Race to Replace Warfarin Chases a Potential $20 Billion US Market

Washington, DCIt's been around for 60 years and is one of the most common, go-to blood thinners prescribed to patients as a means to break up—or ward against—blood clots. But Warfarin, known commercially as Coumadin or Jantoven, is a complex drug that's not easy to get right. Until recently, methods used to determine a patient's suitability and tolerance for Warfarin have been described as "archaic."

Little wonder, given Warfarin's common use as a treatment for atrial fibrillation, or "a-fib", and the first wave of the massive baby boom generation moving into an age where they are beginning to worry about their hearts, that the race is on to come up with an alternative.

To that end, the Wall Street Journal health blog on September 20th reported on the unanimous recommendation for approval by an advisory committee of the US Food and Drug Administration (FDA) of dabigatran, manufactured by Boehinger Ingelheim of Germany. Other gilded competitors are entering the fray, but dabigatran is the front-runner with a decision by the FDA expected for October 19th.

Much is at stake: it is thought the market for a Warfarin alternative could tap into a $20 billion market, in the US alone.

The Warfarin replacement lottery is huge; given the widespread belief that as many as half the heart patients who could, or should be on Warfarin are not, given the complexity of the drug and the difficulty to manage it. Only recently has a genetic test been developed that uses two genetic markers to determine an individual's suitability for Warfarin—in stark contrast to the current standard of using an individual's height and weight to factor Warfarin dosage.

According to the September 13th issue of Business Insurance the genetic testing involves a blood sample, or a cheek swab that looks for two genes capable of determining sensitivity to Warfarin. While expensive—at a cost of between $250 to $400 for each test—such expense is considered far less than that of a full day in hospital, often required if a patient reacts badly to Warfarin.

As reported by Business Insurance, a recent study from the American College of Cardiology found that individuals genetically tested prior to taking Warfarin were 31 percent less likely to be hospitalized, and 29 percent less likely to be hospitalized for bleeding or blood clots over a six-month period.

What's more, the FDA estimated that the introduction of genetic testing as routine Warfarin therapy could prevent 85,000 serious bleeding events and 17,000 strokes annually.

Still, a writer with Business Insurance noted that when she visited the hospital after suffering a blood clot in her leg, the attending physicians and nurses at the facility had not heard of genetic testing, using instead the time-honored method of using an individual's height and weight as the determining factor.

It was reported that Medco Health Solutions Inc. is one of the few HMOs that has adopted genetic testing for determining individual dosage and suitability for Warfarin.

Meanwhile, the race is on for alternatives.