| 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 recommeded dose of edoxaban for patients initiating DVT or PE treatment is 60mg once daily following initial use of a parenteral anticoagulant for 5 to 10 days. Edoxaban 30mg once daily is recommended in patients with one or more of the following clinical factors:
a) Moderate renal impairment (creatinine clearance (CrCl) 30-50 mL/min);
b) Low body weight less than or equal to 60kg, and
c) Concomitant use of P-glycoprotein (P-gp) inhibitors except amiodarone and verapamil.
ODB Program coverage for edoxaban is an alternative to heparin/warfarin for up to 6 months. When used for greater than 6 months, edoxaban 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 or rivaroxaban 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). |
| 554 | INCLUSION CRITERIA:
At risk patients with non-valvular atrial fibrillation, for the prevention of stroke and systemic embolism AND in whom:
1. Anticoagulation is inadequate following at least a 2-month trial on 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 CRITERIA:
1. Patients with impaired renal function (creatinine clearance or estimated glomerular filtration rate less than 30 mL per min);
OR
2. Patients who are greater than or equal to 75 years of age and who do not have documented stable renal function;
OR
3. Patients who have hemodynamically significant rheumatoid valvular heart disease (especially mitral stenosis);
OR
4. Patients who have prosthetic heart valves.
NOTES:
At-risk patients with atrial fibrillation are defined as those with a CHADS2 score of greater than or equal to 1. Prescribers may consider an antiplatelet regimen or oral anticoagulation for patients with a CHADS2 score of 1.
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).
Documented stable renal function is defined as creatinine clearance or estimated glomerular filtration rate maintained for at least 3 months.
DOSING:
The usual recmommended dose is 60mg once daily for the prevention of stroke and systemic embolisms in patients with nonvalvular atrial fibrillation is 60mg once daily; a reduced dose of Edoxaban 30mg once daily is recommended for patients in patients with once or more of the following clinical factors:
a) Moderate renal impairment (creatinine clearance (CrCL) 30-50 mL/min);
b) Low body weight less than or equal to 60kg, and
c) Concomitant use of P-glycoprotein (P-gp) inhibitors excepted amiodarone and verapamil.
Duration of therapy should be individualized after careful assessment of the treatment benefit against the individual risk of bleeding.
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 edoxaban product monograph).
Patients starting edoxaban should have ready access to appropriate medical services to manage a major bleeding event.
There is currently no data to support that edoxaban provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves. As a result, edoxaban is not recommended for these patient populations.
|
| | LU Authorization Period: Indefinite. |
