DABIGATRAN ETEXILATE TO PREVENT STROKE

Dabigatran etexilate for the prevention of stroke and systemic embolism in 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 dabigatran etexilate within its licensed indication for the prevention of stroke and systemic embolism in people with atrial fibrillation. 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 dabigatran.

The manufacturer's submission (MS) explored three regimens of dabigatran for the prevention of stroke in patients with atrial fibrillation (AF). Aspirin monotherapy and clopidogrel plus aspirin were considered secondary comparators. The aim of the MS was to demonstrate that dabigatran was as effective as warfarin, and potentially better, in preventing stroke without a concomitant increase in bleeding.

Findings

Clinical effectiveness: Overall, the evidence shows that dabigatran 150 mg is efficacious in preventing ischaemic stroke and vascular death, without a significant concomitant increase in the incidence of haemorrhagic stroke or major bleeding, although, the incidence of GI bleeds is increased with dabigatran 150 mg compared to warfarin. There seems to be some benefit in a dose reduction in the elderly in terms of haemorrhagic outcomes, and the beneficial effects of dabigatran compared with warfarin seem to be most pronounced in those with poor INR control.

Cost effectiveness: 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. The ERG identified a few alternative assumptions to those used in the model which increased the ICER, although dabigatran was still cost-effective except for  patients with good INR control. 

Conducted by: Eldon Spackman1, Jane Burch2, Rita Faria1, Belen Corbacho1, David Fox2, Nerys Woolacott2

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

Further details

Project page on NIHR HTA Programme website

Related guidance

Commissioned to inform NICE Technology Appraisal Guidance. Dabigatran etexilate for the prevention of stroke or systemic embolism in people with atrial fibrillation. London: National Institute for Clinical Excellence; 2011

Publications

Faria R, Spackman E, Burch J, Corbacho B, Todd D, Pepper C, Woolacott N, Palmer S. Dabigatran for the prevention of stroke and systemic embolism in atrial fibrillation: a NICE single technology appraisal. Pharmacoeconomics 2013; [Epub ahead of print]

Spackman E, Burch J, Faria R, Corbacho B, Fox D, Woolacott N. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: A Single Technology Appraisal. Centre for Reviews and Dissemination and Centre for Health Economics; 2011

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.