Designation Reinforces the Benefit of Kcentra for Warfarin Reversal in the Inpatient Hospital Setting; Kcentra Delivers on CSL Behring’s Promise to Save Lives Using the Latest Technologies
KING OF PRUSSIA, Pa. — September 08, 2015—CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) again extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]). The NTAP for Kcentra is available through September 2016 for eligible Medicare beneficiaries treated in the inpatient hospital setting. Kcentra is the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA) 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.
“With the extension of the NTAP designation for Kcentra, hospitals will continue to have broad access to this specialty biotherapy for warfarin reversal,” said Bill Campbell, Senior Vice President and General Manager, North America, CSL Behring. “Warfarin is an important treatment for millions of people living with cardiovascular disease, but it can lead to severe, potentially life-threatening bleeding. Kcentra restores depleted clotting proteins to reverse the effects of warfarin and demonstrates CSL Behring’s promise to develop and deliver innovative treatments that save lives.”
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 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-2015-08-17/pdf/2015-19049.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[i] following a stroke, heart attack, heart valve surgery, deep vein thrombosis/pulmonary embolism, or certain types of irregular heartbeat, such as atrial fibrillation.[ii] 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.[iii]
About Kcentra®
CSL Behring markets Kcentra as Beriplex® or Confidex® in more than 25 countries. 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 benefits such as tax credits for qualified clinical testing and exemption from certain application fees.
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