Draft NICE guidance unable to recommend dronedarone for atrial fibrillation

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In a draft guidance published on 24 December 2009, the National Institute for Health and Clinical Excellence (NICE) reports that it has decided not to recommend dronedarone (Multaq, Sanofi-aventis) for the use in the UK.

“The evidence provided to the independent appraisal committee indicates that dronedarone is less effective and costs considerably more than existing treatments for controlling atrial fibrillation,” the committee wrote on NICE website.


This draft guidance has been issued for consultation and interested parties have now an opportunity to comment on the draft recommendations made by the independent appraisal committee. NICE has not yet issued final guidance to the NHS.


Andrew Dillon, chief executive of NICE said: “NICE is keen to provide guidance which can help people with atrial fibrillation, but 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 atrial fibrillation.


“The manufacturer’s own data indicated that dronedarone was the least effective of currently used anti-arrhythmic drugs for controlling atrial fibrillation. The drug is much more expensive than existing treatments and the evidence suggests that on balance it offers little additional health benefit.


“The committee also carefully considered information from patients and clinical specialists which indicated that, even though dronedarone does not work as well as existing treatments for atrial fibrillation, it may have fewer side effects so would be welcomed as an alternative option. Improving the quality of life of patients is important to NICE, and the committee was mindful of this. However, the committee noted that the evidence provided was collected over a relatively short period and it was less certain what the longer-term side effects of dronedarone would be. This uncertainty, alongside the drug’s lower effectiveness and higher cost meant that the committee was not able to recommend dronedarone.”


NICE’s preliminary recommendations are available for public consultation until 28 January 2010. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

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