November 8, 2010

Will Medicare Part D Pay for Pradaxa, the New Coumadin Alternative?

Posted in Heart Disease in the News, Heart disease tips, Helpful Heart Links, Uncategorized tagged , , , , , , , , , , , , , , at 7:09 pm by keepyourhearthealthy

Product photo from Boehringer Ingelheim website press release

In it’s short life-span, Pradaxa has already turned the world of cardiology news upside down.  Boehringer Ingelheim has brought us the first good Coumadin alternative in 50 years, but they have yet to get it officially on the Medicare Part D list.

What To Do When You Have Heart Disease Blog has covered the topic of Pradaxa (dabigatran) extensively over the past month since the FDA voted to approve this history-changing alternative to Coumadin.  Patients with atrial fibrillation can now take Pradaxa 150mg twice a day to significantly reduce their risk of stroke.  According to the Pradaxa website, over 2.3 million Americans have atrial fibrillation and having this rhythm disturbance makes a person five times more likely to have a stroke.

Ever since the 1950’s Coumadin has been given to patients with atrial fibrillation because it significantly reduces clotting events such as stroke.  One trial (AFFIRM) even reported that patients taking Coumadin had a 69% lower risk of stroke.  Now the new drug Pradaxa has a large trial (RE-LY) showing that Pradaxa prevents 35% more strokes than Coumadin!

So far, the choice between Pradaxa and Coumadin is a no-brainer.  Pradaxa prevents more strokes and is way less hassle.  Unlike Coumadin, Pradaxa does not require monitoring or dose-changes.  Pradaxa is not affected by foods or other drugs. Quite frankly, the Coumadin regimen was just too complex for some patients to handle…and it carried some very significant risks of bleeding and hemorrhage!

When Will Medicare Pay For Pradaxa?

Now that Pradaxa is finally here to rescue heart patients from the clutches of Coumadin, will they be able to afford it?  Out of pocket costs can be about $250 per month. With prescription coverage (most companies will consider it a “non-preferred drug” right now) the cost can go down to $40 per month.  As of January, 2011, Pradaxa is NOT listed as a covered drug under Medicare Part D. That means that patients who use Medicare Part D will have to pay out-of-pocket if they switch from Coumadin to Pradaxa.  For the retired community relying on Medicare, $250 per month could mean missing a few meals!

There have been some reports of Boehringer Ingelheim working on getting Medicare Part D approval for Pradaxa.  Pradaxa is still not listed in the Medicare database (Medicare Drug Database) today but it may be too soon after it’s FDA approval for the Medicare website to be updated.  Even after calling the main Medicare number though, they confirmed that Pradaxa is not being covered.  I am certain that many Medicare patients will be basing their decision to switch to Pradaxa on cost so hopefully Part D adds it soon!  Check here for updates posted in the future.

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October 4, 2010

Left Atrial Appendage Closure for Patients With Atrial Fibrillation

Posted in New Heart Studies, Uncategorized tagged , , , , , , , , at 3:26 pm by keepyourhearthealthy

Heart left atrial appendage transesophageal ec...

Image via Wikipedia

A new study testing a heart procedure could help prevent strokes in people with atrial fibrillation.

Atrial fibrillation is a very common and fairly benign abnormal heart rhythm.  It is caused by electrical disturbances in the upper chambers of the heart.  One of the biggest concerns related to atrial fibrillation is the possibility of stroke.  Because the upper heart chambers are not pumping effectively, blood has a tendency to “pool” into a small ear-shaped section of the heart called the left atrial appendage.  If blood sits in the left atrial appendage for too long, a clot is formed which can then travel to the brain and cause a stroke.

A new study has been testing the possibility of closing off the left atrial appendage as a means of preventing clot formation.  The device is called a Watchman occluder and it is put during a simple heart catheterization.  No large cuts or general anesthesia required!  Once the device is in place, a person could eventually stop taking Coumadin or warfarin.  The Watchman device cuts the risk of stroke without having to use medication.

The trials are ongoing so you can’t find this device in your general cardiologist’s office yet.  As the device is studied more and proven safe for everyone it may become available to the standard atrial fibrillation patient.  Between this and the new Coumadin alternative (dabagatran), we may be seeing the end of Coumadin once and for all!

September 22, 2010

Goodbye Coumadin!! Hopefully Soon…

Posted in Heart Disease in the News, Heart disease tips tagged , , , , , , , , , , , , , at 12:22 am by keepyourhearthealthy

photo by graur razvan ionut

Praise God!  The FDA has unanimously approved an alternative to Coumadin (warfarin) in atrial fibrillation.  The new drug called Pradaxa or dabigatran has been available in Europe and Canada for quite some time now.

Yesterday, the FDA agreed that Pradaxa should become available to patients with atrial fibrillation (afib) here in the US as well.  Pradaxa is an anticoagulant or “blood-thinner” that helps to significantly reduce the risk of stroke in afib.

Patients and cardiologists have been longing for a drug to replace Coumadin for many years.  Coumadin (warfarin) is a very old drug that was used as rat poison originally and then converted to a pill form to prevent strokes in certain heart patients.  Coumadin has significant bleeding risks and needs to be monitored with blood checks every few days to at least once a month. There are a ton of interactions for Coumadin as well which makes it difficult to adequately control the levels in some patients.

The newly-approved Pradaxa does not have as many bleeding risks and does not require frequent monitoring. Essentially it could be the answer to cardiology’s prayers…or will it?  The biggest obstacle to prescribing Pradaxa once it is officially in the pharmacy will be PRICE.  Currently, the pills cost $8 to $12 per day in other countries.  The reason it costs so much is because physicians use Pradaxa for short-term conditions abroad rather than for long-term use like in atrial fibrillation.  Hopefully, the manufacturers will cut the cost dramatically so that a majority of the patients can afford it!

September 2, 2010

New Alternative to Coumadin and Warfarin?

Posted in Heart disease tips, New Heart Studies tagged , , , , , , , , , , , , at 11:58 pm by keepyourhearthealthy

photo by Michal Marcol

Patients with atrial fibrillation know all too well the problems with Coumadin and warfarin.

Atrial fibrillation is a very common arrhythmia in which the top chambers of the heart beat quickly and erratically.  Since the pumping of the atria is abnormal during atrial fibrillation, a clot can form in the heart.  If the clot travels up to the brain this leads to a stroke.  For this reason, people with atrial fibrillation are at a higher risk of stroke and may need to take a strong blood thinner called Coumadin (generic name warfarin).

Coumadin and warfarin dosages are variable and need frequent monitoring.  One person may only need to take 5mg per day while another person might need 7.5mg per day.  Fingerstick checks are done every few days to every month for checking the level (called INR).  People who cannot or will not take Coumadin need to take at least an aspirin a day to lower the risk of stroke.  Sounds like a lot of work right?

A simpler drug may be available soon!  A new study out of Ontario has reviewed a new medicine called apixaban in terms of replacing Coumadin and warfarin.  When compared with aspirin only, apixaban reduced the risk of stroke and other clotting problems by 54%!  The dose is standard for everyone and apparently there is no need for fingerstick checks.  Let’s pray that apixaban makes it through the next trial so we can truly have a great new alternative to Coumadin!