February 20, 2011

Cardiologists Get Updated Guidelines With Coumadin Alternatives

Posted in Heart Disease in the News, Uncategorized tagged , , , , , , , , , , at 8:11 pm by keepyourhearthealthy

photo by Ambro

An update to the US atrial fibrillation guidelines posted last week has made Pradaxa an official part of the treatment protocol.

When the American Heart Association and the American College of Cardiology published their new atrial fibrillation guidelines in December, many people were left with more questions than answers.  The updated guidelines did not include the newest drug, Pradaxa, which is the only alternative to Coumadin at this point.  At the time the guidelines were published, the American Heart Association promised they would provide an update to the guidelines to include Pradaxa soon.  As promised, the “update” to the “updated guidelines” is officially out.

What do the guidelines say then about this new Coumadin alternative? The guidelines give Pradaxa one of the highest recommendations possible (called a Class I).  They state specifically that it “is useful as an alternative to warfarin [Coumadin] for the prevention of stroke.”  However, they also say, “patients already taking warfarin [Coumadin] with excellent INR control may have little to gain by switching to dabigatran [Pradaxa].”

These new guidelines provide further assistance to cardiologists and patients who desperately needed an alternative to Coumadin.  Through the support of the American Heart Association and the American College of Cardiology, physicians can now prescribe Pradaxa more comfortably for the patients who have trouble taking Coumadin.

February 9, 2011

Important New Information For Pradaxa Patients

Posted in Heart Disease in the News, Heart disease tips tagged , , , , , , , , , , at 1:04 pm by keepyourhearthealthy

photo from Pradaxa press release

Patients who receive their Pradaxa in a bottle are under a new advisement this week.

Many heart-savvy people have heard about a unique new drug called Pradaxa.  This ground-breaking drug burst into the pharmaceutical market in record time after gaining FDA approval late last year.  Pradaxa is famously known for being unique given that it is the ONLY alternative to Coumadin (warfarin) in terms of preventing strokes for the atrial fibrillation population.

Undoubtedly, thousands of patients have already made the switch from Coumadin to Pradaxa.  What many of these patients may not realize though is that Pradaxa is unique in another important way.  Pradaxa pills sold in a bottle are considered “expired” after only 30 days. The capsules are easily effected by humidity so the manufacturer recommends using all the medication within 30 days of opening the bottle.

A 30-day expiry is very unusual given that the standard expiry for most medications is 1 year.  Some pharmacists have returned their bottles to the manufacturer and requested blister packs instead.  Blister packs are sold in Europe and keep each pill individually wrapped, thus safe from the humidity.

In case you are a new Pradaxa user, it is important that you wait until the last minute to open the bottle.  You should also avoid having more than one bottle open at a time.  If you tend to store your pills in 2 different locations (ie. one at work and one at home), you’ll need a different routine for Pradaxa. The Pradaxa bottle has a special lid which keeps the drug stable so you should avoid putting the capsules in a different bottle. The safest place for the pills is inside the manufacturer’s bottle and the pills still expire within 30 days of opening.

January 24, 2011

The Latest on Medicare Part D and Pradaxa

Posted in Heart Disease in the News, Helpful Heart Links tagged , , , , , , , , , , , at 4:01 pm by keepyourhearthealthy

image by renjith krishnan

Medicare Part D is still not paying for the new Coumadin alternative, Pradaxa, but there is hope for Medicare patients looking to make the switch.

Ever since Pradaxa became the first alternative to Coumadin approved for atrial fibrillation, Medicare patients have been eagerly awaiting the announcement of prescription coverage with Medicare Part D.  Three months have gone by and some Medicare patients have already switched despite the high out-of-pocket expense.  Since Medicare does not pay for Pradaxa, patients are spending as much as $250 per month.

According to a Pradaxa representative, only the Military and Medco are currently covering Pradaxa.  The manufacturer has recommended several options though for patients on Medicare who need financial assistance.  A Savings Card is available by signing up for the Pradaxa Support Program.  The Savings Card gives Medicare and Medicaid patients one free month of Pradaxa and continued savings throughout the year. Even patients who already have coverage under companies like Blue Cross and Blue Shield can use the Savings Card to offset a high copay.  These patients will often pay only $30 a month when using their insurance and the card.

If the Savings Card is not a good option for you because you still cannot afford the cost, the Pradaxa representative suggested applying to a third-party assistance program such as Rxhope.com.  Rxhope.com can guide you through the process of receiving Pradaxa for free.  They even have an application specifically for Medicare patients who need Pradaxa.  You can also begin a financial assistance application by calling the manufacturer Boehringer Ingelheim directly at 800-556-8317.

Rest assured, Pradaxa will eventually become approved for coverage by Medicare Part D.  The manufacturer is working diligently on the application process.  Until then, they are hoping patients will benefit greatly by using the Savings Card or signing up for financial assistance.  Check here for updates in the future!

January 13, 2011

The New Coumadin Alternative…What Do Patients Think About It?

Posted in Heart disease tips, Helpful Heart Links, Uncategorized tagged , , , , , , , , , , at 11:47 am by keepyourhearthealthy

image by Idea go

Pradaxa is certainly ideal when you look at how it compares to Coumadin on paper.

Pradaxa is a breakthrough Coumadin alternative that prevents more strokes than Coumadin, does not require fingerstick monitoring and has almost no major interactions with food or other drugs. It sounds like a dream come true for atrial fibrillation patients everywhere who despise Coumadin!

Now that Pradaxa is readily available to patients, what do they think? Is it the amazing new drug that many have expected it to be?  Some say “yes” and some say “no.”  One Pradaxa user posted their experience with the drug on a Pacemaker Club website online and stated they “love the convenience.” Others on the same website complained that it did not work out for them.

The biggest obstacles for many are just what Pradaxa’s manufacturer expected: price and heartburn.  First, many people have to get over the sticker-shock of paying $40 to $250 per month.  Then there’s the common side effect of heartburn.  20% of patients discontinue Pradaxa because it upsets their stomach.

One patient I spoke to stopped it because the heartburn and nausea were intolerable after a few days of switching to Pradaxa.  She eventually switched back to Coumadin and resumed her routine INR checks.  In my opinion she was more likely to get heartburn on the Pradaxa because she also suffers from a large hiatal hernia (a condition where part of the stomach is squeezed up through the diaphragm) which causes problems with acid reflux.  Pradaxa’s manufacturer has already launched a defensive campaign in order to help patients work through problems related to the drug.  Their website www.pradaxa.com offers a support program which includes a hotline and a savings card.  I personally registered for the support program over 2 weeks ago and have yet to receive a response.  Maybe they have a few kinks to work out?

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January 4, 2011

American Heart Association Does Not Include New Coumadin Alternative in Updated Guidelines

Posted in Heart Disease in the News tagged , , , , , , , at 3:34 pm by keepyourhearthealthy

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Image by stevegarfield via Flickr

On December 20th the American Heart Association released the newest guidelines for management of atrial fibrillation…but something’s missing!

Despite the fact that American Heart Association president, Dr. Ralph Sacco, has called the new Coumadin alternatives “a great breakthrough,” the newest atrial fibrillation guidelines do not include the new anticoagulants.  Pradaxa was approved in October of 2010 and yet this guideline just released at the end of December does not guide US physicians on how to use it instead of Coumadin.  The American Heart Association reportedly states they will put out an “update” to the new guidelines at some point soon in order to include Pradaxa.  Until then, cardiologists will be relying on the manufacturer’s guidelines or recommendations from other physicians who are familiar with the drug.  It certainly presents for an interesting situation when the most updated guidelines are no help with the one of the biggest advancements in afib for over 50 years!

November 18, 2010

Is There A New Coumadin Alternative Better Than Pradaxa?

Posted in Heart Disease in the News, New Heart Studies tagged , , , , , , , , at 2:28 am by keepyourhearthealthy

image by Salvatore Vuono

Pradaxa‘s manufacturer, Boehringer Ingelheim, had hoped to keep the cardiology buzz about their drug in the headlines this week.  Much to their chagrin, Bayer/Johnson & Johnson stole the spotlight with their new Coumadin alternative.


Over the past several days, the American Heart Association has been holding it’s Scientific Sessions for American cardiologists in Chicago.  The spotlight of cardiology news over the past month has been a new drug called Pradaxa (dabigatran).  Pradaxa is an alternative to Coumadin that was just approved by the FDA in October and is already available for special order at pharmacies in most states.  Patients with atrial fibrillation have been waiting 50 years for an option other than Coumadin in terms of stroke prevention.

On the Boehringer Ingelheim website, an article about Pradaxa had mentioned they would be presenting their large trial about Pradaxa at the American Heart Association’s Scientific Sessions in Chicago.  The news spotlight however has been stolen by a new, upcoming Coumadin alternative called Xareltorivaroxaban) which is manufactured by Bayer/Johnson & Johnson.  Xarelto has not yet been approved by the FDA but the phase 3 trials were presented at the Scientific Sessions, giving this potential new drug much more publicity than Pradaxa.  The big trial for Xarelto showed that it works just as well as Coumadin at preventing strokes in people with atrial fibrillation.  However, it will likely take at least a year before it is available as a prescription to patients.

So what is the big deal about this new Coumadin alternative called Xarelto?

  1. Xarelto only needs to be taken once a day whereas Pradaxa is twice a day
  2. Xarelto does not require fingerstick monitoring or dose adjustments (same as Pradaxa)
  3. Xarelto was tested in moderate to high risk patients and resulted in less problems with severe bleeding than Coumadin

Even though Xarelto sounds like a great option for patients who do not want to take Coumadin, we still have to look at the facts.  Right now, Pradaxa is the ONLY alternative to Coumadin that is available and FDA-approved.  Other drugs may be coming in the next few years but a better drug than Coumadin has been needed for more than 50 years!  The biggest problem with Pradaxa now is cost.  Out of pocket it is more than $6 per day and Medicare Part D is not covering it at this point. There’s no way to know when or IF Xarelto will be FDA-approved and how much it will cost.  Let’s just pray that we can work out the barriers of price soon so that everyone with atrial fibrillation can enjoy the benefits of stroke prevention without all the hassle of Coumadin.

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November 15, 2010

Another New Coumadin Alternative on the Rise

Posted in Uncategorized tagged , , , , , , , at 7:15 pm by keepyourhearthealthy

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Image via Wikipedia

In October the FDA approved the only alternative to Coumadin thus far, Pradaxa (AKA dabigatran).  Another new alternative has just finished a round of trials and may be joining in the famed distinction of being named “Coumadin alternative.”

This latest anticoagulant drug is called Xarelto (AKA rivaroxaban) and it is manufactured by Bayer/Johnson & Johnson.  The trial which has cardiologists buzzing about this new drug is known as ROCKET-AF.  14,000 patients with atrial fibrillation in the ROCKET-AF trial have been tested with either Coumadin or Xarelto and so far the results are promising.  Xarelto has been shown to be just as effective in preventing strokes as Coumadin.  The greatest difference between this new study drug and Coumadin is that Xarelto does not require dose adjustments and monitoring.

However, unlike the newly approved Pradaxa, Xarelto has not yet been shown to work better than Coumadin for preventing strokes.  The other Coumadin alternatives are not even approved yet and it already looks like Pradaxa has an advantage over the competition.  If approved by the FDA soon, Xarelto could still easily compete by setting their prices lower than Pradaxa.  To be honest, any drug that works as well as Coumadin but without all the hassle is bound to be popular!

 

 

November 3, 2010

How Much Will The New Coumadin Alternative Cost?

Posted in Heart Disease in the News tagged , , , , , , , , at 1:43 am by keepyourhearthealthy

photo by graur codrin

Lately it seems we can hardly get away from the slightest bit of news about the new Coumadin alternative, Pradaxa (dabigatran).

Ever since the FDA approved Pradaxa, news reports have been buzzing about this drug which may replace Coumadin in the future.  Many patients will be happy to dispose of their Coumadin or warfarin tablets in favor of a better drug.  But at what cost?

Pradaxa’s manufacturer Boehringer Ingelheim has released their pricing for the pills at nearly $3.40 per dose.  Patients will be expected to take 150mg twice a day so that means it will actually cost $6.75 per day or more than $200 per month.  And this is just the wholesale cost…who knows what the retailers will charge?

So, is Pradaxa going to be worth the price? Some physicians have already calculated the cost of Pradaxa pills versus the total expense of Coumadin and it appears to be cost-effective.  When you consider the expense of INR checks at least monthly while taking Coumadin, the price of monitoring an anticoagulant like Coumadin really adds up over the years.

Needless to say, cardiologists and patients alike are eager to get rid of Coumadin which Robert Baeten, PA-C, calls   “The most-commonly prescribed, dangerous drug.”  If you hope to switch to Pradaxa in the near future, here are a few things to consider:

  1. If you have no prescription coverage, Pradaxa may cost up to 6 times more than brand name Coumadin
  2. If you have prescription coverage,  Pradaxa copays may be somewhat comparable to Plavix
  3. Pradaxa has been shown in studies to be safer than Coumadin as far as bleeding risk (so less worries about bleeding in your brain if you bump your head while taking Pradaxa)
  4. Pradaxa does not require frequent fingerstick monitoring like Coumadin

Just like everything else in this economy, the bottom line will likely come down to price.  Pradaxa will initially be too expensive for people who do not have prescription drug coverage.  For those who have insurance, it will still likely be a hefty copay but hopefully the prices should improve over time.  I have personally called for pricing of the drug and will post the quotes in the next article:

Yes, Your Pharmacy Can Now Give You An Alternative To Coumadin! Pradaxa is HERE!

October 28, 2010

Canada Adds New Coumadin Alternative To Their Atrial Fibrillation Guidelines

Posted in Heart Disease in the News tagged , , , , , , , , , , , , at 1:47 am by keepyourhearthealthy

 

photo by Bill Longshaw

 

The newest anticoagulant drug Pradaxa (dabigatran) is already in Canada’s atrial fibrillation guidelines…even though it is still not approved to be sold in Canada!

Pradaxa (dabigatran) has made some huge headlines lately in the medical news ever since the FDA voted to approve it in September of this year.  Pradaxa is expected to be the first and only alternative to the super blood thinner Coumadin (warfarin).  For over 50 years people with atrial fibrillation have been forced to take Coumadin as a means of reducing their chances of stroke.  Coumadin requires frequent dose changes and blood checks to monitor the levels whereas Pradaxa does not.  (See previous article Coumadin and Warfarin Alternative Almost Here!)

In Canada, an update to their atrial fibrillation guidelines this week already includes recommendations for Pradaxa.  Surprisingly, Pradaxa is not even approved for market there yet!  It seems as though they have jumped the gun a bit but the authors are defending the update by saying it is “cutting edge.”  They apparently want to be prepared for the release of this promising new alternative drug.  Specifically, they recommend 150mg of Pradaxa to most patients in the future given that Pradaxa’s study showed this dose is more effective at preventing stroke than Coumadin.

The hype surrounding Pradaxa is certainly growing every day.  The manufacturer Boehringer Ingelheim has even started playing commercials here in the US.  Given that Pradaxa is not yet on pharmacy shelves, these commercials do not actually mention the drug name.  They simply offer to give more information about atrial fibrillation in general.  Since Boehringer Ingelheim is most well-known for its prostate drug Flomax, you can be certain the commercials are NOT a way to promote that medicine.  They are clearly gearing up their marketing for the highly anticipated Pradaxa.  And Canada is certainly rolling out the welcome mat!