After a routine physical, Randy Cox’s doctor fast-tracked him to a specialist in Springfield, who insisted he bring his wife or not bother to show up at all. It was February.
“When’s Randy’s birthday?” the specialist had asked Cox’s wife. She told him it was in June. “Don’t plan a party,” he replied.
The doctor instructed Cox to take his shirt off, and inspected under his arms, noting the unmistakable yellow tint of his skin. It was around his hair. The color had also seeped into his eyes.
The doctor diagnosed Cox with hepatitis C, a viral liver infection that can ultimately lead to liver failure or liver cancer. At the time, the drugs that were available didn’t work for most people. Cox was already too sick for one of them, anyway. The doctor told him he’d contracted the virus about a decade earlier.
“I honestly thought I was going to die,” said Cox, now 65. Recently recalling the ordeal that would color his world in fear for more than two decades, he started to choke up.
Sitting in a Bend diner on Third Street not far from his house, he took his hands off his coffee mug so he could slowly remove his glasses, wipe his eyes and continue his story. “Until about a month ago, I thought I was going to die.”
Army veteran Randy Cox, pictured outside his home in Bend, recently obtained hepatitis C treatment through the U.S. Department of Veterans. His doctor told him he's cured. "I'm amazed that I get to turn 65 years old," he said. Joe Kline / The Bulletin
Within the past three years, new drugs with cure rates surpassing 90 percent have come on the market that have dramatically changed the conversation for hepatitis C patients like Cox.
The results are like nothing doctors had seen before: patients’ bodies being effectively rid of the virus within just a few months, rather than living with it for decades.
But the drugs’ exorbitant prices keep them out of reach for lots of people. Some private insurers and government programs for low-income individuals require patients be very sick before they’ll pay for treatment.
Nearly 20,000 deaths in the U.S. were tied to hepatitis C infections in 2014 — more than any year in history, according to the federal government. That number is expected to increase, as the thousands if not millions of cases that have gone undiagnosed for decades erupt into liver scarring or cancer.
Oregon’s Medicaid program is taking especially intense criticism, not only from hepatitis C patients, advocates and physicians, but from the federal government itself, which says the state’s strict treatment criteria is not in line with federal law.
State officials, hesitant to speak on the issue in recent months, promise to revisit their guidelines in September. Advocates argue that’s not soon enough.
As lawsuits force other state Medicaid programs, including Washington’s, to drop their restrictions, a legal battle appears increasingly likely in Oregon.
“I don’t want to impute bad motives on the part of insurers,” said Robert Greenwald, a clinical law professor at Harvard Law School and faculty director of its Center for Health Law and Policy Innovation, “but I do think they feel more comfortable than they should about basically condemning a population and many people within that population to sickness, ill health and ultimately, for some, death, for having these kinds of restrictions.”
‘It’s quiet’
Before hepatitis C was first identified in 1989, an estimated 300,000 were infected with the virus each year, primarily through injecting illegal drugs and from receiving blood transfusions in medical settings, according to the Centers for Disease Control and Prevention.
In 1992, researchers developed a blood test that removed the virus from the blood supply used in blood transfusions.
Roughly 80 percent of the chronic or longstanding cases of hepatitis C afflict baby boomers, people born between 1945 and 1965. If the infections develop into cirrhosis, late-stage scarring of the liver, it happens decades — sometimes 30 years — after the initial infection. Many of the infected are just finding out.
For the rest of that time, there can be virtually no symptoms.
“It’s quiet,” said Maricela Chavez, a 52-year-old Madras resident who was diagnosed in 2002. A doctor told her four years ago that she had probably had the virus for 30 years. “You don’t feel no pain, you just feel tired. It’s scary.”
Maricela Chavez said she didn't feel any pain when she was diagnosed with hepatitis C, even though she had likely had the virus for decades. "It's quiet," says Chavez, pictured with her grandson, 14-year-old Casper Cadena, at her home in Madras. Joe Kline / The Bulletin
The worst is yet to come, according to numerous projections. The CDC believes the prevalence of hepatitis C-related end-stage cirrhosis, liver cancer and deaths will peak in the late 2020s to early 2030s. It now recommends all baby boomers get a one-time screening for hepatitis C, even if they don’t have risk factors. The federal government estimates 3.5 million Americans have hepatitis C, but only half know it.
“Because the most common risk factor is injection drug use, I think people would like to dismiss it as a city drug user problem, but it’s not,” said Dr. Ann Thomas, a public health physician with the Oregon Health Authority. “It’s everywhere.”
Dr. Glenn Koteen, a gastroenterologist with Gastroenterology of Central Oregon, has learned not to be surprised by the people he diagnoses. Hepatitis C doesn’t stick to one creed, gender or race, he said.
“Everyone from CEOs who make a million dollars a year and snorted cocaine in the past to the homeless drug addicts and heroin addicts who shoot up all the time,” Koteen said. “It’s across the board.”
Some research has shown hepatitis C can also be transmitted through the straws or rolled up dollar bills used to snort cocaine, if tiny droplets of blood from one person come in contact with another user.
Oregon’s death rate from hepatitis C was double the national average in 2011. It’s unclear why. The rate of chronic infections tends to be high in Oregon’s rural counties. Jefferson County had the state’s highest rate of chronic infections between 2009 and 2013: 252 cases per 100,000 residents, according to a 2015 Oregon Health Authority report. Second was Malheur County in southeastern Oregon.
Prisons tend to skew the rates, which could help explain what’s happening in Jefferson and Malheur counties, homes of the Deer Ridge and Snake River correctional institutions, respectively.
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The prevalence in rural areas could also be because that’s where there is a large proportion of retirees, said Dr. Mark Loveless, an infectious disease physician in Portland who is a member of an Oregon Health Authority steering committee on hepatitis.
The most common way of getting hepatitis C is through sharing needles during injection drug abuse. Before 1992, many people got it in medical settings, through blood transfusions, organ transplants or needlestick injuries. Being born to a mother with the virus is another mode of transmission, as is getting a tattoo from someone with unsanitary practices, or sexual contact.
Because of the drug abuse connection, many people don’t like to admit they have the virus. Many advocates believe today’s treatment restrictions come from the belief that people who used drugs don’t deserve treatment.
Laurie Hubbard, a communicable disease nurse in Deschutes County who investigates new hepatitis C cases, said she thinks the treatment restrictions for people with hepatitis C is connected to that stigma.
“It doesn’t matter how the disease is contracted in terms of worthiness for care,” she said. “It’s a disease. It’s an infection. As a humane population, we would love to see people with disease and infection have access to care.”
The early days of treatment
Koteen got to work treating hepatitis C when it all started in the mid-’90s, and it was “miserable” work.
Back then, patients received three injections per week of a drug called interferon for 48 weeks. The chances of that getting rid of the virus were only about 16 percent, according to a 2012 study in the journal Clinical Liver Disease. When another drug called ribavirin was added to the mix, the cure rate grew to about 34 percent.
When the number of injections patients needed went down to one per week, the cure rate grew again, this time to about 55 percent, according to the 2012 study.
The drugs’ side effects were so severe, few patients could see their regimens through. People felt like they had the flu: nausea, vomiting and many couldn’t work during the treatment.
Chavez said some days she couldn’t even get out of bed. She was tired. She threw up. Her hair fell out. She developed blisters on her lips, tongue and even in her throat. It hurt to eat. She developed anemia, a common side effect of ribavirin.
A doctor in 2012 told Maricela Chavez, pictured at her home in Madras, that she had likely acquired hepatitis C three decades earlier. At the time, she thought she would die from the virus. Joe Kline / The Bulletin
She watched a friend with cancer die during her chemotherapy treatments, and said the feelings her friend described were exactly what she was experiencing.
“It was very, very bad,” she said.
Even after all that, the drugs didn’t rid Chavez of the virus. In fact, her doctor told her she was worse off than when they had started.
Initially, the drugs were so bad, doctors didn’t treat every patient they diagnosed, Koteen said. For many of them, the slim likelihood of being cured wouldn’t have been worth the unbearable side effects, he said.
That was the case for Cox. By the time the Bend man was diagnosed, he was too sick to take interferon. Instead, the doctor gave him ribavirin, but the odds of that working alone without being combined with interferon were low, a fact the doctor made clear.
“He was upfront about it from the beginning,” Cox said. “He said, ‘You know, there’s a lot of people that their body won’t take this.’”
That was the same doctor who warned Cox’s wife (they’ve since divorced) not to plan a birthday party. It turned out, he’d been right. For weeks, Cox said he was too sick to do anything. In addition to the nausea, he developed rashes all over his body, including on his head.
“Those drugs are so poisonous,” he said.
The doctor stopped the treatment and — out of options — did something that’s typically frowned upon in mainstream medicine: He sent Cox to a naturopathic physician. She whipped up solutions that tasted terrible, but Cox said he eventually felt better again and went back to work. The yellow tint left his eyes.
It seemed this would keep his illness at bay — at least for a while.
Many of Koteen’s hepatitis C patients dealt with severe depression and anxiety even before treatment. Unfortunately, the early medications exacerbated those conditions. Suddenly, they were angry, too. Irritable. They couldn’t get along with their children or spouses. They couldn’t sleep. Coupled with the physical symptoms, many simply couldn’t continue treatment.
At the time, it was common for doctors to pick and choose which patients they treated, Koteen said. Doctors, hearing rumblings of better drugs on the horizon, told patients to wait.
I’m walking out of the dead. I’m a survivor.
— Maricela Chavez
“Since it’s a disease that can take 20 or 30 years, what’s another one or two years?” Koteen said. “All these patients would be waiting in the wings, like airplanes lined up at an airport.”
Dr. Kent Benner, a gastroenterologist with The Oregon Clinic in Portland, said once he got done going over the medications’ side effects — flu-like symptoms, depression, all for a small chance of getting cured — many decided to skip it.
“They look at you and they go, ‘Doc, why would I want to take that?’” he said. “‘I’m going to wait for the new drug you’re telling me is coming out in a few years.’ A lot of patients were on the sidelines.”
Given her previous experience, Chavez was nervous when a doctor told her about the new medications. With the help of a patient assistance foundation, she was able to get a regimen that included Solvaldi for about $30 a bottle. Within three months, her doctor told her she was cured.
“I’m walking out of the dead,” Chavez said. “I’m a survivor.”
New drugs, still out of reach
At the end of 2013, it seemed the wait was over.
That’s when the FDA approved a new drug, Sovaldi, that was showing cure rates around 90 percent. The drug’s treatment regimen — 12 weeks — was much shorter than the drugs of the day, and, best of all, the side effects were minimal. In fall 2014, Harvoni, another drug with an equally impressive cure rate hit the market.
“It’s like taking candy compared to taking toxins in the old days — for the doctor and the patient,” Koteen said.
Dr. Laurie D’Avignon, an infectious disease physician with Bend Memorial Clinic who sees new hepatitis C patients every week, said she was initially skeptical of the high cure rates the drugs’ manufacturer, Gilead Sciences Inc., was reporting. The drugs she’d been giving patients for years had such horrific side effects, most patients couldn’t see the regimens through, much less be cured.
But once she started prescribing the drugs for her patients, D’Avignon realized the side effects were so minimal, patients had no problem seeing the regimens through, and almost all who took them were cured.
“They say, ‘Are you sure it’s working? I don’t feel anything,’” she said.
But the drugs carried an enormous price tag for a 12-week course: $84,000 for Sovaldi and $94,500 for Harvoni.
Suddenly, the problem shifted from the treatments not existing to the treatments being so expensive, they were out of reach for those who needed them.
Oregon’s Medicaid program, the Oregon Health Plan, initially restricted access to Sovaldi to patients with cirrhosis. Eligibility determinations are primarily based on patients’ fibrosis scores, the progression of scarring on their livers. Fibrosis scores range from one — the least severe — to four, the final stage before liver failure, also known as cirrhosis.
Between June and December 2014, OHP was among only four state Medicaid programs that restricted access to Sovaldi to stage 4 fibrosis.
Meanwhile, Gilead reported in July 2014 it had made $3.48 billion on Sovaldi. In the first quarter of 2016, the company said it made about $4 billion on its hepatitis C drugs.
Today, private insurers in Oregon restrict not only which medications they pay for, but the proportion of the total bill they cover.
An analysis of 2016 silver-tier policies in Oregon by the Center for Health Law and Policy Innovation at Harvard Law School found that 22 percent cover only two of the available hepatitis C medications, while 8 percent cover only Sovaldi. Silver policies offered by Atrio, Kaiser Permanente, Moda Health Plans, PacificSource Health Plans, Providence Health Plan, Trillium Community Health Plan and most of those offered by BridgeSpan require members pay for half of the cost of the medications.
You’re not sick enough. You don’t meet the criteria. I think they hope you’re dead or something, that you die.
— Kandice Conry, on her repeated attempts to get hepatitis C treatment covered by insurance.
More than 90 percent of private silver policies in Oregon require prior authorization for the hepatitis C medications. That means after determining the patient needs the medication, the doctor’s office has to send a request to the insurer, which then determines whether the patient meets its criteria.
Prior authorizations are very time consuming for doctors and their staff. Asked whether she has experienced this, D’Avignon, of BMC, laughed.
“The physical act of them completing the treatment — that’s the easy part,” she said. “I think the most challenging part is getting through all of the paperwork.”
Some insurers require that patients prove they haven’t used drugs or alcohol for at least six months before they’ll be approved for treatment.
Using alcohol hastens the progression toward cirrhosis, so D’Avignon said she always recommends her hepatitis C patients abstain from drinking. At the same time, she said she thinks it’s unfair to restrict somebody who has had a few drinks within the past six months from treatment.
“I think it’s really unfortunate when someone comes in and is like, ‘Oh my gosh, a month ago I had a couple glasses of wine with dinner,’ and then to have to say, ‘Well, we need to wait six months from that point until we can submit you for treatment,’” she said. “That seems a little overkill.”
It should be the doctor’s job to determine whether the patient’s drug or alcohol use would interfere with their treatment, Benner, the Portland gastroenterologist, said. In any case, requiring a negative urine screen in patients without histories of alcohol or drug use at least six months prior to approval is “draconian,” he said.
“That is totally unnecessary,” he said. “It’s just a barrier to care.”
Dallas Buyers Club for Hep C
Kandice Conry was among those who passed on interferon when she was diagnosed in 2003.
At the time, Conry, who is being identified by her mother’s maiden name to protect her family’s privacy, was 23 years old and living in San Francisco. She didn’t fully understand the gravity of hepatitis C. That coupled with the horror stories she’d heard about the drug made the decision easy.
“I just knew if it ever came to that point, that I would never try that,” she said. “If it’s going to make me worse, why even do that?”
Around a decade later, Conry, in her mid-30s and raising three kids, decided she couldn’t wait any longer. The disease was making her tired all the time.
“I was exhausted,” she said. “I would sit there on the couch and my husband would be doing stuff, and I would feel so guilty.”
After her insurer denied hepatitis C treatment four times, 36-year-old Kandice Conry, pictured outside of her Redmond home, bought inexpensive medications online. Her doctor confirmed she was cured in 3 months. Joe Kline / The Bulletin
When Harvoni came out in 2014, she asked her doctor, Koteen, about the prospect of getting the drug. Koteen’s nurse told her they’d try to make it happen.
The first denial letter came in March 2015. Conry and her family were covered under her husband’s private Providence Health Plan policy, which he received through his employer. The letter said the scarring in her liver hadn’t progressed enough.
“‘You’re not sick enough. You don’t meet the criteria,’” Conry repeated. “I think they hope that you’re dead or something, that you die.”
The Conrys tried two more times, and received two more rejection letters. The fourth time around, Conry wrote her own letter to Providence, pleading for the medication and explaining how the disease hindered her ability to raise her kids.
Recalling that time while sitting in her Redmond home earlier this summer, Conry’s gaze fell on her young son. He was watching her through a plastic childproof gate, sliding coins through the holes and watching them hit the floor.
“I’d see all these other parents doing stuff,” she said, pausing after she started cry. “I know it’s such a small thing, but to a parent, I think it’s bigger, because I wanted to be able to do lots of stuff.”
After her fourth rejection from Providence, Conry, always researching potential solutions online, found the website for a Dallas Buyers Club-type situation for hepatitis C drugs. The Dallas Buyers Club was a group that smuggled unapproved drugs into the U.S. and sold them to AIDS patients.
Conry’s Buyers Club is a bit different. It’s run by an Australian man, Greg Jefferys, who traveled to India to find affordable, generic hepatitis C drugs after he was diagnosed with the disease in summer 2014. He succeeded, cured himself and has since established a supply chain whereby patients can — upon providing identification, prescriptions or medical records and payment — buy generic Harvoni from India, Bangladesh and Australia through the mail. The process is explained on Jefferys’ website, www.fixhepc.com.
Jefferys has received lots of media attention for his work as the demand for hepatitis C drugs has grown, including stories by CNN, Bloomberg and The Times of India.
When Conry asked Koteen to write her a prescription, he was skeptical.
“I said, ‘I don’t know anything about this,’” Koteen recalled. “‘There are a lot of fakes and frauds, and be careful.’”
Finally, Koteen agreed. Conry sent $1,300 to Jefferys and received an eight-week regimen in the mail in December 2015.
After three months, a blood test showed that Conry, now 36 and raising three children, ages 2, 3 and 16, was cured of hepatitis C, Koteen said.
Kandice Conry, pictured at her home in Redmond, bought inexpensive hepatitis C medication from an online Dallas Buyers Club-type operation. Her doctor was skeptical at first, but confirmed she was cured within three months. Joe Kline / The Bulletin
“She responded to everything,” Koteen said in June, sounding amazed. “Her virus is still undetected, so she’s a cure.”
These days, Conry said she has her energy back. She doesn’t have to worry about infecting her kids anymore, which could happen if they somehow became exposed to her blood. She also doesn’t worry about developing liver scarring or, worse, liver cancer.
Her message to other hepatitis C patients: Don’t give up.
“This situation was such a miracle for me,” she said. “I can’t even share how grateful I am.”
Sick enough for treatment?
Oregon’s Medicaid program has some of the most restrictive treatment criteria in the country, enough to garner warnings from the federal government and the looming threat of a lawsuit from patient advocates.
“Our state is knowingly killing people on Medicaid,” said Lorren Sandt, the executive director of Caring Ambassadors, an Oregon City-based patient advocacy group.
A state committee that sets treatment criteria will meet in September to review the state’s policies, but Sandt, whose organization receives funding from hepatitis C drugmakers, such as Gilead, said she wants to see changes before then.
That leaves OHP leaders in a precarious position. Perhaps unsurprisingly, they’re far from forthcoming when it comes to talking about hepatitis C. OHP provided treatment using the new hepatitis C drugs to a total of 665 members between January 2014 and April 2016, according to numbers provided by the Oregon Health Authority. Officials declined to provide the amount of money spent on the drugs during that time.
Under OHP’s current criteria, hepatitis C patients are not eligible for treatment until they reach fibrosis stage 3 or 4 — 4 being the final stage, or cirrhosis. They can be eligible at stage 2 if they also have HIV.
Asked why it’s necessary for patients to be that sick before qualifying for treatment, Dr. Jim Rickards, the OHA’s chief medical officer, distanced himself from the criteria. He said he started in his position in December, and thus wasn’t involved in much of the discussion by the state committee that sets the criteria, called the Pharmacy & Therapeutics Committee.
“I think based on, again, the review of the medical literature and the outcomes and the effectiveness and efficacy of the different drugs, they felt that those are the most appropriate stages of the disease to treat,” he said.
Rickards declined to go into specifics about the medical literature, instead directing a reporter to the state committee’s meeting recordings and minutes.
But the state committee’s position is not the consensus either within or outside of Oregon. Joint guidelines set by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend treating all patients with hepatitis C, regardless of their fibrosis stages or drug and alcohol use.
“There are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy,” the guidelines state. “These requirements should be abandoned, because they create barriers to treatment, add unnecessary cost and effort, and potentially exclude populations that are likely to obtain substantial benefit from therapy.”
Massachusetts’ Medicaid program lifted its hepatitis C treatment restrictions in June after the state negotiated affordable prices with drugmakers.
A federal judge in May ordered the state of Washington to cover all patients diagnosed with hepatitis C regardless of their fibrosis stage amid a class-action lawsuit filed on behalf of patients. The state’s Medicaid director, in a letter to the U.S. Senate in September 2015, wrote that treating everyone diagnosed with hepatitis C would cost roughly triple the agency’s annual drug budget of roughly $1 billion.
Florida’s Medicaid program removed its fibrosis restrictions, which required patients be at stages 3 or 4, shortly after the Washington ruling in response to a lawsuit there.
In April, New York’s attorney general reached an agreement with seven of the state’s private health insurers to remove their fibrosis criteria. The agreement also forbids the insurers from denying coverage based on drug or alcohol use or because the prescribing physician is not a specialist.
‘We’re talking about a cure’
In November 2015, CMS sent a notice to state Medicaid programs warning them against coverage criteria that may “unreasonably restrict access” to hepatitis C drugs, including requiring patients be at fibrosis stage 3 or 4, instead requiring a period of abstinence from drugs and alcohol and requiring that the drugs be prescribed by a specialist.
Such restrictions would violate federal Medicaid law, according to the notice.
Oregon’s rules used to require six months of abstinence from drugs and alcohol, but the most recent guidelines, updated in February, require that patients be under the care of an addictions specialist. It’s unclear whether those patients can be actively using drugs or alcohol and still receive treatment.
OHP guidelines also require the patient’s treatment regimen be prescribed by or in consultation with a specialist, such as a gastroenterologist, hepatologist or infectious disease physician.
It’s fantastic that for that $15,000 a year, we can keep people (with HIV) healthy and live the rest of their life. In this case, we’re talking about a cure. One time, 12 weeks, one pill a day, for $30,000. That’s it.
— Robert Greenwald, a clinical law professor at Harvard Law School and faculty director of its Center for Health Law and Policy Innovation
Asked whether that means a primary care provider can prescribe the drugs if they communicate with specialists about the case, Rickards said, “It sounds like that’s the case.”
Regarding state plans to respond to the CMS notice, Rickards said state leaders monitor the guidelines on an ongoing basis. He said they’ll likely be updated at the September meeting, by which point a new drug is expected to be available.
Rickards acknowledged hepatitis C drugs are expensive, but said that doesn’t influence Oregon’s restrictions.
“That is true,” he said, ??but when the (Pharmacy and Therapeutics) committee makes these decisions, it really is based on the medical evidence and medical literature that’s available, and so I think that is the main component that goes into their decisions.”
The OHP guidelines pertain only to members who are not enrolled in so-called coordinated care organizations, groups that administer Medicaid regionally. Roughly 90 percent of OHP members are in CCOs, including more than 50,000 people in Central Oregon. Although CCOs are free to set their own coverage criteria, they generally tend to follow the state’s guidelines, Rickards said.
The November CMS notice also warned against allowing groups like CCOs to institute stricter coverage criteria than the state’s as a whole. In a February letter to CCO leaders, Rickards asked them to send him their updated criteria and urged them to ensure they complied with the federal law.
PacificSource Community Solutions, which operates Central Oregon’s CCO, was not among those whose policies were more restrictive than the state’s, Alison Little, the CCO’s medical director, wrote in an email. While PacificSource has the same fibrosis score and drug and alcohol treatment criteria, it does not require that hepatitis C be diagnosed or treated by or in consultation with a specialist.
Advocates argue it would be more cost effective to treat all patients diagnosed with hepatitis C, regardless of their fibrosis stage, rather than risk the patients getting sicker and treating related conditions, such as liver cancer or liver transplants. Some even advocate for treating current drug users in an effort to theoretically slow the spread of the disease among the population.
Greenwald, the Harvard Law School professor, said treatment in many states, after rebates from drug manufacturers, costs Medicaid programs in the $30,000 range. For comparison, programs pay between $12,000 and $15,000 annually to keep HIV patients healthy, he said.
“It’s fantastic that for that $15,000 a year, we can keep people healthy and live the rest of their life,” he said. “In this case, we’re talking about a cure. One time, 12 weeks, one pill a day, for $30,000. That’s it.”
Getting more docs to treat
These days, treatment for hepatitis C is mostly provided by specialists.
Primary care providers are still reluctant to treat the disease — not only because of the hoops insurers make them jump through, but because the medications themselves are still relatively complicated compared with other types of treatments. Not only do most patients take a combination of medications, their regimens must be tailored to one of six hepatitis C genotypes.
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“It’s still fairly complex,” said Benner, the Portland gastroenterologist.
That’s changing, though. The FDA at the end of June approved a new drug, Epclusa, that’s essentially one-size-fits-all. It can be used in patients with all six genotypes.
In an effort to increase the number of primary care providers treating hepatitis C, especially in rural areas, the University of New Mexico developed a program called Extension for Community Healthcare Outcomes, or ECHO.
ECHO provides a platform for specialists at medical centers to give training and advice to rural primary care providers through regular video conferences or teleconference calls. Primary care doctors share their patients’ medical histories, lab results and treatment plans.
A study tested ECHO by dividing 407 patients into two groups, those treated in the primary care setting under the model and those treated at the University of New Mexico Health Sciences Center. The results, published in the June 2011 issue of the New England Journal of Medicine, found the two groups fared basically the same.
Dr. Michael Chang, director of the Portland Veterans Affairs Health Care System’s hepatitis C clinic and section chief of gastroenterology and hepatology, said the VA has been using the ECHO model to mentor more than 25 primary care providers throughout the region.
Treating hepatitis C is slowly getting easier, Chang said, and the advent of drugs like Epclusa will help primary care providers feel comfortable treating the disease.
“Hep C right now is primed to be a primary care-managed disease,” he said.
The VA steps up
Before his diagnosis, Cox, who served in the Army between 1968 and 1971, spent years drinking heavily while working as a painter, which likely hastened the progression of his disease. The doctor who diagnosed him was firm: no more drinking or smoking marijuana if you want to live.
“The way I took it was, ‘If you aren’t ready to change your life, go away, because you’re ready to die from this,’” Cox recalled.
Cox was scared enough to quit everything. He kept drinking the naturopath’s concoctions and felt better for a while, despite working long hours.
Diane Sutton, Cox’s partner of more than seven years, said she’d occasionally notice a yellow hue in Cox’s eyes, but it always cleared up after a few days.
“I wouldn’t say nothing because I didn’t want to alarm him,” she said.
Army veteran Randy Cox received treatment for hepatitis C earlier this year and is now cured. The 65-year-old Bend resident wants to encourage others to get tested and treated, despite the stigma around the virus. Joe Kline / The Bulletin
When Cox’s U.S. Department of Veterans Affairs doctor told him about the new hepatitis C drugs, he was skeptical at first.
“It works,” he recalled her saying to him. So he gave it a shot.
The VA announced in March it would treat all of its hepatitis C patients, regardless of disease stage, after Congress approved $1.5 billion specifically so the VA could buy the expensive drugs.
Another contributing factor was the VA’s ability to negotiate drug prices directly with manufacturers, Chang said. Around the same time, Gilead cut its prices by roughly half for the VA.
“The purchasing power automatically almost doubled,” Chang said, “and that literally was almost overnight.”
Likewise, Medicare in 2014 dropped its restrictions on hepatitis C treatment, instead embracing guidelines set forth by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases, which recommend treating all patients with hepatitis C, regardless of their fibrosis stages or drug and alcohol use.
Only 49 veterans in the Portland VA system, which covers most of Oregon and southwest Washington, received treatment for hepatitis C in 2014. That grew to 377 patients in 2015. Between Oct. 1, 2015, and mid-June, 422 veterans received treatment, Chang said.
About 1,500 veterans in the Portland VA system are still waiting to get treated for hepatitis C, Chang said in June. That includes 74 veterans in Deschutes County, 16 in Crook County and 12 in Jefferson County.
“We’re accelerating pretty rapidly,” Chang said.
Unlike other health care providers, the VA’s barrier isn’t so much access to treatment, but having enough providers to treat patients. That’s why they’re involved with the ECHO project to train primary care providers.
No providers in the Bend outpatient clinic have been trained to provide hepatitis C treatment yet, although the VA sends specialists there once a month to treat patients, Chang said.
Hepatitis C is three to five times more prevalent among veterans compared with nonveterans, Chang said. A 1998 study used a sample of hepatitis C-positive veterans and determined 64 percent of them served in the Vietnam War.
There are a number of reasons why veterans, particularly Vietnam veterans, have higher rates of the infection. Anyone who was injured, hospitalized or received blood transfusions before 1992 is at risk of contracting the virus, placing veterans at particularly high risk.
Getting tattoos from unclean needles is another way hepatitis C can be transmitted, although that’s uncommon. Sexual contact can also transmit the virus, although that’s also uncommon.
Sharing needles during illegal drug use is a common route of hepatitis C transmission, which was a particularly high risk factor during the Vietnam War. When asked about their use of hard drugs for a 1989 federal government study, 2.5 percent of Vietnam veterans said they used hard drugs, while 3 percent were found to have used drugs upon examination. The study defined hard drugs as cocaine, heroin, amphetamines, barbiturates, psychedelics, phencyclidine and methaqualone.
Cox prefers not to disclose where he served, and he said he doesn’t know how he contracted the virus. He figures it was when he was hospitalized during his service.
“They were saving my life,” he said. “They didn’t know they were killing me.”
Today, Cox is cured. But he’s still very aware of the stigma around having hepatitis C, and understands why so many people don’t even want to get tested. His advice: Get tested, get cured.
“It’s curable,” he said. “It’s something we can beat.”
Cox retired about a year ago. He’s humbled by his near-death experience. He tears up easily. He’s excited to go fishing.
He added, “I’m amazed that I get to turn 65 years old.” •
“When’s Randy’s birthday?” the specialist had asked Cox’s wife. She told him it was in June. “Don’t plan a party,” he replied.
The doctor instructed Cox to take his shirt off, and inspected under his arms, noting the unmistakable yellow tint of his skin. It was around his hair. The color had also seeped into his eyes.
The doctor diagnosed Cox with hepatitis C, a viral liver infection that can ultimately lead to liver failure or liver cancer. At the time, the drugs that were available didn’t work for most people. Cox was already too sick for one of them, anyway. The doctor told him he’d contracted the virus about a decade earlier.
“I honestly thought I was going to die,” said Cox, now 65. Recently recalling the ordeal that would color his world in fear for more than two decades, he started to choke up.
Sitting in a Bend diner on Third Street not far from his house, he took his hands off his coffee mug so he could slowly remove his glasses, wipe his eyes and continue his story. “Until about a month ago, I thought I was going to die.”
Army veteran Randy Cox, pictured outside his home in Bend, recently obtained hepatitis C treatment through the U.S. Department of Veterans. His doctor told him he's cured. "I'm amazed that I get to turn 65 years old," he said. Joe Kline / The Bulletin
Within the past three years, new drugs with cure rates surpassing 90 percent have come on the market that have dramatically changed the conversation for hepatitis C patients like Cox.
The results are like nothing doctors had seen before: patients’ bodies being effectively rid of the virus within just a few months, rather than living with it for decades.
But the drugs’ exorbitant prices keep them out of reach for lots of people. Some private insurers and government programs for low-income individuals require patients be very sick before they’ll pay for treatment.
Nearly 20,000 deaths in the U.S. were tied to hepatitis C infections in 2014 — more than any year in history, according to the federal government. That number is expected to increase, as the thousands if not millions of cases that have gone undiagnosed for decades erupt into liver scarring or cancer.
Oregon’s Medicaid program is taking especially intense criticism, not only from hepatitis C patients, advocates and physicians, but from the federal government itself, which says the state’s strict treatment criteria is not in line with federal law.
State officials, hesitant to speak on the issue in recent months, promise to revisit their guidelines in September. Advocates argue that’s not soon enough.
As lawsuits force other state Medicaid programs, including Washington’s, to drop their restrictions, a legal battle appears increasingly likely in Oregon.
“I don’t want to impute bad motives on the part of insurers,” said Robert Greenwald, a clinical law professor at Harvard Law School and faculty director of its Center for Health Law and Policy Innovation, “but I do think they feel more comfortable than they should about basically condemning a population and many people within that population to sickness, ill health and ultimately, for some, death, for having these kinds of restrictions.”
‘It’s quiet’
Before hepatitis C was first identified in 1989, an estimated 300,000 were infected with the virus each year, primarily through injecting illegal drugs and from receiving blood transfusions in medical settings, according to the Centers for Disease Control and Prevention.
In 1992, researchers developed a blood test that removed the virus from the blood supply used in blood transfusions.
Roughly 80 percent of the chronic or longstanding cases of hepatitis C afflict baby boomers, people born between 1945 and 1965. If the infections develop into cirrhosis, late-stage scarring of the liver, it happens decades — sometimes 30 years — after the initial infection. Many of the infected are just finding out.
For the rest of that time, there can be virtually no symptoms.
“It’s quiet,” said Maricela Chavez, a 52-year-old Madras resident who was diagnosed in 2002. A doctor told her four years ago that she had probably had the virus for 30 years. “You don’t feel no pain, you just feel tired. It’s scary.”
Maricela Chavez said she didn't feel any pain when she was diagnosed with hepatitis C, even though she had likely had the virus for decades. "It's quiet," says Chavez, pictured with her grandson, 14-year-old Casper Cadena, at her home in Madras. Joe Kline / The Bulletin
The worst is yet to come, according to numerous projections. The CDC believes the prevalence of hepatitis C-related end-stage cirrhosis, liver cancer and deaths will peak in the late 2020s to early 2030s. It now recommends all baby boomers get a one-time screening for hepatitis C, even if they don’t have risk factors. The federal government estimates 3.5 million Americans have hepatitis C, but only half know it.
“Because the most common risk factor is injection drug use, I think people would like to dismiss it as a city drug user problem, but it’s not,” said Dr. Ann Thomas, a public health physician with the Oregon Health Authority. “It’s everywhere.”
Dr. Glenn Koteen, a gastroenterologist with Gastroenterology of Central Oregon, has learned not to be surprised by the people he diagnoses. Hepatitis C doesn’t stick to one creed, gender or race, he said.
“Everyone from CEOs who make a million dollars a year and snorted cocaine in the past to the homeless drug addicts and heroin addicts who shoot up all the time,” Koteen said. “It’s across the board.”
Some research has shown hepatitis C can also be transmitted through the straws or rolled up dollar bills used to snort cocaine, if tiny droplets of blood from one person come in contact with another user.
Oregon’s death rate from hepatitis C was double the national average in 2011. It’s unclear why. The rate of chronic infections tends to be high in Oregon’s rural counties. Jefferson County had the state’s highest rate of chronic infections between 2009 and 2013: 252 cases per 100,000 residents, according to a 2015 Oregon Health Authority report. Second was Malheur County in southeastern Oregon.
Prisons tend to skew the rates, which could help explain what’s happening in Jefferson and Malheur counties, homes of the Deer Ridge and Snake River correctional institutions, respectively.
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The prevalence in rural areas could also be because that’s where there is a large proportion of retirees, said Dr. Mark Loveless, an infectious disease physician in Portland who is a member of an Oregon Health Authority steering committee on hepatitis.
The most common way of getting hepatitis C is through sharing needles during injection drug abuse. Before 1992, many people got it in medical settings, through blood transfusions, organ transplants or needlestick injuries. Being born to a mother with the virus is another mode of transmission, as is getting a tattoo from someone with unsanitary practices, or sexual contact.
Because of the drug abuse connection, many people don’t like to admit they have the virus. Many advocates believe today’s treatment restrictions come from the belief that people who used drugs don’t deserve treatment.
Laurie Hubbard, a communicable disease nurse in Deschutes County who investigates new hepatitis C cases, said she thinks the treatment restrictions for people with hepatitis C is connected to that stigma.
“It doesn’t matter how the disease is contracted in terms of worthiness for care,” she said. “It’s a disease. It’s an infection. As a humane population, we would love to see people with disease and infection have access to care.”
The early days of treatment
Koteen got to work treating hepatitis C when it all started in the mid-’90s, and it was “miserable” work.
Back then, patients received three injections per week of a drug called interferon for 48 weeks. The chances of that getting rid of the virus were only about 16 percent, according to a 2012 study in the journal Clinical Liver Disease. When another drug called ribavirin was added to the mix, the cure rate grew to about 34 percent.
When the number of injections patients needed went down to one per week, the cure rate grew again, this time to about 55 percent, according to the 2012 study.
The drugs’ side effects were so severe, few patients could see their regimens through. People felt like they had the flu: nausea, vomiting and many couldn’t work during the treatment.
Chavez said some days she couldn’t even get out of bed. She was tired. She threw up. Her hair fell out. She developed blisters on her lips, tongue and even in her throat. It hurt to eat. She developed anemia, a common side effect of ribavirin.
A doctor in 2012 told Maricela Chavez, pictured at her home in Madras, that she had likely acquired hepatitis C three decades earlier. At the time, she thought she would die from the virus. Joe Kline / The Bulletin
She watched a friend with cancer die during her chemotherapy treatments, and said the feelings her friend described were exactly what she was experiencing.
“It was very, very bad,” she said.
Even after all that, the drugs didn’t rid Chavez of the virus. In fact, her doctor told her she was worse off than when they had started.
Initially, the drugs were so bad, doctors didn’t treat every patient they diagnosed, Koteen said. For many of them, the slim likelihood of being cured wouldn’t have been worth the unbearable side effects, he said.
That was the case for Cox. By the time the Bend man was diagnosed, he was too sick to take interferon. Instead, the doctor gave him ribavirin, but the odds of that working alone without being combined with interferon were low, a fact the doctor made clear.
“He was upfront about it from the beginning,” Cox said. “He said, ‘You know, there’s a lot of people that their body won’t take this.’”
That was the same doctor who warned Cox’s wife (they’ve since divorced) not to plan a birthday party. It turned out, he’d been right. For weeks, Cox said he was too sick to do anything. In addition to the nausea, he developed rashes all over his body, including on his head.
“Those drugs are so poisonous,” he said.
The doctor stopped the treatment and — out of options — did something that’s typically frowned upon in mainstream medicine: He sent Cox to a naturopathic physician. She whipped up solutions that tasted terrible, but Cox said he eventually felt better again and went back to work. The yellow tint left his eyes.
It seemed this would keep his illness at bay — at least for a while.
Many of Koteen’s hepatitis C patients dealt with severe depression and anxiety even before treatment. Unfortunately, the early medications exacerbated those conditions. Suddenly, they were angry, too. Irritable. They couldn’t get along with their children or spouses. They couldn’t sleep. Coupled with the physical symptoms, many simply couldn’t continue treatment.
At the time, it was common for doctors to pick and choose which patients they treated, Koteen said. Doctors, hearing rumblings of better drugs on the horizon, told patients to wait.
I’m walking out of the dead. I’m a survivor.
— Maricela Chavez
“Since it’s a disease that can take 20 or 30 years, what’s another one or two years?” Koteen said. “All these patients would be waiting in the wings, like airplanes lined up at an airport.”
Dr. Kent Benner, a gastroenterologist with The Oregon Clinic in Portland, said once he got done going over the medications’ side effects — flu-like symptoms, depression, all for a small chance of getting cured — many decided to skip it.
“They look at you and they go, ‘Doc, why would I want to take that?’” he said. “‘I’m going to wait for the new drug you’re telling me is coming out in a few years.’ A lot of patients were on the sidelines.”
Given her previous experience, Chavez was nervous when a doctor told her about the new medications. With the help of a patient assistance foundation, she was able to get a regimen that included Solvaldi for about $30 a bottle. Within three months, her doctor told her she was cured.
“I’m walking out of the dead,” Chavez said. “I’m a survivor.”
New drugs, still out of reach
At the end of 2013, it seemed the wait was over.
That’s when the FDA approved a new drug, Sovaldi, that was showing cure rates around 90 percent. The drug’s treatment regimen — 12 weeks — was much shorter than the drugs of the day, and, best of all, the side effects were minimal. In fall 2014, Harvoni, another drug with an equally impressive cure rate hit the market.
“It’s like taking candy compared to taking toxins in the old days — for the doctor and the patient,” Koteen said.
Dr. Laurie D’Avignon, an infectious disease physician with Bend Memorial Clinic who sees new hepatitis C patients every week, said she was initially skeptical of the high cure rates the drugs’ manufacturer, Gilead Sciences Inc., was reporting. The drugs she’d been giving patients for years had such horrific side effects, most patients couldn’t see the regimens through, much less be cured.
But once she started prescribing the drugs for her patients, D’Avignon realized the side effects were so minimal, patients had no problem seeing the regimens through, and almost all who took them were cured.
“They say, ‘Are you sure it’s working? I don’t feel anything,’” she said.
But the drugs carried an enormous price tag for a 12-week course: $84,000 for Sovaldi and $94,500 for Harvoni.
Suddenly, the problem shifted from the treatments not existing to the treatments being so expensive, they were out of reach for those who needed them.
Oregon’s Medicaid program, the Oregon Health Plan, initially restricted access to Sovaldi to patients with cirrhosis. Eligibility determinations are primarily based on patients’ fibrosis scores, the progression of scarring on their livers. Fibrosis scores range from one — the least severe — to four, the final stage before liver failure, also known as cirrhosis.
Between June and December 2014, OHP was among only four state Medicaid programs that restricted access to Sovaldi to stage 4 fibrosis.
Meanwhile, Gilead reported in July 2014 it had made $3.48 billion on Sovaldi. In the first quarter of 2016, the company said it made about $4 billion on its hepatitis C drugs.
Today, private insurers in Oregon restrict not only which medications they pay for, but the proportion of the total bill they cover.
An analysis of 2016 silver-tier policies in Oregon by the Center for Health Law and Policy Innovation at Harvard Law School found that 22 percent cover only two of the available hepatitis C medications, while 8 percent cover only Sovaldi. Silver policies offered by Atrio, Kaiser Permanente, Moda Health Plans, PacificSource Health Plans, Providence Health Plan, Trillium Community Health Plan and most of those offered by BridgeSpan require members pay for half of the cost of the medications.
You’re not sick enough. You don’t meet the criteria. I think they hope you’re dead or something, that you die.
— Kandice Conry, on her repeated attempts to get hepatitis C treatment covered by insurance.
More than 90 percent of private silver policies in Oregon require prior authorization for the hepatitis C medications. That means after determining the patient needs the medication, the doctor’s office has to send a request to the insurer, which then determines whether the patient meets its criteria.
Prior authorizations are very time consuming for doctors and their staff. Asked whether she has experienced this, D’Avignon, of BMC, laughed.
“The physical act of them completing the treatment — that’s the easy part,” she said. “I think the most challenging part is getting through all of the paperwork.”
Some insurers require that patients prove they haven’t used drugs or alcohol for at least six months before they’ll be approved for treatment.
Using alcohol hastens the progression toward cirrhosis, so D’Avignon said she always recommends her hepatitis C patients abstain from drinking. At the same time, she said she thinks it’s unfair to restrict somebody who has had a few drinks within the past six months from treatment.
“I think it’s really unfortunate when someone comes in and is like, ‘Oh my gosh, a month ago I had a couple glasses of wine with dinner,’ and then to have to say, ‘Well, we need to wait six months from that point until we can submit you for treatment,’” she said. “That seems a little overkill.”
It should be the doctor’s job to determine whether the patient’s drug or alcohol use would interfere with their treatment, Benner, the Portland gastroenterologist, said. In any case, requiring a negative urine screen in patients without histories of alcohol or drug use at least six months prior to approval is “draconian,” he said.
“That is totally unnecessary,” he said. “It’s just a barrier to care.”
Dallas Buyers Club for Hep C
Kandice Conry was among those who passed on interferon when she was diagnosed in 2003.
At the time, Conry, who is being identified by her mother’s maiden name to protect her family’s privacy, was 23 years old and living in San Francisco. She didn’t fully understand the gravity of hepatitis C. That coupled with the horror stories she’d heard about the drug made the decision easy.
“I just knew if it ever came to that point, that I would never try that,” she said. “If it’s going to make me worse, why even do that?”
Around a decade later, Conry, in her mid-30s and raising three kids, decided she couldn’t wait any longer. The disease was making her tired all the time.
“I was exhausted,” she said. “I would sit there on the couch and my husband would be doing stuff, and I would feel so guilty.”
After her insurer denied hepatitis C treatment four times, 36-year-old Kandice Conry, pictured outside of her Redmond home, bought inexpensive medications online. Her doctor confirmed she was cured in 3 months. Joe Kline / The Bulletin
When Harvoni came out in 2014, she asked her doctor, Koteen, about the prospect of getting the drug. Koteen’s nurse told her they’d try to make it happen.
The first denial letter came in March 2015. Conry and her family were covered under her husband’s private Providence Health Plan policy, which he received through his employer. The letter said the scarring in her liver hadn’t progressed enough.
“‘You’re not sick enough. You don’t meet the criteria,’” Conry repeated. “I think they hope that you’re dead or something, that you die.”
The Conrys tried two more times, and received two more rejection letters. The fourth time around, Conry wrote her own letter to Providence, pleading for the medication and explaining how the disease hindered her ability to raise her kids.
Recalling that time while sitting in her Redmond home earlier this summer, Conry’s gaze fell on her young son. He was watching her through a plastic childproof gate, sliding coins through the holes and watching them hit the floor.
“I’d see all these other parents doing stuff,” she said, pausing after she started cry. “I know it’s such a small thing, but to a parent, I think it’s bigger, because I wanted to be able to do lots of stuff.”
After her fourth rejection from Providence, Conry, always researching potential solutions online, found the website for a Dallas Buyers Club-type situation for hepatitis C drugs. The Dallas Buyers Club was a group that smuggled unapproved drugs into the U.S. and sold them to AIDS patients.
Conry’s Buyers Club is a bit different. It’s run by an Australian man, Greg Jefferys, who traveled to India to find affordable, generic hepatitis C drugs after he was diagnosed with the disease in summer 2014. He succeeded, cured himself and has since established a supply chain whereby patients can — upon providing identification, prescriptions or medical records and payment — buy generic Harvoni from India, Bangladesh and Australia through the mail. The process is explained on Jefferys’ website, www.fixhepc.com.
Jefferys has received lots of media attention for his work as the demand for hepatitis C drugs has grown, including stories by CNN, Bloomberg and The Times of India.
When Conry asked Koteen to write her a prescription, he was skeptical.
“I said, ‘I don’t know anything about this,’” Koteen recalled. “‘There are a lot of fakes and frauds, and be careful.’”
Finally, Koteen agreed. Conry sent $1,300 to Jefferys and received an eight-week regimen in the mail in December 2015.
After three months, a blood test showed that Conry, now 36 and raising three children, ages 2, 3 and 16, was cured of hepatitis C, Koteen said.
Kandice Conry, pictured at her home in Redmond, bought inexpensive hepatitis C medication from an online Dallas Buyers Club-type operation. Her doctor was skeptical at first, but confirmed she was cured within three months. Joe Kline / The Bulletin
“She responded to everything,” Koteen said in June, sounding amazed. “Her virus is still undetected, so she’s a cure.”
These days, Conry said she has her energy back. She doesn’t have to worry about infecting her kids anymore, which could happen if they somehow became exposed to her blood. She also doesn’t worry about developing liver scarring or, worse, liver cancer.
Her message to other hepatitis C patients: Don’t give up.
“This situation was such a miracle for me,” she said. “I can’t even share how grateful I am.”
Sick enough for treatment?
Oregon’s Medicaid program has some of the most restrictive treatment criteria in the country, enough to garner warnings from the federal government and the looming threat of a lawsuit from patient advocates.
“Our state is knowingly killing people on Medicaid,” said Lorren Sandt, the executive director of Caring Ambassadors, an Oregon City-based patient advocacy group.
A state committee that sets treatment criteria will meet in September to review the state’s policies, but Sandt, whose organization receives funding from hepatitis C drugmakers, such as Gilead, said she wants to see changes before then.
That leaves OHP leaders in a precarious position. Perhaps unsurprisingly, they’re far from forthcoming when it comes to talking about hepatitis C. OHP provided treatment using the new hepatitis C drugs to a total of 665 members between January 2014 and April 2016, according to numbers provided by the Oregon Health Authority. Officials declined to provide the amount of money spent on the drugs during that time.
Under OHP’s current criteria, hepatitis C patients are not eligible for treatment until they reach fibrosis stage 3 or 4 — 4 being the final stage, or cirrhosis. They can be eligible at stage 2 if they also have HIV.
Asked why it’s necessary for patients to be that sick before qualifying for treatment, Dr. Jim Rickards, the OHA’s chief medical officer, distanced himself from the criteria. He said he started in his position in December, and thus wasn’t involved in much of the discussion by the state committee that sets the criteria, called the Pharmacy & Therapeutics Committee.
“I think based on, again, the review of the medical literature and the outcomes and the effectiveness and efficacy of the different drugs, they felt that those are the most appropriate stages of the disease to treat,” he said.
Rickards declined to go into specifics about the medical literature, instead directing a reporter to the state committee’s meeting recordings and minutes.
But the state committee’s position is not the consensus either within or outside of Oregon. Joint guidelines set by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend treating all patients with hepatitis C, regardless of their fibrosis stages or drug and alcohol use.
“There are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy,” the guidelines state. “These requirements should be abandoned, because they create barriers to treatment, add unnecessary cost and effort, and potentially exclude populations that are likely to obtain substantial benefit from therapy.”
Massachusetts’ Medicaid program lifted its hepatitis C treatment restrictions in June after the state negotiated affordable prices with drugmakers.
A federal judge in May ordered the state of Washington to cover all patients diagnosed with hepatitis C regardless of their fibrosis stage amid a class-action lawsuit filed on behalf of patients. The state’s Medicaid director, in a letter to the U.S. Senate in September 2015, wrote that treating everyone diagnosed with hepatitis C would cost roughly triple the agency’s annual drug budget of roughly $1 billion.
Florida’s Medicaid program removed its fibrosis restrictions, which required patients be at stages 3 or 4, shortly after the Washington ruling in response to a lawsuit there.
In April, New York’s attorney general reached an agreement with seven of the state’s private health insurers to remove their fibrosis criteria. The agreement also forbids the insurers from denying coverage based on drug or alcohol use or because the prescribing physician is not a specialist.
‘We’re talking about a cure’
In November 2015, CMS sent a notice to state Medicaid programs warning them against coverage criteria that may “unreasonably restrict access” to hepatitis C drugs, including requiring patients be at fibrosis stage 3 or 4, instead requiring a period of abstinence from drugs and alcohol and requiring that the drugs be prescribed by a specialist.
Such restrictions would violate federal Medicaid law, according to the notice.
Oregon’s rules used to require six months of abstinence from drugs and alcohol, but the most recent guidelines, updated in February, require that patients be under the care of an addictions specialist. It’s unclear whether those patients can be actively using drugs or alcohol and still receive treatment.
OHP guidelines also require the patient’s treatment regimen be prescribed by or in consultation with a specialist, such as a gastroenterologist, hepatologist or infectious disease physician.
It’s fantastic that for that $15,000 a year, we can keep people (with HIV) healthy and live the rest of their life. In this case, we’re talking about a cure. One time, 12 weeks, one pill a day, for $30,000. That’s it.
— Robert Greenwald, a clinical law professor at Harvard Law School and faculty director of its Center for Health Law and Policy Innovation
Asked whether that means a primary care provider can prescribe the drugs if they communicate with specialists about the case, Rickards said, “It sounds like that’s the case.”
Regarding state plans to respond to the CMS notice, Rickards said state leaders monitor the guidelines on an ongoing basis. He said they’ll likely be updated at the September meeting, by which point a new drug is expected to be available.
Rickards acknowledged hepatitis C drugs are expensive, but said that doesn’t influence Oregon’s restrictions.
“That is true,” he said, ??but when the (Pharmacy and Therapeutics) committee makes these decisions, it really is based on the medical evidence and medical literature that’s available, and so I think that is the main component that goes into their decisions.”
The OHP guidelines pertain only to members who are not enrolled in so-called coordinated care organizations, groups that administer Medicaid regionally. Roughly 90 percent of OHP members are in CCOs, including more than 50,000 people in Central Oregon. Although CCOs are free to set their own coverage criteria, they generally tend to follow the state’s guidelines, Rickards said.
The November CMS notice also warned against allowing groups like CCOs to institute stricter coverage criteria than the state’s as a whole. In a February letter to CCO leaders, Rickards asked them to send him their updated criteria and urged them to ensure they complied with the federal law.
PacificSource Community Solutions, which operates Central Oregon’s CCO, was not among those whose policies were more restrictive than the state’s, Alison Little, the CCO’s medical director, wrote in an email. While PacificSource has the same fibrosis score and drug and alcohol treatment criteria, it does not require that hepatitis C be diagnosed or treated by or in consultation with a specialist.
Advocates argue it would be more cost effective to treat all patients diagnosed with hepatitis C, regardless of their fibrosis stage, rather than risk the patients getting sicker and treating related conditions, such as liver cancer or liver transplants. Some even advocate for treating current drug users in an effort to theoretically slow the spread of the disease among the population.
Greenwald, the Harvard Law School professor, said treatment in many states, after rebates from drug manufacturers, costs Medicaid programs in the $30,000 range. For comparison, programs pay between $12,000 and $15,000 annually to keep HIV patients healthy, he said.
“It’s fantastic that for that $15,000 a year, we can keep people healthy and live the rest of their life,” he said. “In this case, we’re talking about a cure. One time, 12 weeks, one pill a day, for $30,000. That’s it.”
Getting more docs to treat
These days, treatment for hepatitis C is mostly provided by specialists.
Primary care providers are still reluctant to treat the disease — not only because of the hoops insurers make them jump through, but because the medications themselves are still relatively complicated compared with other types of treatments. Not only do most patients take a combination of medications, their regimens must be tailored to one of six hepatitis C genotypes.
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“It’s still fairly complex,” said Benner, the Portland gastroenterologist.
That’s changing, though. The FDA at the end of June approved a new drug, Epclusa, that’s essentially one-size-fits-all. It can be used in patients with all six genotypes.
In an effort to increase the number of primary care providers treating hepatitis C, especially in rural areas, the University of New Mexico developed a program called Extension for Community Healthcare Outcomes, or ECHO.
ECHO provides a platform for specialists at medical centers to give training and advice to rural primary care providers through regular video conferences or teleconference calls. Primary care doctors share their patients’ medical histories, lab results and treatment plans.
A study tested ECHO by dividing 407 patients into two groups, those treated in the primary care setting under the model and those treated at the University of New Mexico Health Sciences Center. The results, published in the June 2011 issue of the New England Journal of Medicine, found the two groups fared basically the same.
Dr. Michael Chang, director of the Portland Veterans Affairs Health Care System’s hepatitis C clinic and section chief of gastroenterology and hepatology, said the VA has been using the ECHO model to mentor more than 25 primary care providers throughout the region.
Treating hepatitis C is slowly getting easier, Chang said, and the advent of drugs like Epclusa will help primary care providers feel comfortable treating the disease.
“Hep C right now is primed to be a primary care-managed disease,” he said.
The VA steps up
Before his diagnosis, Cox, who served in the Army between 1968 and 1971, spent years drinking heavily while working as a painter, which likely hastened the progression of his disease. The doctor who diagnosed him was firm: no more drinking or smoking marijuana if you want to live.
“The way I took it was, ‘If you aren’t ready to change your life, go away, because you’re ready to die from this,’” Cox recalled.
Cox was scared enough to quit everything. He kept drinking the naturopath’s concoctions and felt better for a while, despite working long hours.
Diane Sutton, Cox’s partner of more than seven years, said she’d occasionally notice a yellow hue in Cox’s eyes, but it always cleared up after a few days.
“I wouldn’t say nothing because I didn’t want to alarm him,” she said.
Army veteran Randy Cox received treatment for hepatitis C earlier this year and is now cured. The 65-year-old Bend resident wants to encourage others to get tested and treated, despite the stigma around the virus. Joe Kline / The Bulletin
When Cox’s U.S. Department of Veterans Affairs doctor told him about the new hepatitis C drugs, he was skeptical at first.
“It works,” he recalled her saying to him. So he gave it a shot.
The VA announced in March it would treat all of its hepatitis C patients, regardless of disease stage, after Congress approved $1.5 billion specifically so the VA could buy the expensive drugs.
Another contributing factor was the VA’s ability to negotiate drug prices directly with manufacturers, Chang said. Around the same time, Gilead cut its prices by roughly half for the VA.
“The purchasing power automatically almost doubled,” Chang said, “and that literally was almost overnight.”
Likewise, Medicare in 2014 dropped its restrictions on hepatitis C treatment, instead embracing guidelines set forth by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases, which recommend treating all patients with hepatitis C, regardless of their fibrosis stages or drug and alcohol use.
Only 49 veterans in the Portland VA system, which covers most of Oregon and southwest Washington, received treatment for hepatitis C in 2014. That grew to 377 patients in 2015. Between Oct. 1, 2015, and mid-June, 422 veterans received treatment, Chang said.
About 1,500 veterans in the Portland VA system are still waiting to get treated for hepatitis C, Chang said in June. That includes 74 veterans in Deschutes County, 16 in Crook County and 12 in Jefferson County.
“We’re accelerating pretty rapidly,” Chang said.
Unlike other health care providers, the VA’s barrier isn’t so much access to treatment, but having enough providers to treat patients. That’s why they’re involved with the ECHO project to train primary care providers.
No providers in the Bend outpatient clinic have been trained to provide hepatitis C treatment yet, although the VA sends specialists there once a month to treat patients, Chang said.
Hepatitis C is three to five times more prevalent among veterans compared with nonveterans, Chang said. A 1998 study used a sample of hepatitis C-positive veterans and determined 64 percent of them served in the Vietnam War.
There are a number of reasons why veterans, particularly Vietnam veterans, have higher rates of the infection. Anyone who was injured, hospitalized or received blood transfusions before 1992 is at risk of contracting the virus, placing veterans at particularly high risk.
Getting tattoos from unclean needles is another way hepatitis C can be transmitted, although that’s uncommon. Sexual contact can also transmit the virus, although that’s also uncommon.
Sharing needles during illegal drug use is a common route of hepatitis C transmission, which was a particularly high risk factor during the Vietnam War. When asked about their use of hard drugs for a 1989 federal government study, 2.5 percent of Vietnam veterans said they used hard drugs, while 3 percent were found to have used drugs upon examination. The study defined hard drugs as cocaine, heroin, amphetamines, barbiturates, psychedelics, phencyclidine and methaqualone.
Cox prefers not to disclose where he served, and he said he doesn’t know how he contracted the virus. He figures it was when he was hospitalized during his service.
“They were saving my life,” he said. “They didn’t know they were killing me.”
Today, Cox is cured. But he’s still very aware of the stigma around having hepatitis C, and understands why so many people don’t even want to get tested. His advice: Get tested, get cured.
“It’s curable,” he said. “It’s something we can beat.”
Cox retired about a year ago. He’s humbled by his near-death experience. He tears up easily. He’s excited to go fishing.
He added, “I’m amazed that I get to turn 65 years old.” •
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