9 April 2010
Preliminary recommendations from NICE restrict the use of dronedarone (Multaq®▼) to a limited group of patients with AF. This group consists of those with non-permanent AF for whom first-line therapy has failed to control their AF and who have at least one specified cardiovascular risk factor, but do not have unstable NYHA class III or IV heart failure. This is not NICE’s final guidance and the recommendations may change after consultation. The closing date for comments on this ACD is 22nd April 2010.
NICE final guidance will be issued in due course. In the meantime, local decision making bodies should consider engaging with stakeholders and agree a protocol for implementation of those recommendations. This includes identifying those patients for whom the drug may be appropriate and ensuring audit or other monitoring arrangements are in place locally to permit effective implementation of NICE’s recommendations.
What does the ACD say?
NICE has published a second appraisal consultation document (ACD) setting out draft recommendations on the role of dronedarone for the treatment of non-permanent atrial fibrillation (AF). It should be noted that this document is not NICE’s final guidance, which may change after consultation. The closing date for comments is 22nd April 2010. Comments may be made online.
The preliminary recommendations are that dronedarone is recommended as an option for the treatment of non-permanent AF only in people:
- whose AF is not controlled by first-line therapy (usually including beta-blockers), that is, as a second-line treatment option, and
- who do not have unstable New York Heart Association (NYHA) class III or IV heart failure, and
- who have at least one of the following cardiovascular risk factors:
- hypertension requiring drugs of at least two different classes
- diabetes mellitus
- previous transient ischaemic attack, stroke or systemic embolism
- left atrial diameter of 50 mm or greater
- left ventricular ejection fraction (LVEF) less than 40%
- age 70 years or older
The ACD says that people who do not meet the criteria above and who are currently receiving dronedarone should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
NICE guidance on AF says that, where it is indicated by stroke risk stratification, health professionals should begin antithrombotic therapy with minimal delay in all patients with newly diagnosed AF, after comorbidities have been appropriately managed. After that, options include rate or rhythm control, depending on whether the AF is paroxysmal, persistent or permanent. Management of AF is discussed further on the atrial fibrillation section of NPC
A standard beta-blocker is the recommended first line treatment if a rhythm control approach is selected for someone with persistent AF, and a beta-blocker or rate-limiting calcium antagonist is recommended first line if a rate control approach is selected in persistent AF or for the first line management of permanent AF. Other treatments should be used when beta-blockers (or rate-limiting calcium antagonists) fail to control symptoms or are contraindicated (see NICE guidance for full details).
Dronedarone is licensed for use in adult clinically stable patients with a history of, or current non-permanent AF to prevent recurrence of AF or to lower ventricular rate. The Summary of Product Characteristics (SPC) states that the use of dronedarone in patients in unstable haemodynamic conditions including patients with symptoms of heart failure at rest or with minimal exertion (corresponding with NYHA class IV and unstable class III patients) is contraindicated. The SPC also states that the use of dronedarone in stable patients with recent (1 to 3 months) NYHA class III heart failure or LVEF <35% is not recommended. Further information on adverse effects, special warnings and contra-indications can be found in the SPC
The recommended dosage of dronedarone is 400 mg twice daily. Dronedarone is available in 400 mg tablets and comes in packs of 20 tablets or 60 tablets. The manufacturer has stated that the cost to the NHS of a pack of 20 tablets will be £22.50 and the cost of a pack of 60 tablets will be £67.50 (excluding VAT). The cost per patient per day based on the recommended dosage will be £2.25 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.
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