Dronedarone for AF rejected in draft NICE guidance

Dronedarone is not cost effective for AF treatment and cannot be recommended for use in the NHS, draft NICE guidance has concluded.

NICE research found that dronedarone cost more and was less effective

NICE said in a statement that the evidence it had reviewed in formulating the draft guidance suggested that dronedarone (Multaq) was less effective and cost ‘considerably more' than existing treatments for controlling AF.

NICE's chief executive Andrew Dillon said the institute was keen to help AF patients. ‘But,' he said, ‘we need to be sure that any treatment we recommend offers real additional benefits for patients — and we need to be confident that those benefits justify the cost to the NHS. In this case, dronedarone costs more, and has not been shown to be more effective, than other treatments for AF.'

Multaq's manufacturer Sanofi-aventis said it was disappointed at the decision.

'Multaq represents one of the most important pharmacological innovations in the treatment of AF for 20 years as it is the only anti-arrhythmic drug which, beyond prolonging time to AF recurrence and providing rate control, is proven to reduce the composite end-point of CV hospitalisation and death in AF patients, all achieved with a favourable safety profile,' the company said in a statement. 'No currently available anti-arrhythmic drugs have ever proven a clinical benefit in reducing outcomes in AF. Multaq represents a significant therapeutic advance in this regard.'

Sanofi-aventis said it would continue to work to ensure that Multaq is made available to those patients who will benefit from this new AF treatment.

NICE's draft recommendations is open to consultation until 28 January.

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