Pradaxa Gains Preferred Formulary Status with Key Pharmacy Benefit Managers

RIDGEFIELD, Conn., March 14, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), today announced that Pradaxa® (dabigatran etexilate mesylate) capsules has received preferred Tier 2 formulary status with CVS Caremark (Commercial Preferred Drug List) and Medco (Commercial Preferred and Part D Drug Lists), two of the largest pharmacy benefit managers covering more than 100 million Americans.(1) 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).(2)

Five months after FDA approval, PRADAXA is now available at the lowest branded co-pay level on formularies that insure about 35 percent of NVAF patients.(1) 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.

In the pivotal RE-LY trial, PRADAXA 150mg capsules taken twice daily reduced the incidence of stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin(2), which was dosed to a target international normalized ratio (INR) of 2.0 to 3.0.(2) The effects of PRADAXA compared to warfarin were more apparent in patients with lower levels of INR control.(2)

"These formulary additions will offer non-valvular atrial fibrillation patients increased access to PRADAXA, including its demonstrated ability to significantly reduce the risk of stroke over warfarin in this patient population," said Wa'el Hashad, vice president, cardiovascular and metabolic disorders marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to a long relationship with CVS Caremark and Medco, and are committed to working with other pharmacy benefit managers as well as offering our own programs to help make PRADAXA available to patients with non-valvular atrial fibrillation."

PRADAXA is the only FDA-approved treatment that has demonstrated significant reductions in the risk of stroke compared to warfarin in patients with NVAF(2) and is the first oral anticoagulant to be approved in the U.S. in more than 50 years in this patient population.

About Atrial Fibrillation and Stroke

Atrial fibrillation, characterized by an irregular heartbeat,(3) can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(3) An estimated 2.3 million Americans are living with atrial fibrillation,(4) and the prevalence is expected to increase to 5.6 million by 2050.(4) Non-valvular atrial fibrillation, which accounts for up to 95 percent of diagnosed cases of atrial fibrillation,(4) 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.(5)  Atrial fibrillation increases the risk of stroke nearly five times(5) and is associated with up to 15 percent of all strokes in the U.S.(5) Atrial fibrillation imposes a substantial economic burden to the healthcare system,(6) specifically the high costs associated with stroke.(7)

About the Storage and Handling of PRADAXA

PRADAXA must be stored in its original packaging(2) and patients should not transfer the capsules to pill boxes or pill organizers.(1) Once the bottle is opened, the product must be used within 30 days.(2) Patients must close the bottle tightly immediately after removing one capsule(2) and must not alter the child-proof cap.(1) 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.(1) When packaged in a blister package, each capsule should only be removed at time of use.(2) After 30 days, patients should safely throw away any unused PRADAXA capsules.(2)

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 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 142 affiliates in 50 countries and more than 41,500 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.

In 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% 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.

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

(2) Pradaxa Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2010.

(3) NHLBI website. “What is AFib?” Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html. Accessed on: August 2, 2010.

(4) Go, AS., et al. “Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management and Stroke Prevention: the ATRIA Study.” JAMA. 2002; 285:2370-2375.

(5) 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 2011 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.

(6) 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.

(7) Harley, C., et al. “Direct Costs And Health Care Utilization Associated With Stroke in the Presence of Atrial Fibrillation in the United States.”  ASAIS Conference, Feb. 2009.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.