliminate any reference to substance abuse,” she said. “It’s insulting and it’s shaming people and it’s not medically relevant.”

Deidre Gifford, director of Rhode Island’s Medicaid agency, told RIPR that treating everyone insured by Medicaid with Hepatitis C would cost an estimated $220 million.

Rhode Island’s Medicaid policy is similar to those being implemented in other states. Among the states that followed suit, Illinois and Oregon were the first to start putting restrictions on which patients are approved to have the costs of the drugs covered by Medicaid.

Taylor said she understands that Medicaid doesn’t have the money to treat everyone infected by Hepatitis C, but “on the other hand, we have an infectious epidemic, and … treating is prevention.”

Treating those who are more likely to spread the disease — the second wave of those infected by the virus — would be more effective in curbing the spread of Hepatitis C, she added, noting that much of the policy is not based on evidence. “Sometimes people who are not experts are making decisions about policies and algorithms.”

“I think we need to be creative with this crisis,” she said, proposing that the Veterans’ Health Administration champion the issue and use its drug-negotiating abilities to cure all veterans of the virus.

Rhode Island’s Medicaid program did not respond to requests for comment by press time.

A previous version of this article incorrectly stated that health reporter Kristin Gourlay said the elderly are at greater risk of carrying Hepatitis C. In fact, she said baby boomers are. The article also previously stated that Sovaldi’s costs are a problem because of Medicaid’s policy. In fact, they are largely a problem because of the high number of people with Hepatitis C. The Herald regrets the errors.



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