| 435 | For the prevention of stroke and systemic embolism in at-risk patients who have non-valvular atrial fibrillation (AF) AND in whom:
1) Anticoagulation is inadequate following a reasonable trial on warfarin; OR
2) Anticoagulation with warfarin is contraindicated or not possible due to inability to regularly monitor via International Normalized Ratio (INR) testing (i.e., no access to INR testing service at a laboratory, clinic, pharmacy, and at home).
Exclusion Criteria: Patients who:
(a) have impaired renal function (creatinine clearance or estimated glomerular filtration rate less than 30mL/min); OR
(b) are greater than or equal to 75 years in age without documented stable renal function; OR
(c) have hemodynamically significant rheumatic valvular heart disease, especially mitral stenosis; OR
(d) have prosthetic heart valves.
Definitions and Clarification:
(a) "documented stable renal function" is defined as creatinine clearance or estimated glomerular filtration rate that maintained for at least 3 months (i.e., 30-49mL/min for 15mg once daily dosing or greater than or equal to 50mL/min for 20mg once daily dosing
for at least 3 months).
(b) "at-risk patients with atrial fibrillation" are defined as those with a CHADS2 score of greater than or equal to 1. Although the ROCKET-AF trial included patients with higher CHADS2 score (greater than or equal to 2), other landmark studies with the 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.
(c) "inadequate anticoagulation" is defined as INR testing results that are outside of 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).
(d) "a reasonable trial on warfarin" is defined as at least 2 months of therapy.
(e) 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 product monograph).
(f) Patients starting rivaroxaban should have ready access to appropriate medical services to manage a major bleeding event.
(g) There is currently no data to support that rivaroxaban provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves, so rivaroxaban is not recommended in these populations.
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| | LU Authorization Period: Indefinite. |
| 444 | For the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) for up to six (6) months. |
| | LU Authorization Period: 6 Months |
| | NOTE: -The recommended dose of rivaroxaban for patients initiating DVT or PE treatment is 15 mg twice daily for 3 weeks, followed by 20 mg once daily.
-ODB Program coverage for rivaroxaban is an alternative to heparin/warfarin for up to 6 months. When used for greater than 6 months, rivaroxaban is more costly than heparin/warfarin. As such, patients with an intended duration of therapy greater than 6 months should be considered for initiation on heparin/warfarin.
-For clarity, coverage will not be provided for patients who have already received 6 months of treatment with apixaban for the same DVT or PE.
-Since renal impairment can increase bleeding risk, it is important to monitor renal function regularly. Other factors that increase bleeding risks should also be assessed and monitored (see product monograph).
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