State health officials issue Sovaldi recommendations

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Sovaldi. (AP Photo/Gilead Sciences)
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ALBANY—New York State health officials outlined recommendations on Thursday that would prioritize prescribing Sovaldi, the expensive but life-saving hepatitis C drug, to about 60 percent of the nearly 60,000 Medicaid patients diagnosed with the disease.

Patients with advanced stages of the disease and those who have also been diagnosed with liver disease, H.I.V. and other conditions associated with hepatitis C infection would have the highest priority to receive the drug. The recommendations still require approval from the state's health commissioner.

Many hepatitis C infections are caused by intravenous drug use, and the state will require patients to show “readiness” to receive treatment, which state health officials defined as a flexible assessment from a doctor about whether or not a patient was using or abusing drugs and alcohol. While studies have shown alcohol use can blunt the drug’s effectiveness, no clinical studies have been done to examine whether drug use has an impact on Sovaldi's success rate.

State health officials said that “no signs of high-risk behavior,” “alcoholism, drug use, or failure to complete” evaluation appointments should be evident in follow-up appointments, in order for patients to continue receiving the drug.

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Patients who have already received a full course of the drug would be less likely to be approved for a second full course of treatment if they become re-infected, state health officials told Capital.

Chronic hepatitis C patients who also have H.I.V. would have to demonstrate they have “no detectable viral load” for the six months prior to receiving treatment, and the drug could only be prescribed by specialists with experience in treating the disease. Patients would have to submit to blood tests during their three- to four-month course of treatment to show the drug is working in order to keep receiving prescriptions.

Those recommendations would narrow the number of people in New York state’s Medicaid program likeliest to receive the drug to about 35,000 people. That could significantly cut the state’s costs for covering Sovaldi, which an Express Scripts report issued earlier this year estimated could cost New York roughly $3.6 billion a year.

The state plans to re-examine its recommendations in six months, because of the extraordinarily rapid pace of change in the hepatitis C drug market. Another drug manufactured by Gilead Sciences, the maker of Sovaldi, is expected to receive F.D.A. approval in early October. And earlier this week, Gilead announced it would allow drugmakers in India to manufacturer a cheaper generic version of the drug.

New York State is already in discussions with Gilead for a deal on the drug’s price, said Janet Elkind, deputy director of the state’s Office of Health Insurance Programs.

“This is an evolving market and it’s going to change,” said Dr. Barbara Rogler, a member of the state’s Drug Utilization Review Board, which met on Thursday.

“We don’t know what’s going to happen, so we really believe that we should take a look at this and we should re-evaluate in six months,” Rogler said.

State Medicaid programs across the country are grappling with the issue of how to manage Sovaldi, which is highly effective but is so expensive that it threatens to blow a hole in state budgets. The drug's wholesale cost is $1,000 per pill, or $84,000 for a standard 12-week course of treatment.

The recommendations place New York on the more permissive end of the scale with states such as Massachusetts and California, state health officials said.

But that is unlikely to satisfy some patient advocates who say there should be no restrictions on the prescription of a drug that can save lives, and which the F.D.A. has said can be prescribed for any patient with a diagnosis of chronic hepatitis C, not just those with the most advanced forms of the disease.

“Consensus is not the same thing as agreement,” said Charles Gonzalez, associate medical director for science and policy at the state Health Department AIDS Institute and a member of the state’s Drug Utilization Review Board.

Gonzalez, who described himself as “a bleeding-heart liberal,” told the assembled state health officials Thursday he had personal misgivings about the board’s recommendations, which would prioritize prescriptions for patients who are already in advanced stages of the disease, instead of making it readily available to anyone with a hepatitis C diagnosis.

“I’d like to point out that two successive governors have made it my job to make sure folks get tested,” Gonzalez said.

“They get screened, get tested and we’re asking folks to wait.”

“That’s a bit of a problem for me, and for folks that I’m trying to protect. It’s rare that we let a disease progress until you must get therapy,” he said.

“Turning other folks away is a bit difficult for me as a clinician, as a physician and as a New York State resident, which makes this a little bit rare," he said. "And that’s my soapbox."