NICE Single Technology Appraisal Guidance No 249 -
Dabigatran etexilate for the prevention of stroke and systemic
embolism in atrial fibrillation
This NICE guidance was published on15 March
2012. The web reference for the appraisal and other
related documents is: http://guidance.nice.org.uk/TA249
NHSScotland should note
that:
1. Recommendations of NICE Single Technology
Appraisals (STAs) have no status in NHSScotland.
2. NHS boards should adhere to the Scottish
Medicines Consortium (SMC) advice.
SMC published a Statement of Advice (672/11) on
this medication for this indication in August 2011. This stated
that:
Dabigatran etexilate (Pradaxa®) is accepted for
use within NHS Scotland for the prevention of stroke and systemic
embolism in adult patients with non-valvular atrial fibrillation
with one or more of the following risk factors:
- previous stroke, transient ischaemic attack,
or systemic embolism
- left ventricular ejection fraction
<40%
- symptomatic heart failure, ≥ New York Heart
Association (NYHA) Class 2
- age ≥75 years
- age ≥65 years associated with one of the
following: diabetes mellitus, coronary artery disease or
hypertension
Dabigatran etexilate was at least as effective
as standard oral anticoagulation at preventing stroke or systemic
embolism in one large, open-label study in patients with atrial
fibrillation and at least one risk factor for stroke. This was not
associated with an increased risk of major bleeding.
The economics case made supports the use of
the proposed sequenced dosing regimen (whereby the dose is reduced
from 150mg twice daily to 110mg twice daily in patients aged ≥ 80
years). This applies whether the alternative treatment is
warfarin, aspirin or ‘no treatment’ (i.e. neither warfarin nor
aspirin).
Access the advice of SMC:
3. There is no material difference between the
recommendations of the NICE STA and SMC.
Published Date: 15 March 2012
