Name Game, Game Change?

I’m thinking “game” this weekend because the Patriots are in the Super Bowl, again, and I will need to watch it like the rest of Boston. I only watched my first football game two years ago when, surprise surprise, the Patriots were in the Super Bowl. Every sports fan knows the Patriots, I am told. It’s easy to cheer for your home teams when the names (Red Sox, Patriots, Bruins, Celtics) endure for decades. It’s harder when it’s the drug companies that make your factor concentrate. There’s a lot of game changing going on lately.

The news was announced just three days ago: Biogen, maker of Eloctate and Alprolix, has spun off its hemophilia division, which has now become an entirely separate and new company called Bioverativ.

Biogen’s two revolutionary products, the first ones with a longer half-life, were game changers. Now there are a few more choices for longer half-life products, but these were the first and were rolled out with much fanfare. Then boom! Three years later, Biogen doesn’t want them anymore.

This is just a reminder to us patients that this is a marketplace, and we are consumers. And companies need to make business decisions—hence the “game.” As consumers, it’s up to us to understand how the game is played, and who are the players. The names have been changing, more rapidly than I can keep up with in the specialty pharmacy arena, and those are truly game changers.

In the factor concentrate manufacturing arena, we had two name changes just in the last few months: Biogen to Bioverativ, and Baxalta to Shire. But this has been happening for years in our community, so here’s a review. It’s worth knowing the players—of which YOU, the consumer, are the most important!

Remember Alpha? Those of you who use Alphanate or Alphanine may wonder why these drugs are called that when sold by the Spanish company Grifols. Simple: Grifols bought Alpha Therapeutics hemophilia therapies years ago and simply kept the drugs’ names the same. (It’s hard to change a drug’s name.) In 2011, Grifols also bought Talecris, making it the third-largest global manufacturer of plasma-derived therapies. Oh, and Talecris? It was a spin-off from Bayer, which didn’t want to keep plasma-therapies anymore. Bayer’s plasma-product Koate-DVI went to Talecris, and Bayer kept Kogenate FS. If you look at the Koate-DVI packaging, you’ll still see the Bayer primary color line around the box!

Baxter Healthcare produced factor concentrates like Recombinate, Advate, Hemofil M and FEIBA. It spun off its hemophilia division, which became an independent company called Baxalta. That didn’t last long. Shire, an Irish pharmaceutical company, liked what it saw and scooped it up. All the former Baxter/Baxalta products now belong to Shire.

The biggest name changer is CSL Behring. I knew it in 1987 as Armour Pharmaceutical. Then in 1996, Armour and Behringwerke (a Geman company) formed a joint venture known as Centeon. Things happen fast: in 1999, Centeon became Aventis Behring. Why? Armour’s parent companies (Rhone-Polenc Rorer and Hoechst) merged to become Aventis. Meanwhile, CSL (an Australian plasma therapies manufacturer) acquired ZLB Blood Transfusion Services. In 2004, CSL acquired Aventis Behring, to form ZLB Behring, later called CSL Behring.

(There’s a comprehensive timeline of this interesting company here.)

Genetics Institute: anyone remember that? They developed BeneFIX and ReFacto (no longer on the market). It evolved into Wyeth, and then was bought by pharma giant Pfizer Inc.

Bayer is one that seems to have stayed the same, but it’s had name changes too. Bayer bought Cutter Labs in 1978 and Miles Labs in 1979. In 1995, they all became Bayer. I think Novo Nordisk (Denmark) has stayed the same… so far!
And some companies dropped out altogether, like the American Red Cross.  And new ones entered, like Octapharma (Switzerland) and Kedrion (Italy), tapped to distribute Koate DVI for Grifols. And Aptevo Therapeutics… oh, which was owned by Cangene (Canada) first, then Cangene was bought by Emergent Biosolutions in 2014! And they all originated from Inspirational Biopharmaceuticals, which in 2013 sold all its product rights to them, and dropped out of the game.

More passes than Tom Brady!

Whew! It’s amazing tracking the history of just the name changes: but we also need to know products. We are tracking who makes what on our website Hemophilia Factor Chart by Brand, available as a download. We are updating it all the time… a necessity to keep track of this ever-changing game, and business.

Baxalta, now part of Shire

Powered by their commitment to you.

There’s been a lot
of change in our community this year, but perhaps none so impactful as the
change in Baxalta, now a part of Shire. Please read below to learn more about
these changes, and click through to learn how Shire will keep on serving you!
Shire, is built on
strength and experience, and is powered by an enduring commitment to you. Each
company brings world-class products, as well as, a foundation for sustained
category leadership in rare diseases.
Combining 60 years
with 30 years of dedicated history to bleeding and rare disorders communities,
the new company has even more resources to offer. What that means for patients
is that Shire is maintaining its solid commitment to you while still offering
innovative products. Introducing new treatments for bleeding disorders, and
making a meaningful difference in the lives of patients and families continues
to be Shire’s main focus.
Shire’s combined
product offerings have expanded the range of therapeutic areas. Shire and
Baxalta are combining 30 years with 60 years of dedicated history to the rare
disease and hematology community. Together they are commitment to the
hematology community.
This is a paid announcement by Baxalta, now part of Shire.
August 2016

USBS/MG1/16-0527a

Pulse on the Road in Sunny California

Speakers Michelle Rice, Kelly Lynn Gonzalez, Laurie Kelley

Warmer than the
California sunshine was the greeting the Pulse on the Road speakers received
when visiting Buena Park on May 13. Executive Director of the Hemophilia
Foundation of Southern California Michelle Kim opened the Friday night event by
welcoming the large audience, who had just finished a delicious meal, and
introducing me, Michelle Rice (vice president public policy and stakeholder
relations, NHF), Paul Clement (science editor, PEN), and Kelly Gonzalez, person
with von Willebrand disease and mother of a child with the same.

See all photos from the event here.
Volunteers Patti Huerta, Linda Clement and
Randi DeSantis
Intro by Michelle Kim

The focus this time was
on access to product choice. Michelle Rice opened the event by speaking about
the many ways payers might choose to block choice of product—and why. Skyrocketing
drug costs combined with a plethora of new biological drugs, and not just in
hemophilia, are breaking the budgets of states and insurers. To contain costs,
payers are looking for ways to streamline contracts with the various
pharmaceutical companies. Payers might attempt to restrict brands under their
formulary. This means you must read your formulary to see if your brand is
covered. They also might attempt “step therapy,” which allows you to keep your
brand, even if it is not on formulary, but only after you “fail” at the
approved brand. What does fail mean? The drop fails to stop your bleeding. This
approach seems quite risky for those with bleeding disorders.

 
My talk followed
Michelle’s and I focused on what you need to know about product choice in order
to challenge your payer to keep the drug you want. Kind of like a Hemophilia
Products 101. We started with the basics: plasma-derived versus recombinant. Safety
versus purity. First, second and third generation drugs. Prolonged half-life
products. And what’s in the pipeline… and that was at once exciting and scary!
You can see that if you are a payer, you will soon be deluged with new
products. I asked the audience to guess how many factor VIII and IX drugs there
are currently on the market. They replied, six? Ten? How about 24! And more to
come.
The evening finished up
with Kelly Gonzalez’s riveting take of how she took control of her own health care
in the face of apathetic payers who did not understand VWD or her needs or that
of her daughter. Kelly’s story is a model for anyone looking to achieve success
in securing products and services. It’s dramatic, gut-wrenching and
inspirational!
When we finished, we had
the audience choose by applause where they’d like a donation from Pulse on the
Road to go, and the Emergency Fund won. POTR gave $1,000 to the HFSC in recognition
of its advocacy and great work for families. Michelle Kim has turned heads with
her new leadership and we look forward to more great things from this vibrant
chapter!
I recalled I first visited
this chapter in 1992, where I first met Paul Clement and wife Linda, who are
now my long-term dear friends, and also colleagues. Paul, as you may know, is
an extraordinary writer and researcher for us at LA Kelley Communications. And
I saw so many others I met here long ago. It was great to see everyone.

Thanks to Michelle and
her team for hosting us; and thanks to Baxalta for supporting this event!

The Education Advantage!

Our community is fortunate to have many different scholarships. In fact, LA Kelley Communications had the first on-line listing of scholarships for the bleeding disorder community! That’s how much I believe in a higher education. Take advantage of what the community is offered! Learn about Education Advantage below! 
Laurie 
Education Advantage – Scholarships for our Community brought to you by Baxalta 

Since 2010, Education Advantage has awarded more than 200 scholarships to US students with bleeding disorders. 
The scholarship program has grown! New for 2016, those with von Willebrand disease are invited to apply! The program continues to be open to hemophilia A, hemophilia B, and inhibitor patients. Education Advantage is open to US students, regardless of which brand of treatment used. 
Education Advantage offers three different scholarships to eligible applicants: 
• University Scholarship:  
       Up to $7,000 for students working toward their bachelor’s degree 
       Renewable for up to 3 additional years 
• Community College and Technical Scholarship:  
       $1,000 for students seeking an associate’s degree or a technical vocational certificate 
       Renewable for up to 1 additional year 
• GED Assistance:  
       One-time $150 reimbursement if you pass the GED test 
Get started on your application today at www.BaxaltaHematology.com/EA 
The application period for 2016 is open now until April 30. You can find more details about the scholarships, meet the previous year’s winners, and find out how quick and easy it is to apply at www.BaxaltaHematology.com/EA

This message is supported with funding from Baxalta
USBS/MG1/16-0041 

A NEW HEMOPHILIA A TREATMENT FROM BAXALTA

It’s a new year, and a new opportunity to check out one of the latest hemophilia treatments to come on the market – ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] from Baxalta. Later this year PEN will publish a complete listing of all current products. For now, please read about the newest hemophilia A treatment!

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] delivers proven prophylaxis with a simple, twice-weekly dosing schedule. ADYNOVATE allows you to infuse on the same 2 days every week.1

ADYNOVATE is intended for people 12 years and older with hemophilia A for on-demand treatment and control of bleeding episodes and routine prophylaxis to reduce the frequency of bleeding episodes. ADYNOVATE is not used to treat von Willebrand disease.1

You should not use ADYNOVATE if you:

  • Are allergic to mice or hamster protein
  • Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your healthcare provider if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

You may be eligible to receive 8 free sample doses of ADYNOVATE with the Freedom of Choice trial program. The program also provides resources to help you with your hemophilia A treatment. Complete the registration form here.
Want to learn more?

  • Get access to programs for people living with hemophilia regardless of treatment.
  • Download resources designed to help you reach your personal goals including a Goals Worksheet, Bleeds Assessment Sheet, ABR Calculator, and Infusion Log.
  • Visit our FAQs page for helpful questions and answers when considering your hemophilia A treatment.

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information

Indication

ADYNOVATE is used on-demand to control bleeding in patients 12 years of age and older with hemophilia A. ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).

ADYNOVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

You should not use ADYNOVATE if you:

  • Are allergic to mice or hamster protein
  • Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]
     

Tell your healthcare provider if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

You should tell your healthcare provider if you:

  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).

Your body may form inhibitors to Factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADYNOVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

You can have an allergic reaction to ADYNOVATE.
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

The common side effects of ADYNOVATE are headache and nausea. Tell your healthcare provider about any side effects that bother you or do not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the accompanying Patient Labeling. To see the Full Prescribing Information, go to www.ADYNOVATE.com.
Reference:
1. ADYNOVATE Prescribing Information. Westlake Village, CA: Baxalta US Inc.

Baxalta and Adynovate are trademarks of Baxalta Incorporated.
USBS/MG159/15-0292

The content of this blog was provided by Baxalta and its publication is sponsored by Baxalta.

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