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 Mylan is grappling with a growing backlash from U.S. consumers,
lawmakers and prosecutors over EpiPen prices, which have risen from
about $100 in 2007 to more than $600 for a pair of the devices. The
EpiPen delivers a dose of epinephrine, an antidote to a severe and
potentially deadly allergic reaction to anything from nuts to bee
stings.
The rising cost has made it difficult for many families to afford
EpiPens, prompting a public outcry that has resonated with
legislators.
Mylan Chief Executive Heather Bresch is to testify about the price
hikes on Wednesday before an oversight committee of the House of
Representatives. Bresch is the daughter of Senator Joe Manchin, a
Democrat from West Virginia.
In her prepared testimony, released on Tuesday, Bresch said Mylan
was already moving to address concerns about price by expanding
discount programs and launching a $300 generic version.
She said that, after rebates, fees and costs, the company makes only
about $100 per EpiPen pack, and that a majority of consumers pay
less than $50 out of pocket for a pack.
Ahead of the hearing, Republicans on the Senate Finance Committee
said they were concerned that Mylan was allowed to inappropriately
classify EpiPen as a generic drug, reducing the potential discounts
to the government’s Medicaid health program for the poor.
“We are concerned that the controls in place, if any, are inadequate
to ensure that Medicaid is receiving the full amount of rebates
afforded to it by law,” the Senate Republicans, led by Orrin Hatch
of Utah, said in a letter to the U.S. Department of Health and Human
Services Inspector General.
Under current law, branded drugs, and generic drugs available from a
single source, are subject to a rebate of at least 23.1 percent of
the average manufacturer price for Medicaid. Non-innovator drugs are
subject to a much lower 13 percent rebate.
The Finance Committee Republicans are asking Inspector General
Daniel Levinson to examine the federal health agency's oversight of
the rebate program.
Mylan has said it has complied with all laws and regulations
regarding rebates.
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Also on Tuesday, West Virginia Attorney General Patrick Morrisey
said he was investigating the rebates and the possibility that Mylan
violated the state's antitrust law when it sued and settled with a
would-be generic competitor. Mylan spokeswoman Nina Devlin said the
company was cooperating with the investigation.
EpiPen has also posed a cost burden to the federal Medicare health
program for the elderly, according to an analysis from the Kaiser
Family Foundation, a health policy research group. Before rebates,
EpiPen costs for Medicare Part D shot up more than 1,000 percent
between 2007 and 2014, from $7 million to $87.9 million, the report
said.
Devlin, in an emailed statement, said that from 2010 to 2015,
rebates to Medicare Part D plans were up 440 percent, which would
reduce the increase stated by the Kaiser Family report. She said
that any analysis that does not take those specific rebates into
account is fundamentally flawed.
While rebates to Medicare, which are not disclosed by the program,
would have offset the cost to a degree, it was still far higher than
a 164 percent increase in EpiPen prescriptions to Medicare patients,
the Kaiser Family report said.
(Reporting By Brendan Pierson and Caroline Humer in New York;
Editing by Dan Grebler and Alan Crosby)
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