Pradaxa® (dabigatran etexilate mesylate) Capsules Gains Preferred Formulary Status with AARP®, Nation's Largest Provider of Medicare Part D Coverage

RIDGEFIELD, Conn., May 19, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that Pradaxa® (dabigatran etexilate mesylate) capsules has received preferred Tier 2 formulary status with all AARP Medicare Part D plans through its pharmacy benefits manager, Prescription Solutions®.  The AARP plans, which include AARP Medicare Rx and AARP MedicareComplete from Secure Horizons, provide prescription drug access to nearly 6.8 million Americans and represent the largest provider of Medicare Part D coverage in the U.S.  The U.S. Food and Drug Administration (FDA) approved PRADAXA in October 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).(1)

More than 25 million Americans are enrolled in a Medicare Part D program, which provides prescription drug coverage for Medicare beneficiaries.  An estimated 2.3 million Americans are living with atrial fibrillation (AFib)(2) and approximately 82 percent are age 65 or older.(2)  A large managed care database study showed that NVAF represents roughly 95 percent of all AFib cases in the U.S.(2)  Atrial fibrillation increases the risk of stroke nearly five times(3) and is associated with up to 15 percent of all strokes in the U.S.(3)

"The addition of PRADAXA to the nation's largest Part D plans helps ensure many more NVAF patients have access to this important medication, which, in a clinical study, has been shown to significantly reduce the risk of stroke compared to warfarin," said Wa'el Hashad, vice president, cardiovascular and metabolic disorders marketing, Boehringer Ingelheim Pharmaceuticals, Inc.  "PRADAXA is now on formulary with AARP, Medco, Express Scripts and several more of the nation's largest managed care providers."

Seven months after FDA approval, PRADAXA is available at the lowest branded co-pay level on formularies that insure more than 45 percent of NVAF patients in the U.S.  This now includes nearly 50 percent of Medicare beneficiaries.  For those patients who may not otherwise be able to afford treatment, BIPI offers patient assistance programs to help provide coverage for the costs of their medications.

Findings from the pivotal, Phase III RE-LY® trial showed that PRADAXA 150 mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin in patients with NVAF.(1) Effects of PRADAXA were more apparent in patients with lower levels of INR (international normalized ratio) control.(1)  Dabigatran was recently recommended in an update to atrial fibrillation treatment guidelines.  PRADAXA is approved to reduce the risk of stroke and systemic embolism in more than 15 countries, including Canada, Japan, New Zealand, Singapore and Israel.  In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use recently issued a positive recommendation for PRADAXA in the member states of the EU for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

About Atrial Fibrillation and Stroke

Atrial fibrillation, characterized by an irregular heartbeat,(4) can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(4)  An estimated 2.3 million Americans are living with atrial fibrillation,(2) and the prevalence is expected to increase to 5.6 million by 2050.(2) Non-valvular AFib refers to cases of atrial fibrillation without rheumatic mitral valve disease, prosthetic heart valve or valve repair, according to the 2006 ACC/AHA/ESC guidelines.(3) Atrial fibrillation imposes a substantial economic burden to the healthcare system,(5) specifically the high costs associated with stroke.(6)

About Pradaxa® (dabigatran etexilate) Capsules

Indications and Usage

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.

WARNINGS AND PRECAUTIONS

Risk of Bleeding

PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Risk factors for bleeding include:

- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).

-Labor and delivery

Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.

Temporary Discontinuation of PRADAXA

Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke.  Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.

Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure

The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other P-gp inhibitors.

ADVERSE REACTIONS

In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events. PRADAXA 150 mg resulted in a higher rate of major GI bleeds and any GI bleeds compared to warfarin. In patients greater than or equal to 75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions.  These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer).  Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.

Other Measures Evaluated

The risk of myocardial infarction was numerically greater in patients who received PRADAXA 150 mg than in those who received warfarin.  

For full PRADAXA prescribing information and medication guide, please visit www.pradaxa.com or contact Boehringer Ingelheim's Drug Information Unit at 1-800-542-6257.

About the Storage and Handling of PRADAXA

PRADAXA must be stored in its original packaging(1) and patients should not transfer the capsules to pill boxes or pill organizers. (7) Once the bottle is opened, the product must be used within 30 days.(1) Patients must close the bottle tightly immediately after removing one capsule(1) and must not alter the child-proof cap.(7) It is recommended that patients date the bottle to expire 30 days after first opening. When more than one bottle is dispensed, patients should only open one bottle at a time.(7) When packaged in a blister package, each capsule should only be removed at time of use.(1)

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion (about 12.6 billion euro) while spending almost 24 percent of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

References

(1) Pradaxa Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; March 2011.

(2)  Go, A.S., et al. "Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management and Stroke Prevention: the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study." JAMA. 2001; 285(18):2370-2375.

(3)  Fuster, V., et al. "ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation – Executive Summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation):  Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society." Circulation. 2006; 114:700-752.

(4) NHLBI website. "What is AFib?" Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html. Accessed on: May 2, 2011.

(5) Coyne, K.S., et al. "Assessing the Direct Costs of Treating Nonvalvular Atrial Fibrillation in the United States." Value in Health.  2006; 9:348-356.

(6) Harley, C., et al. "Direct Costs And Health Care Utilization Associated With Stroke in the Presence of Atrial Fibrillation in the United States." Poster Presentation at ASAIS Conference 2009.

(7) Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.