Are States Obligated to Provide Expensive Hepatitis C Drugs?

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A handful of federal lawsuits against states that have denied highly effective but costly hepatitis C drugs to Medicaid patients and prisoners could cost states hundreds of millions of dollars.

The drugs boast cure rates of 95 percent or better, compared to 40 percent for previous treatments. But they cost between $83,000 and $95,000 for a single course of treatment.

The class actions, all filed in the last eight months in federal courts in Indiana, Massachusetts, Minnesota and Pennsylvania, present a series of extremes: a deadly epidemic, a treatment that can stop the disease in its tracks, and an enormous price tag.

At least 3.5 million Americans have hepatitis C, a virus spread through blood-to-blood contact that is usually contracted through the sharing of needles or other equipment to inject drugs. Left untreated, hepatitis C slowly destroys the liver. Medicaid beneficiaries, a low-income population, have a slightly higher rate of hepatitis C infection than the privately insured, and the rate among prisoners is 30 times higher than in the general population.

The U.S. Food and Drug Administration approved the first of the new drugs, Sovaldi, in 2013. Since then, the FDA has also approved two other drugs, Viekira Pak and Harvoni.

But because the drugs are so expensive, state Medicaid programs and prisons have been restricting them to people in the advanced stages of the disease.

While they are waiting to meet that standard, patients with less advanced hepatitis C may develop cirrhosis, liver cancer or liver failure, which may necessitate a liver transplant. According to the U.S. Centers for Disease Control and Prevention, 60 to 70 percent of those with hepatitis C will develop chronic liver disease; 5 to 20 percent will develop cirrhosis; and 1 to 5 percent will die of liver failure or liver cancer.

The plaintiffs in the lawsuits argue that by denying the drugs to hepatitis C patients, states are violating the law. Under federal law, states can exclude a drug from Medicaid coverage only if its prescribed use “is not for a medically accepted indication” as determined by the FDA.

Federal court cases have established a lower standard for prison health care. Prisons must provide health care to inmates, but can deliver it as they see fit, as long as they don’t demonstrate “a deliberate indifference to serious medical need.”

“A medically necessary treatment is a medically necessary treatment, no matter what the cost,” said Gavin Rose, an attorney for the American Civil Liberties Union, which brought the class action in Indiana in December on behalf of Medicaid beneficiaries in that state who have hepatitis C.

Some infectious disease doctors and legal analysts agree.

Read more of this informative article here: http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/02/09/are-states-obligated-to-provide-expensive-hepatitis-c-drugs

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