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Dronedarone gets thumbs up from NICE in New Appraisal Consultation Document

The National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document (ACD)1 for Multaq® (dronedarone) indicating its intention to recommend its use for the management of patients with atrial fibrillation (AF).

The NICE appraisal committee’s preliminary recommendation is to endorse Multaq® as a first choice therapeutic option after beta-blockers, which are the initial therapeutic option in the NICE clinical guidelines.  Based on this recommendation, Multaq® should be prescribed in non-permanent 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 of greater, LVEF less than 40% or age 70 years or older and who 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 1, the largest study ever performed with an anti-arrhythmic drug in atrial fibrillation and the only study to have ever demonstrated a positive impact on cardiovascular (CV) morbidity and mortality.

In ATHENA, dronedarone reduced the risk of cardiovascular hospitalization or death by a significant 24% vs. placebo on top of standard of care including beta-blockers (p<0.001) with no difference in the rate of serious adverse events (19.9% vs 21.1% respectively; p = 0.31).

The Arrhythmia Alliance welcomed the decision by NICE to recommend approval of dronedarone as a second line treatment option for Atrial Fibrillation (AF) patients, reversing its previous draft guidance.

NICE’s Appraisal Committee recognised that dronedarone can and should occupy a currently vaca(2nt 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.

Trudie Lobban, CEO of the Atrial Fibrillation Association which is campaigning for dronedarone to be approved said: “For thousands of AF patients this news will give them new hope that they will be able to lead a fulfilled and productive life. NICE’s decision is triumph of common sense and will restore patient and healthcare professionals faith in NICE processes and evidence hearing. They took into account the value of the drug to patients whose lives have been crippled with either the symptoms of AF or the side effects of other treatments.  It is important that symptomatic AF patients have access to specialist consultants who will be aware of the benefits of this new drug.

“I would like to thank all the patients, carers and clinicians who took the time to respond to the earlier Appraisal Consultation Document by NICE which ensured that a review was held and evidence from leading arrhythmia clinicians and AF patients was heard. Without their support many thousands of AF sufferers would be left without hope.”

Professor John Camm, Head of the Department of Cardiac & Vascular Sciences at St George’s, University of London, a Trustee of AFA and President of Arrhythmia Alliance said: “This decision will please many clinicians working in our field. It enables us to have the authority to prescribe dronedarone and gives us an additional treatment for patients who may have run out of options. I want to thank the NICE committee for being so responsive to requests to review all the evidence.”

Multaq® will be commercially available in the UK from Tuesday, March 30, 2010.

Multaq® has a fixed dose regimen of twice daily 400 mg tablets to be taken with morning and evening meals. Treatment with Multaq® does not require a loading dose and can be initiated in an outpatient setting. Most common adverse reactions are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and skin rash.

The European Commission granted marketing authorization for Multaq® in November 2009. Multaq® is indicated in the EU in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. 2 The use of Multaq® in unstable patients with NYHA class III and IV heart failure is contraindicated. Because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with Left Ventricular Ejection Fraction (LVEF) <35%, the use of Multaq® is not recommended in these patients.

Multaq® is currently available in the U.S., Canada, Switzerland, Germany, Denmark, Ireland, Norway and Finland and is being launched in most European countries in 2010.

The NICE process for Multaq®

  • The stakeholder consultation period for this ACD closes on 22 April
  • Stakeholder comments submitted to NICE on this ACD will be considered at the Appraisal Committee Meeting on 26 May
  • If a Final Appraisal Determination (FAD) is produced following the Appraisal Committee Meeting it would be expected in early July
  • If the FAD is not appealed, publication of Final Guidance would be expected sometime between July and September.

1. This new appraisal document is not the final NICE guidance on Multaq®.  A consultation period is ongoing until April 22nd, 2010. The appraisal committee will meet again to consider the evidence on May 26, 2010. After this meeting the Committee will prepare the final appraisal determination (FAD) for Multaq®.

References

  1. Hohnloser S.H, Crijns H.J.G.M., van Eickels M, et al. Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation, N Engl J Med 2009; 360:668-78.
  2. European Medicines Agency. European Public Assessment Report.  Doc. Ref.: EMA/625172/2009; EMEA/H/C/1043

Published on: April 9, 2010

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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