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 {{accTitle}} {{accFname}} {{accLname}}, {{customText[ 1. Thank you for taking time to meet with me to discuss Kogenate FS and Helixate FS. You requested some information, and I would like to follow up with you. 2. I'm sorry we missed each other when I stopped by your office. I have some information about Kogenate FS and Helixate FS that I would like to share with you. 3. Hello, I'm a Bayer Representative. I would like to share some information with you about Kogenate FS and Helixate FS that may be useful for you and your patients with hemophilia A. 4. Although we have not yet had the opportunity to meet in person, I would like to send you some information about Kogenate FS and Helixate FS that may be relevant to your patients with hemophilia A. 5. It was great to see you recently at the NHF meeting. I would like to share some information about Kogenate FS and Helixate FS. 6. It was great to see you recently at the HFA meeting. I would like to share some information about Kogenate FS and Helixate FS. 7. It was great to see you recently at the chapter meeting. I would like to share some information about Kogenate FS and Helixate FS. 8. It was great to see you recently at the community event. I would like to share some information about Kogenate FS and Helixate FS. 9. It was great to see you recently at the meeting. I would like to share some information about Kogenate FS and Helixate FS.]}}   Important facts about Helixate FS and Kogenate FS       ■ 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       ■ CVS/Caremark and UnitedHealthcare announced that Helixate FS will no longer be covered under some of their commercial prescription plans as of January 1, 2017   ■ You and your patients can check with insurance providers for any recent changes to the coverage status of Helixate FS           Your patients can learn more at ContinueFactor.com.     Coverage questions for Kogenate FS?       ■ Access Solutions offers insurance, financial support, and trained Case Specialists to allow for a seamless transition   ■ Loyalty Program*: Can assist patients during gaps in insurance coverage. Patients who enroll today will receive a bonus of 12 points   ■ You and your patients can call 1-‌800-‌288-‌8374 8:00am‌-8:00pm‌ (ET) ‌Monday‑Friday to learn more or enroll   *Restrictions apply. Please visit KOVALTRY-us.com/hcp/access-solutions or call 1‌-800‌-288‌-8374 for more information about the restrictions.       INICATIONS       ■ 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.   {{customText[ 1. I would be glad to provide more information to help you and your patients with hemophilia A. If you'd like to speak further, please feel free to contact me at the number below. 2. Since we haven't met in a while, I would welcome the opportunity to talk with you in person about this information. If you're interested, please feel free to contact me at the number below. 3. Thank you for reviewing this information about Kogenate FS and Helixate FS. I hope it was helpful. Please don't hesitate to call me if you have any questions about the information provided or if you need additional materials. 4.Thank you for requesting this information. I am available to answer any questions you may have. Please don't hesitate to call me if there is anything else I can help with. 5. If you have any questions, I would be happy to speak further, or to set up a visit at your convenience.]}}       Sincerely,   {{userName}} {{User.Phone}} Bayer Hematology         Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. Helixate is a registered trademark of CSL Behring. © 2017 Bayer.   All rights reserved.   08/17   PP-575-US-2908   If you would like to contact us, please visit our Contact Us section online.     1‌00 Bayer Boulevard, P‌O Box 915, W‌hippany, NJ 0‌7981-0915 U‌SA   Privacy Policy       Terms and Conditions       Unsubscribe