NICE richtlijnen voor Dronedarone

25/08/2010

Het National Institute for Clinical Excellence (NICE) heeft haar eerste richtlijn betreffende het klinische gebruik van Dronedarone (Multaq, sanofi-aventis) uitgegeven op 24 december 2009, waarin zij adviseren om Dronedarone niet goed te keuren voor het gebruik van niet-permanent atrium fibrilleren. De reden voor dit besluit was op financiële gronden.

NICE GUIDANCE ON DRONEDARONE FOR THE TREATMENT OF NON-PERMANENT ATRIAL FIBRILLATION: A GUIDE FOR CLINICIANS
Nieuws - 25 aug. 2010

August 25, 2010

NICE DECISION ON THE USE OF DRONEDARONE

The National Institute for Clinical Excellence (NICE) issued their original guidance on 24th December 2009 recommending that Dronedarone (Multaq) should not be approved for the treatment of non-permanent atrial fibrillation. The reason for this decision was on the grounds of cost.

Following this announcement there was widespread dismay from clinicians, AF patients and their carers who believed that Dronedarone’s approval would be a useful alternative and addition to the few drug treatments which are currently available. Shortly after the publication of the initial guidance, organisations such as the Atrial Fibrillation Association and the Arrhythmia Alliance launched an appeal against the decision.

Following an appeals process, the NICE Appraisal Committee recognised that Dronedarone can, and should, occupy a currently vacant place in the care pathway, and that for a large and growing number of patients it could represent the only treatment option open to them.

Guidance

NICE’s final guidance was published on 25th August 2010. This states that Dronedarone is recommended as an option for the treatment of non-permanent Atrial Fibrillation only in people:

whose Atrial Fibrillation is not controlled by first-line therapy (usually beta-blockers), that is, as a second-line treatment option, and
who have at least one of the following cardiovascular risk factors:
- Hypertension (high blood pressure) requiring drugs of at least two different classes
- Diabetes mellitus (diabetes)
- Previous transient ischaemic attack (’mini-stroke’), stroke or systemic embolism
- Left atrial diameter of 50mm or greater
- left ventricular ejection fraction less than 40% (noting that the summary of product characteristics (SPC) does not recommend Dronedarone for people with left ventricular ejection fraction less than 35% because of limited experience of using it in this group), or
- Age 70 years or older, and
Who do not have unstable New York Heart Association (NYHA) class III or IV heart failure.

The guidance also states that people who do not meet the criteria, who are currently receiving Dronedarone, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

The detailed guidance; quick reference guide; guidance written for patients and carers; audit support; and costing templates have been published.

Dronedarone

Dronedarone (Multaq) is an anti-arrhythmic drug belonging to the benzofuran class of anti-arrhythmic compounds. Dronedarone has a marketing authorisation for the treatment of adult clinically stable patients with a history of, or current, non-permanent atrial fibrillation to prevent recurrence of atrial fibrillation or to lower ventricular rate. Sanofi-aventis hold the marketing license in the UK.

The Summary of Product Characteristics states that because of the unexplained results of the ANDROMEDA study, the use of Dronedarone in unstable patients with NYHA class III and IV heart failure is contraindicated. There is also a recommendation in the SPC which states that because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with left ventricular ejection fraction less than 35%, the use of Dronedarone is not recommended in these patients. Side effects

The most frequently observed adverse events in people receiving Dronedarone are elevated blood creatinine levels and prolongation of the QT interval. Other common adverse events include bradycardia, rashes, pruritus, fatigue, asthenia and gastrointestinal events such as diarrhoea and vomiting.

Dosage

The recommended dosage of Dronedarone is 400mg twice daily. Dronedarone is available in 400mg tablets and comes in packs of 20 tablets or 60 tablets.

Implementation

The Secretary of State for Health and the Welsh Assembly Minister for Health and Social Services have issued directions to the NHS on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends use of a drug or treatment, or other technology, the NHS must provide funding and resources for it within 3 months of the guidance being published. If the Department of Health issues a variation to the 3-month funding direction, details will be available on the NICE website.

Further information

Please find below, the link to the press release issued by NICE regarding the published guidance for the use of Dronedarone for the treatment of AF.
www.nice.org.uk/newsroom/pressreleases/AtrialFibrillationMoreTreatmentOptions.jsp

The full guidance can be viewed via the below link:
http://guidance.nice.org.uk/TA197