Last week, Bayer announced through a meeting and then letter to patient organizations that it is discontinuing its product Kovaltry. Here is the text of that letter:

Dear Kogenate FS Patients, Caregivers and Healthcare Providers,

Bayer is proud of its legacy in serving the hemophilia A community with its family of rFVIII products, which includes Kogenate FS, Kovaltry and Jivi. Kogenate FS has been used by patients since its approval in 1993, while Kovaltry (2016 approval) and Jivi (for patients 12 and older, 2018 approval) are more recent additions to the Bayer hemophilia A family.

Recognizing the growing shift in patient use away from older standard half-life rFVIII products, such as Kogenate FS, towards more recent standard and extended half-life rFVIII products, such as Kovaltry and Jivi, Bayer has made the decision to discontinue Kogenate FS. Keeping the needs of patients, caregivers and healthcare providers in mind, Bayer has carefully considered that you will need sufficient time to consider and make decisions about your next treatment. The timing of discontinuation will vary by Kogenate FS vial size. Customer demand may lead to depletion of the larger vial sizes of Kogenate FS during the fall of 2022. Remaining Kogenate FS vial sizes are anticipated to be available into 2023.

Kovaltry and Jivi are available to meet the needs of patients currently taking Kogenate FS.

  • All children, adolescent, and adult patients currently taking Kogenate FS who would like a rFVIII product with similarities to Kogenate FS should talk to their healthcare provider about transitioning to Kovaltry. Kovaltry also offers patients currently on Kogenate FS the opportunity to stay on the same dose and frequency.
  • All adult and adolescent patients (12 and older) currently taking Kogenate FS who are interested in an extended half-life (EHL) product should talk to their healthcare provider about transitioning to Jivi. Jivi has a twice-weekly starting dose and, based on bleeding episodes, the potential to step up to every 5 days dosing and fine tune. More patients taking factor VIII treatments have transitioned to Jivi than to any other EHL product in 2020 and 2021*.
  • Both Kovaltry and Jivi use the same Vial Adapter reconstitution device as Kogenate FS and offer the same comprehensive patient support services through Access Services by Bayer™.

It is important for Kogenate FS patients to work with their healthcare provider as they transition products.

Bayer has developed a variety of resources to help as Kogenate FS patients, caregivers, and healthcare providers consider a transition to Kovaltry or Jivi. These include:

  • Stories from Kogenate FS patients who have already transitioned to Kovaltry or Jivi (available on explore.bayer.com)
  • Our Access Services by Bayer™ patient support programs. Through our Free Trial Program, Kogenate FS patients who would like to try Kovaltry or Jivi can receive 1 month of free product, regardless of insurance type or status†. Also, through our $0 Co-Pay Program, most commercially insured Kogenate FS patients who transition to Kovaltry or Jivi can receive either product for as little as $0 per prescription, regardless of income‡. Both Kovaltry and Jivi are covered on 99% of commercial, Medicaid and Medicare Advantage plans nationally§.
  • A dedicated Kogenate FS Hotline. Patients, caregivers and healthcare providers can call 1-833-40-BAYER, 8:30 a.m. – 8:00 p.m. ET, Monday – Friday
  • Our patient website (explore.bayer.com) and healthcare provider website (discover.bayer.com), which include the following information: (1) A Transition Guide, (2) Frequently Asked Questions, (3) Efficacy and safety data from Kovaltry and Jivi clinical studies, including data on patients who transitioned from Kogenate FS, (4) Contact information for your Bayer Representative, and (5) Full details on all of our patient support programs.

We very much value the opportunity to continue to meet your needs. We sincerely hope that Kogenate FS patients, caregivers, and healthcare providers will discuss whether remaining in the Bayer family by transitioning to Kovaltry or Jivi may be the right choice.

If you have questions, you can reach Fernando Andrzejevski, our local hemophilia community consultant for Bayer, at 304-616-1719 or by email at Fernando.andrzejevski@bayer.com .