TA197 Atrial fibrillation - dronedarone: review proposal - July 2012

Review of NICE Technology Appraisal Guidance No.197; Dronedarone for the treatment of non-permanent atrial fibrillation

TA197 was published in August 2010. 

Following safety concerns, the European Medicines Agency has reviewed and amended the marketing authorisation for dronedarone.  This has resulted in a more restricted marketing authorisation than was originally appraised in TA197. However, the evidence suggests that reviewing the guidance would not be of value to the NHS.  There is no new evidence to indicate that dronedarone would be less safe or less effective in the population that meets the revised marketing authorisation.

Consequently, the wording of the guidance should been amended to reflect the changes to the UK marketing authorisation for dronedarone.  Following this, we believe that TA197 should be incorporated into the ongoing update of NICE clinical guideline 36 ‘Atrial fibrillation’.  TA197 would remain in existence alongside the clinical guideline and will be moved to the static guidance list.  This proposal will have the consequence of preserving the funding direction that is linked to the technology appraisal.

In the meantime, a warning about the restricted use of dronedarone should be placed on the TA197 webpage on the NICE website. 

In order to be completely confident that this is appropriate, we are asking all relevant consultees and commentators, to inform us of any evidence which will help us decide the best way to update this guidance.  Please see appendix A for a full list of the organisations we have contacted. 

July 2012

This page was last updated: 03 July 2012