Currentsierra health and lifePolicy 2025D0062L

Edaravone (intravenous) for amyotrophic lateral sclerosis (ALS) — Medical Benefit Drug Policy

Medical benefit drug policy governing coverage criteria for intravenous edaravone for treatment of amyotrophic lateral sclerosis, affecting providers prescribing/administering edaravone under Sierra Health and Life/UnitedHealthcare commercial and community plans.

Policy Summary

Payersierra health and life

PolicyEdaravone (intravenous) for amyotrophic lateral sclerosis (ALS)

Policy CodePolicy 2025D0062L

Change TypeRevised diagnostic and continuation languageinformational updates

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization with supporting medical records, most recent ALSFRS-R, %FVC (≥ 80% for initial therapy), and neurologist prescription/consultation.

SourceLink

POLICY UPDATE CHANGES

Replaced requirement to document 'definite' or 'probable' ALS per El Escorial criteria with a requirement to submit medical records supporting the diagnosis of ALS.

Replaced continuation criterion requiring 'definite' or 'probable' ALS per El Escorial criteria with 'diagnosis of ALS'.

Replaced continuation criterion regarding ventilation to remove 'or tracheostomy' and require only that the patient is not dependent on invasive ventilation.

Updated Background and FDA sections to reflect current information.

Removed title 'Radicava (Edaravone) Coverage Rationale' and replaced references to branded name with 'edaravone'.

12 moMaximum initial authorization duration

12 moMaximum continuation authorization duration

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Coverage Criteria for Edaravone (Intravenous)

Initial Therapy

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

Initial diagnostic documentation: 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: Submission of the most recent ALS Functional Rating Scale–Revised (ALSFRS-R) score confirming that the patient has scores ≥ 2 in all items at the start of treatment.ALSFRS-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 Food and Drug Administration approved labeling.

ORS competence attestation: Provider attestation that the patient or caregiver is not competent or is physically unable to administer Radicava ORS oral suspension either orally or via feeding tube.

Applies when IV administration is considered instead of oral suspension.

Specialist 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 Therapy

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

Diagnosis of ALS.

Current therapy: Patient is currently receiving edaravone therapy.

Ventilation status: Patient is not dependent on invasive ventilation.

Dosing: Edaravone dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling.

ORS competence attestation: Provider attestation that the patient or caregiver is not competent or is physically unable to administer Radicava ORS oral suspension either orally or via feeding tube.

Coverage for edaravone may be constrained by the member's specific benefit plan or by applicable state mandates. Some Certificates of Coverage permit experimental/investigational treatments for life‑threatening illnesses under specified conditions, and state mandates that require coverage for off‑label medication use may supersede policy language. Consult the member specific benefit plan document to determine whether such exceptions apply.

The pivotal evidence includes a double‑blind, parallel‑group, placebo‑controlled phase III trial with a 12‑week pre‑observation period and a 24‑week treatment period. Patients randomized to edaravone (60 mg IV) or placebo were enrolled if they met El Escorial criteria for ALS, had symptom duration ≤ 3 years, and baseline FVC ≥ 70%; the primary endpoint was change in ALSFRS‑R over 24 weeks.

The trial did not show a statistically significant difference in the primary outcome: mean ALSFRS‑R change was -6.35 ±0.84 for placebo versus -5.70 ±0.85 for edaravone, a between‑group difference of 0.65 ±0.78 (p = 0.411). Secondary outcomes showed limited benefit (example: pinch strength) and no significant safety differences between groups. Controlled trial results were mixed, with benefit identified only in post‑hoc selected subgroups rather than the full trial population.

Coding and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J1301

Injection, edaravone, 1 mg

Relevant Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

% Forced Vital Capacity (FVC) — Baseline requirement for initial therapy

Baseline %FVC requirement>= 80% forced vital capacity (%FVC) at the start of treatment for initial therapy

Documentation sourceSubmission of medical records (e.g., chart notes, laboratory values) confirming %FVC >= 80% at treatment start

Related clinical scaleEESP definition uses %FVC >= 80% together with ALSFRS-R criteria in clinical evidence

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for edaravone (Radicava) for the treatment of amyotrophic lateral sclerosis (ALS). Requests must include supporting medical records and clinical measures at treatment start, and prescriptions must be by or in consultation with a neurologist experienced in ALS.

Submit medical records to support ALS diagnosis (chart notes, prior history, diagnostic testing).
Include most recent ALSFRS-R demonstrating scores ≥ 2 in all items at treatment start.
Include %FVC demonstrating ≥ 80% at treatment start.
Include neurologist prescription or documentation of consultation.
A provider attestation that the patient or caregiver is not competent or is physically unable to administer Radicava ORS oral suspension.
Affected code: HCPCS J1301 (injection, edaravone, 1 mg).
Diagnosis code commonly associated: ICD-10 G12.21 (amyotrophic lateral sclerosis).
Initial and continuation authorizations are limited to no more than 12 months each.

Background and Clinical Context

Amyotrophic lateral sclerosis (ALS) is a progressive motor neuron disease that causes progressive weakness, respiratory failure, and shortened survival—median survival from symptom onset is approximately 3 to 5 years. Edaravone is described as a free radical scavenger; its precise mechanism of action in ALS is not established. Clinical trials have evaluated edaravone in patients meeting El Escorial diagnostic criteria and with relatively preserved baseline function, and evidence of benefit has been confined to selected subpopulations in post‑hoc analyses.

Definitions and Abbreviations

EESP — Efficacy-expected subpopulation

TermEfficacy-expected subpopulation (EESP)

DefinitionPatients with scores ≥ 2 points on all 12 items of the ALSFRS-R and a %FVC ≥ 80% at baseline

ContextIdentified in post-hoc analyses as a subgroup in which edaravone may be efficacious; showed significant intergroup differences in ALSFRS-R change over 24 weeks

Use in policyEESP criteria inform evidence interpretation but policy requires submission of ALSFRS-R and %FVC for coverage consideration

dpEESP2y — Definite/probable EESP 2 years

TermDefinite/probable EESP 2 years (dpEESP2y)