Limited Coverage Drugs - Dabigatran

Generic Name / Strength / Form

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

Practitioner Exemptions

  • No practitioner exceptions

Special Notes

  1. Since renal impairment can increase bleeding risk, renal function should be regularly monitored. Other factors that increase bleeding risk should also be assessed and monitored (see dabigatran product monograph). Note that the product monograph recommends dabigatran 110 mg twice daily for patients ≥ 80 years of age.
  2. Patients starting dabigatran should have ready access to appropriate medical services to manage a major bleeding event.
  3. There is currently no data to support that dabigatran provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves. As a result, dabigatran is not recommended for these patient populations.

Additional Information:

Special Authority Request Form(s)