KING OF PRUSSIA, Pa.,
Dec. 1, 2014 /PRNewswire/ --
CSL Behring today announced that the Centers for Medicare and
Medicaid Services (CMS) has extended the new technology add-on
payment (NTAP) for Kcentra® (Prothrombin Complex
Concentrate [Human]) through September
2015 for eligible Medicare beneficiaries treated in the
inpatient hospital setting. Kcentra, the first and only
non-activated 4-factor prothrombin complex concentrate (4F-PCC)
approved by the U.S. Food and Drug Administration (FDA), is
indicated for the urgent reversal of acquired coagulation factor
deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin)
therapy in adult patients with acute major bleeding or in need of
an urgent surgery or invasive procedure. Kcentra, first
approved for use in the U.S. in April 2013, received its NTAP
designation effective October 1, 2013.
"CMS's decision to extend Kcentra's NTAP designation
further recognizes this novel treatment as an important clinical
advancement for patients in need of urgent warfarin reversal," said
Bill Campbell, Senior Vice
President, North America Commercial Operations, CSL Behring.
"The NTAP designation will continue to help provide broader access
to Kcentra in hospitals and further underscores CSL
Behring's commitment to developing and making innovative treatments
for serious medical conditions widely accessible."
Unlike fresh frozen plasma (FFP), the most widely used agent for
warfarin reversal, Kcentra does not require thawing or blood
type matching and can be administered more quickly and with less
volume than FFP.
About the New Technology Add-On Payment (NTAP) Policy
The CMS NTAP policy was implemented in 2001 to support timely
access to innovative therapies for Medicare beneficiaries in the
inpatient hospital setting that are not adequately paid for under
the Medicare Severity Diagnosis-Related Groups (MS-DRGs). To be
eligible for an NTAP, the product must be new and inadequately paid
for under existing MS-DRGs, and must provide a significant clinical
improvement over existing therapies. CMS will continue to reimburse
hospitals an additional amount, up to $1,587.50, for cases involving Kcentra
that exceed the MS-DRG payment amount.
For more information on the CMS NTAP approval for
Kcentra, please visit
http://www.gpo.gov/fdsys/pkg/FR-2014-08-22/pdf/2014-18545.pdf
Prevalence of Warfarin Therapy
Each year,
approximately three to four million people in the U.S. are treated
with the oral anticoagulant warfarin to prevent blood clots from
forming following a stroke, heart attack, heart valve surgery, deep
vein thrombosis/pulmonary embolism, or certain types of irregular
heartbeat, such as atrial fibrillation. However, because of the
deficiency in blood clotting factors induced by warfarin treatment,
patients may experience severe bleeding. It is estimated that
emergency departments across the U.S. see approximately 29,000
cases annually for warfarin-associated bleeding.
About Kcentra®
In more than 25 countries, CSL
Behring markets Kcentra as Beriplex® or
Confidex®. In December 2012,
the FDA granted Orphan Drug Designation to Kcentra for the
treatment of patients needing urgent reversal of Vitamin K
antagonist therapy due to major bleeding and/or surgical
procedures. The FDA's Orphan Drug Designation program provides
orphan status to unique drugs and biologics defined as those
intended for the safe and effective treatment or prevention of rare
diseases that affect fewer than 200,000 people in the U.S. Orphan
designation qualifies the sponsor of the product for important tax
credits, elimination of FDA license application fees and certain
marketing incentives.
Important Safety Information
Kcentra®, Prothrombin Complex Concentrate (Human), is a
blood coagulation factor replacement product indicated for the
urgent reversal of acquired coagulation factor deficiency induced
by Vitamin K antagonist (VKA—e.g., warfarin) therapy in adult
patients with acute major bleeding or the need for urgent surgery
or other invasive procedure. Kcentra is for intravenous use
only.
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC
COMPLICATIONS
Patients being treated with Vitamin K antagonist therapy have
underlying disease states that predispose them to thromboembolic
events. Potential benefits of reversing VKA should be weighed
against the risk of thromboembolic events, especially in patients
with history of such events. Resumption of anticoagulation therapy
should be carefully considered once the risk of thromboembolic
events outweighs the risk of acute bleeding. Both fatal and
nonfatal arterial and venous thromboembolic complications have been
reported in clinical trials and postmarketing surveillance. Monitor
patients receiving Kcentra, and inform them of signs and symptoms
of thromboembolic events. Kcentra was not studied in subjects who
had a thromboembolic event, myocardial infarction, disseminated
intravascular coagulation, cerebral vascular accident, transient
ischemic attack, unstable angina pectoris, or severe peripheral
vascular disease within the prior three months. Kcentra might not
be suitable for patients with thromboembolic events in the prior
three months.
Kcentra is contraindicated in patients with known
anaphylactic or severe systemic reactions to Kcentra or any
of its components (including heparin, Factors II, VII, IX, X,
Proteins C and S, Antithrombin III and human albumin).
Kcentra is also contraindicated in patients with
disseminated intravascular coagulation. Because Kcentra
contains heparin, it is contraindicated in patients with
heparin-induced thrombocytopenia (HIT).
Hypersensitivity reactions to Kcentra may occur. If
patient experiences severe allergic or anaphylactic type reactions,
discontinue administration and institute appropriate
treatment.
In clinical trials, the most frequent (greater than or equal to
2.8%) adverse reactions observed in subjects receiving
Kcentra were headache, nausea/vomiting, hypotension, and
anemia. The most serious adverse reactions were thromboembolic
events, including stroke, pulmonary embolism and deep vein
thrombosis.
Kcentra is derived from human plasma. The risk of
transmission of infectious agents, including viruses and,
theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be
completely eliminated.
The safety and efficacy of Kcentra in pediatric use have
not been studied, and Kcentra should be used in women who
are pregnant or nursing only if clearly needed.
For more information about Kcentra, please visit
www.kcentra.com or call toll-free 1-855-4KCENTRA. For full
prescribing information, please visit
www.kcentra.com/prescribing-information.aspx.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics
industry. Committed to saving lives and improving the quality of
life for people with rare and serious diseases, the company
manufactures and markets a range of plasma-derived and recombinant
therapies worldwide.
CSL Behring therapies are used around the world to treat
coagulation disorders including hemophilia and von Willebrand
disease, primary immune deficiencies, hereditary angioedema and
inherited respiratory disease, and neurological disorders in
certain markets. The company's products are also used in cardiac
surgery, organ transplantation, burn treatment and to prevent
hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma
collection networks, CSL Plasma. CSL Behring is a global
biopharmaceutical company and a member of the CSL Group of
companies. The parent company, CSL Limited (ASX:CSL), is
headquartered in Melbourne,
Australia. For more information, visit
http://www.cslbehring.com/.
Contact:
Greg
Healy
CSL Behring
Office: 610-878-4841
Mobile: 610-906-4564
Greg.Healy@cslbehring.com
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SOURCE CSL Behring