Limited coverage drugs – dabigatran

Special Authority criteria 

Approval period

Inclusion:

At-risk patients with non-valvular atrial fibrillation (AF)ⁱ, for the prevention of stroke and systemic embolism AND:

1. In whom anticoagulation is inadequateⁱⁱ following at least a 2-month trial of warfarin

OR

2. For whom anticoagulation using warfarin is contraindicated or not possible due to inability to regularly monitor the patient via International Normalized Ratio (INR) testing (i.e., no access to INR testing services at a laboratory, clinic, pharmacy and at home)

Exclusion:

1. Patients with impaired renal function (creatinine clearance or estimated glomerular filtration rate <30 mL/min)

OR

2. Patients who are ≥ 75 years of age and who do not have documented stable renal functionⁱⁱⁱ

OR

3. Patients who have hemodynamically significant rheumatic valvular heart disease (especially mitral stenosis)

OR

4. Patients who have prosthetic heart valves

Notes:

i. At-risk patients with AF are defined as those with a CHADS₂ score of ≥ 1

ii. Inadequate anticoagulation is defined as INR testing results that are outside the desired INR range for at least 35% of the tests during the monitoring period (i.e., adequate anticoagulation is defined as INR test results that are within the desired INR range for at least 65% of the tests during the monitoring period)

iii. Documented stable renal function is defined as creatinine clearance or estimated glomerular filtration rate maintained for at least 3 months (i.e., 30-49 mL/min for 110 mg twice daily dosing or ≥ 50 mL/min for 150 mg twice daily dosing)

Indefinite