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In the latest dust-up over the high cost of hepatitis C drugs, the American Civil Liberties Union is threatening to sue Colorado officials if they refuse to widen access to the medications in the state Medicaid program.

The saber rattling came in response to a long-standing policy by the state Medicaid program to restrict coverage only to people with the most advanced stages of liver disease, such as cirrhosis.


“Basically, Colorado has been withholding treatment from Medicaid recipients until they have measurable damage to their livers. And we believe that the restrictions violate the Medicaid statute,” Mark Silverstein, the ACLU of Colorado Legal Director, told STAT. “We hope they’ll do the right thing, but we’re prepared to pursue litigation otherwise.”

The state’s Drug Utilization Review Board met last night to review requests to widen coverage and a decision is due on Sept. 1.

Since 2013, the state has spent $26.6 million treating 326 hepatitis C patients, or about $82,000 per person, according to a spokesman for the state Department of Health Care Policy and Financing, which oversees the state Medicaid program. If the state were to cover every Medicaid patient with hepatitis C, regardless of the stage of their disease, it would cost $174 million. “It could be a budget problem,” he said.


The showdown comes amid increasing pressure on public and private payers to loosen coverage restrictions on the hepatitis C medicines. These new types of treatments began arriving in early 2014 and boast very high cure rates, but are also costly, ranging in price from $54,600 to $94,500, depending upon doses and regimen, although this is before rebates or discounts are applied.

High cure rates prompted many physicians to write prescriptions — notably, for the Sovaldi and Harvoni drugs sold by Gilead Sciences. Drug makers and their supporters have argued the near-term outlay saves money down the road on treating liver failure or liver cancer, and on liver transplants.

Payers have complained that the medicines are straining their budgets, and a growing number of payers have instituted coverage restrictions. Those moves, however, are starting to backfire. Last November, the Obama administration wrote state Medicaid programs that they may be violating federal law by restricting access to hepatitis C medicines. And last May, a federal court judge ordered the Washington state Medicaid program to lift coverage restrictions.

In April, seven commercial insurers reached a deal with the New York attorney general to remove barriers to coverage. The health plans had to eliminate restrictions that require their members to have an advanced stage of the disease. And various commercial insurers in Washington state and California recently eased coverage restrictions in response to lawsuits filed by consumers.

Lawsuits are also pending against the Massachusetts state prison system and the Indiana Family and Social Services Administration, the latter of which was filed by the ACLU.