How long should you
wait to treat a possibly fatal but curable disease? That's a question
with major implications for millions of patients and for insurers and
government programs that have to pay for the treatment.
In the last year this question
has focused on hepatitis C, a viral infection of the liver that, left
untreated, can lead to cirrhosis, cancer, liver failure and death.
Hepatitis C is the leading cause for liver transplants in the United
States.
The virus can be eliminated in
more than 90 percent of the individuals who take newly approved drugs
over a three-month treatment - but at a staggering cost of $75,000 to
$100,000 per patient. Treating everyone in the U.S. who has the
hepatitis C virus would cost at least $200 billion. To put that in
perspective: In a typical year, U.S. spending on all prescription drugs
is $300 billion to $360 billion.
In July the California Department
of Health Care Services ordered a new protocol that will mean many
thousands of Medi-Cal patients will have to wait for treatment. But far
from jeopardizing lives, the department is helping solve the hepatitis C
conundrum with a sensible policy: Treat everyone who needs it, but not
until treatment is necessary.
As serious as hepatitis C can be,
it often produces no symptoms - no cirrhosis, cancer or liver failure.
Many of the estimated 3 million to 7 million infected people in the U.S.
and 130 million to 170 million worldwide do not know they have the
disease; most fail to develop symptoms over their lifetime.
Statistically, only a third will ever be seriously troubled by their
infection.
The California protocol
essentially calls for two things: watchful waiting, and using simple
screening indicators. One indicator - called FIB-4 - is calculated from
routine blood tests and estimates the amount of scarring on the liver.
It is inexpensive, easy to measure and shown to be highly predictive of
the disease's progression.
Treatment to eliminate the virus
can be delayed until the marker shows heightened liver fibrosis
(scarring), without significantly increasing a patient's risk for
illness and death.
The marker was revealed during
research we began four years ago with pharmaceutical companies and the
Veterans Administration aimed at demonstrating to infected veterans when
they needed to embark on a different hepatitis C treatment - an
onerous, yearlong drug regimen - or face organ failure. A simple test
every six months or so can alert a physician to whether the risk of
serious complications is increasing.
The California protocol will, in a
way, ration care, and any form of rationing is controversial. Consumer
groups and some health insurance companies have called for
investigations into the costs of hepatitis C drugs to pressure drug
makers to roll back prices. Manufacturers contend their products are a
bargain, even at a very high price, because the American healthcare
system would otherwise have to deal with the long-term consequences of
millions of chronic hepatitis C cases. (The first of these medications
are already coming under price pressure after the introduction of
competing therapies.)
But the state's protocol provides
a way through the thicket. A California Association of Health Plans
study released in June estimated that treating the 127,000 Medi-Cal
patients with hepatitis C for one year might cost $438 million to $1.71
billion. By implementing the screening protocol, Medi-Cal can probably
hold costs to the lower part of that range without risking patient
health.
Other states are starting to
implement similar protocols. Now physicians, health insurance companies,
managed care organizations and other government health-care programs
need to follow suit to manage the new, highly effective but very
expensive treatments for hepatitis C.
Doing so will strike a practical,
and humane, balance. Knowing who does not need treatment right away
improves access for those who do.
Neither D. Steven Fox, an
assistant professor at University of Southern California, nor Jeffrey S.
McCombs, an associate professor at the USC School of Pharmacy, has a
financial interest in hepatitis C therapies or tests.
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