CurrentSierra Health and LifePolicy 2026D0062M

Edaravone (Radicava) for amyotrophic lateral sclerosis (ALS)

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This policy governs medical benefit coverage criteria for intravenous edaravone (Radicava) for treatment of amyotrophic lateral sclerosis and applies to UnitedHealthcare commercial members under Sierra Health and Life in North Carolina.

Policy Summary

PayerSierra Health and Life

PolicyEdaravone (Radicava) for amyotrophic lateral sclerosis (ALS)

Policy CodePolicy 2026D0062M

Change TypeNo material change

Effective DateMay 1, 2026

Last ReviewMay 1, 2026

Next Review Date

Key ActionObtain prior authorization with submission of medical records, recent ALSFRS-R scores, %FVC, and provider attestation when requesting IV edaravone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1301HCPCS code

G12.21

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CurrentSierra Health and LifePolicy 2026D0062M

Edaravone (Radicava) for amyotrophic lateral sclerosis (ALS)

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Policy Summary

PayerSierra Health and Life

PolicyEdaravone (Radicava) for amyotrophic lateral sclerosis (ALS)

Policy CodePolicy 2026D0062M

Change TypeNo material change

Effective DateMay 1, 2026

Last ReviewMay 1, 2026

Next Review Date

Key ActionObtain prior authorization with submission of medical records, recent ALSFRS-R scores, %FVC, and provider attestation when requesting IV edaravone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1301HCPCS code

G12.21

Coverage Criteria for Edaravone (Radicava)

Initial Therapy

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

Initial therapy criteria: 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

Initial therapy criteria: 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 at the start of treatmentALSFRS-R ≥2 on all items

Initial therapy criteria: Submission of medical records (e.g., chart notes, laboratory values) confirming that the patient has a percent forced vital capacity (%FVC) ≥ 80% at the start of treatment%FVC ≥ 80%

Initial therapy criteria: Edaravone dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling

Initial therapy criteria: 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

Oral formulation (Radicava ORS) is a pharmacy benefit

Initial therapy criteria: Edaravone is prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS

Initial therapy criteria: Initial authorization will be for no more than 12 months≤ 12 months

Continuation Therapy

For continuation of therapy, ALL of the following must be met:

Continuation therapy criteria: Diagnosis of ALS

Continuation therapy criteria: Patient is currently receiving edaravone therapy

Continuation therapy criteria: Patient is not dependent on invasive ventilation

Continuation therapy criteria: Edaravone dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling

Continuation therapy criteria: 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 decisions for edaravone (Radicava) must follow the member's specific benefit plan and applicable state mandates. Some Certificates of Coverage may allow experimental/investigational treatments for life‑threatening illnesses under certain conditions; where a state mandate applies it supersedes plan language. Providers should consult the member-specific benefit plan document and relevant state requirements when determining coverage eligibility.

Available clinical trial evidence does not support broad use of edaravone across all stages of ALS. The pivotal 24‑week randomized trial did not meet its primary endpoint: the intergroup difference in change of ALSFRS‑R at the end of treatment was not statistically significant (difference 0.65 ± 0.78; p = 0.411). Reported secondary benefits were limited and inconsistent, and the authors concluded the study failed to demonstrate efficacy to delay ALS progression. Post‑hoc analyses have identified narrow subgroups (the policy’s defined efficacy‑expected subpopulation (EESP) and a dpEESP2y subset) in which greater treatment effect was suggested, but evidence outside these identified subgroups is weak.

Coding and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J1301

Injection, edaravone, 1 mg.

Relevant Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

inv-07: Forced vital capacity (%FVC) — Baseline %FVC ≥ 80%.

ThresholdBaseline %FVC ≥ 80% at treatment start

Documentation requiredSubmission of medical records confirming %FVC ≥ 80% (e.g., chart notes, laboratory values) at the start of treatment

Applies toInitial therapy eligibility for intravenous edaravone (Radicava)

inv-08: ALS Functional Rating Scale - Revised (ALSFRS-R) — Baseline score ≥ 2 points on all 12 items.

ThresholdBaseline ALSFRS-R score: ≥ 2 points on all 12 items at treatment start

Documentation requiredSubmission of the most recent ALSFRS-R confirming scores ≥2 on all items

Provider Responsibilities and Documentation

Prior Authorization

Prior authorization required for IV edaravone

Prior authorization is required for intravenous edaravone (Radicava). Submit a prior authorization request that includes supporting medical records, the most recent ALSFRS‑R score, %FVC measurement, attestation regarding inability to use Radicava ORS, and confirmation that the prescribing or consulting clinician is a neurologist experienced in ALS. Initial and continuation authorizations are limited to no more than 12 months.

Include J1301 on claim for IV edaravone (injections billed per 1 mg).
Authorization duration ≤ 12 months.

Step Therapy

Provider attestation: oral vs IV administration

When requesting IV edaravone, the provider must attest that the patient or caregiver is not competent or is physically unable to administer Radicava ORS oral suspension either orally or via feeding tube (oral Radicava ORS is covered under the pharmacy benefit).

Attestation required for both initial and continuation requests.

Background on Amyotrophic Lateral Sclerosis and Edaravone

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, fatal motor neuron disease characterized by degeneration of voluntary motor neurons, progressive weakness, and eventual respiratory failure, with median survival of approximately 3–5 years from symptom onset. Edaravone is described as a free radical scavenger; its mechanism of action in ALS is not fully understood. Clinical trial data suggest any meaningful benefit may be confined to a select early‑stage subgroup, which informs the policy’s requirement for baseline functional and respiratory criteria prior to treatment initiation.

Definitions and Subpopulations

inv-14: Efficacy-expected subpopulation (EESP) — Patients with ALSFRS-R scores ≥2 on all 12 items and %FVC ≥80% at baseline.

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

Clinical relevanceIdentified as the efficacy-expected subpopulation (EESP) in post-hoc analyses showing greater treatment benefit

Use in policyEESP criteria are required for initial therapy eligibility and were the subgroup showing significant intergroup differences in clinical trials

inv-15: dpEESP2y — Subset of EESP with definite or probable ALS by El Escorial criteria and disease duration ≤2 years; identified in post-hoc analyses.

DefinitionSubset of EESP with definite or probable ALS by El Escorial criteria and disease duration ≤ 2 years (dpEESP2y)

Evidence note

Policy Revision History

05/01/2026updatedLatest

Clinical Evidence and References sections updated; previous policy version 2025D0062L archived.

2026-05-01effective_date

Policy number 2026D0062M effective date recorded on policy cover page.