CurrentUnitedHealthcarePolicy N/A

Step therapy for Savaysa (edoxaban)

This policy governs prior authorization step therapy requirements for coverage of Savaysa (edoxaban) for UnitedHealthcare members, specifying initial and reauthorization criteria and exceptions such as established use and state mandates.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Savaysa (edoxaban)

Policy CodePolicy N/A

Change TypeOperational & reference updates (annual review)

Effective DateJun 1, 2025

Next Review DateMar 1, 2025

Key ActionDocument trial and failure, contraindication, or intolerance to apixaban (Eliquis) or rivaroxaban (Xarelto) to obtain initial authorization.

SourceLink

POLICY UPDATE CHANGES

Added cancer state mandate footnote.

Updated references in annual review.

12 monthsauthorization duration

Eliquis, Xareltorequired trial alternatives

CrCl >95 mL/minsafety limitation

Step Therapyprogram

Coverage Criteria for Savaysa (edoxaban)

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Initial Therapy

Covered when ANY of the following are met:

Initial Authorization - Trial/Failure: History of failure, contraindication, or intolerance to one of the following: (1) Eliquis (apixaban) OR (2) Xarelto (rivaroxaban).

Initial Authorization - Established Use: Member is currently established on Savaysa (edoxaban).

Authorization will be issued for 12 months.

Reauthorization

Covered when ALL of the following are met:

Reauthorization: Documentation of positive clinical response to therapy.

Reauthorization will be issued for 12 months.

Savaysa (edoxaban) should not be used in patients with creatinine clearance greater than 95 mL/min for the indication of nonvalvular atrial fibrillation (NVAF). This limitation is based on observed data showing an increased risk of ischemic stroke compared to warfarin at the highest dose studied.

Step	Requirement	Coverage
1	Member must have a history of failure, contraindication, or intolerance to at least one of the specified oral anticoagulants: Eliquis (apixaban) or Xarelto (rivaroxaban).	Coverage allowed after trial or documented contraindication/intolerance
Exception	Member is currently established on Savaysa (no prior trial of alternatives required).	Coverage allowed for established users

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Initial prior authorization (step therapy) is required. For initial approvals, document a trial and failure, contraindication, or intolerance to an alternative oral anticoagulant—specifically Eliquis (apixaban) or Xarelto (rivaroxaban). If the member is currently established on Savaysa, initial step therapy may be waived. Authorization is issued for 12 months.

Affected products: Savaysa (edoxaban) initial authorization
Required alternatives: Eliquis (apixaban) or Xarelto (rivaroxaban)
Authorization length: 12 months

Step Therapy

Step Therapy Requirement

Step therapy requirement — the member must try an alternative oral anticoagulant (Eliquis or Xarelto) prior to coverage for Savaysa unless they are already established on Savaysa. The provider must document the trial of the alternative agent and the outcome.

Member must trial Eliquis or Xarelto prior to Savaysa coverage unless already on Savaysa
Document start/end dates, dose, and reason for discontinuation where applicable

Denial Risk

Denial Risk if Trial Not Documented

Failure to document a history of trial and failure, contraindication, or intolerance to Eliquis or Xarelto may result in denial of the request. Be sure to include clinical notes, prior medication history, or other documentation supporting the trial and the clinical rationale for switching to Savaysa.

Denial risk if documentation of trial/failure/contraindication/intolerance to Eliquis or Xarelto is not provided
Include clinical notes and medication history to support the authorization

Documentation Required

Documentation Required for Reauthorization

For reauthorization, provide documentation of a positive clinical response to Savaysa. UnitedHealthcare may also use claims/medication history, diagnosis codes (ICD-10), and automated claim logic to approve initial or reauthorization requests where applicable.

Reauthorization requirement: documentation of positive clinical response
Claims/medication history and diagnosis codes may be used for automated approvals
Reauthorization length: 12 months

Background

Savaysa (edoxaban) is FDA-approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with a parenteral anticoagulant. As noted in the FDA-labeled information, this policy requires a trial of an alternative oral anticoagulant prior to coverage of Savaysa as part of step therapy.

Definitions

NVAF (Nonvalvular atrial fibrillation) definition

DefinitionNonvalvular atrial fibrillation (NVAF): atrial fibrillation in the absence of significant mitral stenosis or a mechanical heart valve.

Relevance to SavaysaSavaysa is FDA‑approved to reduce risk of stroke and systemic embolism in patients with NVAF; certain safety limitations (e.g., CrCl >95 mL/min) apply.

Implication for coveragePolicy step‑therapy and contraindication statements use the NVAF definition to determine appropriate use and exclusions.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Savaysa (edoxaban)

Policy CodePolicy N/A

Change TypeOperational & reference updates (annual review)

Effective DateJun 1, 2025

Next Review DateMar 1, 2025

Key ActionDocument trial and failure, contraindication, or intolerance to apixaban (Eliquis) or rivaroxaban (Xarelto) to obtain initial authorization.

SourceLink

On This Page

OpenPayer

Step therapy for Savaysa (edoxaban)

Coverage Criteria for Savaysa (edoxaban)

Initial Therapy Requirements

Reauthorization / Continuation Criteria

Coding

Step Therapy Requirements

Provider Actions and Documentation Requirements

Background

Definitions

Site of Care / Dispensing