NICE reaffirms positive opinion on Multaq
pharmafile | July 19, 2010 | News story | Sales and Marketing | Multaq, NICE, antiarrhythmic, dronedarone
In its final draft guidance, UK cost-effectiveness body NICE has reaffirmed its previous positive opinion to recommend the limited use of Sanofi-Aventis’ Multaq.
Multaq (dronedarone) has been given a preliminary green light as a second line treatment in patients with additional cardiovascular risk factors such as diabetes whose atrial fibrillation (AF) has not been controlled by first line therapy.
Sir Andrew Dillon, NICE chief executive, said: “The independent appraisal committee concluded that although dronedarone reduced atrial fibrillation recurrence compared with placebo, it appeared to be less effective for atrial fibrillation recurrence than other antiarrhythmic drugs.
“However, it noted comments from patients and clinical experts received during consultation on a previous draft that all current antiarrhythmic drugs have side effects that have a significant impact on quality of life with long term use. It heard from patient experts that some people with atrial fibrillation might prefer to take dronedarone because it has fewer side effects, despite it being less effective in preventing recurrence of atrial fibrillation.”
Dillon added: “The Committee also accepted evidence that the risk of mortality with dronedarone was likely to be lower than with current antiarrhythmic drugs. Finally, because the cost-effectiveness estimates for the drug were largely based on a single clinical trial, which included people who had a higher risk of a major cardiovascular event, we have recommended that dronedarone is considered as a treatment option only in people who have additional cardiovascular risk factors such as diabetes or high blood pressure.”
In earlier draft guidance published in January, NICE initially was not prepared to recommend the AF treatment because of concerns over cost. In March however, the drugs watchdog was persuaded that Multaq was an advance over existing second line antiarrhythmic drugs such as amiodarone, sotalol and class 1c drugs.
In particular, NICE said amiodarone and other antiarrhythmia drugs carried with them the risk of raised mortality in patients, something not seen in Multaq’s data.
This will be a boost to Sanofi as it is depending on new drugs such as Multaq to sustain sales and offset generic competition.
The draft guidance is now with consultees who have the opportunity to appeal against the proposed guidance. Final guidance is set to be published in August.
Ben Adams
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