ModifiedCentenePolicy CP.PHAR.343

Edaravone (Radicava, Radicava ORS) coverage

Defines medical necessity criteria, dosing, and prior authorization requirements for edaravone (intravenous and oral) for treatment of amyotrophic lateral sclerosis (ALS) for Centene lines of business including Commercial, HIM/ICHRA, and Medicaid.

Policy Summary

PayerCentene

PolicyEdaravone (Radicava, Radicava ORS) coverage

Policy CodePolicy CP.PHAR.343

Change TypeApproval durations revisedgeneric IV redirectionadded ORS

Effective DateJul 1, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation confirming ALS diagnosis per revised El Escorial/Airlie House criteria and listed eligibility criteria.

SourceLink

POLICY UPDATE CHANGES

Revised approval durations: Medicaid/HIM to 12 months and Commercial to 6 months or to the member's renewal date, whichever is longer.

Added generic redirection for IV Radicava requests to use generic intravenous edaravone unless contraindicated or adverse effects.

Added new oral suspension formulation (Radicava ORS) to coding/coverage considerations.

Revised approval durations: Medicaid/HIM to 12 months and Commercial to 6 months or to the member's renewal date, whichever is longer.

≥18Minimum age for coverage

FVC ≥80%Respiratory function requirement

≤2 yrsMax disease duration (initial)

12 mo

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Coverage Criteria for Edaravone (ALS)

Initial Therapy (ALS)

Covered when ALL of the following are met:

Initial ALS criteria: 1. Diagnosis of definite or probable ALS per the revised El Escorial/Airlie House diagnostic criteria (see Appendix D); 2. Prescribed by or in consultation with a neurologist; 3. Age ≥ 18 years; 4. Concomitant use of riluzole at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 5. Independent living status (able to eat a meal, excrete, or move without assistance and not needing help in everyday life); 6. Percent predicted forced vital capacity (% FVC) ≥ 80%; 7. Disease duration ≤ 2 years; 8. Baseline revised ALS Functional Rating Scale (ALSFRS-R) score with ≥ 2 points in each of the 12 items; 9. For brand intravenous Radicava requests, member must use generic intravenous edaravone unless contraindicated or clinically significant adverse effects are experienced; 10. Dose does not exceed any of the following: (a) For intravenous administration: 60 mg per day for each treatment cycle; (b) For oral administration: 105 mg per day for each treatment cycle; (c) Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period; (d) Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods followed by 14-day drug-free periods.see text

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to the member's renewal date, whichever is longer.

Continuation Therapy (ALS)

Covered for continuation when ALL of the following are met:

Continued therapy criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Member continues to meet all of the following: (a) Independent living status; (b) Percent predicted FVC ≥ 80%; (c) Revised ALSFRS-R score with ≥ 2 points in each of the 12 items; 4. For brand intravenous Radicava requests, member must use generic intravenous edaravone unless contraindicated or clinically significant adverse effects are experienced; 5. If request is for a dose increase, the new dose must not exceed: (a) For intravenous administration: 60 mg per day for each treatment cycle, or (b) For oral administration: 105 mg per day for each treatment cycle; and (c) Treatment cycle limits of daily dosing for 10 days out of 14-day periods followed by 14-day drug-free periods.see text

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to the member's renewal date, whichever is longer.

Other diagnoses/indications

Other indications:

Other/Off-label uses: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (new indication, age expansion, or new dosing), follow the specified formulary or non‑formulary policy for the relevant line of business as listed (see policy references).; 2. If the requested use (diagnosis, age, dosing) is not listed in Section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for ICHRA, CP.PMN.53 for Medicaid).

Non‑FDA approved indications not addressed in this policy are not authorized unless sufficient documentation exists per off‑label use policies.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

The inclusion or exclusion of any HCPCS, CPT, or NDC codes listed in this policy is for informational purposes only and does not, by itself, guarantee payment or coverage. Coverage is determined by the member's benefit plan, applicable coding guidance, and current payer policies; providers should verify coding and coverage prior to claim submission.

The pivotal trials that informed approval of edaravone used strict eligibility criteria (revised El Escorial/Airlie House criteria). Patients who do not meet those strict diagnostic and functional eligibility requirements at the time of initial or continued approval are assumed unlikely to derive benefit from edaravone based on available evidence; such patients will not meet medical necessity criteria until further data support broader use.

This clinical policy is intended as a guide to medical necessity and to assist with coverage determinations; it is not a contract and does not guarantee payment. Coverage decisions remain subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law. Providers must follow applicable Health Plan administrative policies and current coding guidance when submitting authorization requests or claims.

Coding and Billing

Referenced HCPCS/NDC codesHCPCS

C9399	Unclassified drugs or biologicals (edaravone oral suspension)
J1301	Injection, edaravone, 1 mg
J8499	Prescription drug, oral, non chemotherapeutic, nos (edaravone oral suspension)

Referenced HCPCS/Drug CodesHCPCS

C9399	Unclassified drugs or biologicals (edaravone oral suspension)
J1301	Injection, edaravone, 1 mg
J8499	Prescription drug, oral, non chemotherapeutic, nos (edaravone oral suspension)

Percent predicted forced vital capacity (FVC)

ThresholdPercent predicted forced vital capacity (FVC) >= 80%

Use in initial approval% FVC >= 80% required for initial therapy per eligibility criteria

Use in continued therapy% FVC >= 80% must be maintained for continuation of therapy

Provider Actions and Prior Authorization

Denial Risk

Documentation missing or non‑covered indication

Requests lacking documentation that the member meets all approval criteria, or requests for non‑FDA approved indications without sufficient off‑label evidence per the plan’s off‑label use policies, will be denied.

Off‑label requests require sufficient supporting evidence per CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace/ICHRA), or CP.PMN.53 (Medicaid).

Documentation Required

Supporting documentation required

Provider must submit documentation (such as office chart notes, lab results, ALSFRS‑R scores, %FVC results, and other clinical information) supporting that the member has met all applicable approval criteria. Documentation should show diagnosis per revised El Escorial/Airlie House criteria, neurologist involvement, baseline and ongoing functional measures, and any rationale for brand product use when generic redirection applies.

Include ALSFRS‑R item scores and %FVC results.

Background

Edaravone is a free‑radical scavenger approved for the treatment of amyotrophic lateral sclerosis (ALS). Clinical trials supporting approval used narrowly defined eligibility criteria (revised El Escorial/Airlie House diagnostic criteria and ALSFRS‑R functional requirements), which informed the policy's requirement for strict diagnostic confirmation and functional thresholds for coverage.

Definitions and Scales

Revised El Escorial/Airlie House diagnostic criteria

DefinitionRevised El Escorial/Airlie House criteria require signs of LMN degeneration, signs of UMN degeneration, and progressive spread of symptoms or signs

Diagnostic componentsLMN evidence by clinical, electrophysiological or neuropathologic exam; UMN evidence by clinical exam; progressive spread of signs

Exclusion criteria within criteriaAbsence of electrophysiological or neuroimaging evidence of other disease processes that could explain LMN/UMN signs

Classification detailsDefines clinically definite, probable, probable‑lab supported, and possible ALS based on regional distribution of UMN and LMN signs

ALSFRS-R (Revised ALS Functional Rating Scale)

Scale description