NICE has revised its original recommendation that dronedarone (Multaq) should not be used to treat atrial fibrillation (AF) – a disturbance of the heart’s rhythm.
After considering comments on the previous draft guidance, the independent Appraisal Committee decided to recommend limited use of the drug as a second-line treatment in people with additional cardiovascular risk factors whose AF has not been controlled by first-line therapy (usually including beta-blockers).
Although the committee did not change their conclusion that dronedarone is not as effective as other anti-arrhythmic drugs in preventing the recurrence of AF, it accepted evidence that the drug did not lead to an increase in the risk of mortality, unlike the anti-arrhythmics with which it was compared.
The Appraisal Committee also noted comments from patients and clinical experts received during consultation on the previous draft that all current anti-arrhythmic drugs, but particularly amiodarone, had side effects which had a significant impact on quality of life with long-term use.
Overall, the Committee concluded that dronedarone was likely to result in fewer adverse effects than amiodarone.
Andrew Dillon, Chief Executive of NICE, said: “Whilst dronedarone has not been shown to be as effective as existing treatment options in controlling atrial fibrillation, and is more expensive, short-term evidence suggests that it is associated with fewer side-effects. Therefore we are pleased that, following public consultation on the first draft of this guidance, we have been able to identify circumstances in which dronedarone could be offered as a cost effective treatment option.”
These preliminary recommendations are available for public consultation from
30 March until 22 April 2010.
Belen Garijo, Senior Vice President, Pharmaceutical Operations Europe, sanofi-aventis, commented: “We appreciate the thorough and comprehensive evaluation of the Multaq clinical and economic dossier that NICE has performed and believe that this preliminary recommendation by NICE provides a valuable benchmark to guide sanofi-aventis’ ongoing efforts to have the Multaq value proposition in AF patients recognised within Europe and beyond.”