Additional data sways NICE in favor of Pradaxa

The U.K.'s cost-effectiveness watchdog has done an about-face on the new clot-fighter Pradaxa. The National Institute for Health and Clinical Excellence recommended the use of Boehringer Ingelheim's pill after the company produced some additional data. The draft guidance would allow the U.K.'s National Health Service to use Pradaxa to prevent stroke and systemic embolism in patients with atrial fibrillation.

In August, NICE issued a draft guidance demanding more information from Boehringer. Apparently, the additional information was enough to persuade NICE that Pradaxa would be a good use of health system resources. The recommendation does advise doctors to discuss with patients the risks of the the new drug compared with warfarin, the old standard Pradaxa and a couple of other new anticoagulants are seeking to replace.

Warfarin requires regular monitoring and dose adjustments, while Pradaxa does not. However, warfarin has a quick-to-administer antidote that can reverse serious bleeding, and Pradaxa does not. NICE's Carole Longson noted Pradaxa's 150-mg dose is more effective at reducing stroke risk than warfarin is, and the 110-mg dose is equally effective.

"[W]e are pleased to say that the additional information and analysis received from the manufacturer has enabled the committee to recommend dabigatran as a cost-effective use of NHS resources for the prevention of strike and systemic embolism in people with AF," Longson said in a statement.

Pradaxa could thus become the first warfarin alternative accepted for use by the NHS. Xarelto, a competing drug from Bayer, recently won a key committee's recommendation for European approval as a stroke preventive, while the promising Eliquis from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) hasn't yet been approved. Final guidance is expected in December.

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