Colorado Rocky Mountain Health Plans edaravone Coverage Update

Coverage Criteria for Edaravone (intravenous)

Initial Therapy

Covered when ALL of the following are met:

Diagnosis 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 baseline: 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 treatment.scores ≥ 2 each item

Pulmonary function baseline: Submission of medical records confirming baseline percent 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.

Oral administration inability 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.

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:

Ongoing diagnosis: 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.

Coverage for intravenous edaravone (Radicava) is provided only when the specific clinical criteria in this policy are met and supporting documentation is submitted. Plan members should be evaluated against the policy requirements including a confirmed diagnosis of amyotrophic lateral sclerosis (ALS), baseline functional assessment using the ALSFRS‑R with each item scored ≥ 2, and baseline pulmonary function with percent forced vital capacity (%FVC) of ≥ 80%. The policy applies to edaravone administered as an intravenous medical benefit; the oral suspension formulation (Radicava ORS) is a pharmacy benefit and intravenous administration requires a provider attestation that oral or feeding‑tube administration is not possible.

Coverage is subject to the member’s plan benefits and any applicable state mandates. No additional specific exclusions are listed beyond the stated medical necessity criteria; however, services not meeting all listed criteria or lacking required documentation may be denied.

Randomized trials of edaravone in ALS produced mixed results. A 24‑week randomized study did not meet its primary endpoint: change in ALSFRS‑R at study end showed a between‑group difference of 0.65 (p = 0.411), and most secondary outcomes were not significantly different; the study authors concluded it failed to demonstrate efficacy in the overall trial population.

Post‑hoc analyses and extension trials identified efficacy‑expected subpopulations (EESP), particularly a subgroup defined as dpEESP2y (definite/probable EESP with disease duration ≤ 2 years), in which treatment differences were larger and suggested a potential benefit (for example, a 2.79 change in ALSFRS‑R from weeks 24–48 in the dpEESP2y post‑hoc analysis, p = 0.0719). Because primary trial results were not statistically significant in full trial populations, the clinical evidence supports benefit primarily in these selected early‑stage subgroups rather than broadly across all patients with ALS.

Coding and Clinical Thresholds

Applicable CPT/HCPCS CodesHCPCS

J1301

Injection, edaravone, 1 mg.

Applicable Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

%FVC baseline

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

When requiredSubmitted as part of initial authorization to confirm pulmonary function eligibility

Measurement contextPercent forced vital capacity (%FVC) must be from medical records (pulmonary function testing) at treatment start

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for edaravone (Radicava) intravenous administration for ALS. Submit the prior authorization request before initiating therapy and include all supporting clinical records listed below. Initial authorizations will be for no more than 12 months; continuation authorizations will be for no more than 12 months.

Applicable codes: J1301 (Injection, edaravone, 1 mg)
Diagnosis: G12.21 (Amyotrophic lateral sclerosis)

Step Therapy

Route and Benefit / Provider Attestation

Route/benefit: Edaravone administered by intravenous infusion is covered under the medical benefit and requires prior authorization. Radicava ORS (edaravone) oral suspension is obtained under the pharmacy benefit; if oral therapy is requested, the provider must attest that the patient or caregiver is not competent or is physically unable to administer the oral suspension orally or via feeding tube.

Background on Amyotrophic Lateral Sclerosis and Edaravone

Amyotrophic lateral sclerosis (ALS) is a progressive, fatal motor neuron disease characterized by degeneration of motor neurons controlling voluntary muscles. Patients experience progressive weakness of limbs, bulbar muscles, and respiratory muscles, with most individuals surviving approximately 3–5 years from symptom onset; about 10% survive 10 or more years.

Edaravone is described as a putative free radical scavenger; its precise mechanism of action in ALS is unknown. It has been studied to slow functional decline in ALS, but clinical trial results have been mixed with potential benefit observed mainly in narrowly defined early‑stage patient subgroups.

Definitions

EESP (definition)

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

PurposeIdentified by post-hoc analysis as a subgroup in which edaravone may be efficacious

Evidence contextSignificant intergroup difference in ALSFRS-R change at 24 weeks was observed in this subgroup (p = 0.036)

dpEESP2y (definition)

dpEESP2y (definite/probable EESP, disease duration ≤ 2 years)Meets EESP criteria plus definite or probable ALS by El Escorial revised criteria and disease duration ≤ 2 years

Size in trialsIncluded 72 patients in post-hoc analysis (32 placebo, 40 edaravone)

Policy Revision History

2026-05-01revisionLatest

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

OpenPayer

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