State restrictions for hepatitis C drug may go too far

(Reuters Health) - State-run insurance programs for the poor may be putting up illegal barriers that prevent people with hepatitis C from getting a new treatment, a new study suggests.

"We had this idea that there were restrictions in place, but we didn't anticipate the breadth of these restrictions," said study author Robert Greenwald of the Center for Health Law and Policy at Harvard Law School in Jamaica Plain, Massachusetts.

About 3.2 million people in the U.S. are infected with hepatitis C, but many do not feel ill or know they have the disease, according the Centers for Disease Control and Prevention (CDC). There are about 17,000 new infections each year.

Without treatment, the hepatitis C virus can lead to liver failure, liver cancer or even death.

In 2013, the U.S. approved a new drug known as sofosbuvir, which is marketed here as Sovaldi by Gilead. Given in combination with other drugs, sofosbuvir achieves very high cure rates in patients with the difficult to treat infection.

But sofosbuvir costs about $1,000 per day, which adds up to about $84,000 for a 12-week course, the researchers write in Annals of Internal Medicine.

For the new study, Greenwald and his colleagues searched the Medicaid websites of each state and the District of Columbia in 2014. Medicaid, the state-run health insurance for the poor, is partly funded by the U.S. government.

Overall, 42 state Medicaid programs put restrictions on payments for sofosbuvir. About three quarters only allow the drug to be used when hepatitis C has already caused liver damage known as fibrosis or an even later stage of damage known as cirrhosis.

The vast majority of states include drug- and alcohol-based restrictions on payments for the drug, including abstinence and drug screening.

About two thirds of states restrict who may prescribe the medication, the researchers write. In a third of states, for example, it can only be prescribed by a specialist. In the other third, nonspecialists can prescribe it but they have to consult a specialist first.

About a quarter of states have restrictions based on the person's HIV status.

"I think the restrictions have significant personal and public health implications," Greenwald told Reuters Health.

"I think anybody with a communicable disease or other medical condition should be taking this extremely seriously, because this gets to how our country responds to a cure," he added.

What's more, the researchers found many of the restrictions vary by state and do not correspond with the recommendations of medical organizations like the Infectious Diseases Society of America and the American Association for the Study of Liver Disease.

Also, the researchers say, the restrictions may violate a federal regulation that says state Medicaid programs must provide coverage for drugs consistent with the labels from the U.S. Food and Drug Administration if the manufacturer has a rebate agreement with HHS.

"What we’re really seeing here is this huge push back and frankly the insurer ruling the day so that the focus has been really on cost," Greenwald said.

The researchers caution that they only examined traditional Medicaid fee-for-service programs, and not managed care organizations, which may impose additional restrictions not cataloged in their results.



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