Why No Multaq for the UK?

The one million people in the UK who suffer from atrial fibrillation, a condition in which the normal heart rhythm becomes disrupted, could benefit from a new drug, Multaq. This is the first atrial fibrillation drug to be newly developed for at least ten years and it was approved for use in the EU last year. This all sounds like good news but the National Institute of Clinical Excellence (NICE) in the UK recently announced that it would not be approving Multaq for use in the NHS.

Disputing the Evidence for Multaq Efficacy

The Atrial Fibrillation Association does not agree with the NICE decision, and has stated that it views the evidence from clinical trials to be very convincing. Large trials done by Sanofi-Aventis, the pharmaceutical company that has developed Multaq, show that the drug is able to treat atrial fibrillation very effectively. They also show that it also makes the hearts of patients with this condition healthier with continued use. This is something that the currently used drugs do not do, even though they have more frequent and more severe side effects.

The appraisal committee from NICE that reviewed the evidence were less impressed. They concluded that Multaq did reduce atrial fibrillation quite significantly compared to a sham drug, or placebo, but that it was not as effective as the best drugs currently in use. The committee insists that the evidence does not show that Multaq can reduce the risk of stroke in patients with atrial fibrillation as much as other drugs and they dispute that Multaq saves lives.

What Do the Drug Trials Show?

Clinical trials were carried out in a large number of people with atrial fibrillation – about 7000 altogether – from across Europe. Other European countries have accepted that it reduces the number of patients that need to be hospitalised and that it does cut the number of deaths from any cause, not just causes related to problems with heart rhythm.

The approval bodies in other European countries have accepted the evidence and have allowed Multaq to be prescribed to patients. In the first six months after the drug was launched in the summer of 2009, euro 25 million was spent in the whole of the EU to buy Multaq for people with atrial fibrillation.

The Question of Cost

NICE has been heavily criticised several times over the last few years for denying UK patients access to new drugs that are readily available throughout the rest of the EU, and further afield in the US. The most commonly cited reason for their decisions to block the use of drugs by the NHS is cost. NICE sets a ceiling on the cost of individual drugs compared to the improvement in health that they offer.

At the moment, the NICE ruling does not mention cost, it just questions the evidence that supports the use of Multaq but cynics suggest that cost could be a factor.

The Campaign for Multaq in the UK

With euro 100 million in annual sales projected for Multaq across Europe, plenty of patients in other EU countries will benefit but UK patients will lose out on this new drug if the NICE ruling is not changed. NICE has bowed to pressure from vocal patient groups over their decision on other drugs and is able to change its view. Bearing this in mind, the Atrial Fibrillation Association has been calling for patients and other interested parties to express their concern about the NICE decision. They hope that Multaq will be another drug that is subject to a NICE U-turn and that UK patients will eventually gain access to this new treatment.