While their makers fight lawsuits and regulators keep watch on safety questions, the U.K.'s cost-effectiveness gatekeepers figure the new generation of anticoagulants should be used more to fight stroke, not less.
After reviewing the data on strokes and atrial fibrillation against the use of clot-fighters new and old, the National Institute for Health and Care Excellence has weighed in with treatment guidance, saying that thousands more patients should be taking the drugs. And many of those should be using newer market entrants--Boehringer Ingelheim's Pradaxa; Bayer and Johnson & Johnson's ($JNJ) Xarelto; and Pfizer ($PFE) and Bristol-Myers Squibb's ($BMS) Eliquis--rather than the old standby, warfarin.
Only half of patients who should be taking anticoagulants are actually doing so, said Mark Baker, NICE director of clinical practice. To cut the number of people with atrial fibrillation who go on to die or be disabled by stroke, "This needs to change," he said (as quoted by PharmaTimes).
Warfarin is a known commodity, with its problematic dosing, food interactions, and constant monitoring--but an effective and quick antidote in vitamin K. The newer meds have important advantages over warfarin beyond their ease of use, boasting better effectiveness, less bleeding or both. They don't as yet have proven, easy antidotes. Even so, these are "potential lifesavers" for some people with AF, including the newly diagnosed, those taking warfarin and those using aspirin for stroke prevention, NICE says.
The new guideline recommends that these new-generation anticoagulants be adopted across the U.K.'s National Health Service, with or without local review and approval, PharmaTimes notes.
That's not to say that NICE--or other gatekeepers, or the drugmakers themselves for that matter--are unaware of the new meds' risks. Boehringer recently agreed to pay $650 million to settle thousands of lawsuits over Pradaxa's safety, and all three drugs have antidotes in development. A few lawsuits over Xarelto side effects are in the works in the U.S. as well.
The FDA has reviewed a host of serious adverse events reported on Pradaxa, including a number of deaths, and concluded that the drug is as safe as warfarin when used as directed. The agency continues to keep an eye on the new anticoagulants, however, and is encouraging development of antidotes.
Meanwhile, the new anticoagulants have been popular among doctors. EvaluatePharma has predicted that the market for anticoagulant drugs will expand by 11.5% annually through 2018, hitting $15.3 billion in sales. That makes it the fastest growing therapeutic area. Sales of Pradaxa last year increased by nearly 9% in euro terms to hit €1.2 billion ($1.645 billion), according to Boehringer.
- read the PharmaTimes story
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