ModifiedUnitedHealthcarePolicy 2025 P 1392-4

Radicava ORS (edaravone) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization criteria for Radicava ORS (edaravone) for treatment of amyotrophic lateral sclerosis (ALS), including approval durations and allowance for automated approvals and supply limits.

Policy Summary

PayerUnitedHealthcare

PolicyRadicava ORS (edaravone) prior authorization

Policy CodePolicy 2025 P 1392-4

Change TypeAnnual review; updated durations

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Radicava ORS; approvals issued for 12 months for both initial authorization and reauthorization when criteria met.

POLICY UPDATE CHANGES

Effective date set to 10/1/2025 and initial/reauthorization approval durations updated to 12 months in 7/2024.

Program established as Prior Authorization/Notification for Radicava ORS (edaravone) originally in 7/2022.

1Covered Indication (ALS)

12 monthsAuthorization Duration (Initial/Reauthorization)

AllowedAutomated Approvals

Coverage Summary

Defines UnitedHealthcare prior authorization and reauthorization criteria for Radicava ORS (edaravone) for treatment of amyotrophic lateral sclerosis (ALS). Prior authorization/notification is required under Program Number 2025 P 1392-4. Effective date: 2025-10-01. Initial authorization and reauthorization approval durations are 12 months when criteria are met.

Initial Authorization

Radicava ORS will be approved based upon the following criterion:

Diagnosis of amyotrophic lateral sclerosis (ALS)

Authorization will be issued for 12 months.

Reauthorization

Radicava ORS will be approved based upon the following criterion:

Documentation of positive clinical response to Radicava ORS therapy

Authorization will be issued for 12 months.

Additional Clinical Rules

Operational allowances and limits that may affect approval:

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic (use of automated approval)

Supply limits may be in place

Provider Actions & Billing Impact

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Radicava ORS. Approvals for both initial authorization and reauthorization are issued for 12 months when criteria are met.

Documentation Required

Documentation of clinical response for reauthorization

For reauthorization, the provider must document a positive clinical response to Radicava ORS therapy. Providers should ensure documentation of clinical benefit is included when requesting reauthorization.

Billing Rule

Automated approvals permitted

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic using automated approval processes.

Billing Rule

Supply limits

Supply limits may be applied to the dispense quantity. Check plan-specific limits as state mandates, federal requirements, or member benefit plans may also impact coverage.

Background & Clinical Evidence

Radicava ORS (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS). UnitedHealthcare manages coverage of Radicava ORS through a Prior Authorization/Notification program with periodic P&T reviews (P&T approval dates: 7/2022, 7/2023, 7/2024, 7/2025) and an effective date of 10/1/2025 for the current program.

Positive clinical response: Not explicitly defined in the policy; requires documentation by the provider that the therapy benefits the member in order to meet reauthorization criteria.

Reference: Radicava ORS [package insert], Mitsubishi Tanabe Pharma Corporation, November 2022.

Revision History

7/2022creation

Program established as Prior Authorization/Notification for Radicava ORS (edaravone); P&T approval recorded.

7/2024annual_review

Annual review updated initial authorization and reauthorization durations to 12 months and effective date set to 10/1/2025.

7/2025annual_reviewLatest

Annual review with no changes to coverage criteria; reference updated.