New drugs offer hope, barriers for hepatitis C patients

For patients with hepatitis C, the last year has brought great hope: New drugs that are highly effective with few side effects. But their high cost has led Medicaid officials in Pennsylvania and other states to put up barriers for patients, treating only the sickest ones and leaving many others to wait.

"This is an unprecedented approach we've had to take with these drugs," said Terri Cathers, pharmacy director for Pennsylvania's Office of Medical Assistance Programs. "We've not done this before for other treatments as long as I've been in the business."

The approach, she said, is a direct result of the cost, which can range up to $150,000 per patient.

But some doctors who treat hepatitis C say the state's effort is discriminatory and shortsighted.

"We providers feel like this is really not the way that we need to be allocating health care," said Stacey Trooskin, an infectious diseases physician who specializes in hepatitis C. "We know that people who are treated earlier respond better to treatment."

Trooskin says private insurers also deny coverage, but are amenable to appeals. Not Pennsylvania Medicaid. The state's hep C policy is disproportionately harming the poor, she said.

Pennsylvania's is one of 35 state programs placing barriers on the drugs, according to a Sept. 29 report from the consulting firm Viohl and Associates. New Jersey does not currently require any prior authorization for the new hep C drugs - but officials there are considering controls. As of Nov. 20, NJ FamilyCare had paid more than $46 million to give one hep C drug, Sovaldi, to 621 patients, mostly on Medicaid.

In another sign of how contentious the new drugs have become, SEPTA, the regional transit agency, recently sued Sovaldi's maker, Gilead, alleging that its pricing was unjustified. SEPTA's self-funded health insurance plan spent $2.4 million on Sovaldi alone in 2014, said Benjamin Johns, a lawyer for the agency.

And Express Scripts, the nation's largest manager of prescriptions, announced on Dec. 22 that it will require all patients to use Viekira Pak - a treatment from drug maker AbbVie that had been approved just three days earlier - instead of Sovaldi and another widely used medicine, in a bid to hold down costs.

Hepatitis C is a viral disease that is transmitted through the blood and is now spread largely through injection drug use. It scars the liver, sometimes leading to cancer or a transplant. About 3.2 million Americans are thought to be infected, most of them baby boomers. But symptoms may not appear for decades, and many carriers are unaware they carry the virus.

To get the drugs in Pennsylvania, Medicaid now uses prior authorization guidelines, which require patients to be assessed for treatment compliance, show the amount of damage to their liver or virus in their systems, and prove they are abstinent from drugs and alcohol through tests and a confirmation of six months of sobriety from a doctor, Cathers said. Generally, only patients with significant liver damage get approval.

The state also asks if patients have been treated before, and if so, why it failed.

Patients who are denied the drugs must wait for prices to go down or their disease to progress, or try to get free or discounted medication through a drug company patient assistance program, if they qualify.

Doctors say they have to go to great lengths to get Medicaid patients approved, generating up to four denials before a final rejection. They say that employees must spend eight to 12 hours to get a patient drug approval.

Sovaldi, an effective hep C treatment, costs $84,000 for 12 weeks of the daily pills containing sofosbuvir.

Harvoni, a sofosbuvir and ledipasvir combination pill, costs $94,500 for a full 12-week course, but some patients with less liver damage can be cured with a $63,000, eight-week treatment.

Sovaldi is used in combination with other drugs such as Janssen Pharmaceuticals' pill Olysio, pushing the cost up to $150,000 for 12 weeks.

The new drugs change the game for hep C by offering daily pills with cure rates of more than 90 percent. The treatments are well-tolerated, with minor side effects of fatigue and headaches.

Older treatment relied on a combination of pegylated interferon and ribavirin. Patients were often deterred by interferon's weekly injections, severe side effects, and lower success rate.

Trooskin, an assistant professor at Drexel University College of Medicine, warns her patients up front about the difficulty of getting the new pills, particularly if they are on Medicaid. She said that Medicare has been covering them but that private insurance companies sometimes reject them the first time - then generally relent.

She called new hep C treatments "the greatest public health accomplishment of our generation." But it's not enough to have a cure. Anyone who needs it has to be able to get it, she said.

Trooskin receives grant funding from Gilead and sat on hepatitis C advisory boards for the company.

A Gilead spokeswoman said in a statement that the pricing of Harvoni and Sovaldi reflects their value and will save the nation's health system over time, since the average cost of a liver transplant was $577,100 in 2011.

Responding to the drug restrictions, the spokeswoman wrote that starting therapy earlier has produced a higher cure rate in studies, which would cut future costs of treating advanced liver damage.

Paul Yabor, 52, of Juniata, had moderate liver damage from hepatitis C when he was first denied the drugs by his private insurer. Then he got approval, thanks to advocacy, he said. He began treatment, which he found free of side effects, in June and finished in September. Now he has no hep C virus detectable in his system.

"Behind this medication are sick people who are dying," he said. "We're dealing with a system that basically says: Is it more affordable to let someone die than to live? Or how little can we give out to make the most profit?"

Carl Grant, 64, of South Philadelphia, hasn't been so fortunate. More than two decades with the infection has left him with severe liver damage, but he said he avoided the old treatment because of its severe side effects. Grant's cirrhosis puts him at risk for liver cancer or needing a transplant.

He was prescribed two of the new drugs in July. His Medicaid HMO, Keystone First, denied the $150,000 cost.

Months after his doctor first prescribed the drugs for him, Grant attended a first appeal hearing on Dec. 9. Joining him were nurse practitioner Jody Gilmore, coordinator of the viral hepatitis program at Penn Presbyterian Medical Center, and Lance Haver, director of the city's Office of Consumer Affairs. Both spoke on his behalf to a company-employed doctor hearing the appeal.

"We have a cure, so let me have that cure," Grant said beforehand. "As a United States citizen, I feel like I'm being cheated."

When Grant was first denied Sovaldi and Olysio, Keystone First suggested that he try a cheaper regimen of Sovaldi, pegylated interferon, and ribavirin, Gilmore said. But when she applied for those drugs, Grant was denied again.

Keystone First wouldn't discuss Grant's case with a reporter, but said its protocols are approved by Pennsylvania Medicaid and are subject to "a rigorous review process" based on evidence.

"About 80 percent of hepatitis C patients don't experience a progression of their disease," the company said in a statement. "For those that do, we have developed protocols to put them on the path to wellness as quickly as possible."

Grant is awaiting a decision that Gilmore said will likely depend on the results of a new scan to confirm the extent of his liver damage.

The nurse practitioner said all her Medicaid patients are getting denials, generally at least two to four times, for the new hep C drugs. The process, she said, takes months.

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@LauraEWeiss16