Oncology & Hematology Coding Alert

According to the website: www.kcentra.com, 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). Kcentra is essentially a blood coagulation factor replacement product. It replaces the depleted clotting proteins and reverses the effect of warfarin which is a Vitamin K antagonist used as an anticoagulant. It is a plasma protein concentrate prepared from pooled human plasma. Blood clotting proteins that are components of Kcentra include heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin.

Your physician will use this therapy for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA) therapy, for example warfarin. Patients who will be candidates for this therapy include adults with acute major bleeding or those who are in need of an immediate surgery or invasive procedure. This therapy is administered by intravenous route.

For more information about Kcentra, you may go to www.kcentra.com. For full prescribing information, you may visit www.kcentra.com/prescribing-information.aspx. 

The FDA’s Orphan Drug Designation program: The FDA provides ‘orphan’ status to some therapies, drugs, and biologic agents which are intended for the safe and effective treatment or prevention of rare diseases. The term ‘rare’ implies that the disease should affect fewer than 200,000 people in the U.S. 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 ‘orphan’ drug status implies that the therapy or product would be entitled to some benefits which may include tax credits for qualified clinical testing and also an exemption from some application procedure fees.

FDA approval and NTAP status: Kcentra was first approved for use in the U.S. in April 2013 and this therapy received its NTAP designation effective October 1, 2013.