NICE needs more evidence on rivaroxaban for prevention of stroke in atrial fibrillation patients


In preliminary recommendations published on 9 January, NICE is asking Bayer HealthCare for more information on its product rivaroxaban (Xarelto), for the prevention of stroke and systemic embolism in people with atrial fibrillation.

Commenting on NICE’s draft recommendation, Carole Longson, NICE Health Technology Evaluation Centre director, said: “The importance of effective antithrombotic therapy in people with atrial fibrillation who are at risk of developing potentially fatal blood clots cannot be overestimated. The most commonly used antithrombotic – warfarin – is associated with a number of problems, such as the need for frequent monitoring of the blood’s clotting, which can have an adverse effect on quality of life and make compliance difficult for some people. Rivaroxaban, like dabigatran, which NICE is also assessing, represents a significant potential benefit for people with AF because it does not require regular monitoring and dose adjustments.

“The Committee concluded, however, that the population included in the single trial presented by the manufacturer as evidence of rivaroxaban’s cost-effectiveness was not reflective of all the people with atrial fibrillation in the UK who would be eligible for treatment with the drug. In particular the Committee was concerned that the people in the warfarin arm of the trial on average did not achieve as good control of their blood clotting as might be expected in clinical practice in the UK. It was also concerned that the risk of stroke and systemic embolism for the population in the trial was higher than for the overall population eligible for treatment with rivaroxaban. The Committee felt that both these factors could mean that the relative effectiveness of rivaroxaban compared with warfarin had been overestimated for the UK population. The Committee is therefore minded not to recommend the drug on the basis of the available evidence pending the receipt of additional information from the manufacturer that will address these issues.”

NICE has not yet issued final guidance to the NHS. Those wishing to comment on NICE’s draft recommendations have until 30 January to do so. Feedback received during consultation may result in changes to the preliminary recommendations and will be considered by the Appraisal Committee at their next meeting.

Rivaroxaban has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation who have one or more risk factors such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischaemic attack.