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 forming1 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 across the U.S. see approximately 29,000 cases annually for warfarin-associated bleeding.3
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 (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse ractions 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/.
1 Zareh M, Davis A, Henderson S. Reversal of warfarin-induced hemorrhage in the emergency department. West J Emerg Med. 2011;12(4):386-392.
2 Raife TJ, Rose JS, Lentz SR. Bleeding from acquired coagulation defects and antithrombotic therapy. In: Simon TL, Snyder EL, Solheim BG, Stowell CP, Strauss RG, Petrides M, eds. Rossi's Principles of Tranfusion Medicine, 4th ed. Oxford, UK: Wiley-Blackwell; 2004: 376-390.
3Wysowski D, Nourjah P, Swartz L. Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action. Arch Intern Med. 2007;167(13):1414-1419.