NICE seeks more data on Bayer’s Xarelto for stroke prevention

The National Institute for Health and Clinical Excellence said Monday in preliminary guidance that it needs more information to be submitted before being able to recommend NHS funding of Bayer’s Xarelto (rivaroxaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The drug, which Bayer is developing with Johnson & Johnson, was cleared for this use in Europe in December.

Carole Longson, NICE’s health technology evaluation centre director, noted that evidence submitted by Bayer on the cost-effectiveness of Xarelto “was not reflective of all the people with atrial fibrillation in the UK who would be eligible for treatment with the drug.” She added that a number of factors, including that in a clinical trial of the oral anticoagulant patients who received warfarin did not achieve as good control of their blood clotting as might be expected, meant that “the relative effectiveness of [Xarelto] compared with warfarin had been overestimated for the UK population.”

Longson said that the appraisal committee “is therefore minded not to recommend the drug on the basis of the available evidence pending the receipt of additional information from [Bayer] that will address these issues.”

In November last year, NICE backed the use of Boehringer Ingelheim’s Pradaxa (dabigatran) as an option for the prevention of stroke and systemic embolism in people with AF.