Clinical Policy: Edoxaban (Savaysa)
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Defines medical necessity and prior authorization criteria for edoxaban (Savaysa) for Medicaid members, including indications, dosing limits, and documentation requirements for prescribers.
No material clinical or coverage changes in this revision.
Coverage Criteria for Edoxaban (Savaysa)
Other/Off-label Indications — Other diagnoses/indications
Other diagnoses/indications:
Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policy CP.PMN.53.
Non–FDA approved uses of edoxaban that are not specifically addressed in this policy are not authorized unless the prescriber provides sufficient documentation of efficacy and safety consistent with the payer's off‑label use requirements (see off‑label use policy CP.PMN.53) or as allowed by the member's evidence of coverage. Requests for off‑label indications should include supporting clinical rationale and references demonstrating adequate evidence for the proposed use.
Coverage for edoxaban is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance) and to applicable state and federal requirements and Health Plan administrative policies. This clinical policy provides medical necessity guidance to assist in coverage decisions and benefit administration but does not guarantee payment.
Edoxaban (Savaysa) has been shown to have reduced efficacy in NVAF patients with creatinine clearance greater than 95 mL/min; therefore, use in this population is not supported by this policy and an alternative anticoagulant should be used. This contraindication/limitation is reflected in the boxed warning and the labeling for NVAF.
Provider Requirements and Prior Authorization Actions
Prior authorization and required prescriber documentation
Prescriber must obtain prior authorization before edoxaban (Savaysa) is covered and document the clinical indication, any prior use or failure of apixaban (when step therapy applies), recent renal function (CrCl within past 90 days for NVAF), and that requested dosing is within the policy limits. Approval duration is 12 months for initial and continued therapy.
- Document indication (NVAF, DVT/PE, or cancer‑associated VTE).
- If NVAF, include recent (within 90 days) CrCl ≤ 95 mL/min.
- Confirm dose ≤ 60 mg/day and 1 tablet per day.
- If step therapy applies, document prior apixaban use/failure per policy.
Prior authorization governed by Health Plan documents
This clinical policy is intended as guidance to assist coverage decisions; specific prior authorization requirements, benefit coverage, and the effective date are governed by the member's Health Plan administrative policies and the evidence of coverage/contract documents.
- Policy is a guide to medical necessity and does not guarantee payment.
- Effective date and specific PA rules are determined by the Health Plan and benefit documents.
Step‑therapy: failure of apixaban required prior to approval
Prior authorization requires evidence that the member failed treatment with apixaban (Eliquis) at maximally indicated doses for ≥30 days, unless apixaban is contraindicated or the member is intolerant to it.
- Failure = inadequate response or intolerable adverse effects after ≥30 days at maximally indicated doses of apixaban.
- If contraindicated or intolerant to apixaban, document rationale.
Required supporting documentation to accompany PA requests
Providers must submit supporting documentation with the prior authorization request, such as office chart notes, laboratory results, and other clinical information demonstrating the member meets all approval criteria.
- Examples: office notes, lab results (including CrCl), medication history documenting prior apixaban use or intolerance.
- Include documentation of response to therapy for continuation requests.
Follow Health Plan procedures and evidence of coverage
Follow the Health Plan's procedures and the member's evidence of coverage; this clinical policy provides guidance on medical necessity but does not replace Health Plan administrative processes or guarantee payment.
- Adhere to plan‑level PA submission processes and state‑specific continuity of care addendums when applicable.
- This policy guides medical necessity determinations but is not a contract.
Denial risk: insufficient documentation or unsupported off‑label use
Requests may be denied if documentation does not demonstrate that the member meets the approval criteria or when requested use is a non‑FDA indication not addressed in this policy without sufficient off‑label evidence per CP.PMN.53.
- Lack of required clinical documentation (e.g., no CrCl, no prior apixaban trial) risks denial.
- Non‑FDA indications require sufficient documentation per the off‑label use policy; otherwise the request may be denied.
Coverage decisions subject to member coverage documents and plan rules
Coverage decisions and benefit administration remain subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administrative policies and procedures.
- Evidence of coverage, certificate of coverage, policy, or contract of insurance govern final determination.
- State and federal requirements and plan‑level administrative policies also apply.
Initial Therapy Criteria
Continuation Therapy Criteria
Continuation Therapy 96 Single Node Summary
Approval duration: 12 months
Step Therapy Requirements
| Step | Requirement | Details |
|---|---|---|
| 1 | ||
| Failure or contraindication to apixaban (Eliquis) required prior to approval | ||
| Must have trial of Eliquis (apixaban) for ≥ 30 days at maximally indicated doses unless contraindicated or clinically significant adverse effects occur; Eliquis dosing example: NVAF 5 mg PO BID (20 mg/day max). |
Coding and Clinical Thresholds
Quantity Limits for Edoxaban (Savaysa)
Definitions
Background
Edoxaban (Savaysa) is an oral factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with non‑valvular atrial fibrillation and for the treatment of deep venous thrombosis and pulmonary embolism following 5–10 days of initial parenteral anticoagulant therapy. The agent carries boxed warnings highlighting the risk of reduced efficacy in NVAF with CrCl > 95 mL/min, increased thrombotic risk with premature discontinuation, and the potential for spinal/epidural hematoma with neuraxial procedures.
Revision History
Clinical policy last reviewed by the Health Plan (policy CP.PMN.227).
Clinical policy effective date governed by the Health Plan (effective as of date determined by the Health Plan).
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