Costly hepatitis C cure strains Idaho’s budget
If he had known a tattoo he got in prison in the late 1980s would give him a deadly infectious disease, Robert E. Gibbish Jr. would not have done it. But once he found out he was infected, he kept getting prison tattoos of elaborate demons and skulls.
“I figured I was already dirty, I might as well finish them up,” said Gibbish, of Nampa, who returned to prison in 2014 at the Idaho State Correctional Institution south of Boise on drug and assault charges.
He believed it was just a matter of time before he succumbed to an incurable disease.
“I’ve seen what it does to people out here. The ammonia levels build up in them. Their legs swell up. … It is hard to watch your friends go through that and die.”
When his kidneys failed last year, Gibbish, 49, suspected hepatitis C was calling in its chit. The Idaho Department of Correction sent him to a specialist in Boise. The specialist recommended that Gibbish receive a new hepatitis C drug.
It took nearly a year of wading through red tape, but in February, Gibbish was given the drug regimen: a pill a day for 12 weeks.
“Once I got the treatment, I started feeling better almost immediately,” he said. “They checked my enzymes 30 days after I started the treatment and it showed ‘nondetectable.’ I’ve had hep C for 30 years. … I feel better than I have in decades.”
A cure, and now a dilemma
Until recently, many hepatitis C sufferers resigned themselves to a death sentence.
In late 2013 and early 2014, two new hepatitis C drugs, Sovaldi and Harvoni, came on the market. Made by Gilead Sciences of Foster City, California, the drugs boast a stunning 90-plus percent cure rate and few side effects.
“This is one of the biggest medical breakthroughs in the last two centuries,” said Dr. Terry Box, a liver specialist at the University of Utah.
But the drugs terrify those who must pay for them. Sovaldi costs $84,000 for a standard 12-week course, or $1,000 per daily pill. Harvoni costs $94,000.
That has put Idaho and other states in a bind: They don’t have enough money to cure all the Medicaid patients and prison inmates they must care for who have hepatitis C.
The hep C problem
Hepatitis C is a blood-borne viral infection that attacks the liver. It is most commonly transmitted through infected needles used for drugs and through nonsterile tattoo and body-piercing equipment.
While the virus can be deadly, it usually causes no symptoms for years or even decades after the initial infection, so many people don’t know they have it, said Dr. Magni Hamso, an internist at with Terry Reilly Health Services in Boise and a clinical instructor at the University of Washington’s Boise internal-medicine residency program.
The disease can lead to a slew of liver problems including scarring, cirrhosis, cancer and liver failure. For some sufferers, a liver transplant is the only option for survival.
The greatest number of people with hepatitis C are those born from 1945 to 1965.
“Baby boomers are the highest carriers, most likely because they were recipients of blood transfusions during a time when we were not screening the blood supply – so through no fault of their own,” said Dr. David Hachey, a pharmacist and professor with Idaho State University’s family medicine department in Pocatello.
The hepatitis C virus was not identified until the late 1980s. Screening the blood supply did not start until 1992.
The Centers for Disease Control and Prevention estimates about 3.5 million Americans are living with hepatitis C, and roughly half are unaware of it.
Deaths are also rising because of a new wave of infections among young people who inject illicit drugs, especially opioids.
Hepatitis C killed more Americans in 2013 than the combined number of deaths from 59 other infectious diseases reported to the CDC, including HIV, Staphylococcus aureus, tuberculosis and pneumococcal disease.
“The increasing HCV-associated mortality trend underscores the urgency in finding, evaluating and treating HCV-infected persons,” said a May CDC report.
Until recently, the drugs of choice for treating hepatitis C were interferon and ribavirin, which have a less than 50 percent cure rate and other problems.
“The side effects are terrible,” Hamso said. “People felt like they had a flu continuously, and the treatment was injection-based – once a week for almost a year, sometimes longer.
“These newer agents seem to be very safe,” Hamso said. “People might have some headaches, sometimes they get a rash. But not many more side effects than that.”
Costly cure
Rarely does a doctor get to tell someone with a deadly infectious disease that he is cured, Hamso said.
“We did not have a name for the disease until the 1980s,” said Box, the University of Utah liver specialist. “We could not even study it in a lab until the late ’80s and early ’90s. The reason we are where we are today, a mere 25 years after we name the disease, is that the science has moved forward at an astronomical rate.
“You cannot name another viral disease for which a cure has been developed in such a short period of time from acknowledging its existence,” Box said.
And prospects only get better. A new Gilead drug that works on all hepatitis C genotypes is expected to receive the federal green light within weeks.
“With the advent of the new product in July, the overall cure rate for everything except genotype 3 is going to be between 97 and 99 percent,” Box said. “That is incredible.”
Still, the drugs cannot eradicate the disease.
“The problem with absolute eradication, as we have had with smallpox, is that we do not have a vaccine that we can give to people who are going to go out and shoot up,” Box said. “It is IV drug use that is the vector today, and that is not going away.”
Rationed
Hepatitis C disproportionately affects low-income people and prison inmates. That makes it a major concern for state-run Medicaid and prison medical programs, which are responsible for caring for Medicaid enrollees and inmates.
Limited funds and high demand have forced many states to restrict coverage to those patients with the most severe liver scarring, called fibrosis.
“I certainly sympathize with the people who have to create these thresholds or these qualifications for treatment,” Box said. “I do not think anybody is withholding therapy out of any other motive than they are in charge of a budget, and these are budget-busting costs.”
Hepatitis C patients also draw limited sympathy because of the self-inflicted nature of the disease. That means treatment costs draw more resistance than, say, the cost of treating cancer, Box said.
“There is also an internal stigma, where you have a patient who may look at themselves as less worthy or dirty, so … they are not going to want to talk about their disease with someone,” said Hachey, the Idaho State University professor.
Gilead gives the drugs
to the uninsured
Medicaid patients are less likely to be approved for the drugs than patients covered by Medicare or private insurers. A University of Pennsylvania study last year analyzed 2,321 prescriptions in four states and found 46 percent of Medicaid patients were denied, compared with 10 percent of privately insured patients and 5 percent of Medicare patients. Idaho’s recent Medicaid denial rate is 43 percent.
But one group has been able to get the life-saving drugs almost on demand, and at no cost: the low-income and uninsured. That’s because Gilead gives them Sovaldi and Harvoni at no charge.
Hamso has about 10 patients at various stages of treatment, and all are getting Sovaldi or Harvoni free.
One of them, Caridad Soto, 64, of Boise, has had hepatitis C for 20 years. She does not know how she contracted it. She did not want to take interferon or other treatments because of side effects. Last year, three-quarters of her liver was affected by the disease.
“My doctor said to me, ‘Caridad, there’s a new treatment that’s more effective – 90 percent effective. Do you want to try it?’ ” Soto told the Statesman. “She told me, ‘There are no side effects. Your hair’s not going to fall out. You won’t feel bad.’ I said, ‘Oh, OK, perfect.’ ”
She took one pill a day for three months. She no longer has hepatitis C.
Medicaid dilemma
Last November, the Centers for Medicare and Medicaid Services issued a notice to all state Medicaid programs saying they could be violating federal law if they deny treatment to Medicaid patients with hepatitis C. Federal rules say the programs must cover prescription drugs approved by the Food and Drug Administration for all enrollees when the treatment is medically necessary.
A U.S. Senate report in December said more than half of state Medicaid programs restricted the new hepatitis C drugs to “only the sickest patients.”
The CMS said some state Medicaid programs limit the treatment only to patients with liver fibrosis at Stage 3 or 4 on a scale of 1 to 4, who abstain from drug and alcohol abuse and who receive treatment from specialists, not general practitioners.
Idaho has all three of these requirements. To guard against substance abuse, Idaho requires patients first to pass a urine test within one month of requesting treatment.
From last July 1 through April 1, the state said, 101 Idaho Medicaid participants requested hepatitis C treatment. The state approved 58 at a cost of $5.9 million, an average of about $100,000 per patient, because some patients required more than the standard 12 weeks of treatment.
Of the 43 people denied treatment, 30 had a fibrosis score of F2 or less, eight were active substance abusers, three had incomplete requests and two were too ill.
The Idaho Department of Health and Welfare’s estimated cost in the fiscal year starting July 1 for hepatitis C treatment is $7.5 million, about 4 percent of its $204 million budget for prescription drugs.
“We do everything possible to provide Medicaid participants with the pharmaceuticals they need, while being good stewards of taxpayer dollars,” said department spokesman Tom Shanahan.
Washington state was sued by Medicaid enrollees with hepatitis C. On May 27, a federal judge granted a preliminary injunction ordering the state to provide coverage “without regard to fibrosis score.”
Prison dilemma
The Idaho Department of Correction does not know how many of its inmates have hepatitis C, though it has tested some. “So far about 120 inmates are positive,” said Murray Young, regional medical director for Corizon Health, the Tennessee contractor that provides medical services to IDOC inmates.
National studies estimate 10 percent to 30 percent of the prison population is infected with hepatitis C. That means anywhere from 800 to 2,400 of Idaho’s 8,000 inmates could have hepatitis C, a potential cost of $67.2 million to $201.6 million for the medication, not including lab tests and monitoring. IDOC’s total operating budget this year is $230 million.
Last year, IDOC received $800,000 from the state to treat 10 inmates with the new drugs. The treatment cured them, said Josh Tewalt, the department’s budget and policy administrator.
The department follows a Federal Bureau of Prisons guideline on treatment criteria, which makes treatment for fibrosis stages 3 and 4 a priority. About 45 inmates qualify for treatment under the guideline, Tewalt said.
When prison officials started putting together their budget for fiscal 2017, Young told the Board of Correction it could expect to pay $122,000 per inmate, including the drugs and other treatment costs, by going through Corizon. For the 45 inmates, that would cost $5.5 million.
The department found a way to reduce that: IDOC worked out a deal in which the prison obtains the drugs at a discounted rate similar to Idaho Medicaid’s, saving $2.4 million.
“Future hep C appropriation requests will be based on the number of individuals meeting the treatment criteria at the reduced price,” Tewalt said. “This innovative solution does provide us with a blueprint should a similar situation present itself in the future with new and emerging treatments.”
Gibbish was the first IDOC inmate to receive the hepatitis C treatment this year.
“When they say 90 percent cure rate, they are correct,” said Gibbish, who has a parole hearing in October. “Everybody I know who has done the treatment is cured.”