2017 Insurance Coverage Updates: Factor VIII         IMPORTANT SAFETY INFORMATION Kogenate® FS, Antihemophilic Factor (Recombinant) and Helixate® FS, Antihemophilic Factor (Recombinant) are contraindicated in patients who have life‑threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the products. Continue reading below >     Dear Healthcare Professional,       In recent months, there have been changes announced regarding Factor VIII treatment coverage that will affect the hemophilia A community.       The purpose of this email is to provide clarification around these ongoing developments to help you and your patients make informed decisions when considering treatment choices.       ■ CVS/Caremark and UnitedHealthcare recently announced that Helixate FS, Antihemophilic Factor (Recombinant) will no longer be covered under some of their commercial prescription plans as of January 1, 2‌017       ■ Under some commercial prescription plans, CVS/Caremark and UnitedHealthcare have identified Kogenate FS, Antihemophilic Factor (Recombinant) as an alternate therapy option to Helixate FS       ■ For those affected patients deciding to remain on Helixate FS, they will be subject to the full product cost starting Jan‌uary 1, 2017       As the manufacturer of Helixate FS, Bayer realizes patients and caregivers may have questions about these changes when speaking with their healthcare professionals.       Some important information to know:       ■ Kogenate FS and Helixate FS contain the same factor (active pharmaceutical ingredient and formulation) and are manufactured by Bayer in the same facility   ■ Bayer has an agreement to supply this factor to CSL Behring, who markets it as Helixate FS   ■ Bayer's supply agreement with CSL Behring will continue through D‌ecember 31, 2‌017, at which point Helixate FS will no longer be manufactured   ■ Bayer will continue to manufacture Kogenate FS   ■ Kogenate FS and Helixate FS have different reconstitution systems   ■ Kogenate FS is covered by all major insurance companies       Your patients can learn more at ContinueFactor.com.     Both patients and healthcare professionals who have questions related to Kogenate FS coverage can call Bayer Access Solutions at 1‑800‑288‑8374, Monday through Friday, 8:00 AM – 8:00 PM (ET), for more information.       INDICATIONS       ■ Kogenate® FS and Helixate® FS are Antihemophilic Factors (Recombinant) indicated for:         ■ On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.     ■ Perioperative management of bleeding in adults and children with hemophilia A.     ■ Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre‑existing joint damage.     ■ Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.       ■ Kogenate FS and Helixate FS are not indicated for the treatment of von Willebrand disease.       IMPORTANT SAFETY INFORMATION       ■ Kogenate FS and Helixate FS Antihemophilic Factors (Recombinant) are contraindicated in patients who have life‑threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the products.   ■ Hypersensitivity reactions, including anaphylaxis have been reported with Kogenate FS and Helixate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Kogenate FS or Helixate FS if symptoms occur and seek immediate emergency treatment.   ■ Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate FS and Helixate FS predominately in previously untreated patients. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.   ■ Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII.   ■ Serious adverse reactions seen with Kogenate FS and Helixate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high‑titer inhibitors necessitating alternative treatments to factor VIII.   ■ The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin‑related hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) associated infections.       For additional important risk and use information, please see full Prescribing Information for Kogenate FS and Helixate FS.       You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑8‌00‑FDA‑1088.       Bayer is committed to supporting the hemophilia A community with a variety of patient and community support programs. We will continue to provide relevant managed care updates if and when they become available.       If you have any questions about Kogenate FS, you can reach out to your Bayer Representative.       Sincerely,       Doug Grant       Vice President and General Manager, U.S. Rare Diseases       Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. Helixate is a registered trademark of CSL Behring. © 2017 Bayer.    All rights reserved.    02/17    PP‑575‑US‑2803       Please note: this e-mail is not monitored for replies. If you would like to contact us, please visit our Contact Us section online.