CLINICAL NEWS
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Featured research from recent issues of Blood
PAPER SPOTLIGHT
Access to and Costs of
Generic Medications in the
United States: A Perspective
Between 2004 and 2013,
the broader availability of
generic drugs saved the U.S.
health-care system nearly
$1.5 trillion. However, a
number of issues, including
certain industry tactics, have
made it difficult for some
generic drugs to reach the
market, or to the patients
who need these treatments.
With a limited number
of generic drugs available,
approximately one in five
Americans admit to not
filling prescriptions due to
costs, according to Gregory
H. Jones, BS, and colleagues
from MD Anderson Cancer
Center in Houston, Texas. In
a recent perspective article
published in Blood, Mr. Jones
and co-authors discussed
the rising costs, as well as
the strategies pharmaceutical companies use to delay
or prevent the timely availability of these medications.
“Drug companies – both
patented and generic manufacturers – are collaborating
to subvert legislations that
were well-meant to help
make generics available and
affordable earlier to patients
with cancer,” corresponding
author Hagop Kantarjian,
MD, told ASH Clinical News.
“Unfortunately, these sorely
needed generics are increasingly out of reach.” For more
from Dr. Kantarjian about
the factors that keep these
affordable drugs from the
market, see the SIDEBAR.
How do pharmaceutical
companies delay patient
access to affordable generic
drugs? The authors identified several strategies.
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ASH Clinical News
Patent Settlements
Patent rights are one of the
biggest obstacles to generic
availability, according to the
authors. Over the years, the
makers of brand-name drugs
have developed strategies to
extend patents and delay the
availability of generic formulations to extend brand-name
exclusivity. One tactic is “reverse payment” or “pay-fordelay,” in which the patent
company agrees to pay the
potential generic company to
delay entry of the drug to the
market. The Federal Trade
Commission (FTC) estimates
that these settlements
cost taxpayers, insurance
companies, and consumers
approximately $3.5 billion
per year. However, according
to a recent report from the
FTC, the number of pay-fordelay settlements has been
declining (see Data Stream
on page 16).
“The danger [of these
arrangements] derives from
the mutual financial benefit
to both brand and generic
producers at the expense of
patients and our health-care
system,” wrote Mr. Jones
and colleagues.
Product Hopping
Product hopping (also
called “forced switching”
or “evergreening”) involves
brand-name companies
switching the market for a
drug, prior to its patent expiration date, to a reformulated version whose patent
expires later. Though the
drug now has an expanded
patent, it offers little to no
therapeutic advantages.
Dr. Jones and co-authors
offer the following example:
The new version of a drug
could have a different tablet
or capsule dose, prompting doctors or pharmacists
to switch patients to the
new drug formulation; if a
generic version of the drug
becomes available, pharmacists cannot substitute the
reformulated version for this
generic because state laws
only allow for substitutions
when the dosage strength or
other characteristics remain
the same. According to the
authors, when patients are
forced to switch from a drug
with a near-expired patent
to the new formulation, only
10 to 20 percent go back to
a generic version once it is
made available.
Banning of Cross-Border
Drug Importation
Though drug prices are
high in the United States,
a brand-name drug overseas can cost just 20 to 50
percent of the price U.S.
patients pay. In addition,
some generic formulations
are available earlier in other
countries. Unfortunately, the
authors explained, the U.S.
Food and Drug Administration Safety and Innovation
Act does not allow patients
to import drugs for individual use that are valued at
$2,500 or less due to public
safety concerns. “Allowing
cross-border importation of
drugs would improve market
forces and increase pressure
for more affordable drug
prices,” they noted.
ASH Clinical News spoke with Hagop
Kantarjian, MD, about access and cost of
generic medications.
A SH Clinical News: How does the problem of expensive or unavailable generic
medication specifically affect patients
with hematologic disorders?
Hagop Kantarjian, MD: We are paying
a lot for drugs, but, more importantly,
because of the shift of the burden to
patients by the insurance companies,
patients are having to pay sometimes 20
to 25 percent in out-of-pocket costs. So,
for a patented drug whose generic version is delayed or high-priced, this could
effectively mean patients are going to pay
$20,000 or $30,000 a year. Patients cannot afford them.
Also, the introduction of reasonably
priced generics could save our health-care
system close to $1.5 trillion over a period
of 10 to 15 years, according to one study
estimate. The timely availability of affordable generics is very important for the
U.S. health-care system and for individual
patients with cancer who cannot afford to
pay for these drugs out-of-pocket.
Will we reach a point where drug prices
are just too high?
They are already too high – way too
high. Some cancer drugs cost in excess
of $100,000 per year; that means paying
more than $100,000 for one year lived.
In the past, we assumed that $50,000
was a reasonable price for a year lived.
In my opinion, we have exceeded the
point of “exorbitant” pricing and have
entered the realm of profiteering off
high cancer drug prices.
How do you think the pharmaceutical
industry would respond to the arguments
you and co-authors present in the article?
The industry has to decide: Are they
going to continue with high prices (with
the mission of maximizing profit at the
expense of harming patients), or will they
redirect their course to a dual mission of
helping patients and making a reasonable
profit? Today, the pharmaceutical industry
resembles a Wall Street corporation where
they seek to maximize profit even if they
are harming the U.S. health-care system
and patients. This has to change. Drug
companies have legislation and laws to
their benefit, and now the patients are
not able to have early access to affordable
generics. We have to reverse this.
Continued on page 21
March 2016