— A wonder drug came on the market two years ago that cures
hepatitis C, a potentially deadly liver disease afflicting
millions of Americans, killing 15,000 a year.
problem is, many patients could not afford it. A standard
course of Sovaldi cost $84,000, or $1,000 a day. And many
insurers would not approve it for any but the sickest of
we had this disease we couldn’t cure, and this drug is
developed and it’s almost like a miracle," said Dr.
Paul J. Thuluvath, a gastroenterologist and liver specialist
at Mercy Medical Center in Baltimore, who has treated
hepatitis for 25 years. "I was so upset it was so
and others say barriers put up by private insurance companies
and state Medicaid programs aimed at controlling costs have
made it hard for patients to get the drug, many left to worsen
as they sought charity or appealed their cases.
million people in the United States have hepatitis C, but the
number could spike as more baby boomers adhere to new medical
guidelines to get tested for the infection that leads to liver
damage, cancer and even more costly transplants.
people contracted hepatitis C through transfusions and
transplants before the blood supply was screened in the 1990s.
Infection is now more common from tainted needles or, less
commonly, from sex.
cost highlights a growing debate that could intensify as
breakthrough therapies for high cholesterol, heart failure and
other ailments are approved.
makers defend the costs as necessary to bring radical new
medications to market. And insurers defend treating the
sickest patients first because of the price and because damage
usually takes time.
estimated 100,000 people in Maryland are infected with
hepatitis C, but there is no tally for the number of people
treated. Thuluvath said insurers have approved prescriptions
for more than 440 people, or most of his sickest patients,
since October, when Harvoni, a second-generation hepatitis C
drug costing $94,000, was approved.
a professor at the University of Maryland School of Medicine
and author of a forthcoming hepatitis guide, has two staff
members working full time on insurance appeals. About 30
percent to 40 percent of the prescription requests initially
are rejected, even for some patients in later stages of the
spend so much time appealing," he said. "But my
experience has been better than expected, and better than my
peers around the country."
affiliated with Johns Hopkins Hospital have filled thousands
of prescriptions for the drugs, also filing appeals in many
cases, officials said.
state Medicaid program paid for the drugs for 534 hepatitis C
patients in 2014, and expects to cover more this year, said
Dr. Mona Gahunia, chief medical officer for the Maryland
Department of Health and Mental Hygiene.
priority is to make sure people who need them the most can get
them without a lot of hurdles," she said.
those people is Michael Roesen, of Frederick, Md., who is
nearing the end of his Harvoni treatment. Each month for six
months, the small staff at the Frederick County Hepatitis
Clinic where he goes has had to plead with his Medicaid
managed-care organization to refill the prescription.
Callahan, the clinic’s executive director, called it
baffling, considering Roesen’s high viral load and liver
damage — and his immediate response to the drugs. His
infection was nearly undetectable after 10 days on the drug.
infection had festered because a previous insurer would not
cover the drugs, he said. Another would not even issue a
policy because a blood test revealed he had hepatitis.
volunteer patient advocate at the clinic files most of the
appeals, using her personal cellphone minutes to call and wait
on hold with insurers. The extra work is a burden on the small
nonprofit that operates on grants, donations and discounted
rent at Frederick Memorial Hospital. It can afford only one
who believes he was infected by a tattoo needle in 1999, was
grateful for the clinics’ efforts and the state insurance.
He had beaten unrelated cancer, but years of the hepatitis
infection were debilitating. The fatigue made his work in
warehouses and installing drywall tough.
have a new attitude about life," Roesen said during a
recent checkup. "I feel great."
and private insurers follow guidelines that require, for
example, that patients wait until they have advanced disease
or see specialists. Even then, high deductibles can put drugs
out of reach, doctors and advocates say.
Healthcare and Kaiser Permanente of the Mid-Atlantic States
say their coverage decisions are consistent with clinical
Kaiser Mid-Atlantic President Kim Horn said the high drug cost
is not sustainable and that the company is trying to
"influence the national discussion on affordable
to the Express Scripts Drug Trend Report,
"specialty" drugs for chronic and difficult
conditions accounted for just 1 percent of U.S. prescriptions
but 31.8 percent of drug spending in 2014.
Peter Beilenson, CEO of Evergreen Health Co-op, said his
company has few restrictions on covering the drug because
curing the infection staves off more expensive treatments,
including transplants, which cost hundreds of thousand of
it’s gross profit" for drug companies, he said.
"If you look at other countries, like France and Germany,
the company sells them for half the price as when U.S.
taxpayers were involved in developing the drugs."
spokeswoman for the drugs’ maker, Gilead Sciences, said
there are programs for the uninsured and underinsured and
tiered pricing for less wealthy countries. So far, 310,000
people worldwide have gotten the drugs, including 210,000 in
the United States.
treatment for other chronic diseases, Sovaldi and Harvoni
offer a cure at a price that significantly reduces hepatitis C
treatment costs and delivers significant savings to the health
care system over the long term," said Cara Miller, the
prices do reflect costs from research, much of which fails,
said George T. Haley, a marketing professor at the University
of New Haven, in Connecticut. He said it also reflects the
lack of bargaining power by the largest U.S. health programs,
Medicare and Medicaid.
Gilead did not develop the drug, rather it bought Sovaldi’s
maker, which had initially priced it at $36,000, less than
half what Gilead charges.
analysis by the nonprofit Institute for Clinical &
Economic Review determined that, based on its costs and
benefits, the price of Sovaldi should be $36,000 to $42,000.
company has begun offering rebates now that there is another
competitor and more on the horizon, said Dr. Steven Pearson,
the institute’s president. But he said access nationwide
remains a "pretty mixed picture."
costs make more sense when the drugs benefit only a few,
Pearson said. The hepatitis drugs and others for common
ailments in the pipeline should spark serious debate about
Simon, president of the Hepatitis C Association, was diagnosed
with advanced hep C in 1991 after a doctor discovered that her
liver was enlarged during a routine exam. She believes it
stemmed from a blood transfusion after a car accident.
she credits Gilead with helping offset the costs for some and
private groups for helping others, she said the costs remain
too high for many.
who quit her job as a teacher to head the national advocacy
group based in New Jersey, got a Sovaldi competitor, called
Viekira Pak, through a clinical trial by AbbVie Inc. She was
cured in six weeks, though her liver damage must be monitored
because patients can develop cancer.
tried every treatment and nothing worked. The side effects
were worse than the disease," she said. "Fatigue and
muscle and joint pain, headaches, fever. I was anemic and
getting really sick.
she added, "the point is these new drugs are curing