NICE is producing guidance on using rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF) in the NHS in England and Wales. 

Draft recommendations have been published for consultation, stating that the Committee is minded not to recommend rivaroxaban for use within this indication, and requesting that the manufacturer provide revised cost-effectiveness analyses for consideration at the second Appraisal Committee meeting.  Specifically, the analyses should compare rivaroxaban with warfarin as follows:

• The characteristics of the cohort in the model should represent people with AF in the UK. Therefore ideally the baseline risks of events in the patient cohort in the model should be derived from the General Practice Research Database or the UK GP practice-based survey.

• The analyses should use clinical-effectiveness data from the safety-on-treatment population of the ROCKET-AF trial, and use all point estimates from this trial regardless of statistical significance.

• The effect of the low proportion of time in therapeutic range on warfarin in the ROCKET-AF trial should be accounted for by considering subgroup analyses by country or centre.

• The analyses should incorporate a fixed annual warfarin INR monitoring cost of £242 per person.

NICE invites comments from the consultees and commentators for this appraisal and the public; the consultation period runs until the 30th January 2012.  Please see the link below for further details, including the evidence considered (evaluation report).