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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.

Your New Secret Weapon

For me, documentation has always been key, and I’ve kept everything from my past. 
Actress Diane Keaton

I can’t say I’ve kept everything from my past, but I’m pretty good at recording things. Part of that is the journalist in me, part of it is the economist I used to be. When my first child was born with hemophilia, it seemed natural to me to use a spreadsheet to record every single bleed and outcome, log in every single vial of factor with lot number and assay size, and record every single doctor’s visit. I thought everyone did that. Data is valuable.

Data and documentation may also be your secret weapon in the new health care environment. None of us really knows yet how the new administration will affect the Affordable Care Act, but it’s trying to repeal it. While we wait for the dust to settle, the single best thing you can do right now, if you are not already doing it, is document everything. Every bleed. Every vial of factor. Every doctor’s visit. Every Explanation of Benefit  (you are receiving them, right?). Every insurance paper. And above all, every phone call to your insurance company.

As someone who never documented phone calls, I learned the hard way how important this is. About 12 years ago some unsavory characters (not from the hemophilia community) had a business run-in with me and it required legal mediation. As my lawyer and I sat across from them and their lawyer, I was shocked, annoyed and impressed that they had documented every single phone call we had ever made, and were even quoting me! Even while I fumed, I thought, What a great idea. Note to self: document all calls.

And so I do. It’s been helpful for recalling details, promises, and problems. It impresses people. It frees me up to not try to remember everything later on.

You don’t need to document to impress people, but you will be glad if you document your insurance calls. You may one day need these notes to waive a fee, to get a reimbursement, or to file a complaint. Something tells me we’re in for a lot of patient complaints down the road!

Hemophilia Federation of America has made documentation easier. Their Patient Insurance Log Book has pages already set up for you to log in calls. And at the end of the book is a complete glossary of insurance terms, and even the procedures to file a complaint for each of the major insurance companies! 

So get your secret weapon ready: order a Patient Insurance Log Book and record everything regarding insurance. It can save time—and money—someday.

Order the Patient Insurance Log Book at www.hemophiliafed.org or call 800-230-9797.

Rx for Post-Inauguration Healthcare Uncertainty

To live in freedom, one must grow used to a life full of agitation, change and danger. — Alexis de Tocqueville

The inauguration is over and we have a new president. The day after the inauguration, mass protests for women’s rights occurred in major cities across America.  There’s a predominant feeling of fear and uncertainty in America now, perhaps more so than with any other new president that I can ever remember. Some of it is reflective of the times we are in: wars in the Middle East, radical terrorist groups, manufacturing decline and job outsourcing, dictators with their fingers on threatening global weapons and a seeming hatred for America. Uncertainty clouds our future look at the economy, international stability, and above all for families with bleeding disorders, the fate of the Affordable Care Act.

I recall in 2008 we hit the road to present our symposia “Pulse on the Road” to several states each year, to alert our community to the coming insurance reform. In 2009 so many audiences we met with had no clue what was about to happen. Insurance caps, copays, tiers, PBMs, formularies, Medicaid changes, preauthorization—this was all new stuff. Around 2011, we noticed a marked change. Audiences were picking up all the terms and concepts. Why? They were beginning to experience the changes. Some of the changes were brilliant: no caps! You could get as much factor as you needed. No pre-existing conditions! Really, anyone with hemophilia should be able to get insurance. And limits to out-of-pocket costs. The Medicaid expansion gave people in some states eligibility. Millions of people accessed healthcare that didn’t have it before.

But the “affordable” in Affordable Care Act was always suspect to me. Who was going to pay for these changes? No annual caps and no lifetime limits meant we could get the drugs we needed, a blessing for those with chronic disorders. The parents of children with hemophilia who burned through $1 million of coverage in a few years would have had to change insurance or change jobs even. Some parents simply couldn’t do that. Now, no longer, thanks to the ACA.

But we saw that insurance companies—payers—were being hit with the skyrocketing costs as a result. Their countermove was not surprising: cost-shifting to consumers. This manifested in different ways: restriction of choice. You suddenly couldn’t get the specialty pharmacy you wanted. Next came restrictions of drugs to a formulary. You could get factor but maybe not the one you want. Higher copays—way higher. Higher premiums. The benefits that seemed so great suddenly had a consequence that bit into our disposable income while restricting access to some of the therapies we wanted.

The ACA became a double-edged sword. Payers were fighting back.



President Trump, as he pledged, on his first day on the job, issued an executive order addressing the Affordable Care Act, basically seeking repeal of it. Now, nothing can happen overnight. The administration needs heads of the departments of Health and Human Services, Treasury and the CMS Administration and IRS Commissioner to be confirmed in order to act on this executive order. This will take time.

While we wait, the best advice our Pulse on the Road team kept giving our audiences in these truly uncertain times:

1.     Read your insurance plan every year at enrollment time. So much is changing so fast, and you must know the print, and the fine print. Don’t ever assume that just because you have the same employer, same insurer and same plan, things are staying the same.
2.     Calculate annual out-of-pocket costs. You need to have a few thousand saved up just to cover rising coinsurance, copays and deductibles.
3.     Sign up for your factor manufacturer’s co-pay assistance program. They all have them, and from what the manufacturers tell me, a lot of people in the bleeding disorder community are not taking advantage of them. Big mistake!
4.     Sign up for a free factor program. You can get limited free trial doses of a different product from what you are on; or your factor manufacturer may have a compassionate program to keep you, the loyal customer, with factor until you can get insurance to cover you.
5.     Talk to your social worker at your HTC and/or your state hemophilia organization to get up-to-date information about what’s happening in your state, with your plan.

It’s going to be an uncertain time for a while, but the bleeding disorder community is one of the best medical patient communities for advocating for its needs, and for keeping informed. Sign up at www.hemophilia.org or www.hemophiliafed.org for current news about the ACA, and health care reform and repeal as it relates to bleeding disorders.

The Mountains are Calling…

The mountains are calling, and I must go. —John Muir

What is it that makes someone crave climbing hard, cold, dangerous mountains? Is it the challenge? The view? The bragging rights?

I never knew I loved mountains so much until I was well into my 40s and took up rock climbing on a whim. And that was in a gym. When I tried it outside, on New Hampshire’s Cathedral Ledge, a 500-foot sheer drop, I was hooked forever. A combination of fear, exhilaration, adrenaline, relief, and a huge sense of accomplishment flooded me. I knew very well there was a chemical aspect of this as endorphins coursed through my blood, making me feel drunkenly happy. Welcome to my new addiction.

I also knew that the intense concentration I had just experienced for four straight hours made me completely forget the world, any worries, the future, the past. Everything was reduced to, “Find that next nub to put your toe on and hang on for your life.” It was remarkably clarifying, much like skydiving, or even playing a complex piano piece. Such intense focus actually relaxes the brain when you finish the jump or performance. It’s like meditation.

And then, there’s just something inexplicable to me about rocks. I love them. I love the sight of them, color, feel. When I see a pretty rock at my feet, I pick it up to examine it. When I drive down the highway, I scan the dynamited masses on either side and imagine trying to scale them. When I am in Utah, my rock mecca, I just gape at the surreal world of red, striated rocks that reveal the history of the earth, the mesas, the hoodoos. When I get close to rocks, I feel something; energy? I know some people swear by the healing power of certain rocks. I don’t know about that, but I do know being near them makes me feel connected to earth, to life, to the universe.

My view of Kilimanjaro August 2016

Climbing is less about the view, and more about the journey, overcoming fears, pushing yourself to extreme limits, wringing out every ounce of strength (and oxygen) in you to see how much you can handle. It’s a psychological test set among the most beautiful places on earth.

Last summer I couldn’t wait to jump out of bed once or twice a week at 4:30 am, grab my gear, and head north to New Hampshire’s Mt. Washington for a 7-hour strenuous hike. You finish utterly wiped out, starving, grimy, sweaty, and deliriously happy. That was in preparation for Mt. Kilimanjaro last August.

Now I am training again—for Everest base came, in two and a half months.

Chris Bombardier

I’ll be following in the footsteps of mountaineer Chris Bombardier, person with hemophilia B, friend, and fellow board member of Save One Life. Chris also loves mountains, and he is lucky enough to live in Denver, and grew up among rocks. Chris is attempting to complete the Seven Summits, the highest mountains on each of the seven continents. He’s completed five to date (though has “temporarily” been denied access to Mt. Vinson in Antarctica due to his hemophilia). Well, when he was denied, he thought, “I’ll show them! I’ll just climb Everest first!” So Chris will be attempting to summit Everest in early May!

If successful, Chris will become the first person with hemophilia in history to reach all Seven Summits.

He’s done five of them: Kilimanjaro (Africa), Aconcagua (South America), Denali (North America), Elbrus (Europe), and Cartstenz Pyramid (Australia). Now, just Everest in Nepal and Vinson in Antarctica remain.

You may know Chris, a rising star in the hemophilia community. I first met Chris in 2011 at NACCHO, when he was about to climb Kilimanjaro with his uncle, and I was about to climb it a few months after him as a fundraiser for Save One Life. He shared his dream and I heartily approved and told him I would help if at all possible. I’ve followed each of his summits; we helped fund one of them. When no funding seemed apparent and he would get downcast, I told him to stay positive, it will happen; nothing will stop someone with such big and noble dreams. And sure enough, the funding for Everest was daunting, for anyone but especially a young man from Denver. But luckily, I’m not the only one who believes in Chris! Octapharma, a privately owned Swiss company that manufactures blood clotting medicine, funded Chris’s fees and travel entirely!

Best of all, this historical event will be captured on film and made into a documentary by Patrick James Lynch, another rising star in hemophilia, and Believe Ltd.

Chris on Aconcagua, with picture
of Brian, a suffering child with hemophilia,
Chris’s motivation

And there is a higher goal, beyond challenging ourselves and setting records in the hemophilia community. Chris wants above all to highlight the gaping disparity in treatment between the developed and developing countries. And as you know, this has been a passion of mine for the past 20 years. I’m thrilled that Chris cares as much as I do about changing the lives of 300,000 people worldwide with no access to factor. In fact, Chris is betting his life on it: a climb up Everest is difficult and dangerous. Chris is taking these risks because his reward is that the spotlight will be put on those who suffer even more.

Save One Life has been working in Nepal for years and we sponsor over 80 people there with hemophilia. We helped provide funding to rebuild homes post-earthquake, and LA Kelley Communications has helped pay for surgeries. It’s a country dear to us all.

So why do we climb? To feel rare emotions—euphoria, extreme exhaustion, deep joy, eternal gratitude. To overcome out fears; to push ourselves to the limits; to do something with lasting impact—a historical climb, a movie about hemophilia; and hopefully to change the lives of our fellow community members who need our help.

And me? I’m going to base camp at 17,600 feet after a nine day hike through stunning vistas (with yaks!), spending two days with Chris, then descending, leaving him to prepare for the climb about a month afterwards. I’ll have some stories to tell, and prayers to leave for my friend, one of the bravest guys I know.

Follow Chris’s preparation and climb on his Facebook blog Adventures of a Hemophiliac.      

  

Happy New Year!

I’m taking a nice break from work and blogging while wishing everyone a happy new year!

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