CurrentUnitedHealthcarePolicy 2025D0062L

Edaravone (intravenous) for ALS

Defines medical necessity criteria for intravenous edaravone administration for amyotrophic lateral sclerosis (ALS) for UnitedHealthcare commercial/community plans, including initial and continuation authorization criteria, required documentation, prescriber requirements, dosing alignment with FDA labeling, and authorization durations.

Policy Summary

PayerUnitedHealthcare

PolicyEdaravone (intravenous) for ALS

Policy CodePolicy 2025D0062L

Change TypeRevised criteria; title and template updates

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization with medical records including ALSFRS-R score and %FVC and ensure neurologist involvement; authorizations limited to 12 months.

POLICY UPDATE CHANGES

Revised coverage criteria: initial therapy requirement simplified to submission of records supporting diagnosis of ALS (removed explicit 'definite' or 'probable' El Escorial wording).

Continuation therapy criteria revised to replace prior El Escorial phrasing and to change ventilation language to 'not dependent on invasive ventilation'.

Title changed from 'Radicava (Edaravone) Coverage Rationale' to 'Edaravone' and references to brand name replaced with generic.

Updated Background and FDA sections to reflect current information.

Template update on 07/01/2025 updating Benefit Considerations.

2Authorization types (Initial, Continuation)

12 monthsMax authorization duration

Coverage Summary

Coverage stance: covered with criteria for intravenous edaravone (IV) for amyotrophic lateral sclerosis (ALS) under the medical benefit; oral edaravone (Radicava ORS) is managed under the pharmacy benefit and IV edaravone is covered only when the policy’s medical necessity criteria are met.

Initial Therapy (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Submission of medical records to support diagnosis of ALS: Submission of medical records (e.g., chart notes, previous medical history, diagnostic testing including: imaging, nerve conduction studies, laboratory values) to support the diagnosis of ALS
ALSFRS-R item scores: Submission of the most recent ALS Functional Rating Scale-Revised (ALSFRS-R) score confirming that the patient has scores ≥ 2 in all items of the ALSFRS-R criteria at the start of treatment≥ 2 in all items
%FVC threshold: Submission of medical records (e.g., chart notes, laboratory values) confirming that the patient has a % forced vital capacity (%FVC) ≥ 80% at the start of treatment%FVC ≥ 80%
FDA dosing: Edaravone dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling
Operational requirement to follow FDA dosing
Provider attestation regarding oral formulation: Provider attestation that the patient or caregiver is not competent or is physically unable to administer Radicava ORS (edaravone oral suspension) either orally or via feeding tube
Neurologist involvement: Edaravone is prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS
Authorization duration: Initial authorization will be for no more than 12 months≤ 12 months

Continuation of Therapy (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of ALS
Current therapy: Patient is currently receiving edaravone therapy
Ventilation exclusion: Patient is not dependent on invasive ventilation
FDA dosing: Edaravone dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling
Operational requirement to follow FDA dosing

Not Medically Necessary / Exclusions

Implicit exclusions based on criteria not met:

ANY of the following

No documentation of ALS diagnosis: Patients who do not have medical record documentation supporting ALS diagnosis
ALSFRS-R item scores too low: Patients with ALSFRS-R item scores < 2 in any item at treatment start< 2 in any ALSFRS-R item
%FVC below threshold: %FVC < 80% at treatment start (for initial therapy per policy)%FVC < 80%

Applicable Codes

Applicable HCPCS / J-codes (not explicitly listed in document)HCPCS

No codes listed

NDC (oral Radicava ORS referenced under pharmacy benefit)NDC

No codes listed

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required for initial and continuation therapy

Prior authorization is required for both initial and continuation edaravone therapy. Authorizations for initial and continuation treatment are limited to no more than 12 months.

Initial and continuation authorizations limited to 12 months.

Documentation Required

Medical records submission

Submit medical records including chart notes, prior medical history, and diagnostic testing (for example imaging, nerve conduction studies, and laboratory values) to support the diagnosis of ALS and documentation of %FVC. Provide the most recent ALS Functional Rating Scale-Revised (ALSFRS-R) score to demonstrate baseline function.

Submit most recent ALSFRS-R score.

Clinical Evidence & Guidelines

Canadian ALS NetworkGuideline recommendation: CALS (2020) recommends IV edaravone for select patients (disease duration <2y, FVC>80%, ALSFRS-R >2, steady decline)

A phase III confirmatory randomized, double-blind, placebo-controlled trial evaluated IV edaravone with change in ALSFRS-R as the primary endpoint; the between-group difference in ALSFRS-R change at 24 weeks was not statistically significant (difference 0.65; p=0.411).

Post-hoc and subgroup analyses from the extension and related studies identified a possible benefit in a select dpEESP2y subgroup (post-hoc difference 2.79 between 24 and 48 weeks; p=0.0719), though overall study and extension results were not statistically significant for most endpoints.

Guidance from the Canadian ALS Research Network (2020) recommends IV edaravone only for a select patient population (disease duration < 2 years, FVC > 80%, all ALSFRS-R subcomponent scores > 2, and demonstrated steady decline in ALSFRS-R over a 3-month interval).

Background

Background: Edaravone (Radicava) is an intravenous treatment option for amyotrophic lateral sclerosis (ALS). Clinical trials have produced mixed efficacy results: the pivotal phase III study did not meet its primary efficacy endpoint, though post-hoc and subgroup analyses suggested possible benefit in narrowly defined patient subsets characterized by shorter disease duration, higher baseline respiratory function, higher ALSFRS-R item scores, and a demonstrated steady decline prior to treatment.

Oral edaravone suspension (Radicava ORS) is obtained through the pharmacy benefit; IV edaravone is addressed under the medical benefit and is covered only when the policy’s documented medical necessity criteria are satisfied.

dpEESP2y: Post-hoc subgroup criteria referenced in trial analyses (patients meeting specific entry criteria); document does not fully define the acronym.

Revision History

06/01/2025revised

Revised coverage criteria: initial therapy requirement simplified to submission of medical records supporting a diagnosis of ALS (removed explicit 'definite' or 'probable' El Escorial wording).

06/01/2025revised

Continuation therapy criteria revised to replace prior El Escorial phrasing and to change ventilation language to 'not dependent on invasive ventilation' (removed 'or tracheostomy').

06/01/2025revised

Title changed from 'Radicava (Edaravone) Coverage Rationale' to 'Edaravone' and references to brand name replaced with generic.