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Canadian Drug Review Reimbursement Decision


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  Pradaxa
Generic dabigatran etexilate
Company Boehringer Ingelheim (Canada) Ltd.
Indication atrial fibrilation
Condition Cardiovascular
Submission Type
Patient Population This submission for dabigatran (administered as dabigatran etexilate) is for the new Health Canada indication of prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate. The anticoagulant activity of dabigatran is through direct inhibition of thrombin. It is available as 110 mg and 150 mg capsules for this indication. The Health Canada-recommended dose is 150 mg twice a day, but in geriatric patients, especially those older than 75 years who have at least one other risk factor for bleeding, Health Canada recommends that a reduced dose of 110 mg twice a day may be considered.
Status Complete
Date of Recommendation 2011-06-22
Recommendation Summary List with criteria/condition
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that dabigatran be listed for the prevention of stroke and systemic embolism in patients with atrial fibrillation meeting one of the following criteria: • Patients in whom warfarin is indicated but who fail to achieve adequate international normalized ratio (INR) control, despite monitored warfarin treatment, such as with: regular INR testing, dosage adjustment according to a validated nomogram, and patient education. Patients who fail to achieve adequate INR control should be referred to an anticoagulation management service, if available. or • Patients who have a history of a serious hypersensitivity reaction to warfarin.
Reason for Recommendation 1. In one large open-label randomized controlled trial (RCT) (RE-LY) the annual incidence of stroke or systemic embolism was statistically significantly less with dabigatran 150 mg twice daily (1.11%) compared with adjusted dose warfarin (1.71%); however the annual incidence with dabigatran 110 mg twice daily (1.54%) was not statistically significantly different compared with adjusted dose warfarin. In a pre-planned subgroup analysis the benefit of dabigatran 150 mg twice daily, compared with adjusted dose warfarin, was primarily observed in centres that failed to achieve adequate INR control. 2. The daily cost of dabigatran ($3.20) is greater than warfarin ($0.06 or approximately $1.16 when monitoring costs are included).
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.


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