CurrentUnitedHealthcarePolicy CS2025D0062N

Edaravone (Radicava) — Medical Benefit Drug Policy for Amyotrophic Lateral Sclerosis

This UnitedHealthcare Medical Benefit Drug Policy governs coverage criteria and prior authorization requirements for edaravone (Radicava) when used to treat amyotrophic lateral sclerosis (ALS) under medical benefit drug plans.

Policy Summary

PayerUnitedHealthcare

PolicyEdaravone (Radicava) — Medical Benefit Drug Policy for Amyotrophic Lateral Sclerosis

Policy CodePolicy CS2025D0062N

Change TypeUpdated applicable HCPCS codes

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of ALS diagnosis, baseline ALSFRS-R scores (all items ≥ 2) and %FVC ≥ 80% prior to initiation.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable HCPCS codes to reflect quarterly edits; replaced C9399, J3490, and J3590 with Q5157.

12 momaximum initial authorization duration

≥80% FVCrequired baseline %FVC

ALSFRS-R ≥2required baseline ALSFRS-R

J1301HCPCS (edaravone)

G12.21ICD-10 (ALS)

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Coverage Criteria for Edaravone (Radicava)

Initial Therapy

Covered when ALL of the following are met

Initial therapy criteria: Submission of medical records (e.g., chart notes, prior history, diagnostic testing including imaging, nerve conduction studies, laboratory values) to support the diagnosis of ALS; submission of the most recent ALSFRS-R score confirming scores ≥ 2 in all items at the start of treatment; submission of medical records confirming percent forced vital capacity (%FVC) ≥ 80% at the start of treatment; edaravone dosing for ALS in accordance with FDA‑approved labeling; edaravone prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS; initial authorization limited to no more than 12 months.ALSFRS-R ≥ 2 on all items; %FVC ≥ 80%

Based on Coverage Rationale.

Continuation of Therapy

Covered when ALL of the following are met

Continuation criteria: Diagnosis of ALS; patient is currently receiving edaravone therapy; patient is not dependent on invasive ventilation; edaravone dosing for ALS in accordance with FDA‑approved labeling; edaravone prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS; authorization for continuation limited to no more than 12 months.see individual nodes

Based on Coverage Rationale and Instructions for Use.

Patients who are dependent on invasive ventilation are excluded from eligibility for continuation of edaravone therapy. Documentation demonstrating dependence on invasive mechanical ventilation may result in denial of continuation coverage.

Use of edaravone outside the defined trial-like subpopulations (for example, patients who do not meet the EESP or dpEESP2y characteristics) lacks clear evidence of efficacy. The confirmatory phase III trial did not demonstrate a statistically significant difference in the primary outcome (change in ALSFRS‑R) for the overall study population, and benefits were suggested only within narrowly defined post‑hoc subgroups.

Applicable Codes and Clinical Thresholds

Applicable HCPCS CodesHCPCS

J1301	Injection, edaravone, 1 mg.
Q5157	Replaced previous miscellaneous codes per revision (policy history).

Applicable Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

Trial/subgroup thresholds

Disease duration (dpEESP2y)≤ 2 years

Baseline %FVC requirement≥ 80% forced vital capacity (%FVC)

Baseline ALSFRS-R item scoresScores ≥ 2 on all 12 ALSFRS-R items

Requirements for Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — submit documentation to demonstrate diagnosis of ALS and baseline assessments. Failure to submit supporting medical records (including chart notes, diagnostic testing, laboratory values), the most recent ALSFRS-R with all item scores ≥ 2, or baseline %FVC may result in denial of the request.

Submit chart notes, previous medical history, diagnostic testing (imaging, nerve conduction studies), and relevant laboratory values.
Include the most recent ALSFRS-R with all item scores ≥ 2 at treatment start.
Include baseline %FVC demonstrating %FVC ≥ 80% at treatment start.
Document edaravone dosing consistent with FDA-approved labeling and intended duration (initial authorization ≤ 12 months).
Indicate neurologist involvement: prescribed by or in consultation with a neurologist experienced in ALS.

Step Therapy

No Step Therapy

No step therapy requirement specified. Coverage decisions are criteria-based and do not require failure of other agents prior to edaravone approval.

Key Definitions and Subpopulations

Efficacy-expected subpopulation (EESP)

DefinitionPost-hoc clinical trial subgroup defined by baseline ALSFRS-R scores ≥ 2 on all 12 items and baseline %FVC ≥ 80%

Size in trial analysisEESP included 104 patients (50 placebo, 54 edaravone)

Efficacy signalStatistically significant intergroup difference in ALSFRS-R change for EESP (2.2, p = 0.036)

dpEESP2y (restricted subgroup)

DefinitiondpEESP2y = EESP criteria plus definite or probable ALS by El Escorial criteria and disease duration ≤ 2 years

Size in trial analysisdpEESP2y included 72 patients (32 placebo, 40 edaravone)

Background

Amyotrophic lateral sclerosis (ALS) is a progressive motor neuron disease characterized by degeneration of upper and lower motor neurons, leading to loss of voluntary muscle control and eventual respiratory failure. Clinical trials of edaravone in ALS enrolled patients with relatively early disease (onset within 3 years, baseline forced vital capacity requirements) and functional ability sufficient for activities of daily living; the overall phase III trial failed to show a statistically significant benefit in the primary outcome, though subgroup analyses suggested possible benefit in narrowly defined early‑stage populations.