Tough Choices Over a Pricey but Effective Drug for Hepatitis C

Via Star Tribune

By: Glenn Howatt

Hepatitis C is one of the most common infectious diseases, with the potential to cause serious liver damage, so patients were thrilled when a set of revolutionary new medications became available five years ago.

But at $90,000 per treatment course, the drugs were pricey, and many states, including Minnesota, balked at covering them under their taxpayer-funded Medicaid programs.

Since then, however, the treatment cost has fallen dramatically — in some cases to $24,000 — and is expected to fall further after generics are introduced this year. Now advocates are urging Minnesota to drop its restrictions, which they say prevent patients from getting medications that are highly effective and stop the spread of the virus. “I am frustrated seeing my patients walking around with infections that I could treat with a snap of my finger,” said Dr. Ryan Kelly, a primary care physician at the Community-University Health Care Center in Minneapolis.

Minnesota is one of only 12 states that require patients with an addiction history to maintain a six-month period of sobriety before they can start taking hepatitis C drugs, although some can get the medication with three months’ sobriety if they are in addiction treatment. By comparison, 32 states either have no sobriety restrictions or require basic screening and counseling to weed out patients who are not good candidates for treatment.

Kelly plans to meet soon with officials at the Minnesota Department of Human Services, which runs the Medicaid program, in an effort to change its policy.

Nearly 35,000 infected

The current restrictions, which also require that the drugs be prescribed only by or in consultation with a specialist, such as a gastroenterologist or hepatologist, were introduced when the new treatments came online in 2014.

Nearly 35,000 people in Minnesota are infected with hepatitis C, according to the Minnesota Department of Health. On average, 2,200 people in the state are diagnosed with the virus every year, but the state can’t say when they acquired the infection. Disease researchers say that many more are infected but have never been tested.

Hepatitis C, which can lead to liver cirrhosis and cancer, is spread mainly through blood. Many infections are caused when street drug users share needles.

“Hepatitis C is on the rise mostly because of the rise in injecting drug users,” said Kelly. “If we treated people who are spreading the infection, more costs would be saved down the road.”

A state official says the sobriety restrictions are necessary to prevent people from becoming reinfected should they relapse after getting hepatitis C treatment.

“We want them to be treated in a way that will be successful,” said Dr. Jeff Schiff, medical director for Medicaid and MinnesotaCare. “The cost has come down significantly, but it is still a very significant cost per treatment course.”

Kelly said the decision to prescribe hepatitis C treatment drugs should be left to the doctor who knows the patient best. As with other diseases, doctors weigh many factors before writing a prescription, including the patient’s likelihood to comply with the treatment.

“It is a moral restriction that has nothing to do with [patient] health and doesn’t need to be there,” he said.

Schiff said he’s open to a discussion about the future of the state policy.

“The landscape is evolving since these [drugs] came on the market,” he said. “Through our internal conversation we have decided that we will take another look at this policy.”

Sober for his daughter

Gabriel Bliss, 31, has been waiting since April to get the medications that will cure his hepatitis C. He had been a long-term heroin user but quit after his best friend died from a batch that contained fentanyl. He learned of his hepatitis infection while in detox.

“I have a 3-year-old daughter, and she is the main reason that I am still alive and the main reason that I am sober,” he said in a recent interview at his Richfield house.

Bliss gets his insurance through one of Minnesota’s Medicaid managed-care plans, which administer benefits to about 850,000 of the 1.1 million residents who are on the program. All of them have similar restrictions to the state policy.

After quitting heroin, Bliss saw a specialist but got turned down for hepatitis meds because he had smoked marijuana.

“I figured that if I wasn’t on other hard drugs it would be OK,” he said. “Had I known that, I wouldn’t have smoked, because it is a lot more important for me to get rid of hep C.”

Now, he has to wait until March before getting treated. In the meantime, he’s concerned that he might infect others, either through an open wound or even sexual contact, which presents a low risk.

“I don’t know why there are restrictions on it,” he said. “You would think that you want people to be healthy because it would cost less in the long run.”

Nationwide, state Medicaid programs are being urged — and sometimes sued — to drop treatment barriers. Led partly by the Center for Health Law and Policy Innovation at Harvard University, 21 states have dropped or reduced requirements that patients must suffer some liver damage before they are treated, a requirement that Minnesota never used.

Nine have relaxed sobriety restrictions, and six have loosened specialist requirements.

“What we are seeing here are measures that are deliberately put in place to stop people who need medically necessary care versus cost concerns,” said Phil Waters, an attorney with the Harvard center. He said the restrictions are “discriminatory and illegal.”

An ‘early win’

Phil Gyura, a certified nurse practitioner with Minneapolis-based Livio Health, used to practice in New York. He said access to treatment expanded significantly when that state dropped most of its restrictions in 2016.

“From a public health standpoint, the more people that we cure, the less likely it is to spread,” said Gyura, director of addiction care and behavioral health integration at Livio.

He said Minnesota has a unique opportunity to expand hepatitis C treatment because so many people get drug or alcohol treatment in centers. “They have the nursing staff and they have the structure,” he said. “It can be an early win in their sobriety.”

Both Gyura and Kelly said most of their patients want to get treatment directly from a primary care doctor rather than a specialist.

“I see many people at my clinic who view our clinic as their medical home,” Kelly said. “Being referred to a different clinic to see a specialist, especially to a confusing large hospital system, is a huge barrier.”

Schiff said state policy would allow patients to consult a specialist electronically, without visiting an unfamiliar clinic or hospital. “It would be relatively easy for that provider to get on a telemedicine platform … and do that consultation in real time,” he said.

Nonetheless, critics of the specialist requirement say it hearkens back to the days when the only treatment for hepatitis C involved toxic intravenous drugs, which also weren’t as effective as the newer pills.

“It has become much less complicated to treat,” Kelly said.