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Robust response to NICE decision on dronedarone

The National Institute for Health and Clinical Excellence (NICE) published their preliminary decision on 24th December 2009, not to recommend the use of the antiarrhythmic, dronedarone, for the treatment of atrial fibrillation (AF) patients on the NHS. The decision has been met with protests from the medical community, politicians and the heart rhythm charity, Arrhythmia Alliance.

Last December’s appraisal consultation document  (ACD) (which can be accessed here), is not NICEs final guidance on this technology, and following the initial consultation period, there will be another publicly held Appraisal Committee meeting in Manchester on 24th February 2010. This meeting will consider comments from the consultees, which includes dronedarone manufacturers, sanofi-aventis, as well as professional /specialist and patient/carer groups, such as Heart Rhythm UK (HRUK) and the Arrhythmia Alliance, Atrial Fibrillation Association, and others. The Committee will also consider comments made by non-consultees and will then prepare the final appraisal determination (FAD), which subject to appeal by consultees, may be used as the basis for NICEs guidance on using dronedarone in England and Wales.

crowd3bIn its initial consideration the Appraisal Committee also assessed the submission by the Evidence Review Group (ERG) which was prepared by the Centre for Reviews and Dissemination (CRD) and the Centre for Health Economics (CHE), University of York. They decided that they could not give the drug a positive recommendation based on their assessments of cost effectiveness.

Critics of the ruling argue that dronedarone, while costing more (about £2/day) than other agents, such as amiodarone, offers patients a better short-term side effect profile. The protests were spearheaded by the Daily Express (27 January) who voiced concerns from a number of Members of Parliament, notably Mark Hunter, Liberal Democrat MP for Cheadle who was quoted saying, “At the end of the day, dronedarone, represents a huge step forward for heart patients. It’s a breakthrough drug and if it can benefit all these people, then it’s got to be worthy of reassessment by NICE”.

A group of over 170 doctors are also reported to have written in protest to NICE calling on it to reverse its verdict, claiming that the expense (of dronedarone) is neglible compared with the burden of the effects of atrial fibrillation to the NHS.

Published on: March 3, 2010

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association

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