The Atrial Fibrillation Association is calling on all stakeholders to oppose the National Institute for Health and Clinical Excellence’s rejection of Multaq on the National Health Service.

According to the heart charity, extensive trials with Sanofi-Aventis’ Multaq (dronedarone) - the first new anti-arrhythmic drug (AAD) launched in the last decade – have shown that the drug is not only effective in treating AF but also has a unique ability to improve long-term cardiac health in patients.

Moreover, it says studies have demonstrated that Multaq is able to cut the incidence of AF “to a level at least equal to that of current anti-arrhythmic drugs available” but with “far fewer side effects than commonly experienced by patients prescribed currently available drugs”, and that it’s use could lead to a reduction in hospitalisation and stroke.

However, in what AFA describes as a “shock decision”, NICE published preliminary recommendations late last year denying patients with AF access to the drug on the NHS on doubts over its efficacy and cost-effectiveness.

According to NICE’s Appraisal Committee, while Multaq reduced AF recurrence compared with placebo it appears to be less effective than other anti-arrhythmic drugs, and it said it had not been persuaded “that a reduction in the risk of all-cause mortality for Multaq compared with placebo and other anti-arrhythmic drugs had been demonstrated”, nor that the drug was associated with a lower stroke risk than other therapies on the market based on the evidence submitted.

Furthermore, it concluded that the use of Multaq as an alternative to the gold standard treatment amiodarone, class 1c agents, or sotalol for anti-arrhythmic treatment of AF could not be considered a cost-effective use of NHS resources.

But Trudie Lobban, AFA’s founder and chief executive, slammed the decision, saying: “There is a great strength of feeling across the health and AF communities that the draft NICE guidance on Multaq would deny patients a first-in-class, first-in-a-generation treatment option”.

Consequently, the heart charity is urging patients, carers, supporters and healthcare professionals to take part in a large-scale assault on NICE’s proposals – to alert both the Institute and the Department of Health “to the retrograde step that the draft guidance would pose” – by submitting objections before the close of the consultation period on January 28, to help change the cost watchdog’s mind.

Atrial Fibrillation (AF) is the most common form of heart rhythm disturbance and is estimated to effect in excess of one million people in the UK, with 200,000 newly diagnoses every year.