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 The warning published by the New England Journal of Medicine comes
in the wake of recent of drug price gouging, most notably for Turing
Pharmaceuticals' anti-parasite drug Daraprim and Mylan's EpiPens,
designed to prevent death following a severe allergic reaction.
"It's certainly part of the larger trend in brand name drugs and old
off-patent generics" that have been subject to large price hikes in
recent years, said Ravi Gupta, coauthor of the opinion piece and a
fourth-year medical student at the Yale University School of
Medicine in New Haven, Connecticut.
He and his colleagues from Yale and the Mayo Clinic in Rochester,
Minnesota found that a 10-pack of naloxone sold by the Pfizer
company Hospira had more than doubled in price from $62.29 in 2012
to $142.49 this year.
But that increase is dwarfed by Kaleo's naloxone auto-injector
system, which went from $690 for two injections in 2014 to $4,500 in
2016, an increase of more than 500 percent in just two years.
Other manufacturers have not increased their prices, but Kaleo and
Hospira represent most of the sales, the Gupta team writes.
"Here are drugs that are lifesaving in an acute situation, and both
the EpiPen and naloxone prices have skyrocketed," Gupta told Reuters
Health. "The lack of attention to naloxone's price increases may be
associated with the stigma of people who use opioids, whereas the
EpiPen is for children."
Pfizer spokeswoman Rachel Hooper countered that "Hospira has
responsibly priced naloxone,” in an email.
"We believe our actions have reflected sensitivity to the need for
the product, and also take into account the reality and necessary
investments needed to produce high-quality generic drugs," she told
Reuters Health.
Kaleo's vice president of corporate affairs, Mark Herzog, said in an
email that the company has special programs that allow patients and
caregivers to get naloxone at no cost if they have a prescription
and commercial insurance. "To cover the cost of this program for
patients, we increased the list price," he said.
“Drug pricing is a complex issue that involves multiple
stakeholders, including insurers, payers and pharmacies," Herzog
said.
But, Gupta said, "patient discount programs are not necessarily a
sustainable solution, and even if they're offering the autoinjector
for a significantly reduced price, it's often put back on the
patients themselves through an increase in insurance premiums."
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Naloxone has been available in generic form since 1985. In recent
years there has been a push to make naloxone widely available to
people without medical training in hopes of preventing both heroin
overdoses and deaths from overuse of opioid-based prescription
drugs, which have been twice as common as heroin overdose deaths.
All but four states have at least one law designed to expand access
to naloxone.
Kaleo's special pen designed for untrained people was approved in
2014. A nasal spray formulation was approved in 2015. While Kaleo
increased its price more than sixfold since 2014, Adapt has kept its
Narcan nasal spray at $150 for two doses.
Gupta and his colleagues said Kaleo raised its price "significantly
and without explanation the month before the Centers for Disease
Control and Prevention released new guidelines encouraging doctors
to prescribe naloxone as a precaution to patients at risk for an
overdose."
To solve the problem, they said the federal government might want to
bring down the price by purchasing in bulk, creating a stable demand
that might encourage other companies to compete, a strategy that
keeps vaccine costs low. The government also has the right to
manufacture Kaleo's auto-injector at a lower price and simply pay a
royalty for use of the patent.
The government could also allow importation of a comparable product
from overseas, a strategy that has been proposed for combating the
hefty price increases imposed for U.S.-produced generic drugs.
"When governments promote naloxone use, they have a responsibility
to ensure the drug’s affordability," the Gupta team writes. "Taking
action now is essential to ensuring that this lifesaving drug is
available to patients and communities."
SOURCE: http://bit.ly/2hkIXd2 New England Journal of Medicine,
online December 7, 2016.
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