Deb Scott looked into the eyes of the woman dying from hepatitis and saw her own future.
A social service aide at a skilled nursing
facility, Scott could see that the woman's stomach was bloated with
fluid and hear her cry out in pain.
Scott was healthy at the time, but because she
had hepatitis C, she kept that woman in her thoughts. She stopped
daydreaming about her retirement or imagining seeing her grandchildren
grow up.
"I seriously believed my life would be
dramatically shortened by this horrible disease," said Scott, now 63. "I
never planned my future. I was told too many times I would not have a
future."
Like the 3.5 million Americans with hepatitis
C, Scott was elated when, starting in 2013, the Food and Drug
Administration approved new antiviral drugs that boasted a hepatitis
cure rate of almost 100 percent with few side effects.
But they've proven an elusive cure for many. A
full course of treatment can range from $83,000 to $189,000. The hefty
price tag has led Medicaid agencies, prisons and private insurers to
restrict access to the drugs.
—
—
'Unique in modern medicine'
Hepatitis C is a virus spread through
blood-to-blood contact, mainly from sharing needles, and there is no
vaccine. The virus affects up to 4 percent of adults in the United
States. Michael Charlton, medical director of Intermountain Medical
Center's liver transplantation program, says just 2 percent of Utah
adults are infected — and most don't know it.
Still, it's the No. 1 reason Utahns need liver
transplants. And while a small portion of people are able to defeat the
virus via their own immune systems, most will develop a chronic
infection that often leads to liver disease and, less commonly,
cirrhosis or liver cancer.
Scott believes she got hepatitis when she was
hospitalized in the 1970s with a broken jaw. That decade — when
intravenous drug use was high, blood products weren't screened for the
virus and now-standard universal precautions for how body fluids are
handled weren't used — was the height of hepatitis infection.
But the virus has come roaring back because of the exploding levels of abuse of heroin and methamphetamine.
Hepatitis C is Utah's second-most commonly
reported communicable disease, after chlamydia and before influenza that
results in hospitalization. And Utah's rate has jumped, in part because
more are getting tested as they've heard about the wonder drugs.
Previous treatments could cure only up to 50
percent of cases, and included injecting interferon, which caused
diarrhea and hair and weight loss.
The new, interferon-free, oral treatments have
proven safe and highly effective. The drugs include Sovaldi and Harvoni,
both made by Gilead Sciences; AbbVie's Viekira Pack; and Janssen
Research and Development's Olysio.
Hepatitis C could go the way of smallpox and
disappear if treatment were widely available, said Charlton, who is a
member of a national panel that created recommendations on how to manage
and treat hepatitis.
"It might even be unique in modern medicine,"
he said. "You give patients pills for 12 to 24 weeks and those pills
will make the hepatitis C virus go away and never come back, if there
isn't a new infection down the road."
While treatment was once prioritized for sicker
patients, the guidelines now say everyone with a chronic infection —
except those with a short life expectancy — should be treated, and
treatment should start before patients develop liver disease. Studies
show that delaying treatment can increase the chances of liver-related
death fivefold.
But many public and private insurers have continued to restrict the drugs to patients with advanced stages of liver disease.
—
Denied treatment
Through the 1990s, Scott tried various
combinations of drugs, injecting herself with interferon and living with
flu-like symptoms for more than a year. At one point, her liver was
heavily scarred and she was close to developing cirrhosis. And while she
did improve, she expected her liver to eventually fail.
But getting better meant she couldn't take
Sovaldi. Scott's private insurer, whom she didn't want to name, told her
in 2014 she needed to be sicker to qualify for the treatment. The
company refused to cover it, she said, even after her doctor wrote in an
appeal that the insurance company would be responsible if she died.
An unknown number of Utahns have been denied
treatment. The Utah Insurance Department says it isn't able to tally how
many have complained to the agency about hepatitis C coverage problems
or the outcomes of those appeals.
But it does track how many complaints proceed
to an external review, the final stage of the appeals process. Last
year, five cases were reviewed; in three cases insurers were required to
provide coverage. The Insurance Department denied a Tribune records
request for those findings.
Restrictions on access and the high cost of
treatment prompted the U.S. Senate Finance Committee to investigate
Gilead's pricing practices. A report issued in December found the
manufacturer focused on maximizing revenue even though it knew a lower
price would allow more people to be treated.
The committee sought public comment on how to
address the problem of the high prices of breakthrough drugs while
ensuring patient access. Some ideas included requiring manufacturers to
offer higher rebates for such drugs and expediting the approval of
generic drugs.
In response, Gilead defended its pricing,
noting that the drugs benefit patients and are less costly than the
possible long-term effects of the chronic condition such as liver cancer
and liver transplants.
All of the large national private insurers
surveyed in the investigation required some level of disease severity,
and that the restrictions were largely based on reducing costs. In Utah,
SelectHealth's prior authorization for Sovaldi requires information
about disease severity.
The Senate report also found widespread
restrictions among Medicaid agencies and fears among Medicaid managers
that the drugs would destroy their budgets. Just a sliver of Medicaid
beneficiaries who have the virus, less than 3 percent, got treatment in
2014.
A 2015 study published in the Annals of
Internal Medicine found most agencies pay only for patients with
advanced liver disease, and some require patients to abstain from drugs
or alcohol, contrary to medical guidelines.
That's led to class-action lawsuits by Medicaid
beneficiaries in Indiana and Washington, with plaintiffs' attorneys
claiming it is illegal to withhold curative drugs based on their cost.
—
Cure or endure
Utah's Medicaid program is different: It says
it has approved all requests for hepatitis treatment during the current
fiscal year.
It requires minimal prior authorization for
the drugs, along with tests to detect the virus and determine its
genotype. However, the state doesn't cover the genotyping test.
The Utah Health Policy Project, which advocates
for expanded Medicaid coverage, has received no complaints about
Medicaid's hepatitis coverage.
But the drugs are taking a bite out of Utah's Medicaid budget.
A year after Sovaldi was approved, it shot to
the top of the list of drugs Utah Medicaid spends the most on,
outranking medications for much more common conditions such as diabetes
and depression. In 2014, the state paid $5.5 million for 66 patients to
take the wonder drug.
In 2015, once Harvoni was widely available, it
took the No. 2 spot on Utah's list. Gilead's drugs cost Utah Medicaid
$9.7 million last year. That's nearly 10 percent of its $102.7 million
medication budget, though the actual costs are likely lower because
Medicaid gets rebates from drug manufacturers.
Utah has no plans to restrict access, said Emma Chacon, Utah's Medicaid operations director.
"Other states may have a higher percentage of
beneficiaries with hepatitis C diagnoses than we do," she said. "Our
intention is to continue to provide it as we have without any additional
restrictions."
Utah's Department of Corrections, however,
limits how many prisoners it treats — spending about $800,000 last year
to treat eight prisoners.
Five times as many inmates are in line for the
treatment because they meet most of the prison's criteria for care,
which includes having enough time left on their sentence (18 months) to
finish the treatment, testing negative for drugs for the prior two
years, and having consistently abnormal liver lab tests.
Tony Washington, health services administer for
Corrections' Clinical Services Bureau, said the 40 to 45 inmates would
benefit from the treatment, but there isn't enough money to treat them
all in a year. This year, the Legislature allocated $400,000, though the
prison will likely spend more than that.
"Most of these inmates are not here for life," Washington said. "They could be treated after they leave prison."
Prisons can and do use budget decisions to dole
out care, though demonstrating "deliberate indifference" to serious
medical needs is illegal. Attorneys representing prisoners have filed
class-action lawsuits against Massachusetts, Minnesota and Pennsylvania
for denying access to hepatitis C drugs.
But Utah's chapter of the American Civil Liberties Union could find just three complaints from prisoners since 2013.
As in the Medicaid system, Utah's prison
system spends the most money on hepatitis C drugs. "What it would cost
to treat one hepatitis C patient, you could probably treat 50 of our
more typical chronic care patients [who have diabetes or hypertension]
for a year," said Bruce Burnham, a doctor at the prison.
Hepatitis C treatments are straining the U.S.
Department of Veterans Affairs medication budget, too. In Utah, the VA
spent $4.4 million last year to treat 125 veterans. That's much higher
than what it pays for the more commonly used and next most expensive
medication, insulin, at $1.75 million in 2015. Congress recently
earmarked $1.5 billion to treat veterans for hepatitis C.
—
'So much relief'
Happily for Scott, Intermountain Medical
Center was seeking patients like her for a trial of Merck's new
antiviral. She joined in 2014 and says that within a month, the amount
of virus detected in her blood dropped to zero.
"The doctor described it as an [atomic] bomb going off," she said. "It just obliterated" the virus.
She and her husband recently bought a motor
home and are considering living in Texas or Alaska when they retire.
"It's a dream come true," she said. "I've had so much relief and so much
joy in knowing that I don't have this disease anymore."
The FDA approved the drug Scott used, named
Zepatier, earlier this year. Its list price of $54,600 for a 12-week
course was heralded as a game changer. Zepatier is expected to
eventually help lower costs across the industry as Gilead and others are
forced to compete.
"Maybe I contributed just a teeny bit to one
more drug being on the market that will help a lot of people. I hope
so," Scott said. "It would be such an easy disease to get rid of."
Intermountain Medical Center was involved in a
recent trial of another Gilead hepatitis drug that Charlton says will
advance medicine again.
The company's latest product could simplify
treatment because it covers all genotypes of the virus. The company
submitted an application to the FDA in October to combine Sovaldi with a
drug that inhibits the replication of the virus. The treatment has
proven effective even for people in liver failure, improving liver
function for half the patients.
"We were able to cure people who had life-threatening liver failure," said Charlton, a co-principal investigator in the study.
He sympathizes with patients who want to be
cured and with the drug companies who want a return on their investment,
noting that the development costs of Sovaldi "exceeded $11 billion."
"As a doctor, I would like to treat any illness
that a patient I'm seeing is suffering from. But we also live on planet
Earth," he said. "Sometimes treatments are expensive."
In time, he said, costs will come down. And in
many cases, time is on the patient's side. "Luckily," Charlton said,
"it's a slow illness. It's a disease of decades."
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