RetiredUnitedHealthcarePolicy CSLA2025D0062K

Edaravone (for Louisiana Only)

State-specific UnitedHealthcare Medical Benefit Drug Policy for edaravone limited to Louisiana members, defining initial and continuation coverage criteria, applicable HCPCS/diagnosis codes, background, evidence, and policy history including retirement effective April 1, 2026.

Policy Summary

PayerUnitedHealthcare

PolicyEdaravone (for Louisiana Only)

Policy CodePolicy CSLA2025D0062K

Change TypeRetired (policy retired Apr 1, 2026)

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit medical records supporting ALS diagnosis, recent ALSFRS-R showing ≥2 on all items, and %FVC ≥80%; edaravone must be prescribed by or in consultation with a neurologist; initial authorization limited to no more than 12 months.

POLICY UPDATE CHANGES

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

Title changed from Radicava (Edaravone) to Edaravone and replaced references to Radicava with edaravone.

Revised coverage criteria to simplify diagnostic support and continuation criteria (removed 'definite'/'probable' El Escorial specification and tracheostomy language).

Archived previous policy version CSLA2024D0062J.

1Covered Indication (ALS)

2Objective thresholds required (ALSFRS-R & %FVC)

2026-04-01Retirement Date

Coverage Summary

This Louisiana-specific UnitedHealthcare Medical Benefit Drug Policy (Policy Number CSLA2025D0062K) addresses coverage of edaravone for amyotrophic lateral sclerosis (ALS). The policy limits applicability to Louisiana members and aligns edaravone dosing with the United States FDA-approved labeling. The policy status is RETIRED effective 2026-04-01, with retirement and disenrollment noted for Louisiana plan membership.

Coverage Rationale - Initial Therapy

Edaravone is proven and medically necessary for the treatment of ALS when ALL of the following are met for initial therapy:

ALL of the following

Initial requirements: Submission of medical records to support the diagnosis of ALS (e.g., chart notes, previous medical history, diagnostic testing including: imaging, nerve conduction studies, laboratory values)
ALSFRS-R: 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 treatmentALSFRS-R items >= 2
Pulmonary function: Submission of medical records confirming that the patient has a % forced vital capacity (%FVC) ≥ 80% at the start of treatment%FVC >= 80%
Dosing: Edaravone dosing for ALS is in accordance with the United States FDA approved labeling
Dosing must follow FDA label
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
Authorization duration limit

Coverage Rationale - Continuation of Therapy

Authorization for continuation of edaravone is permitted when ALL of the following are met:

ALL of the following

Diagnosis of ALS
Current therapy: Patient is currently receiving edaravone therapy
Ventilation: Patient is not dependent on invasive ventilation
Dosing: Edaravone dosing for ALS is in accordance with the United States FDA approved labeling

Provider Actions & Prior Authorization

Prior Authorization

Initial authorization requirement

Initial authorization requires submission of medical records supporting the ALS diagnosis, the most recent ALSFRS-R demonstrating scores ≥ 2 on all items, documentation showing %FVC ≥ 80% at treatment start, evidence that edaravone dosing follows the FDA label, and that edaravone is prescribed by or in consultation with a neurologist. Initial authorization will be for no more than 12 months.

Affected codes: J1301, G12.21
Submit medical records, recent ALSFRS-R (≥2 on all items), %FVC ≥80%, neurologist prescribing/consult, dosing per FDA label
Initial authorization ≤ 12 months

Prior Authorization

Continuation authorization requirement

Applicable Codes

Drug HCPCSHCPCSCovered

J1301

Injection, edaravone, 1 mg

Diagnosis Codes (Referenced)ICD-10

G12.21

Amyotrophic lateral sclerosis

Clinical Evidence Summary

Intergroup difference 0.65 (p=0.411)Phase III trial primary endpoint — not statistically significant

3.01 (p=0.027)Post-hoc dpEESP2y subgroup ALSFRS-R difference — statistically significant

Clinical trials of edaravone showed inconsistent overall benefit: the pivotal phase III trial did not meet its primary endpoint (ALSFRS-R change not statistically significant), but post-hoc analyses identified subpopulations with potential benefit. Two subgroups were described: the efficacy-expected subpopulation (EESP) and the definite/probable EESP with disease duration ≤2 years (dpEESP2y). Per the policy definitions, EESP patients had baseline ALSFRS-R item scores ≥2 on all items and %FVC ≥80%, and the dpEESP2y subgroup met EESP criteria plus disease duration ≤2 years (and El Escorial definite/probable diagnosis in trial definitions). The policy specifies edaravone dosing is aligned with the FDA label.

Background & Definitions

Edaravone is described as a free radical scavenger with an unknown exact mechanism of therapeutic effect in ALS. It is indicated for the treatment of amyotrophic lateral sclerosis. The randomized phase III trial context included a 24-week treatment period with ALSFRS-R as the primary endpoint; overall trial results were not statistically significant, but post-hoc subgroup analyses suggested benefit in select patients. This policy applies only to Louisiana members and states that edaravone dosing must follow the FDA-approved labeling.

Thresholds

ALSFRS-R item scores>= 2 on all 12 items

%FVC>= 80%

EESP: Efficacy-expected subpopulation defined as patients with ALSFRS-R scores ≥ 2 on all 12 items and %FVC ≥ 80% at baseline.

dpEESP2y: Definite/probable EESP with disease duration ≤ 2 years — meets EESP criteria and has disease duration ≤ 2 years (trial definitions included El Escorial definite/probable diagnosis for dpEESP2y).

Unproven Uses / Exclusions

Per the continuation criteria, patients who are dependent on invasive ventilation are excluded from continuation coverage. The policy revision removed prior mention of tracheostomy dependence, replacing it with the single exclusion of invasive ventilation dependence.

Revision History

2025-07-01administrative

Title changed from 'Radicava (Edaravone)' to 'Edaravone' and references to Radicava replaced with edaravone (administrative/title change, non-material).

2025-07-01criteria_change

Material revision of initial and continuation criteria: simplified diagnostic wording to 'diagnosis of ALS' (replacing 'definite'/'probable' El Escorial specification) and removed tracheostomy mention under continuation.

2026-04-01retirementLatest