Researchers: Sovaldi Analysis Could Be Used In Lawsuits Against Medicaid

Researchers at Harvard and Brown universities are analyzing state Medicaid programs' coverage restrictions for the expensive hepatitis C drug Sovaldi, and the findings could lay the groundwork for beneficiaries to sue states, although a Harvard law instructor said legal action is a last resort. Patient advocates are especially angry at states that refuse to give the hepatitis C drug to alcoholics and drug addicts, arguing the policy is discriminatory and has no medical basis.

Malinda Ellwood, clinical instructor of law at Harvard's Center for Health Law and Policy Innovation, stressed that the findings are preliminary; researchers must verify them with states and some states are still considering restrictions. Researchers are starting with Medicaid fee-for-service and hope to analyze prescribing restrictions in other areas, such as Medicaid managed care and states' policies on who can treat patients with both hepatitis C and HIV.

Researchers found 30 states with prior authorization restrictions, which vary widely.

The majority of those 30 states restrict the drug to people with alcohol or drug-abuse problems. Among them, 12 states require that patients be sober and off street drugs for six months or longer before they qualify for Sovaldi, Ellwood said. Six states have abstinence periods between one month and three months, and five states require either abstinence or that patients be in treatment programs.

Lynn Taylor, assistant professor of medicine at Brown University, said she is appalled by states that withhold the drug from people with alcohol and drug addictions. African Americans are twice as likely to get infected by hepatitis C, according to the Centers for Disease Control and Prevention, and abstinence restrictions sharpen health care disparities between the poor and the rich, Taylor said. (Harvard and Brown researchers are both analyzing Medicaid restrictions by state and may jointly publish their results, Ellwood said.)

There is no medical reason for abstinence restrictions, Taylor argued, adding that some physicians mistakenly believe that people with alcohol and drug addictions are less likely to stick to their drug regimen. Not only is there no evidence of that, Taylor said, there do not appear to be any other diseases for which Medicaid refuses to cover treatments due to alcohol or drug use.

Taylor said it's wrong to penalize patients who are trying to beat addiction by refusing to treat a separate condition. The rational she heard from states is that drug users may reinfect themselves. However, she said research established long ago that a small percentage of patients get reinfected. It's not right to deny treatment to an entire population because of a few, she added. Reinfection is also a problem for other diseases, she noted, and the government doesn't ration treatments for those infections with restrictions on alcohol and drug use.

Although Taylor dislikes all types of restrictions, she said she understands why states are prioritizing treatment to those who are sickest to deal with Sovaldi's price, which costs $84,000 per course. FDA is expected to approve next month a second drug by Gilead Sciences that will be combined with Sovaldi in a single pill, which is expected to add significantly to the treatment's cost. That pill will not need to be taken with interferon, which makes many patients very ill, so it is expected to be a sought-after treatment. Also, Sovaldi already cures more than 90 percent of many types of patients, and the combo pill is expected to have an even better cure rate and to reduce the treatment period from 12 weeks to as few as four weeks.

All 30 states require that patients show some degree of sickness, and most require a metavir score of at least F3, which requires a liver biopsy, before their Medicaid programs will cover Sovaldi, Ellwood said.

Natarajan Ravendhran, chief of gastroenterology and liver disease at St. Agnes Hospital in Baltimore, said it's wrong to require such an invasive procedure to check on the severity of a disease to determine whether patients may receive a cure. Also, it's not clear when someone crosses from stage two to stage three liver disease, and it's difficult to time when to do follow-up biopsies to monitor the progress of liver disease. He said the restrictions often put both patients and their doctors in a difficult position, and he gave as an example one of his patients who is in stage one and wants to have children but cannot until her disease gets bad enough to merit treatment.

Ellwood said 21 states also restrict who may prescribe Sovaldi. That's concerning because there may not be enough specialists to prescribe the drug to those who need it. Nine states require that specialists prescribe hepatitis C drugs, and 12 states require that prescribers consult with specialists.

The university researchers are working with National Viral Hepatitis Roundtable, which has called on HHS Secretary Sylvia Burwell to convene a meeting among drug makers, plans, patients and providers to figure out how to make Sovaldi available to everyone infected with hepatitis C. Patient groups are considering suing Medicaid programs in states with particularly strict limits on Sovaldi, but Ellwood said the group she is working with prefers solutions to lawsuits.

States are in a particularly difficult position. There is a high rate of infection among Medicaid beneficiaries and prison systems. Also, states must balance their budgets each year so even though Gilead priced its drug commiserate with the current cost of treatment, those costs are all up front and states cannot stretch them out over the 20 year to 30 years that they normally would have had to cover those costs. -- John Wilkerson