NICE nudges rivaroxaban toward approval
The U.K.’s National Institute for Health and Clinical Excellence (NICE) appraisal committee recommended rivaroxaban for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in a final appraisal determination. The recommendation is subject to appeal until April 17.

If the recommendation is approved, physicians will have the option of prescribing the oral direct factor Xa inhibitor rivaroxaban (Xarelto, Janssen Research & Development), for treatment of nonvalvular AF patients whose international normalized ratio (INR) is not well controlled with warfarin. The patients must have one or more risk factors such as congestive heart failure; hypertension; be 75 years old or older; have diabetes; or have had a prior stroke or transient ischemic attack.

The appraisal committee wrote that it reviewed evidence for the ROCKET-AF trial, which demonstrated the non-inferiority of rivaroxaban compared with warfarin for the composite of stroke and non-central nervous system systemic embolism as well as showed a comparable safety profile. It also considered a number analyses submitted by the manufacturer, including cost-effectiveness analyses, and concluded the most plausible incremental cost-effectiveness ratio for the patient population eligible for rivaroxaban fell within an acceptable range.

Pending NICE’s final guidance, the National Health Service providers have been instructed to determine funding for specific treatments locally.

NICE also approved the use of the anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) for patients with nonvalvular AF on March 28 following recommendations issued earlier in the month.