Kogenate FS

Coming Changes: Kogenate® FS Discontinued

Laurie Kelley June 5, 2022

It was bound to happen sooner or later: in a community flush with hemophilia A therapies, one of them would have to give.

This past week Bayer announced that it would discontinue production of Kogenate® FS (Antihemophilic Factor (Recombinant), which has been in use since 1993. I’m nostalgic about it leaving; when it appeared, my second born was only 3. We used it at one point. We educated the community that it was the exact same product as Helixate®FS… though many parents tried to argue with me that they had different names and were from different companies, and were therefore different. They were not.

But times are truly changing. We have extended half-life (“long lasting”) products now; we have products made from a human cell line, and not hamster cell lines. We even have transgenic animal therapies. And we have Hemlibra, an injectable with a half-life of over 600 hours.

But above all, we have probably too many factor products for hemophilia A patients, who number around 20,000 in the US. How will the market justify all the products?

Our factor chart below shows 12 products for hemophilia A that are recombinant, and five products that are plasma-derived (from human blood). Some manufacturers, like Bayer, Novo Nordisk and Takeda, have multiple factor VIII products. It’s like they are in competition with themselves. Some are standard factor products and others are extended half-life.

Bayer’s press release says: “Recognizing the growing shift in patient use toward more recent products, such as Kovaltry® (Antihemophilic Factor (Recombinant)) and Jivi® (Antihemophilic Factor (Recombinant), PEGylated-aucl), Bayer has made the decision to discontinue Kogenate® FS (Antihemophilic Factor (Recombinant)) in the United States.  

“Keeping the needs of patients in mind, Bayer is keenly aware that they will need sufficient time to work with their HCP to make decisions about their 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.

“As Kogenate FS patients and their caregivers embark on the next step of their journey, Bayer is committed to supporting them. Attached, please find our discontinuation announcement for your reference. Additionally, we have set up a website (explore.bayer.com) and a dedicated Kogenate FS hotline for anyone who has questions regarding this discontinuation, (1-833-40-BAYER), which is available Monday – Friday, 8:30am – 8:00pm ET.” See the full press release here.

If you are a Kogenate FS user, it’s time to contact your HTC staff and discuss next steps. We’ve been through this before over the decades: we know that some patients want to stay with the manufacturer, and will switch to their other products. Other patients will take this as an opportunity to learn more about other products from other manufacturers. Whichever you are, be sure you make your decision with your HTC staff… not the internet! Not even with me. Call the manufacturer and speak with your HTC staff, learn more about these products, and then choose which is right for you.

And probably more change is coming, in products, manufacturers… and eventually gene therapy.

Resolve to be a master of change rather than a victim of change.— Brian Tracy

A NEW Co-Pay/Co-Insurance Assistance Program

Laurie Kelley February 3, 2013
It’s Superbowl Sunday, but take time to read this important press release: while it’s meant only for Kogenate® FS users, remember that almost all manufacturers of blood-clotting products have some kind of assistance program. I’ll post them as I hear of them, but don’t hesitate to call your manufacturer to find out what they are doing to help you with insurance!
PSI AND BAYER HEALTHCARE INTRODUCE A CO-PAY/CO-INSURANCE  ASSISTANCE PROGRAM
Patient Services, Inc. (PSI) and Bayer HealthCare are pleased to announce the Kogenate® FS
Co-pay/Co-Insurance Assistance Pilot Program. The pilot program is funded by Bayer to help qualified Kogenate® FS patients with their out-of-pocket payments.
What is offered through the
pilot program?
PSI will administer and determine eligibility for the Program to help Kogenate® FS patients afford
their copay/coinsurance expenses.
Patients are qualified to
apply for the pilot program* if they:
· have Hemophilia A.
· meet specific financial criteria for enrollment.
· currently have private health insurance.
. Who is not eligible for
assistance?
·Patients on public health insurance, including (but is not limited to) patients insured through Medicare, Medicaid, TriCare, DOD plans, PCIP programs, and High Risk Plans associated with a PCIP.
· Patients enrolled in Bayer Assistance Programs.
Once approved…
·
Financial assistance may be provided for up to 12 months or as long as funding is available. Funds administered by PSI can only be used towards a patient’s co-pay/co-insurance expenses for Bayer’s Kogenate® FS.
·
Financial assistance will be based on each patient’s specific health plan design and annual income, subject to yearly and per payment maximums.
· As a condition of payment, patients and pharmacies must comply with all contractual obligations made with Third-Party Payers and insurance companies, and must provide notice of any benefits received and the value of this program to all payers as required by law, contract, or otherwise.
For inquiries regarding the Kogenate® FS Co-pay/Co-Insurance Assistance Pilot Program, please contact Bayer’s Factor Solutions at 1-800-288-8374. Please remember that applications will be processed and patients will be enrolled on a first-come, first-served basis. Program may be cancelled or changed at any time without notice.
Interesting Book I Just Read
Ice Balloon: S. A. Andree and the Heroic Age of Arctic Exploration by Alec Wilkinson [Kindle]
The story of S. A. Andrée, the visionary Swedish aeronaut who, in 1897, during the age of Arctic exploration, convinced donors to fund an attempt to be the first to discover the North Pole by flying to it in a hydrogen balloon. The book is an easy read, and covers the history of Arctic exploration, failed attempts to reach the pole, a glimpse into Andrée’s past and makeup, his reasons for being obsessed with attempting this, despite many misgivings by experts. If you are new to readings about polar exploration you will love this adventure book. Learning about balloons, how they are handled and how they stocked it for a long haul trip was fascinating! But… the book is a mixed bag. I have been studying polar exploration for over a decade and have an extensive collection of biographies and books. So for me, this book was a bit fluffy: the writing was good, but there was a lot of filler. Six chapters alone were spent on an unrelated story about the Greeley expedition, I guess just to show how tough it can be in the Arctic? But it was disconnected to the rest of the story, and you’d be better off reading Ghosts of Cape Sabine, which is superb reading about the Greeley expedition (which is now legendary). I am glad Andrée’s story was told, but honestly, there isn’t much to his story. He went up, he came down, and his diaries, terse and factual, left little information on what happened. A lot of the book consists on just quoting directly from the diaries. This books gets mixed reviews on Amazon.com. It’s definitely worth reading, but it could have been better. Two/five stars.

Brainstorming in Naples

Laurie Kelley March 10, 2008


I spent this weekend in beautiful Naples, Florida, attending a Bayer Multidisciplinary Board meeting. This is a fascinating chance to brainstorm on concerns within the community with some talented and diverse people, to discuss current insurance trends, and hear about new ideas on treatment coming from a manufacturer.

One the most interesting segments was listening to Dr. Glenn Pierce, VP Clinical Studies at Bayer, and former NHF president, share progress on Bayer’s longer lasting formulation for Kogenate FS. While we wait for a cure, which could take years, longer lasting factor could be the next great thing for our treatment. Imagine prophylaxis that only requires one shot a week, but is as effective as three shots a week.

As always, I am humbled by how fortunate we are to have in our community so many dedicated to our welfare, and who joined us this weekend, such as Dr. Craig Kessler, currently chair of MASAC, Dr. Prasad Mathew, Regina Butler, RN, and Mike Rosenthal, formerly of the Hemophilia Association (Arizona). And as consumers we are grateful to be included in these round table, informal gatherings. This weekend I was able to see my buddy Rich Pezzillo, friend Kyle Callahan (former president of HHS), and fellow mother Shari Bender, whose husband Steve sits on the NHF board.

While I cannot share the topics we discussed, I can say that these opportunities are golden to learn and to give feedback. If anyone is offered the chance to serve on any manufacturer, HTC or home care advisory board, I strongly encourage them to participate. Thanks to Bayer for providing us all this wonderful opportunity to serve! (Photos: Rich Pezzillo and Mike Rosenthal; Craig Kessler with Shari Bender and Laurie Kelley)

Great Book I Just Read: The Truth About the Drug Companies by Dr. Marcia Angell. You may think this is a strange juxtaposition, after I just attended a drug company sponsored meeting, but I am researching an article on marketing by the pharmaceutical companies. Angell, former editor of the prestigious New England Journal of Medicine, has an axe to grind for sure, but reports on the behind the scenes maneuvers by “big pharma” as it attempts to weild influence over both consumers and law makers. While this is mostly about pharmaceuticals (pills) and not biologics (typically injectibles, like factor) it nonetheless will open your eyes and make you more critical when you order or purchase any pharmaceutical product– and critical when you meet with your physician. Angell describes practices such as how the drug companies influence physicians to prescribe their products through gifts, junkets and marketing programs. Most interesting is her claim that the cost of marketing is much greater than the cost of R&D. It’s well known that the drug industry is America’s most profitable, and she discusses some of the reasons why this is so, and perhaps why it should not be so. Not totally applicable to the factor industry, but it is excellent food for thought. Three/four stars.

Dr. Craig Kessler, Shari Bender, Laurie Kelley
Cheers!! Rich Pezzillo and Mike Rosenthal
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