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The superiority of dabigatran to warfarin, as reported by the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial, may be offset by its cost, according to an editorial1 published recently in Circulation.

Dr Jerry Avorn (Harvard Medical School) writes that the RE-LY trial was not designed to take account of dabigatran’s cost, which he estimates at ≈$3000 per year compared to warfarin’s ≈$48 per year “in many pharmacies”.  Accepting that this aspect may have seemed less vital at the time, he asserts that “at present, as the cost of medical care, especially through Medicare, looms as the single largest threat to the US economy, attention must be paid”.

Dr Avorn emphasises the very fact that dabigatran is a novel treatment as cause for caution, the potential complications of warfarin treatment being comparatively better understood and prepared-for.  Assessing whether the new drug is cost-effective compared to its predecessor, he cites various other contributing factors:

  • Dabigatran is administered twice a day, making it more likely that doses will be missed than with a drug (like warfarin) taken once a day.
  • Patients adhere less well to expensive drugs than to their more affordable alternatives. Stretching out doses of a costly drug will mean that patients are more likely to have their anticoagulation drop to nonprotective levels, increasing their risk of stroke.
  • When a patient taking warfarin veers above or below the ideal range of anticoagulation, it can be detected with an international normalised ratio (INR) test; no such testing is available for dabigatran.

Avorn also questions the superiority of dabigatran reported by the RE-LY trial in which, despite lowering risk of stroke, the drug also led to a significant increase in symptomatic dyspepsia.  A statistically significant 38% increase in the risk of myocardial infarction with dabigatran was initially reported; when 30 new myocardial infarctions were found on closer inspection of trial data, that incidence remained elevated at a 27% increase, but fell below the conventional level of statistical significance.

He asserts that more real-world experience is needed to reveal “the actual benefit-risk relationships inherent in dabigatran as used routinely, and, therefore, its cost-effectiveness” outside of the trial setting.  Accepting that dabigatran may prove a safer alternative to warfarin in time, “until we know more about its track record…there is merit to the recent joint professional society recommendation of the American College of Cardiology and the American Heart Association that for those who are currently stable and doing well on warfarin until we learn more, staying the course with that annoying old standby may be a prudent—and certainly affordable—course of action for the near future”.

and the other side of the coin

In contrast to this editorial there was a cost-effectiveness study2 of dabigatran for stroke prophylaxis in patients with atrial fibrillation (AF) by Drs Shimoli V Shah and Brian F Gage (Washington University School of Medicine), published in the same issue.  The authors developed a decision-analysis model from the results of RE-LY and other trials, comparing the cost and quality-adjusted survival of various antithrombotic therapies in a hypothetical cohort of 70-year-old patients.  They set a cost-effectiveness threshold of $50,000/quality-adjusted life-year, estimating the cost of dabigatran as $9 a day.

They found that the relative benefits of dabigatran depended on how well warfarin therapy was managed.  For patients already taking warfarin who had excellent INR control, dabigatran 150 mg (twice daily) was not found to be cost-effective, while for patients with poor INR control it was.  They conclude that “the benefits of dabigatran outweigh costs in AF patients at moderate to high risk of stroke and/or hemorrhage unless their INR control with warfarin therapy would be excellent”.


1 Avorn J.  The relative cost-effectiveness of anticoagulants: obvious, except for the cost and the effectiveness. Circ 2011;123:2519-21. doi: 10.1161/CIRCULATIONAHA.111.030148

2 Shah SV, Gage BF.  Cost-Effectiveness of Dabigatran for Stroke Prophylaxis in Atrial Fibrillation. Circ 2011;123:2562-70. doi: 10.1161/ CIRCULATIONAHA.110.985655

Published on: August 2, 2011

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association

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