In its final draft guidance published 16th July, the National Institute for Health and Clinical Excellence (NICE) reaffirmed the decision in its previous draft to recommend the limited use of the drug as a second-line treatment in people with additional cardiovascular risk factors whose AF has not been controlled by first-line therapy.
NICE chief executive Sir Andrew Dillon 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.”
He continued: “The Committee also accepted evidence that the risk of mortality with dronedarone was likely to be lower than with current anti-arrhythmic 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.”
The draft guidance is now with consultees, who have the opportunity to appeal against it. Final guidance is expected to be published by the end of August. Once NICE issues its guidance on a technology, it replaces local recommendations across the National Health Service.
About the guidance
1. Atrial fibrillation (AF) is one of the most common heart rhythm disturbance conditions. It can cause symptoms such as palpitations and tiredness.
2. AF is associated with an increased risk of thrombus (blood clot) formation and thromboembolism including ischaemic strokes.
3. The prevalence of AF increases with age with a prevalence of 0.5% at age 50-59 years increasing to almost 9% at age 80-89 years. In the UK, more than 46,000 new cases of AF are diagnosed each year.
4. Standard baseline therapy for AF may include drugs to maintain sinus rhythm, where beta-blockers are usually the first choice. Where standard baseline therapy with a beta-blocker is ineffective, contraindicated or not tolerated, second line therapy is chosen according to various factors including whether the person has structural heart abnormalities. Either flecainide or sotalol may be chosen if there are no structural abnormalities and amiodarone may be used in people with structural heart disease.
5. The cost per day based on the recommended dosage of dronedarone would be £2.25. The cost of an existing comparator drug, amiodarone, is approximately £0.05 per day.
6. View the appraisal of dronedarone for atrial fibrillation for further information.