CurrentUnitedHealthcarePolicy CS2026D0062P

Edaravone for amyotrophic lateral sclerosis (ALS)

This UnitedHealthcare Medical Benefit Drug Policy governs coverage criteria and authorization requirements for edaravone (Radicava) for treatment of ALS for applicable commercial members; it specifies clinical criteria, documentation and coding referenced for benefit determination.

Policy Summary

PayerUnitedHealthcare

PolicyEdaravone for amyotrophic lateral sclerosis (ALS)

Policy CodePolicy CS2026D0062P

Change TypeClinical evidence and references updated

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization with medical records including most recent ALSFRS-R and %FVC to support initiation.

SourceLink

POLICY UPDATE CHANGES

Updated Clinical Evidence and References sections to reflect the most current information.

J1301HCPCS code

G12.21Diagnosis code

≤12 moMax initial auth

ALSFRS-R ≥2Functional threshold

%FVC ≥80%Respiratory threshold

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Coverage Criteria for Edaravone (Radicava)

Initial Therapy

Covered when ALL of the following are met

Initial authorization criteria: Submission of medical records to support the diagnosis of ALS (chart notes, previous medical history, diagnostic testing including imaging, nerve conduction studies, laboratory values)

ALSFRS-R baseline: Submission of the most recent ALSFRS-R score confirming that the patient has scores ≥ 2 in all items at the start of treatmentALSFRS-R ≥ 2 on all items

Respiratory function: Submission of medical records confirming that the patient has %FVC ≥ 80% at the start of treatment%FVC ≥ 80%

Dosing: Edaravone dosing for ALS is in accordance with United States FDA approved labeling

Prescriber: 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

Covered when ALL of the following are met

Diagnosis of ALS is documented

Current therapy: Patient is currently receiving edaravone therapy

Ventilation status: Patient is not dependent on invasive ventilation

Dosing continued: Edaravone dosing for ALS is in accordance with United States FDA approved labeling

Patients who do not meet the post-hoc identified subpopulations (EESP or dpEESP2y) or who fail to meet the study entry respiratory and functional thresholds are outside the population in which benefit has been observed. The policy requires documentation of baseline function and respiratory status prior to initiation: specifically, a baseline ALSFRS-R demonstrating scores ≥ 2 on all items and a baseline respiratory measure of %FVC ≥ 80%. These thresholds reflect the subgroup analyses that identified patients most likely to experience slowed functional decline with edaravone and therefore are required for coverage determination.

Use of edaravone in broader ALS populations that do not meet the specified initiation criteria has not demonstrated efficacy. The pivotal trial did not show a statistically significant treatment effect in the full randomized population, and guideline-level summaries note that evidence of benefit is limited to a select subgroup (patients with early disease, preserved respiratory function, and ALSFRS-R item scores ≥2). For patients outside these study-defined subgroups, the available evidence does not support a clear clinical benefit.

Applicable Codes and Clinical Thresholds

Applicable HCPCS CodesHCPCS

J1301

Injection, edaravone, 1 mg

Applicable Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

inv-07: ALSFRS-R item scores — ≥ 2 on all ALSFRS-R items

ThresholdPatient must have ALSFRS-R scores ≥ 2 on all 12 items at treatment start

Documentation requiredSubmit the most recent ALSFRS-R score demonstrating ≥ 2 on all items with initial authorization request

Role in coverageMeeting this ALSFRS-R threshold is required for initial coverage of edaravone per policy criteria

inv-08: % Forced Vital Capacity (%FVC) — ≥ 80%

Threshold% Forced Vital Capacity (%FVC) ≥ 80% at the start of treatment

Documentation requiredSubmit medical records confirming %FVC ≥ 80% with initial authorization request

Provider Actions / Authorization Requirements

Prior Authorization

Prior authorization required — ≤ 12 months; specialist involvement

Prior authorization is required. Initial authorization will be for no more than 12 months, and edaravone must be prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS.

Initial authorization limited to ≤ 12 months
Prescriber: prescribed by or in consultation with a neurologist experienced in ALS
Supporting records must be submitted to demonstrate criteria are met

Step Therapy

Step therapy — None specified

No step therapy requirements are specified in this policy.

Background

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive motor neuron disease that leads to progressive weakness, respiratory failure, and death. Median survival is approximately 3–5 years from symptom onset, with roughly 10% of patients surviving beyond 10 years. Clinical trials of edaravone have focused on patients early in their disease course who retain substantial functional ability and respiratory capacity; definitions used in analyses include criteria such as El Escorial diagnostic categories and preserved activities of daily living at baseline.

Definitions and Subpopulations

inv-14: ALS — definition and clinical description

DefinitionAmyotrophic lateral sclerosis (ALS) is a rapidly progressive, invariably fatal neurological disease that attacks neurons responsible for controlling voluntary muscles

Clinical courseCharacterized by gradual degeneration and death of motor neurons leading to progressive weakness, loss of voluntary movement, and respiratory failure

PrognosisIndividuals with ALS usually survive for 3 to 5 years from symptom onset; about 10% survive 10 or more years

Mechanism of edaravoneEdaravone is characterized as a free radical scavenger; its exact therapeutic mechanism in ALS is unknown

inv-15: EESP (efficacy-expected subpopulation) — criteria: ≥2 on all ALSFRS-R items and %FVC ≥ 80% at baseline

EESP definition

Policy Revision History

2026-05-01archived_previous_version_and_content_updateLatest

Archived previous policy version CS2026D0062O and updated Clinical Evidence and References sections; effective date 2026-05-01.

Policy Summary

PayerUnitedHealthcare

PolicyEdaravone for amyotrophic lateral sclerosis (ALS)

Policy CodePolicy CS2026D0062P

Change TypeClinical evidence and references updated

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization with medical records including most recent ALSFRS-R and %FVC to support initiation.

SourceLink

On This Page

Role in coverage%FVC ≥ 80% is required (with ALSFRS-R ≥2 on all items) to define the EESP for which edaravone showed benefit

Documentation Required

Required documentation — medical records, ALSFRS‑R, diagnostic testing, labs

Submit supporting medical records including chart notes and prior history, diagnostic testing (imaging, nerve conduction studies), laboratory values, the most recent ALSFRS‑R score confirming ≥ 2 on all items, and %FVC value to document baseline respiratory function.

Medical records to support ALS diagnosis (chart notes, prior history)
Diagnostic testing: imaging, nerve conduction studies
Laboratory values as applicable
Most recent ALSFRS‑R score showing ≥ 2 on all items at treatment start
%FVC value showing ≥ 80% at treatment start

Denial Risk

Denial risk if required documentation is missing

Denial may be triggered if required documentation is not submitted, including medical records supporting the ALS diagnosis, a recent ALSFRS‑R demonstrating ≥ 2 on all items, and a %FVC value of ≥ 80% at treatment initiation.

Failure to submit chart notes, diagnostic testing, laboratory values, or ALSFRS‑R score may result in denial
Missing %FVC documentation at treatment start may result in denial

Patients with scores ≥ 2 on all 12 ALSFRS-R items and %FVC ≥ 80% at baseline (post-hoc identified efficacy-expected subpopulation)

Evidence basisEESP was identified in post-hoc analyses where edaravone showed a significant treatment effect compared with placebo

Documentation neededBaseline ALSFRS-R (all items ≥2) and %FVC ≥ 80% must be submitted to support classification as EESP

inv-16: dpEESP2y — subset of EESP with definite/probable ALS and disease duration ≤ 2 years

dpEESP2y definitionSubset of EESP who, in addition to EESP criteria, have definite or probable ALS by El Escorial revised criteria and disease duration ≤ 2 years

Population size in trialsdpEESP2y group included 72 patients in the post-hoc analysis (32 placebo, 40 edaravone)

Relative efficacyPost-hoc analysis showed a larger intergroup difference in ALSFRS-R change for dpEESP2y (3.01, p = 0.027) than for EESP alone