October 20th, 2010

Finally: Dabigatran – A New Oral Anticoagulant Is Approved by the FDA

CardioExchange welcomes this guest post reprinted with permission from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem, Evanston, IL, and a Clinical Associate Professor of Medicine at University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes.

A new era of nonvalvular atrial fibrillation management has arrived.

Tuesday, the FDA approved the first new anticoagulant in fifty years: dabigatran, marketed by Boehringer Ingelheim Pharmaceuticals under the trade name Pradaxa, for stroke prevention in patients with nonvalvular atrial fibrillation. The move was widely anticipated after the drug’s unanimous 9-0 FDA advisory panel recommendation for approval a month ago. The drug will be available in 75 milligram and 150 milligram dosages and is taken twice daily.

Patients at high risk for thromboembolism from nonvalvular atrial fibrillation are candidates for the drug, including patients with previous stroke or transient ischemic attack, a left ventricular ejection fraction of less than 40%, New York Heart Association class II or higher heart-failure symptoms within 6 months before screening for the medication, and age of at least 75 years, or age 65 to 74 years plus diabetes mellitus, hypertension, or coronary artery disease.

Patients who should NOT receive the drug include patients with the presence of a severe heart valve disorder, stroke within 14 days or severe stroke within the last 6 months, a condition that increases the risk of hemorrhage, a creatinine clearance of less than 30 mL per minute, active liver disease, or pregnancy. Patients taking quinidine should not take the medication because of a significant drug interaction.

The drug does not typically require measurement of blood thinning levels (prothrombin times expressed as an international normalized ratio (INR) of clotting time to a standard clotting control).

The approval was based on the prospective, randomized RE-LY trial recently published in the New England Journal of Medicine that compared the safety and efficacy of two doses of dabigatran (110 mg and 150 mg twice daily) to conventional warfarin (Coumadin) therapy in 18,113 patients and showed that:

dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage.

It should be noted that the FDA did not approve the lower, 110-mg dose of the medication.

The drug’s most common side effect was dyspepsia (GI upset), but liver enzyme elevations were not different from those seen with warfarin.

The questions now are two: when will it be available? and how much will it cost?

Typically it takes about 3 to 6 months to finalize product packaging, labeling and distribution after a drug is approved.  As far as price goes, my bet is that it’s going to cost about ten times the cost of warfarin. I’d estimate $6 to $9 per day. (One writer calculated the cost of dabigatran in the U.S. based on its cost in Canada at approximately $7,000 to $9,000 per patient-year — four to five times the cost of warfarin, despite the increased physician and laboratory costs required to monitor the INR). A researcher from the RE-LY trial countered:

It should also be kept in mind that total direct and indirect costs for management of anticoagulation with warfarin far exceed the cost of the drug. In a recent study, the direct costs during the first year of anticoagulation with warfarin in primary care were calculated at Swedish krona 16,244, corresponding to U.S. $2,230. This does not include expenses to patients for travel to the laboratory, lost time from work, or an accompanying caregiver.

I suspect it will be hard for insurers to swallow the cost of this drug at first, and coverage may not be immediately available, but hopefully the superior convenience and stroke prevention will justify the drug’s initial price. Fortunately, other thrombin inhibitors will soon compete in price with dabigatran, shortening its exclusive first-to-market reign.

Comments are closed on this post, but please join the conversation at our Dabigatran Resource Round-Up.

One Response to “Finally: Dabigatran – A New Oral Anticoagulant Is Approved by the FDA”

  1. Robin Motz, M.D., Ph.D. says:

    And wait till they show it can replace Enoxaprin, etc.; for DVT Rx. and/or prevention. The sky will be the limit, and the patient pressure for HOM’s and MCR to approve a non-injectable Rx will be enormous.