As Minnesota insurers limit access to hepatitis C drugs, patients chafe

Kelly Krodel thought a miracle had arrived just in time — in a drug that could eliminate the hepatitis C infection she had carried for three decades before it started to wreck her liver.

Turns out, she's going to have to live with the virus a bit longer. As long as the South St. Paul woman is reasonably healthy, her health insurance won't pay the drug's five- or even six-figure cost.

"Now there's a cure and I can't even touch it," she said. "It makes you so angry."

Krodel is one of a growing number of hepatitis C patients in Minnesota caught in a bind between the exorbitant cost of the year-old medications — Harvoni, Sovaldi and Viekira Pak — and the tight restrictions insurers have used to prevent the drugs from busting their budgets.

Two weeks ago a Los Angeles woman sued her insurer over the denial of hepatitis C medication, and last week an advocacy group sued on behalf of two Minnesota prison inmates who were denied state-funded prescriptions.

The battle could be the first of many in coming years, as other revolutionary medications offer hope against chronic and deadly diseases, but at high prices manufacturers charge to recoup their research investments. Critics note there is something particularly frustrating about denying coverage for hepatitis C patients until they show complications; the viral infection can leave patients symptom-free for years but eventually cause failure or cancer of the liver.

"That's a lot like telling people they have to have a heart attack before they'll treat their high blood pressure," said Dr. Craig Peine, a liver specialist at Hennepin County Medical Center with growing piles of request letters from patients, and denial letters from insurers, on his desk.

Hepatitis C is spread through contact with infected blood — frequently from sharing needles for illicit drug use. In Minnesota, only about 40 new cases are confirmed each year, but there are an estimated 42,500 people living with the infection in the state.

Insurance restrictions emerged after federal approval in late 2014 of Abbvie's Viekira Pak and Gilead Sciences' Harvoni, which proved in studies to be more than 90 percent effective at eliminating any detectable trace of hepatitis C from the bloodstream. Harvoni debuted at around $1,000 a pill, or roughly $90,000 for a typical 12-week course of treatment.

Minnesota saw an immediate impact; its Medicaid program for low-income residents spent $1 million on hepatitis C medications in 2013, but $9 million last year.

Medicaid administrators across the country responded with restrictions, often requiring patients to first show symptoms such as liver scarring, or seeking assurances that patients have the sobriety and reliability to take the drugs for 8 to 12 weeks.

In Minnesota, the fee-for-service portion of Medicaid won't cover Viekira Pak unless patients with histories of drug and alcohol abuse have been sober for six months or sober for three months while participating in addiction treatment. Doctors must "attest" that patients are stable enough to complete the medication course. Other states have instituted a one-and-done policy, meaning they won't cover it again if patients get reinfected.

"You're dealing with a vulnerable population of patients, many of whom have alcohol or drug problems," said Jeff Myers, president and chief executive of Medicaid Health Plans of America, "and you're dealing with a drug that is literally $30,000 a box."

Krodel isn't sure when she was infected, but she had been a habitual heroin user, sometimes sharing needles, until she achieved sobriety in 1985. She didn't know she had the infection until a decade later, when she got tested after a friend tested positive.

Now a drug and alcohol counselor for Hennepin County, Krodel, 56, says she's fortunate she hasn't suffered any symptoms while she has watched friends or clients die of the disease. It has been a nervous existence, though, especially when tending to the skinned knees of her children or other moments when she worried she could transmit the blood-borne virus to them.

Lately she has felt fatigue, which could be due to a busy life, but also is a symptom of hepatitis C.

"I'm fortunate I'm not 'sick, sick.' I've had it a long time," she said. "But … it isn't until 20 years or more that it really starts showing its face."

Peine said that anxiety is legitimate. Older treatments using interferon can be toxic and harsh on patients, but living with a severe infection weighs on them. He has tried to obtain free and discounted medication direct from the manufacturers of the new drugs, but the demand is high.

"It's a glorious medication, particularly Harvoni," Peine said. "Patients are routinely hugging us, saying, 'I've been fighting this all my life and now it's done.' "

While the medication is remarkable, insurers could waste millions prescribing it, considering that 20 percent of hepatitis C infections clear themselves naturally, said David Lassen, chief clinical officer of Eagan-based Prime Therapeutics, a pharmacy benefits manager which advised Blue Cross and Blue Shield of Minnesota in its coverage policy.

Insurance restrictions, combined with careful monitoring by doctors to determine when infections worsen, are increasingly important, he said.

"It's really not waiting around for someone to get more sick. It's preventing a scenario where you treat someone who might have otherwise never become sick."

Insurers and their pharmacy benefit managers have been trying to negotiate down the high costs by arranging preferred or exclusive contracts with drugmakers. Myers said in some cases that has cut the cost in half, but even $30,000 to $50,000 for a course of treatment can overwhelm health insurance budgets.

Tennessee's Medicaid program spent one-sixth of its drug budget on one hepatitis C medication last year, he noted.

Myers said his organization is studying how state Medicaid programs adjust their restrictions as costs change. Over time, the population of patients needing the treatment should shrink as fewer patients carry the virus and spread it to others.

Meantime, patients such as Krodel are growing impatient.

Reports of copycat versions of the drug for $10 a pill in Bangladesh have emerged, and Gilead has reached contracts with companies to provide a comparable version of Harvoni in India for less than $1,000 for an entire course.

Krodel recently checked the cost of tickets to New Delhi.

"The flight there is like $3,000," she said, "so I would be better off. But I'm scared to do that."

Jeremy Olson • 612-673-7744