Blog Archive

Sunday, January 25, 2009

You Otta See the Other Guy

A quiet Sunday morning, everyone sleeping, and I am up making muffins... when Tommy calls. 8 am? I hear Slipknot's "Wait and Bleed" ringtone blaring, and answer. Tommy was in Lowell, Massachusetts last night, staying over at his apartment. Not likely he would be coming home at 8 am on a Sunday. He said he needed factor right away and left his supplies with us. What happened? He fell.

About 15 minutes later he showed up, looking like he had been in a horrible fight. Forehead, cheek, nose and upper lip swollen and scraped. His nose had bled a lot. He and his buddies had been horsing around at 2 am, when he grabbed one of their hats and ran. He must have hit a patch of what we call "black ice" and slid then fell face first, and kept going. His face scraped the pavement.

Of course we're less worried about what the outside looks like than what's happening inside. That he waited 5 hours to get factor into him was a bit disconcerting. Did he hit his head hard, and where? He isn't sure. So for the second time in a month I get infuse my adult son. His hands and elbow and knees are scraped as well. The last time he infused himself (last week) he missed the vein, and must not have held the gauze on too tightly afterwards. His hands are both completely black and blue. So we go for a vein up higher in the hand.

This is an interesting time, folks. Transitioning. As a parent you get to see if 21 years of care and instruction have made a dent in your child's understanding. You get to watch them, in many ways, struggle with all the things you struggled with when you first learned your baby had hemophilia: is he really bleeding? Must I infuse him now? Why is it always in the middle of the night? Or on a weekend? Or on a holiday? Or at DisneyWorld? How many veins can we blow in a day? How many more people are giong to ask, how did he get that shiner? (or goose egg) Why didn't I bring the factor with me???

School starts tomorrow for him after a long break. He's got some explaining to do to all the students, friends and teachers who will see him. Or not. He can just tell them the other guy got it a lot worse.



UPDATE TUESDAY, 5,000 IUs later...

We visited the ER, had a CT scan (haven't done that since he was 2?), and all is well. Only his elbow, knee, nose, forehead and pride were hurt!




Great Book I Just Read
Adrift by Steven Callahan

This is the incredible true story of one of the only persons in history to survive longer than a month alone at sea. In 1982, for 76 days, Steven Callahan, an experienced sailor, drifts 1800 nautical miles across the Atlantic, in a leaky inflatable raft he dubs the Runner Ducky when his cherished boat the Napoleon Solo is sunk during a gale. Despite the catastrophe, and his horrific struggle to survive, Steven’s name for his new home reflects a wry humor, unbridled optimism and even perspective, all of which no doubt led to his amazing survival. Aside from his amazing stamina in constantly trying to keep a solar still functional, bailing out his raft, checking his location via a home made sextant, perhaps the most amazing thing in the book is Callahan’s reverence for the dorado fish (mahi mahi) that eventually accompany him under his raft the entire way to Guadeloupe island, where he eventually lands. His relationship with the fish is almost spiritual, and even after his rescue, he worries about them and silently thanks them. Callahan still sails, and is inventor of a new raft called the Clam, which he created based on his knowledge of survival in the open sea-- a lasting gift to other sailors from his sacrifices and near-death experience. Four stars!

Sunday, January 18, 2009

Exciting News From Wash DC!!!


Tremendously great news from our nation's capital. Life is about to change for a lot of people--but it's nothing to do with a new president. Finally, a product has been approved by the US FDA for those with factor I deficiency!

It's called RiaSTAP (Fibrinogen Concentrate (Human)), and it's indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (factor I deficiency), including afibrinogenemia and hypofibrinogenemia. RiaSTAP is a heat-treated, lyophilized fibrinogen powder made from pooled human plasma.

From www.businessspectator.com.au: "The approval by the FDA requires further study after marketing to confirm the product provides meaningful benefits to patients. The safety of Riastap, derived from human blood plasma, 'appears to be acceptable,' FDA reviewers said. The drug is already sold in parts of Europe as Haemocomplettan P."

For more info, check out this site:

http://www.fda.gov/cber/products/riastap.htm

From the NHF website:

"Factor I deficiency is actually a collective term for several rare inherited fibrinogen deficiencies. Fibrinogen may be absent from the blood altogether (afibrinogenemia), present in only very low levels in the blood (hypofibrinogenemia), or measurable in normal quantities but defective (dysfibrinogenemia).

"The incidence of Factor I deficiency is estimated at 1 to 2 per million. It is inherited in an autosomal recessive fashion, which means it affects men and women equally.

"Fibrinogen helps platelets to glue together to form the initial 'plug' in response to an injury. Therefore, people with factor I deficiency, have a combined bleeding disorder because both platelets and clotting are abnormal. The severity of the disorder is directly related to the amount of fibrinogen present.

"Afibrinogenemia and hypofibrogenemia are usually diagnosed in newborns who can present with head bleeds, bleeding after circumcision and from the site of the umbilical cord. Easy bruising, nose and mouth bleeds, and soft tissue bleeds are also common. Joint bleeding is relatively uncommon. Women with afibinogenemia have an increased risk of spontaneous abortion. Persons with dysfibrinogenemia may have a disposition to thrombosis."

It's great to know there is now somethign commercially avaiable for patients. This is another great from CSL Behring.
Congratulations to all!

Monday, January 12, 2009

Stepping Over the Line

I read a great article today in the Columbia Tribune about step therapy... an insurance cost cutting measure, meant for the common good, but which has caused great concern in the hemophilia community. So far it has been attempted in the hemophilia community, but our advocates have fought and won protection against this. Read on... (edited)

Who's the Doctor?
Insurers reject prescriptions to save money.
Published Sunday, January 11, 2009
http://www.columbiatribune.com/2009/Jan/20090111Feat002.asp

Two years ago, Tracey Joyce of Webb City showed up at her local pharmacy expecting to get a refill for an anti-arthritis medication. She'd been taking the drug, Celebrex, since she had a shoulder surgery two years earlier and says it made her pain manageable.

But at the pharmacy counter she got a surprise.

"They told me, 'Express Scripts has said they won't pay to fill this,' " Joyce recalled. "'They want you to do a step program.' "

Joyce was referring to Express Scripts, the St. Louis-based pharmacy benefit management (PBM) company that administers prescription benefits for more than 50 million people nationwide. The company is contracted through Joyce's insurer, Mercy Health Plans, and is paid to lower drug costs.

Sometimes this means asking patients to try generic drugs instead of name-brand drugs and at other times to try alternative medications or alternative treatments for their illnesses. This is commonly called "step therapy" or the "fail first" approach.

Joyce, though, didn't want to fail first. She had been prescribed Celebrex in part because she has a history of ulcers, and the medication doesn't damage the stomach lining. She and her doctor agreed she needed that drug and that drug only. But the step therapy required that she try three months of Advil, Aleve or Naproxen before Express Scripts would authorize payment for Celebrex.

Joyce said she had no choice but to try the step therapy because of costs. After three months of taking the alternatives, she was "allowed" by the PBM to go back on Celebrex. But something still didn't feel right, she said.

Soon afterward, chest pains sent her to the emergency room, and doctors discovered she had six ulcers. Her primary-care physician, Andrew Roudebush, blamed the step therapy drugs, which, he said, can actually harm the stomach lining and make ulcers worse.

Above, Tracey Joyce battled with her health insurance company after a pharmacy benefit management company changed her medication to a lower-cost drug. Below, Andrew Roudebush, Joyce's personal care physician, believes the changes worsened Joyce's ulcers.

"My view is they're practicing medicine without a license," Roudebush said of the way the PBM intervened in the doctor-patient relationship.

Joyce said the decision ultimately cost her insurer more money than the drug ever would have. "I ended up with a $14,000 hospital overnight stay because they wouldn't pay for the $100 bottle of pills."

"It's been an issue with a lot of people, and it seems to be getting progressively worse," Nold said. "In general terms, this is what happens all day long." Unlike most other patients, Joyce was in a position to do something about this problem. She works as the legislative assistant to state Rep. Bryan Stevenson, R-Webb City, and she asked her boss to change the law.

"My thing is right is right, and wrong is wrong," Joyce said. “Doctors went to medical school, doctors did all the training and they have to keep a license. Let's let them practice medicine instead of the clerks that are on the other end of the 1-800 line."

Only a doctor can write a prescription, but doctors say insurance companies are second-guessing their decisions.

MANAGING DRUG COSTS

Step therapy grew in popularity earlier this decade as costs of pharmaceuticals skyrocketed. Express Scripts, for example, said the use of step therapy among its members grew from 4.5 million at the end of 2002 to 11.7 million in 2004.

The company touts the savings of the programs. A 2004 study by the American Journal of Managed Care indicated implementing step therapy programs for three main drug classes--drugs used to treat ulcers, depression and arthritis, respectively -- reduced total costs for those classes by 38 percent during a two-year period.

Express Scripts labels drugs as "front-line" and "back-up" drugs for certain chronic conditions like high blood pressure and arthritis. Front-line drugs are typically cheaper generics, and back-up drugs are the name-brand versions.

"Step therapy programs are only developed in therapy classes where the generic and brand-name options are considered highly interchangeable," Palumbo said. This is "based on clinical practice guidelines, primary literature and/or feedback from practicing physicians."

Palumbo added that in "rare instances" where it's necessary, the company has an exceptions process that allows doctors to override the PBM step therapy. But for physicians like Roudebush, the exceptions process is frustrating. Roudebush said he has had little luck with the override option and has found the back and forth wrangling with PBM clerks and nurses takes several days and usually ends with a "no" from the PBM.

Step therapy, he said, is often not a choice between two equal options. "They're just making a financial decision, which I respect, but I don't feel like I frivolously prescribe medicines that are the most expensive," he said. "I think I use what's best for the patient."

Nold agreed. He said he regularly has to give his patients repeated, medically unnecessary endoscopic procedures simply to "prove" to insurance companies they need stronger medication. "They'll end up coming back to get another scope just to prove" the drugs are "not adequate, and that's sad," he said.

ANGRY PATIENTS

During the last legislative session, Joyce was among several people pushing for PBM reform. The language to regulate the practice was eventually written into legislation, House Bill 1332.

Among other things, the bill would have given physicians the power to override step therapy decisions when treatment is expected to be ineffective. It also caps the time limit on step therapies at 14 days.

The House and Senate overwhelmingly passed similar, but not identical, versions of the bill. The session ended before the differences in the two versions could be reconciled. Joyce said Stevenson was at work on a new PBM oversight bill last week and that he planned to submit it soon.

Keele testified before a state Senate committee in support of HB 1332 last year.

Joyce said she will continue to strongly advocate for the legislation until it passes. It has become her cause, and she has been getting thumbs-up from people everywhere she goes.

"You've got people with business degrees telling people with medical degrees what to prescribe," he said. "Did you go to business school to know which stomach medicine is best for me? I don't think so."

Reach T.J. Greaney at (573) 815-1719 or tjgreaney@columbiatribune.com.

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Read carefully. Step therapy assumes that two drugs are interchangeable, so the question begged is this: are factor VIII drugs interchangeable? Can an insurance company switch your factor brand to another to save on expenses? That's what some have tried to do, and most like will try to do. Stay tuned... and watch your step.
 
Bayer