DRONEDARONE FOR ATRIAL FIBRILLATION

Dronedarone for atrial fibrillation: an assessment based on the manufacturer’s submission to NICE

Background

The aim of this NICE STA was to appraise the clinical and cost-effectiveness of dronedarone within its licensed indication for the treatment of atrial fibrillation (AF) and atrial flutter (AFL). CRD researchers together with researchers from the Centre for Health Economics (CHE) comprised the Evidence Review Group for this STA. The work involved a detailed assessment of the manufacturer’s submission to NICE on the clinical and cost-effectiveness of dronedarone.

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. The incremental cost effectiveness ratio (ICER) of dronedarone was relatively robust and less than £20,000 per quality adjusted life year (QALY). Exploratory work undertaken by the Evidence Review Group identified that the main drivers of cost effectiveness were the benefits assigned to dronedarone for all-cause mortality and stroke.  Dronedarone is not cost-effective relative to its comparators when the only effect of treatment is a reduction in atrial fibrillation recurrences.

Conducted by: E Maund1, C McKenna2, M Sarowar2, D Fox1, M Stevenson2, C Pepper2, S Palmer2, N Woolacott1

1. Centre for Reviews and Dissemination; 2. Centre for Health Economics, University of York

Further details

Project page on the NIHR HTA Programme website

Related 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; 2010

Publications

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):55-62

Funding

Commissioned by the NIHR HTA Programme in support of NICE's Single Technology Appraisal process.

NICE’s single technology appraisal (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.