NICE changes its mind on Multaq
pharmafile | March 30, 2010 | News story | Sales and Marketing | Multaq, NICE, Sanofi-Aventis
NICE has given preliminary approval of Sanofi-Aventis’ Multaq for the management of patients with atrial fibrillation.
The decision reverses an earlier initial ruling in December, which said the drug was too expensive to recommend for NHS use.
But after consultation, NICE has been persuaded that Multaq (dronedarone) is an advance over existing second-line anti-arrhythmic drugs such as amiodarone, sotalol and class 1c drugs.
In particular, the cost and clinical effectiveness body said amiodarone and other anti-arrhythmic drugs AADs carried with them the risk of raised mortality in patients, something not seen in Multaq’s data.
Sanofi-Aventis has deliberately held back the launch of the drug in the UK until the ruling was published, such is its importance to uptake in the health service.
Multaq will be commercially available in the UK from today, Tuesday 30 March, and NICE looks set to issue its final recommendation within weeks.
The NICE appraisal committee has endorsed Multaq as a second-line option after beta-blockers, which are the initial therapeutic option in the NICE clinical guidelines.
This means Multaq can be prescribed in non-permanent atrial fibrillation (AF) patients with at least one of the following cardiovascular risk factors:
• Hypertension requiring drugs of at least two different classes
• Diabetes mellitus
• Previous transient ischemic attack
• Stroke or systemic embolism
• Left atrial diameter of 50mm or greater
• LVEF (ventricular ejection fraction) less than 40%
• Or where patients are aged 70 years or older and do not have unstable New York Heart Association (NYHA) class III or IV heart failure.
This patient population corresponds to the patients included in the ATHENA study, the largest study ever performed with an AAD in atrial fibrillation and the only one to demonstrate a positive impact on cardiovascular morbidity and mortality.
“Sanofi-Aventis is pleased that NICE has acknowledged the benefits of Multaq for non-permanent AF patients who have been awaiting a new therapeutic option that safely treats their symptoms and improves their long-term cardiovascular outcomes,” declared Belen Garijo, the company’s senior vice president of pharmaceutical operations in Europe.
“We appreciate the thorough and comprehensive evaluation of the Multaq clinical and economic dossier that NICE has performed and believe that this preliminary recommendation by NICE provides a valuable benchmark to guide Sanofi-Aventis’ ongoing efforts to have the Multaq value proposition in AF patients recognised within Europe and beyond.”
The decision is significant for Multaq, as many countries use NICE’s decisions to inform their own reimbursement decisions.
Reports suggest that a similar preliminary review of the drug in France has concluded it offered ‘moderate’ benefits. This could mean Sanofi-Aventis will have to market the drug at a lower price than existing treatments, and only be reimbursed up to 35 per cent.
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