Limited Coverage Drugs - Rivaroxaban for atrial fibrillation (AF)

Generic Name

rivaroxaban for atrial fibrillation (AF)

Strength

15 mg and 20 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:

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

OR

2. 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:

  1. At-risk patients with AF are defined as those with a CHADS2 score of ≥ 1. Although the ROCKET-AF trial included patients with higher CHADS2 scores (≥ 2), other landmark studies with other newer oral anticoagulants demonstrated a therapeutic benefit in patients 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 testing 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 an estimated glomerular filtration rate maintained for at least 3 months (i.e., 30-49 mL/min for 15 mg once daily dosing or ≥ 50 mL/min for 20 mg once daily dosing).

Indefinite

Practitioner Exemptions

  • None

Special Notes

  1. Since renal impairment can increase bleeding risk, it is important to monitor renal functioning regularly. Other factors that increase bleeding risk should also be assessed and monitored (see rivaroxaban product monograph).
  2. Patients starting rivaroxaban for AF should have ready access to appropriate medical services to manage a major bleeding event.
  3. There is currently no data to support that rivaroxaban for AF provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves. As a result, rivaroxaban for AF is not recommended for these patient populations.

Additional Information

Special Authority Request Form