Limited Coverage Drugs - Apixaban for atrial fibrillation (AF)

Generic Name

apixaban for atrial fibrillation (AF)

Strength

2.5 mg and 5 mg
Form tablet

Special Authority Criteria

Approval Period

Inclusion:

At-risk patients with non-valvular AFi, for the prevention of stroke and systemic embolism AND in whom:

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

OR

  1. 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 < 25 mL/min)

OR

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

OR

  1. patients who have hemodynamically significant rheumatic valvular heart disease (especially mitral stenosis)

OR

  1. patients who have prosthetic heart valves.

Notes:

  1. At-risk patients with AF are defined as those with a CHADS2 score of ≥ 1. Prescribers may consider an antiplatelet regimen or oral anticoagulation for patients with a CHADS2 score of 1.
  2. 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).
  3. Documented stable renal function is defined as creatinine clearance or estimated glomerular filtration rate maintained for at least 3 months.

Indefinite

Practitioner Exemptions

  • None

Special Notes

  1. Dosing: the usual recommended dose is 5 mg twice daily; a reduced dose of 2.5 mg twice daily is recommended for patients with at least 2 of the following: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 133 micromole/litre.
  2. 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 apixaban product monograph).
  3. Patients starting apixaban for AF should have ready access to appropriate medical services to manage a major bleeding event.
  4. There is currently no data to support that apixaban for AF provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves. As a result, apixaban for AF is not recommended for these patient populations.

Additional Information:

Special Authority Request Form(s)