HERTFORDSHIRE, England and
PITTSBURGH, Aug. 17, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced that its subsidiaries, Mylan
Inc. and Mylan Specialty L.P., have signed an agreement with the
U.S. Department of Justice ("DOJ") and two relators finalizing the
Medicaid drug rebate settlement that the Company announced on
Oct. 7, 2016 for $465 million.
The settlement resolves claims relating to the classification of
EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector for purposes of
the Medicaid Drug Rebate Program. The question in the underlying
matter was whether the EpiPen products were properly classified
with the Centers for Medicare and Medicaid Services ("CMS") as a
non-innovator drug under the applicable definition in the Medicaid
Rebate statute and subject to the formula that is used to calculate
rebates to Medicaid for such drugs. EpiPen Auto-Injector has been
classified with CMS as a non-innovator drug since before Mylan
acquired the product in 2007 based on longstanding written guidance
from the federal government.
The settlement provides for resolution of all potential Medicaid
rebate liability claims by the federal government, as well as
potential claims by certain hospitals and other covered entities
that participate in the 340B Drug Pricing Program. The settlement
allocates money to the Medicaid programs of all 50 states and
establishes a framework for resolving all potential state Medicaid
rebate liability claims within 60 days. In connection with the
settlement, Mylan also has entered into a Corporate Integrity
Agreement with the Office of Inspector General of the Department of
Health and Human Services. The settlement does not contain an
admission or finding of wrongdoing. Mylan will reclassify EpiPen
Auto-Injector for purposes of the Medicaid Drug Rebate Program and
pay the rebate applicable to innovator products effective as of
April 1, 2017.
Mylan CEO Heather Bresch commented, "As we said when
we announced the settlement last year, bringing closure to this
matter is the right course of action for Mylan and our stakeholders
to allow us to move forward. Over the course of the last year, we
have taken significant steps to enhance access to epinephrine
auto-injectors, including bringing a solution to the fast-changing
healthcare landscape in the U.S. by launching an authorized generic
version at less than half the wholesale acquisition cost of the
brand and meaningfully expanding our patient access programs. Mylan
has always been committed to providing patients in the U.S. and
around the world with access to medicine, and we look forward to
continuing to deliver on this mission."
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in more than 165 countries and territories.
We are one of the world's largest producers of active
pharmaceutical ingredients. Every member of our more than
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at Mylan.com.
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SOURCE Mylan N.V.