Minnesota DOC Sued Over Failure to Provide New Hepatitis C Treatment Protocol

On May 1, 2015, two prisoners at MCF-Stillwater filed a civil rights lawsuit against the Minnesota Department of Corrections, Centurion Managed Care (a division of Centene Corporation), DOC Commissioner Tom Roy and several physicians. The suit alleges that the defendants “refuse to provide the ‘breakthrough’ drug treatment, viz. the hepatitis-C [HCV] treatment community standard-of-care, which will cure Plaintiffs’ HCV infection in three months from its inception.”

According to a press release issued by the International Humanitarian Law Institute, the lawsuit is “the first federal civil rights class action in the nation” to challenge the failure of state prison officials to provide prisoners with a new, more effective hepatitis C treatment protocol.

The plaintiffs, Minnesota state prisoners Ronaldo Ligons and Barry Michaelson, seek to represent a class of similarly situated prisoners. Ligons, incarcerated since 1992, was prescribed the standard 48-week HCV treatment protocol using interferon in 2006. The treatment was not successful. Michaelson initially tested negative for HCV but tested positive for the disease in 2010. The suit states that Michaelson tested positive “only after being double-bunked with a bleeding, HCV-positive cellmate and his exposure to other sources of HCV in MN DOC facilities.”

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FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

File this under ‘Show me the data.’

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.38%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Here’s what happened:

Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.

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Consumers Sue Anthem for Denying Coverage for a Gilead Hepatitis C Drug

The controversy over the new crop of hepatitis C treatments has taken yet another turn as consumers are starting to file lawsuits against insurers that deny them access to the medicines. Over the past two weeks, two different women alleged that Anthem Blue Cross refused to pay for the Harvoni treatment sold by Gilead Sciences GILD -1.74% because it was not deemed “medically necessary.”

The issue emerges after more than a year of debate over the cost of the medicines and complaints by public and private payers that the treatments have become budget busters. The new hepatitis C treatments, which are sold by Gilead Science and AbbVie, cure more than 90% of those infected and, in the U.S., cost from $63,000 to $94,500, depending upon the drug and regimen, before any discounts.

In response, drug makers have been pressured to offer discounts and some state Medicaid programs, for instance, set restrictions before providing coverage to some hepatitis C patients. By setting restrictions, payers hope to limit the number of patients for whom coverage is provided. And this is the tack that Anthem Blue Cross has pursued, according to court documents.

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