CurrentColorado Rocky Mountain Health PlansPolicy IEXD0062.09

Edaravone (intravenous) for amyotrophic lateral sclerosis (ALS) — Medical Benefit Coverage Criteria

Defines medical benefit coverage criteria for intravenous edaravone (Radicava) for treatment of ALS for UnitedHealthcare Individual Exchange plans (applies to all states except Nevada where a different commercial policy applies).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyEdaravone (intravenous) for amyotrophic lateral sclerosis (ALS) — Medical Benefit Coverage Criteria

Policy CodePolicy IEXD0062.09

Change TypeOperational updates (benefit routing and applicable states)

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization with medical records including ALSFRS-R (all items ≥2) and baseline %FVC ≥80% to support initiation and continuation requests.

SourceLink

POLICY UPDATE CHANGES

This policy refers to edaravone for administration by intravenous infusion by a healthcare professional; Radicava ORS (edaravone) oral suspension is obtained under the pharmacy benefit.

Applicable states language was updated; Nevada is excluded and directed to the UnitedHealthcare Commercial Medical Benefit Drug Policy.

J1301HCPCS code

G12.21ICD-10

≤12 moInitial auth

≤12 mo

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Coverage Criteria for Intravenous Edaravone (Radicava)

Initial Therapy

Covered when ALL of the following are met for initial therapy:

Initial therapy requirements: 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; submission of the most recent ALS Functional Rating Scale–Revised (ALSFRS-R) confirming scores >= 2 on all items at the start of treatment; medical records confirming % forced vital capacity (%FVC) >= 80% at the start of treatment; edaravone dosing in accordance with FDA‑approved labeling; edaravone prescribed by or in consultation with a neurologist experienced in ALS; initial authorization limited to no more than 12 months.

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Continuation therapy requirements: Diagnosis of amyotrophic lateral sclerosis (ALS); patient is currently receiving edaravone therapy; patient is not dependent on invasive ventilation; edaravone dosing in accordance with FDA‑approved labeling; edaravone prescribed by or in consultation with a neurologist experienced in ALS; authorization limited to no more than 12 months.

Patients who are dependent on invasive ventilation are excluded from eligibility for continuation of edaravone therapy.

Use of intravenous edaravone outside the defined coverage criteria or in populations without demonstrated benefit is not supported. Clinical trial evidence showed benefit only in select subpopulations (the post‑hoc EESP and dpEESP2y groups); overall trial results did not demonstrate significant efficacy. Therefore, treatment that does not meet the specified functional and pulmonary thresholds or the subgroup characteristics is not covered.

Providers should consider that demonstrated benefit was observed in patients with ALSFRS‑R item scores ≥ 2 on all items and %FVC ≥ 80% at baseline, and in analyses limited to patients with disease duration ≤ 2 years (dpEESP2y). Evidence does not support edaravone for other stages or populations of ALS.

Coding and Clinical Thresholds

Procedure/CPT/HCPCS CodesHCPCSCovered

J1301

Injection, edaravone, 1 mg.

Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

inv-07: Baseline %FVC — clinical threshold at treatment start

Baseline %FVC>= 80% at the start of treatment

Measurement timing%FVC must be documented at treatment start (baseline) in submitted medical records

Source of documentationChart notes or laboratory values confirming %FVC ≥ 80% must be included with prior authorization

inv-08: ALSFRS-R item scores — clinical threshold (>=2 on all items) at treatment start

ALSFRS-R item scoresScores >= 2 on all 12 ALSFRS-R items at the start of treatment

Documentation requirementSubmission of the most recent ALSFRS-R confirming all item scores ≥ 2 must accompany prior authorization

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for edaravone (J1301) for treatment of amyotrophic lateral sclerosis (ALS). Initial authorizations will be for up to 12 months. Continuation authorizations will be for up to 12 months.

Affected code: J1301 (Injection, edaravone, 1 mg)
Initial authorization duration: up to 12 months
Continuation authorization duration: up to 12 months

Documentation Required

Required Documentation

Submit supporting clinical documentation with the prior authorization request. Include clinical notes, diagnostic testing, and objective measures that verify diagnosis and baseline function. Expect requests to be denied if required documentation is missing or criteria are not met.

Medical records to support ALS diagnosis (e.g., clinic notes, prior history, imaging, nerve conduction studies, laboratory values)

Background on Amyotrophic Lateral Sclerosis and Edaravone

Amyotrophic lateral sclerosis (ALS) is a progressive motor neuron disease that leads to loss of voluntary muscle function and respiratory failure; median survival is generally measured in years. Edaravone is an intravenous agent thought to act as a free radical scavenger; its precise mechanism in ALS is not fully known.

Randomized trials of edaravone did not show statistically significant benefit in the overall study populations, but post‑hoc analyses identified an efficacy‑expected subpopulation (EESP) — defined by ALSFRS‑R scores ≥ 2 on all 12 items and %FVC ≥ 80% at baseline — and a more restricted dpEESP2y group (EESP criteria plus definite/probable ALS by El Escorial criteria and disease duration ≤ 2 years) in which slowing of functional decline was observed.

Clinical use of intravenous edaravone should therefore be targeted to patients who meet these functional and pulmonary thresholds and who are managed with individualized discussion of goals, risks, and benefits.

Key Definitions and Subpopulations

inv-14: EESP / dpEESP2y definitions — define efficacy-expected subpopulation and dpEESP2y criteria

EESP definitionEfficacy-expected subpopulation (EESP): patients with scores >= 2 on all 12 ALSFRS-R items and baseline %FVC >= 80%

dpEESP2y definitiondpEESP2y: EESP criteria plus definite or probable ALS by revised El Escorial criteria and disease duration <= 2 years

Clinical relevancePost-hoc analyses showed statistically significant slowing of ALSFRS-R decline in both EESP and dpEESP2y subgroups, with larger effect in dpEESP2y