CurrentCignaPolicy N/A

Savaysa (edoxaban) prior authorization

Cigna coverage policy for prior authorization of Savaysa (edoxaban) for anticoagulation indications, specifying covered FDA‑approved and select supportive‑evidence uses and requirements for approvals.

Policy Summary

PayerCigna

PolicySavaysa (edoxaban) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests; approvals are provided for specified durations per indication (e.g., 1 year for atrial fibrillation and DVT/PE).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA‑approved indications

2Supportive uses listed

1 yrTypical approval duration

≥18Minimum age

Coverage Criteria for Savaysa (edoxaban)

inv-01: FDA-Approved Indications

Covered when ALL required conditions for FDA‑approved uses are met:

Atrial Fibrillation (or Atrial Flutter): Approve for 1 year if the patient meets BOTH of the following (A and B): A) Patient is ≥ 18 years of age; AND B) Patient has an estimated creatinine clearance ≤ 95 mL/min.≤ 95 mL/min

Deep Vein Thrombosis or Pulmonary Embolism, Treatment: Approve for 1 year if the patient is ≥ 18 years of age.

Requires prior 5–10 days of parenteral anticoagulant per product indication (see overview).

inv-02: Other Uses with Supportive Evidence

Covered when criteria below are met for select non‑FDA uses supported by evidence:

Policy Summary

PayerCigna

PolicySavaysa (edoxaban) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests; approvals are provided for specified durations per indication (e.g., 1 year for atrial fibrillation and DVT/PE).

SourceLink

On This Page

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DVT prophylaxis after hip replacement: Approve for 60 days if the patient is ≥ 18 years of age.

Based on available supportive evidence.

Treatment or prevention of other thromboembolic-related conditions: Approve for 6 months if the patient meets BOTH of the following (A and B): A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of: i) Patient has tried warfarin, fondaparinux, or a low molecular weight heparin product (e.g., enoxaparin, dalteparin); OR ii) Patient has been started on Savaysa for the treatment of an acute thromboembolic condition.

Examples include superficial vein thrombosis, splanchnic vein thrombosis, hepatic vein thrombosis, or prophylaxis in high-risk patients.

Savaysa (edoxaban) is not medically necessary for prophylaxis of venous thromboembolism in an acutely ill medical patient. The policy specifically lists venous thromboembolism prophylaxis in acutely ill medical patients as a condition not covered and notes that alternative agents (for example, rivaroxaban/Xarelto) are labeled and supported for this use.

Savaysa (edoxaban) is considered not medically necessary for any other uses not explicitly listed as covered in this policy. The exclusions list is intended to be non‑exhaustive and will be updated as new published data become available.

Coding and Clinical Thresholds

No specific CPT/HCPCS/ICD codes listedmixed

No codes listed

Creatinine clearance threshold — atrial fibrillation approval

Threshold valueEstimated creatinine clearance ≤ 95 mL/min required for approval for atrial fibrillation (or atrial flutter)

Applies toAtrial fibrillation (or atrial flutter) FDA‑approved indication

Age requirementPatient must be ≥ 18 years of age

Approval durationApprove for 1 year when threshold and age criteria are met

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Savaysa (edoxaban) for covered indications. Typical authorization durations are noted per indication in the policy (e.g., 1 year for atrial fibrillation and DVT/PE treatment; 60 days for DVT prophylaxis after hip replacement; 6 months for other thromboembolic-related conditions when criteria met). When approvals are issued in months, 1 month = 30 days.

Prior authorization required for Savaysa (edoxaban) — review indication-specific approval durations in the policy.
Approvals measured in months use 30-day months for duration calculations.

Step Therapy

Required Prior Trial or Acute-Start Exception

Some uses require a prior trial of alternate anticoagulant therapy or documentation that Savaysa was started for acute treatment. For other thromboembolic-related conditions (non–FDA labeled), approve for up to 6 months when the patient is ≥ 18 years and ONE of the following is met: (i) trial of warfarin, fondaparinux, or a low molecular weight heparin (e.g., enoxaparin, dalteparin); OR (ii) documentation that Savaysa was initiated for acute thromboembolic treatment. Note: prior use of apixaban, rivaroxaban, or dabigatran does NOT require a trial of warfarin or LMWH.

Required prior trial: warfarin OR fondaparinux OR low molecular weight heparin (e.g., enoxaparin, dalteparin) — unless patient previously tried apixaban, rivaroxaban, or dabigatran.
Acute-start exception: approval allowed if Savaysa was started for treatment of an acute thromboembolic condition.

Documentation Required

Plan Document and Coding Alignment

Verify the member's benefit plan for coverage and any applicable exclusions before submitting an authorization or claim. Coverage determinations are governed by the terms of the applicable benefit plan document in effect on the date of service; plan language supersedes this policy when conflicts exist.

Confirm benefits and any plan-specific exclusions in the member's Evidence of Coverage/Plan Document.
Medical necessity and coverage are determined per the applicable benefit plan and relevant laws/regulations.

Denial Risk

Coding and Billing Denial Trigger

Claims submitted without covered diagnosis or procedure codes that align with the policy-supported indications may be denied. When billing, use the most appropriate and current codes as of the date of submission.

Claims for services billed with diagnoses or procedure codes not covered under this policy may be denied as not covered.
Ensure billing uses the appropriate codes effective on the date of service.

Background

Edoxaban (Savaysa) is an oral direct Factor Xa inhibitor approved for anticoagulation indications including reduction of stroke and systemic embolism in non‑valvular atrial fibrillation and for treatment of deep vein thrombosis and pulmonary embolism following an initial course of parenteral anticoagulation. The product carries a boxed warning regarding reduced efficacy in non‑valvular atrial fibrillation patients with a creatinine clearance >95 mL/min.

Definitions and Safety Warnings

Boxed warning (reduced efficacy)

Warning summaryBoxed warning: Savaysa has a boxed warning advising avoidance in non‑valvular atrial fibrillation patients with creatinine clearance > 95 mL/min due to reduced efficacy.

Affected populationPatients with non‑valvular atrial fibrillation and creatinine clearance > 95 mL/min

Recommended actionAvoid use of Savaysa in these patients

Source contextWarning described in product overview for Savaysa (Factor Xa inhibitor)