this Friday, July 8, 2016 photo, a pharmacist holds
a package of EpiPens, an epinephrine autoinjector
for the treatment of allergic reactions, in
Sacramento, Calif. Price hikes for the emergency
medicine have made its maker, Mylan, the latest
target for patients and politicians infuriated by
soaring drug prices.
N.J. — Sky-high price hikes for EpiPen, the injected
emergency medicine for severe allergic reactions to foods
and bug bites, have made its maker the latest target for
patients and politicians infuriated by soaring drug
company, Mylan, has a virtual monopoly on epinephrine
injectors, potentially life-saving devices used to stop a
runaway allergic reaction. Mylan N.V., which has
headquarters in Hertfordshire, England, and Pittsburgh,
has hiked prices as frequently as three times a year over
the past nine years, pushing its list price for a package
of two syringes to more than $600.
A look at
40 million Americans have severe allergies to spider
bites, bee stings and foods like nuts, eggs and shellfish.
They at risk for a serious reaction — anaphylactic
shock. Symptoms quickly escalate from wheezing, hives and
skin swelling to rapid heartbeat, trouble breathing and
convulsions and, without treatment, possibly death.
precaution, many carry EpiPens, which contain the best
"antidote," the hormone epinephrine. Last year,
more than 3.6 million U.S. prescriptions for two-packs of
EpiPens were filled, according to data firm IMS Health.
That earned Mylan nearly $1.7 billion.
Q: How do
A: In an
emergency, the syringe is jabbed against the thigh. The
needle inside injects the epinephrine into muscle tissue.
But that can be difficult in a panic or with a child who
won't hold still. The syringes expire after a year.
did the price for EpiPens get so high?
drugmakers, Mylan periodically hikes its prices. In 2007,
when Mylan took over rights to EpiPen, a pair of syringes
cost $93.88. According to Elsevier Clinical Solutions'
database of prices set by manufacturers, Mylan raised the
price 5 percent the in 2008 and 2009, when a competitor
hit the market. Its price jumped 20 percent in late 2009,
followed by a series of 10 percent and 15 percent
increases. The price hit $609 per pair in mid-May.
can Mylan do that?
A: In the
U.S., drug manufacturers charge what they think the market
will bear. Unlike other countries, the U.S. government
doesn't regulate drug prices, though the Veterans Affairs
and Medicaid negotiate big discounts. Mylan hasn't
answered questions about how it justifies its price hikes.
A statement released Monday didn't address prices.
do people really pay?
depends on an individual's insurance coverage. Private
insurers often negotiate discounts off the list price, and
patient out-of-pocket costs vary by plan. But patients
with high-deductible plans or no insurance can pay list
price or more, depending on the pharmacy. In its
statement, Mylan said most customers have insurance that
limits their copayments, or they can use a copay discount
card to save $100.
statement recommended that people review their coverage.
It also says that since 2012, Mylan's EpiPen4Schools
program has given schools more than 700,000 free EpiPens.
there any competition?
Barely, and few people know about it. One cheaper product
remains on the market, Adrenaclick. But EpiPen, introduced
in 1987, is so well known that most doctors prescribe it
without considering Adrenaclick, and pharmacists can't
substitute that for EpiPen, said Evelyn Hermes-DeSantis,
director of drug information services at Rutgers
University's pharmacy school. A pair of Adrenaclick
syringes costs $142 to $380 at pharmacies, according to
online comparison sites.
has a U.S. patent giving it a monopoly until 2025,
according to Evercore ISI analyst Umer Raffat. Generic
maker Teva has permission to launch a version but hasn't
gotten regulatory approval yet. A rival injector called
Auvi-Q was recalled last year because of potential
inaccurate dosing, Raffat noted, and a third product has
twice been rejected because of issues with the injector.
there another alternative?
people get prescriptions for epinephrine vials and get a
doctor to put it in syringes. But Rutgers' Hermes-DeSantis
said that raises concerns about sterility and proper
Q: Why is
there such a furor now?
prices are a hot topic in the presidential race, and
Congressional committees have been investigating
eye-popping increases by other companies. New drugs for
cancer and rare diseases can cost hundreds of thousands of
dollars and older drugs, even some generics, have had
unprecedented price spikes. With the increase in
high-deductible insurance plans, more people are paying
the full cost of prescriptions. And the back-to-school
season means some families are facing sticker shock as
they buy new EpiPens to keep at their child's school.