CurrentUnitedHealthcarePolicy N/A

Radicava ORS (edaravone) prior authorization

Defines prior authorization and reauthorization criteria for Radicava ORS (edaravone) for treatment of amyotrophic lateral sclerosis (ALS) for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyRadicava ORS (edaravone) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionSubmit prior authorization with documentation of ALS diagnosis for initial approval; provide documentation of positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period for initial approval

12 monthsauthorization period for reauthorization

ALSindication covered (diagnosis)

Prior Authutilization management program type

Coverage Criteria

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Initial Authorization

Covered when ALL of the following are met:

Initial Authorization criteria: Diagnosis of amyotrophic lateral sclerosis (ALS)

Authorization will be issued for 12 months.

Reauthorization

Covered when ALL of the following are met:

Reauthorization criteria: Documentation of positive clinical response to Radicava ORS therapy

Authorization will be issued for 12 months.

Coverage of Radicava ORS (edaravone) is subject to state mandates, federal regulatory requirements, and the member's specific benefit plan; these requirements may modify or limit coverage under this policy. Providers should verify member benefits and applicable state or federal mandates prior to requesting prior authorization. This policy does not replace other applicable UnitedHealthcare medical policies or utilization management programs—those policies may impose additional requirements or restrictions that affect coverage decisions.

Initial Therapy Criteria

Initial Authorization

Covered when ALL of the following are met:

Initial: Diagnosis of amyotrophic lateral sclerosis (ALS)

Initial authorization issued for 12 months.

Continuation / Reauthorization Criteria

Reauthorization (Continuation)

Covered when ALL of the following are met:

Continuation/Reauthorization: Documentation of positive clinical response to Radicava ORS therapy

Authorization renewed for 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Initial Authorization — prior authorization required

Prior authorization is required for Radicava ORS when used to treat amyotrophic lateral sclerosis (ALS). Initial authorizations are issued for 12 months.

Affected drug: Radicava ORS
Authorization duration: 12 months

Documentation Required

Initial authorization documentation

Documentation of the member's diagnosis of amyotrophic lateral sclerosis (ALS) is required to support an initial authorization request for Radicava ORS.

Required documentation: Clinical record confirming ALS diagnosis (ICD-10 code(s) as applicable)

Documentation Required

Reauthorization — documentation of positive clinical response required

Reauthorization of Radicava ORS requires documentation demonstrating a positive clinical response to therapy. Reauthorizations are issued for 12 months. State mandates and member-specific benefit plan coverage may affect reauthorization.

Required documentation: Clinical notes or assessments indicating improvement or clinical benefit on Radicava ORS
Authorization duration: 12 months

Denial Risk

Potential automated denial triggers

UnitedHealthcare may approve initial authorizations or reauthorizations based solely on available claims/medication history, diagnosis codes (ICD-10), and/or automated claim logic. Lack of supporting claim history or appropriate diagnosis codes may trigger an automated denial. Supply limits or other utilization management rules may also apply.

Potential automated approval sources: prior claim history, medication fills, ICD-10 diagnosis codes
Automated denial triggers: absence of supporting claim/medication history or missing/incorrect diagnosis codes
Other considerations: supply limits and other utilization management programs may affect approval

Step Therapy

Step therapy

No specific step therapy requirements are stated for Radicava ORS in this policy.

Step Therapy

Step	Requirement
1	No specific step therapy requirements stated in the document; UnitedHealthcare may still apply additional clinical rules such as approvals based on prior claim/medication history, diagnosis codes, or claim logic, and supply limits may be in place.

Quantity Limits

Radicava ORS (edaravone) — Supply / quantity limits

Quantity limit summarySupply limits may be in place for Radicava ORS (edaravone).

Measurement periodPer month (document notes supply limits may be applied).

Impact on approvalsSupply limits may contribute to automated denials or require supporting claim/medication history for approval.

Site of Care

Note

No site‑of‑care restrictions specified

The policy does not impose any site‑of‑care restrictions for administration or dispensing of Radicava ORS.

Definitions

ALS — definition

DefinitionAmyotrophic lateral sclerosis (ALS) — a neurodegenerative disease for which Radicava ORS is indicated.

Indication in policyRadicava ORS is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Authorization implicationA documented diagnosis of ALS is required for initial authorization of Radicava ORS.

Background

Radicava ORS (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS). This policy defines the prior authorization and reauthorization requirements to ensure appropriate use of Radicava ORS in covered members.

For initial authorization, coverage is provided when there is a documented diagnosis of ALS. Reauthorization requires documentation of a positive clinical response to Radicava ORS therapy. In both cases, authorizations are issued for 12 months.

Providers must submit documentation supporting the diagnosis and, on reauthorization requests, objective evidence of clinical benefit. Note that authorization and continued coverage remain subject to any applicable state mandates, federal requirements, and the member’s specific benefit plan, which may alter coverage or impose additional conditions.

Policy Summary

PayerUnitedHealthcare

PolicyRadicava ORS (edaravone) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionSubmit prior authorization with documentation of ALS diagnosis for initial approval; provide documentation of positive clinical response for reauthorization.

SourceLink

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