DRONEDARONE FOR ATRIAL FIBRILLATION
Dronedarone for atrial fibrillation
Background
This project was undertaken as part of NICE’s single technology appraisal (STA) process. The STA process is specifically designed for the appraisal of a single product, device or other technology, with a single indication. The STA process normally covers new technologies and is designed to provide recommendations in the form of NICE guidance soon after the technology is introduced into the UK market. The principal evidence in the STA process is submitted by the manufacturer or sponsor of the technology.
The primary output of these projects is an Evidence Review Group (ERG) report.
The project assessed the manufacturer's submission to NICE on the use of dronedarone for the treatment of atrial fibrillation (AF) and atrial flutter (AFL), including an assessment of both the clinical and cost-effectiveness evidence submitted by the company.Findings
The evaluation of clinical effectiveness in the submission comprised a summary of evidence from all relevant RCTs of dronedarone together with a systematic review in which dronedarone was compared with of all relevant AADs. Within the systematic review direct, indirect and MTC syntheses were presented.
The evidence presented demonstrates that dronedarone has a beneficial effect on AF recurrence and ventricular rate during recurrence but results based on direct and indirect analyses indicate that dronedarone is a less effective AAD than direct comparators.
The economic model structure was considered appropriate for the decision problem, and the general approach employed by the manufacturer to estimate lifetime cost-effectiveness was deemed appropriate and met the requirements of the NICE reference case approach. However, the ERG identified a number of potential issues related to the submission and electronic model which were considered to compromise the validity of the model results.
Conducted by: E Maund1, C McKenna2, M Sarowar2, D Fox1, M Stevenson2, C Pepper2, S Palmer2, N Woolacott11. Centre for Reviews and Dissemination; 2. Centre for Health Economics
Further details
Project page on the NIHR HTA Programme websiteRelated guidance
Commissioned to inform NICE Technology Appraisal Guidance: Dronedarone within its licensed indication for the treatment of atrial fibrillation. London: National Institute for Clinical Excellence; 2010Publications
McKenna C, Maund E, Sarowar M, Fox D, Stevenson M, Pepper C, Palmer S, Woolacott N. Dronedarone for atrial fibrillation and atrial flutter. a Single Technology Appraisal. Centre for Reviews and Dissemination and Centre for Health Economics, 2009
McKenna C, Maund E, Sarowar M, Fox D, Stevenson M, Pepper C, Woolacott N, Palmer S. Dronedarone for the treatment of atrial fibrillation: a NICE Single Technology Appraisal. Pharmacoeconomics 2012;30(1):35-46
Maund E, McKenna C, Sarowar M, Fox D, Stevenson M, Pepper C, Palmer S, Woolacott N. Dronedarone for atrial fibrillation and atrial flutter. Health Technol Assess. 2010; 14 (Suppl. 2):55-62Funding
Commissioned by the NIHR HTA Programme in support of NICE's Single Technology Appraisal process
Status: Completed