CMS Approves New Technology Add-On Payment for CSL Behring's Kcentra™
Designation Recognizes Kcentra as an Important New Advance for Urgent Reversal
of Warfarin in Adult Patients with Acute Major Bleeding while Improving
KING OF PRUSSIA, Pa., Aug. 13, 2013
KING OF PRUSSIA, Pa., Aug. 13, 2013 /PRNewswire/ --CSL Behring today
announced that the Centers for Medicare and Medicaid Services (CMS) has
approved a new technology add-on payment (NTAP)for Kcentra™ (Prothrombin
Complex Concentrate [Human]) for use in the inpatient hospital setting for the
urgent reversal of warfarin therapy in adult patients with acute major
bleeding. Kcentra, the first non-activated 4-factor prothrombin complex
concentrate (4F-PCC), was approved by the U.S. Food and Drug Administration
(FDA) in April 2013 for this use.
(Logo: http://photos.prnewswire.com/prnh/20130627/NY39350LOGO )
"The CMS NTAP approval recognizes that Kcentra is a significant clinical
advancement for reversing the effects of warfarin in patients who experience
acute major bleeding," said Lynne Powell, Senior Vice President, North America
Commercial Operations, CSL Behring. "This approval will help facilitate
adoption of Kcentra among healthcare professionals who treat Medicare patients
on warfarin therapy by providing broader access to Kcentra."
About the New Technology Add-On Payment 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 new
product must provide a substantial clinical improvement over existing
therapies. Beginning October 1, 2013, CMS will reimburse hospitalsan
additional amount, up to $1,587.50, for cases involving Kcentra that exceed
the MS-DRG payment amount.This add-on payment for Kcentra will continue for
at least two years.
For more information on the CMS NTAP approval for Kcentra, please visit
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^1
following a stroke, heart attack, heart valve surgery, deep vein
thrombosis/pulmonary embolism, or certain types of irregular heartbeat, such
as atrial fibrillation.^2 However, because of the deficiency in blood clotting
factors induced by warfarin treatment, patients may experience severe
bleeding. It is estimated that emergency departments in the U.S. see
approximately 29,000 cases annually for warfarin-associated bleeding.^3
About the Kcentra Pivotal Clinical Trial
The randomized, controlled Phase IIIb study used as the basis for the FDA
approval of Kcentra was the first prospective analysis to compare a 4-factor
PCC and vitamin K with plasma and vitamin K for urgent warfarin reversal in
patients with acute major bleeding. Kcentra achieved the endpoints of
hemostatic efficacy with respect to the adequacy of stopping a major bleed
assessed over 24 hours from the start of infusion (72.4 percent of patients
receiving Kcentra versus 65.4 percent receiving plasma) and INR reduction
(</=1.3) at 30 minutes post treatment (62.2 percent of patients receiving
Kcentra versus 9.6 percent receiving plasma).
The secondary endpoints included plasma levels of major clotting factors
(Factors II, VII, IX, X, proteins C and S); time to INR correction; and safety
and tolerability (including all-cause mortality). A single Kcentra infusion
produced a rapid and sustained increase in plasma levels of clotting factors
II, VII, IX, and X within 30 minutes post-treatment (p values<0.0001) with 87
percent less volume (105 mL +/-37 mL versus 865 mL +/- 269 mL) than plasma.
Additionally, infusion time with Kcentra was seven times faster than with
plasma (24 minutes versus nearly 3 hours for plasma).
The most common adverse reactions (frequency >/=2.8%) observed in subjects
receiving Kcentra were headache, nausea/vomiting, arthralgia, and hypotension.
The most serious adverse reactions were thromboembolic events including
stroke, pulmonary embolism and deep vein thrombosis.
Kcentra contains four vitamin K-dependent factors: Factor II (prothrombin),
Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and
S. In more than 25 countries, CSL Behring markets Kcentra as Beriplex^® or
In December 2012, the FDA granted Orphan Drug Designation for 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
Warning: 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 (DIC), cerebral
vascular accident, transient ischemic attack, unstable angina pectoris, or
severe peripheral vascular disease within the prior three months. Kcentra
might not be suitable in patients with thromboembolic events in the prior
Kcentra™, Prothrombin Complex Concentrate (Human), 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. Kcentra is not indicated for urgent reversal of VKA anticoagulation
in patients without acute major bleeding. Kcentra is for intravenous use only.
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 DIC. Because Kcentra contains
heparin, it is contraindicated in patients with heparin-induced
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
(>/=2.8%) adverse reactions observed in subjects receiving Kcentra were
headache, nausea/vomiting, arthralgia, and hypotension. 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
For more information about Kcentra, including full prescribing information,
please visit www.kcentra.com/prescribing-information.aspx or call toll-free
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
diseases in the newborn. CSL Behring operates one of the world's largest
plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL
Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne,
Australia. For more information, visit www.cslbehring.com.
Senior Manager, Public Relations & Communications
^1 Zareh M, Davis A, Henderson S. Reversal of Warfarin-Induced Hemorrhage in
the Emergency Department. West J Emerg Med. 2011 November; 12(4): 386–392.
Rossi's Principles of Transfusion Medicine, 4^th edn. Chapter 24: Bleeding
^2 from Acquired Coagulation Defects and antithrombotic therapy – Thomas J.
Raife, Jeffrey S. Rose, & Steven R. Lentz. ISBN: 978-1-4051-7588-3
Wysowski D, Nourjah P, Swartz L. Bleeding complications with warfarin use:
^3 A prevalent adverse effect resulting in regulatory action. Arch Intern Med.
2007; 167 (13) : 1414-1419
SOURCE CSL Behring
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