N/A

Dabigatran/ Edoxaban Special Authorization Request Form (ABC 60019)

STEP THERAPY

"AT RISK PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION

SPECIAL AUTHORIZATION (step therapy approval process)

FIRST-LINE DRUG PRODUCT(S): WARFARIN

For at-risk patients (CHADS2 score of greater than or equal to 1) with non-valvular atrial fibrillation (AF) for the prevention of stroke and systemic embolism AND in whom one of the following is also present:
- Inadequate anticoagulation (at least 35% of INR testing results outside the desired range) following a reasonable trial of warfarin (minimum two months of therapy); OR
- Anticoagulation with warfarin is contraindicated as per the product monograph or not possible due to inability to regularly monitor via International Normalized Ratio (INR) testing (i.e. no access to INR testing services at a laboratory, clinic, pharmacy, or at home).

Note: Some or all direct oral anticoagulants may have contraindications to use or precautions with use, for example: related to prosthetic heart valve disease, rheumatic valvular heart disease, renal function, or age. Refer to the product monograph for additional information.

Special Authorization may be granted for 24 months.

Note: If a claim for the Step therapy drug product is rejected, pharmacists can use their professional judgment to determine the appropriateness of using the intervention code(s) noted below to re-submit a claim. The pharmacist is responsible to document on the patient's record the rationale for using the second-line therapy drug.
UP - First-line therapy ineffective
UQ - First-line therapy not tolerated

VENOUS THROMBOEMBOLIC EVENTS

SPECIAL AUTHORIZATION

For the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE).

The recommended dose of edoxaban for patients initiating DVT or PE treatment is 60 mg once daily following initial use of a parenteral anticoagulant for 5-10 days. A reduced dose of 30 mg once daily is recommended for patients with one or more of the following clinical factors:
- moderate renal impairment (creatinine clearance (CrCL) 30-50 mL/min)
- low body weight <= 60 kg (132 lbs)
- concomitant use of p-glycoprotein inhibitors except amiodarone and verapamil.

Drug plan 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.

Special authorization may be granted for up to 6 months."

All requests for edoxaban must be completed using the Dabigatran/Edoxaban Special Authorization Request Form (ABC 60019).