| NEW YORK, March 27
NEW YORK, March 27 The amount that drugmaker
Mylan NV avoided paying the U.S. government in Medicaid
rebates for its EpiPen emergency allergy treatment since 2007
likely exceeds a proposed $465 million settlement the company
announced in October, according to a study by private drug
pricing experts published on Monday.
Mylan, which was already under fire for steep price
increases on the devices, said in October it agreed to settle
with the U.S. government after it was accused of improperly
classifying EpiPen with the Medicaid Drug Rebate Program as a
generic treatment. Mylan, which said earlier this month that it
was still working to finalize the settlement, did not admit
Drugmakers pay a rebate of 13 percent to state Medicaid
programs on sales of generics, rather than a minimum rebate of
23.1 percent on branded drugs.
According to estimates in the study, Mylan avoided paying
more than $426 million in rebates between 2012 and 2016 by
classifying EpiPen as a generic.
The amount Mylan underpaid Medicaid may exceed the
settlement, the study's authors suggest, because their estimate
covers two EpiPen formulations over only four years. Mylan
acquired EpiPen in 2007 and it had been classified as a generic
since 1997, according to the Centers for Medicare & Medicaid
The study was conducted by Jing Luo at Brigham and Women's
Hospital in Boston, and Aaron Kesselheim and Jerry Avorn at
Harvard Medical School, and published in JAMA Internal Medicine.
EpiPen is an automatic injector, delivering a dose of
life-saving epinephrine to treat severe allergic reactions.
Mylan doubled the price of a pair of the devices to $600 last
year, up from $100 in 2007.
In response to the furor, Mylan launched its own generic
version of EpiPen priced at $300 for a two-pack.
A separate study published in the same journal said that
from 2007 to 2014, patients’ average out-of-pocket spending on
EpiPen more than doubled to $75 a year from $34 a year.
The proportion of patients with out-of-pocket costs of at
least $100 climbed from 4 percent to 18 percent during the study
period, while the share of patients with costs of at least $200
increased from 0.1 percent to almost 5 percent.
A Mylan spokesperson declined to comment on the Medicaid
In January, Mylan said that about 90 percent of consumers
who got its brand or generic EpiPen had an out-of-pocket cost of
less than $50. During the same time frame last year, 80 percent
of patients paid less than $50 out-of-pocket, the company said.
(Additional reporting by Michael Erman; Editing by Steve