DENVER (CN) — One of the 70,000 Coloradans with hepatitis C has brought a federal class action agaisnt the state because its Medicaid program does not cover breakthrough therapies for the fatal disease.
Robert Cunningham, who was diagnosed with hepatitis C in 2004, sued the Colorado State Department of Health Care Policy and Financing on Monday, for refusing to approve treatment with Direct Acting Antivirals, or DAAs, enormously expensive drugs that are remarkably effective in treating a once-incurable disease.
The most widely known of these new drugs is Harvoni (sofosbuvir/ledipasvir), but Cunningham names seven other drugs and/or drug combinations that have been effective, with daily pills taken for two to three months.
Harvoni costs $1,125 per pill in the United States, on average: $94,500 for a typical course of treatment.
Cunningham claims Colorado refused to cover his treatment because he has a Metavir Fibrosis Score of F1, which indicates (after F0) the least amount of liver scarring, on a 0-4 scale in which F4 indicates full-blown cirrhosis. Colorado's Medicaid restrictions require a patient to have a Metavir Fibrosis Score of at least F2 to receive a direct-acting antiviral drug, Cunningham says.
Calling DAAs "the only feasible cure for the disease," Cunningham adds: "The treatment denied [by Colorado] is approved by the U.S. Food and Drug Administration; is strongly urged by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America; and is recommended by the federal agency responsible for administering Medicaid. It is provided by Medicare, the VA and the overwhelming majority of commercial health insurers."
According to Cunningham's lawsuit, hepatitis C is the deadliest infectious disease in the United States, killing 20,000 people in 2014. Five million U.S. residents have the disease — more than 1 percent of the population — 70,000 of them in Colorado, according to the complaint. And, Cunningham says, 14,400 Colorado Medicaid beneficiaries have the disease.
The Colorado Department of Health Care Policy and Financing declined comment on the lawsuit.
However, a spokesperson said that on Sept. 1 the state relaxed requirements for hepatitis C patients to get the drugs, from F4 or F3 to F2. It also eliminated a six-month abstinence period formerly required of drug and alcohol users, so long as the patient is receiving drug or alcohol counseling and has been in a treatment program for at least a month.
The new authorization requirements take effect Oct. 1.
Cunningham seeks class certification and an injunction. He is represented by Sara Neel and other attorneys with the American Civil Liberties Union of Colorado in Denver. Neel did not immediately respond to a request for comment Thursday.
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