Novo Nordisk

Resources for People with Inhibitors

In 2005, when I first sat with US families with inhibitors and
listened—really listened—to their challenges, I was blown away. First, by how
much they struggle: standard factor doesn’t work to clot the blood, different
treatment protocols sometimes fail, children are on prescription painkillers,
with ports and surgeries. Second, by how separated they were from the rest of
the community, shunned almost. “No one understands our challenges,” one mother
told me, “and when we share, they back away.” Hemophilia with inhibitors was
almost like a separate disorder. Third, I was amazed by how stoic and strong
these families are! And even more amazed by the lack of resources for them.
happy to say so much has changed in the US since 2005. We now have inhibitor summits,
financial aid programs, books, and even a camp! All for families with
inhibitors. At long last, our hemophilia community has embraced the inhibitor
families, and we’ve united.
I learned about the struggles of inhibitor families, I vowed to write a comprehensive
guide to dealing with and living with inhibitors—and I did! From the interviews
for Managing Your Child’s Inhibitor
emerged the need for a summer camp. A colleague took that idea and eventually
did just that. What will knowing the needs of the inhibitor community lead you
to do?
by ordering these free resources and enrolling in the patient assistance
programs. Having inhibitors is tough enough, but knowing there are colleagues
and professionals waiting to help you will ease the path forward.
Managing Your Child’s Inhibitor
Laureen A. Kelley and Paul Clement
Written by parents of children with hemophilia, this
comprehensive resource is the first and only book about inhibitors in the
world. From the parents’ and patients’ point of view, it extensively covers
topics such as pain management, surgery, family life, products, and treatment
regimens. Published by LA Kelley Communications, Inc. with funding by an
unrestricted grant from Novo Nordisk.
To order:
The Great Inhibinator!
Chris Perretti Barnes
This richly illustrated storybook introduces a preschool boy
with hemophilia and an inhibitor. He manages his feelings by becoming a
Halloween superhero called the
Great Inhibinator. Written by the mother of a child with
hemophilia and inhibitors. For ages 4–7. Sponsored by Bayer HealthCare and
To order:
Inhibitor Education Summits
The only national educational forums for inhibitor patients
to meet and learn about their rare complication. Offers lectures from experts
in the field and interactive forums with parents and patients. National
Hemophilia Foundation (NHF) provides these summits only for people living with
inhibitors, covering most travel expenses for participants.
Funded through a grant from Novo
Nordisk Inc. and Baxalta Incorporated.
For info:
Inhibitor Family Camp
Camp addresses the unique needs of children with active
inhibitors, and their families. The full weekend of education, support, and fun
is held twice yearly, with camper costs covered. Funding provided by Novo
Nordisk Inc. Camp is designed and operated by Comprehensive Health Education Services.
For info:
Novo Nordisk’s NovoSecure is a comprehensive patient support
program for patients with hemophilia A, hemophilia A or B with inhibitors,
factor VII deficiency, acquired hemophilia, Glanzmann’s thrombasthenia, or
factor XIII deficiency, regardless of product choice. Replacing SevenSECURE®,
NovoSecure allows enrollees to apply for a variety of programs, including
• Competitive scholarship program
• Life coaching with HeroPath™
• Career counseling
• Insurance support
Nordisk also offers product and copay assistance programs to eligible patients
who have been prescribed Novo Nordisk products.
For info:
1-844-NOVOSEC (1-844-668-6732)
CARE (Coverage, Assistance, Resources,
and Education) to help patients take control of their healthcare needs through
insurance and product assistance. Copay or coinsurance support may be
available to reduce out-of-pocket costs associated with a Baxalta product.
Baxalta Resource Helpline 888-229-8379
To enroll in CARE: 855-322-6282

Submit Your Application for HeroPath™ Today!

Navigating adulthood is challenging enoughfrom asserting your independence, to building relationships, to choosing a direction in life. Living with hemophilia can make this life stage even more complex, which is where HeroPath™ comes in. Apply to HeroPath™ today for the chance to work with talented life coaches and your peers to learn new skills and techniques to help you excel in your daily life and chart a clear path forward.

What: For the second year in a row, Novo Nordisk has partnered with Jeffrey Leiken, CEO at Evolution Mentoring International, to offer HeroPath™, an empowering program that offers life coach and peer support to help teens ages 16-19 and adults ages 20-25.

Who: Given the hemophilia community’s positive feedback from HeroPath™ 2014, Novo Nordisk has expanded the program so that all people with hemophilia A or B (with or without inhibitors) ages 16-25 who live in the United States and are privately insured may apply.

How: Visit the HeroPath™ website  to complete your official HeroPath™ application, which requires answering several multiple-choice questions and providing a short written explanation (up to 150 words) of why you are a great fit for the program. Not one for writing? You can provide a 60-second video explanation instead—just upload your video to YouTube™ and paste the URL into the application form. Check out the website for sample responses to help get your creative juices flowing.

When: All entries must be received by 11:59 p.m. EDT on Monday, June 15, 2015. Jeff will select up to 50 participants based on their answers to the multiple-choice questions and the level of creativity and original thought conveyed through their short-response or video entries. Entries will be judged on a rolling basis. Applicants will be notified of their selection as early as Tuesday, June 16, 2015.

Why: Up to 50 selected participants will attend one of two unforgettable kickoff weekends with Jeff, his team of expert coaches, and fellow peers.

Kickoff one: July 31-August 2, 2015
Up to 25 participants
Ages: 20-25
Location: Philadelphia, PA

Kickoff two: August 7-9, 2015
Up to 25 participants
Ages: 16-19
Location: Philadelphia, PA

Spanish-speaking coaches and Spanish interpreters will be on-site at the kickoff weekends. After the kickoffs, all participants will continue to receive personalized, one-on-one monthly coaching for the following year.

See what some of last year’s participants had to say about HeroPath™:
·        Introducing the HeroPath™ Program
·        HeroPath™: What This Program Means to Me

What parents need to know: HeroPath™ isn’t just a weekend retreat—it’s a yearlong program designed to help offer participants the tools to identify:
·        Their professional career paths based on interests, strengths, talents, and natural inclination.
·        The types of people to associate with personally and professionally
·        The kind of person they want to be (Jeff and his team will help participants give voice to their own values)

For some participants, it may be their first time away from home. HeroPath™ will allow them to meet peers with similar experiences and challenges. The program is structured to provide participants with resources to help them better manage their state, stay focused, and make better decisions under pressure.

Selected participants (and guardian if the participant is younger than 18) will receive travel details 2 to 4 weeks before the kickoff weekend once all their required paperwork is complete. A planning team also will be available via phone and e-mail in the weeks leading up to the kickoff to address outstanding questions. Details will be included in the official program welcome letter.

This is a paid announcement by BioSector 2

One Giant Leap Backward for Treatment: Novitas, WTH?*

(see update in red below!)

who knows me, knows I don’t swear. Really. Went through childbirth three times,
twice without anesthesia, and not a foul word passed my clenched teeth. (See translation
for “WTH” below.) But when I read a recent decision by a payer, I was tempted
to let loose. 

is a Medicare administrative contractor for two jurisdictions: 1) AR, CO, NM, OK, TX, LA, MS and 2) PA,
DC, MD, DE, NJ, and parts of northern VA. That’s a lot of people impacted by their decisions. Remember I’ve been
warning you and warning you, since 2005 to be exact, that payers would be exerting more infleunce over our treatment? You do remember the “Coming Storm”
article, yes?
it’s happening. And the community has been vigilantly safeguarding our right to
access to therapies and treatment. First payers got in on the specialty
pharmacy gig. Cigna, Aetna… they all started forming their own specialty
pharmacies and could legally force you to switch to use theirs. That was a game
treatment changes. So many HTC people told me this wouldn’t, couldn’t, mustn’t
happen. How could a payer, an insurance company, have a say in what a physician
Wake up. Novitas has mandated in
those jurisdictions above that if patients use NovoSeven RT® (to treat their inhibitor)
they must infuse under the direct supervision of a physician. Like, in his office! And NovoSeven usually requires every
two hour doses to resolve a bleed.

This decision is called “local
coverage determination (LCD)” and it is troubling: 
Novitas writes “Factor VIIa
… is indicated for the treatment of bleeding episodes in hemophilia A or B
patients or with acquired hemophilia. NovoSeven, as noted in the Prescribing
Information for the product, should be administered to patients only under the
supervision of a physician experienced in the treatment of hemophilia. Novitas
notes this product would not be appropriate to be used in a self-administration
situation and the supervision should be ‘direct’ as in ‘incident to’ in an
office under Part B Medicare.”

Uh oh. As noted in the Prescribing Information? True. The Novo Nordisk
PI that comes with the product does say “Administer NovoSeven RT to
patients only under the supervision of a physician experienced in the treatment
of bleeding disorders.” Yikes. It’s not what we meant to say! But Novitas is
taking us literally, so yeah, they do have a case there.  
But, according to the Social Security
Act, Medicare allows for hemophilia patients deemed competent to administer at
home. Without medical supervisions. Like, the way we have been doing it for
years. And it doesn’t say everyone except
NovoSeven users. So Novitas, yeah, you are restricting treatment against what the federal government allows.

And NHF’s MASAC recommendation #227
specifically says patients should always keep doses on hand for emergencies
(like, at home).

So what’s a manufacturer, pharmacist, or patient to do?
Well, Barb Forss of Washington figured that
one out. She’s a severe FVII deficient patient who self-infuses NovoSeven RT
daily for prophylaxis, and every 3 hours for a bleed, until it’s resolved.
 She’s been using this product for over 14 years.  Is she supposed to
go to her HTC every time she needs treatment? She would have to move in with
her HTC team whenever she as a bleed. I hope they have a nice room with a view for
her there.
But Barb doesn’t want a new apartment in a
hospital. She wrote to Novitas, and said, “I went undiagnosed for 47 years. I
was hospitalized over 50 times and tethered to an infusion pole for days and
sometimes even weeks.  If they threw enough [fresh frozen plasma] at me, I
would eventually stop bleeding, then sometimes start again after being released
from hospital.  You can’t imagine how the quality of my life has improved
being able to self-infuse my NovoSeven and avoid hospitalization from bleeding
for the first time in my life.” She adds: “If this decision were to come down
in WA state when I’m on Medicare next year, that would mean I would need to
drive 220 miles roundtrip, daily, just for my prophy infusion at my HTC in
Seattle.  And I suppose just bring an overnight bag and camp out at my HTC
for the duration of any internal bleeds so that I could be monitored by my
doctor, right?”
I think Barb is close to swearing.
In case Novitas still doesn’t get it, she
adds:  “Please reconsider this determination.  Every patient I know
who uses NovoSeven can self-infuse blindfolded, it’s as easy as pie and does
not require a doctor to be there.”  
Novo Nordisk wrote in as well, asking to change the PI text to  “Initiate treatment with NovoSeven RT
under the supervision of a qualified healthcare professional experienced in the
treatment of bleeding disorders.” Then the patient can take over (like we always
know the Hemophilia Alliance, NHF and HFA are all mobilizing to get this
time is running out. This decision took effect April 9. Barb tells me there is
a 45-day response window. We need to let Novitas know this is not a good
decision, and must be rolled back.
Noviats does allow you to challenge the decision,
but only individually: “If changes or revisions to the policy are to be
considered, you must submit a LCD Reconsideration request which can be found on
our website at:  This process is a mechanism for interested parties to
request a revision to an LCD.  Requests must be submitted in writing, and
must identify the language that the requestor wants added to or deleted from an
LCD. Requests must include a justification supported by new evidence, which may
materially affect the LCD’s content or basis.”
Blah. Lots of words and work. But we will do
it, until our community rolls it back. Hey, if we can get ABC to eat their
words about hemophilia being a result of inbreeding, and have them redo a sitcom,
surely we can get Novitas to change this horrible decision.
Ironically, in the signature of the email of
the Novitas CMD Research Analyst, Medical Affairs, who is responding to the
community, is this thoughtful little quotation:
 “It is not what you do for your
children, but what you have taught them to do for themselves, that will make
them successful.” –Ann Landers

That means
everything except self-infusion with Novo Seven RT, I guess.
For more
info and to get involved, contact NHF at 212.328.3700,
Contact the Novitas rep at (717) 526-3785.
the heck?

 Great Book I Just Read
Dead Wake: The Last Crossing of the Lusitania
Erik Larson [Kindle]
Larson is one of America’s best historical storytellers and his latest
book, on the 100th anniversary of the sinking of “Lucy” on May 7, 1915,
is fantastic. He deftly weaves together WWI history, politics, engineering of
these empresses of the sea, and personal stories of individuals on board. A
tragic tale, Larsen shows how plenty of intel was available that could have prevented
the sinking of Cunard’s masterpiece by a single torpedo from U-20 and the
deaths of over 1,700 people. Still, no one would believe that Germany could
fire upon a passenger ship. Contrary to popular belief, the sinking did not
bring the US into the war, not right away. Another 2 years would pass. Five/five

UPDATE 5.12.15 from NHF: “NHF is aware of the Medicare contractor, Novitas’ new local coverage determination on clotting factor coverage and its policy that patients infusing NovoSeven may not self-infuse in the home.  NHF staff, joined by HTC Medical Directors from LA and PA have spoken with Novitas’ Medical Director about our concerns with this policy and have provided Novitas with requested literature on this subject.  In addition, MASAC, at its last meeting passed a resolution recommending that self-infusion of inhibitor treatments is the current standard of care.  This information will also be sent to Novitas.

We suggest that patients on Medicare living in states under Novitas’ jurisdiction, who are on NovoSeven talk to their HTC about the impact of this policy on their care.  Together with the HTCs, patients can determine whether there is a need to contact Novitas. “

April 17: World Hemophilia Day!

Friday was World Hemophilia Day, celebrated in honor of the birth date of Frank Schnabel, the founder of the World Federation of Hemophilia, based in Montreal, Canada.

All across the globe hemophilia organizations arranged to have famous landmarks lit up in red at night in solidarity. As well, many people in various companies and nonprofits wore red, as a sign of solidarity.

I was asked to speak to employees at the new Novo Nordisk plant in Lebanon, New Hampshire, where  the new product Novoeight, is being made. It was a lovely two hour ride from my home in Massachusetts. I had a quick tour of the new plant by none other than Scott Evangelos, a process scientist, but also a friend for 30 years, who ironically just happens to have been hired last September by Novo Nordisk. Not only is he a family friend, but his wife Sara, has been my editor for 20 years. All the things you read from us, from books to newsletters, have been vastly improved by her gifted skills in editing.

WHD in Tunisia

I spoke about hemophilia, its complication, treatment and of course inhibitors, as Novo Nordisk makes an inhibitor drug, Novo Seven RT. Half of my talk was dedicated to the 75% of our community which lacks treatment, and I shared slides of some of the families I have met on my journeys.

WHD in Pakistan
WHD in Seattle!

Unlike everyone there, who all wore read, I wore white, to show my solidarity for those who do not get treatment. Due to company policy, I was unable to take photos! It was a lovely event, and I hope the employees have a better sense of our community, and their new role in it. It was a pleasure to tell them “Welcome to our community,” for they belong as well as the patients.

Thanks to Sue Clark for arranging this great event!

Great Book I am Reading
Stiff: The Curious Lives of Human Cadavers [Kindle]
by Mary Roach

Mary Roach has done it again. Taken an offbeat topic–what happens to the human body after it dies?–and at once educates and entertains. From the ancient Egyptians, to medical research, to cosmetic surgery to crash tests, she shows us all the ways we use corpses. Roach interviews and gets the facts and stories, but also inserts herself in the story and her thoughts, which are witty and hysterical. She is a gifted writer with tons of curiosity. The human corpse has contributed much to our understanding of the body and world, making our lives better and safer. Read this to learn, to grow in appreciation and for a good laugh! Four/five stars.

Celebrating Life at NHF

With my heroes Vaughn Ripley and
Barry Haarde

The beautiful speech given at NHF by chair Jorge de la Riva stressed caring, and the dangers of indifference. Jorge, the father of a teen with hemophilia, deftly drummed home by a quotation from Holocaust survivor Elie Weisel, whose book Night, I just reread a few weeks ago:


“The opposite of love is not hate, it’s indifference. The opposite of art is not ugliness, it’s indifference. The opposite of faith is not heresy, it’s indifference. And the opposite of life is not death, it’s indifference.” ― Elie Wiesel

How appropriate to use Weisel to remind our community that if we do not watchdog our own interests, we may be hurt–again. And this is why the theme of this year’s meeting was “Nothing about us, without us.” More and more, NHF (and HFA and other groups) are steering the interests of the community, from research, to data collection, to blood supply safety, to genotyping. We’ve come a long way in 20 years, and paid a hard price.
Derek Nelson and Chris Bombardier

Val Bias, CEO of NHF and person with hemophilia, gave a speech on the many and exemplary accomplishments of not only the NHF but of various groups and individuals in our community. During the videos shown, I thought instead of two people who have done extraordinary, history-making things in our community, just this year—Chris Bombardier, the first person with hemophilia in the world to conquer four of the seven summits. And Barry Haarde, who has now ridden his bike three times across America, to bring attention to the public of hemophilia and HIV. It’s nice that we showcased who we did, but Chris and Barry volunteered weeks of their lives to do something no one else has ever done, which are extraordinary feats even without hemophilia!

We did acknowledge them, at the Save One Life Celebration on September 17 at the Intercontinental Hotel in Washington DC, just before NHF kicked off. It was a lovely event, with about 77 attendees, including donors and sponsors. We honored special people who have helped make Save One Life a success so far:

 Over 1,300 people with hemophilia in 12 countries who live in poverty supported directly with financial aid 80 scholarships to foreign individuals since 2012 8 micro enterprise grants in 2014
Over $1.5 million in direct aid!
Laurie with friend and colleague Val Bias, CEO of NHF

All this goes to people who live on the fringe of life, the poor, the suffering, in places like India, Zimbabwe, Pakistan and Honduras. And we honored Chris and Barry who have raised so much money for us. And our Inspiration Award went to Mark Skinner, former NHF president, WFH president and current WFH USA president (and personal friend) who has inspried me for many years with his brilliant insights, his compassion for the poor and his endless volunteerism. Accepting the award for him was Mike Rosenthal, executive director of WFH USA. We were surprised and pleased to see Doug Loock in attendance, who, back when he worked for the American Red Cross in 2000, gave us our first grant, and was the first supporter to help us!


Thanks to NHF for allowing us to hold the even at their event (thanks, Val!); and to ASD Healthcare (thank you, Neil  Herson!) for being our major supporter of the event. Also thanks to Baxter, Novo Nordisk and CVS Health for supporting the event.

Best news of all? We picked up 30 more sponsored children as a result! 
If you want to learn more or support a child, please visit


Laurie with Neil Herson, president of ASD Healthcare, accepting award for Chris Bombardier
Usha Parasarathy accepting award for Program Partner of Year

Great Book I Just Read
Blood Meridian [Kindle]
Cormac McCarthy

The author of No Country for Old Men does it again. This is a masterpiece, an American classic, written with such skill and depth that you cannot skim, cannot rush; it has to be savored, thought about, explored. The main character, a young man only referred to as “the kid,” runs away from home in the south and heads west in the 1800s. He meets many groups and characters, but ultimately joins a scalping posse, intent on capturing as many Indian scalps to sell as possible.  Like many of McCarthy’s stories, the theme is bleak, desperate, dusty and desolate, like the land the kid crosses. The main theme seems to be that evil lurks everywhere: there are no good guys or bad guys in the Wild West: just survival. And every single person, whether Indian, white, male or female, harbors evil deep within in the quest for survival. It’s a somber read, but the writing style alone is like a delicate fabric of words, woven so that you see no seams, only a beautiful, dark, and captivating cloth; worth reading if you want to read something by a master. Five our of five stars.

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