ModifiedmhnPolicy CP.PHAR.343

Edaravone (Radicava, Radicava ORS) coverage

Defines medical necessity criteria, prior authorization and coverage details for edaravone (intravenous and oral) for treatment of amyotrophic lateral sclerosis (ALS) for Centene-affiliated health plans across specified lines of business.

Policy Summary

Payermhn

PolicyEdaravone (Radicava, Radicava ORS) coverage

Policy CodePolicy CP.PHAR.343

Change TypeMaterial updates to approvals, formulations, and redirection of IV requests

Effective DateJul 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with supporting documentation showing the member meets all approval criteria, including diagnosis per revised El Escorial criteria and required baseline measures.

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; ICHRA line of business added.

Added generic redirection for IV Radicava requests to initial and continued criteria.

Added new oral suspension formulation.

Clarified that 'El Escorial' refers to revised El Escorial or Airlie House diagnostic criteria.

Medicaid/HIM = 12 moapproval duration

Commercial = 6 mo/renewalapproval duration

% FVC ≥ 80%Pulmonary function

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≤ 2 yrsDisease duration

IV 60 mg; Oral 105 mgDosing limits

ICHRA addedlines of business

Coverage Criteria for Edaravone (ALS)

Initial Therapy — Covered when ALL of the following are met for Initial Approval (Amyotrophic Lateral Sclerosis).

Covered when ALL of the following are met for Initial Approval (Amyotrophic Lateral Sclerosis).

Initial ALS criteria: 1. Diagnosis of definite or probable ALS per the revised El Escorial/Airlie House diagnostic criteria (see Appendix D).

Concomitant therapy: 4. Concomitant use of riluzole at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced.

Formulation and generic redirection: 9. For brand intravenous Radicava requests, member must use generic intravenous edaravone unless contraindicated or clinically significant adverse effects are experienced.

Dosing and treatment cycles: 10. Dose does not exceed the following: (a) Per-day maximum: IV 60 mg or oral 105 mg; (b) Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period; (c) Subsequent treatment cycles: daily dosing for 10 of 14 days followed by a 14-day drug-free period.

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

Continuation Therapy — Covered when ALL of the following are met for Continued Therapy (Amyotrophic Lateral Sclerosis).

Covered when ALL of the following are met for Continued Therapy (Amyotrophic Lateral Sclerosis).

Eligibility for continuation: 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 protections.

Clinical response: 2. Member is responding positively to therapy.

Formulation and generic redirection: 4. For brand intravenous Radicava requests, member must use generic intravenous edaravone unless contraindicated or clinically significant adverse effects are experienced.

Dose changes for continued therapy: 5. If request is for a dose increase, new dose must not exceed: (a) per-day maximums — IV 60 mg or oral 105 mg; and (b) treatment cycle schedule of daily dosing for 10 of 14 days followed by a 14-day drug-free period.

Other indications / Off-label guidance

Other indications or recent label changes:

Other indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., new indication, age expansion, or dosing regimen), refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see policy references in section III/B).

See related policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16) for specific routing depending on formulary status and line of business.

Off-label uses: 2. If the requested use (diagnosis, age, dosing regimen) is not listed under 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 health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid).

Policy updates / applicability

Policy updates and applicability notes

Policy applicability and approval durations: Edaravone was added to the Policy/Criteria applicability section; IV Radicava requests are redirected to initial and continued criteria; approval durations were revised: Medicaid/HIM = 12 months; Commercial = 6 months or to the member's renewal date, whichever is longer; ICHRA line of business added.

See full policy for specific eligibility and clinical criteria and Appendix D for diagnosis definitions per revised El Escorial/Airlie House.

Coverage is not authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the provider submits sufficient documentation demonstrating efficacy and safety per the applicable off‑label use policies. Refer to CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid when evaluating off‑label requests.

Coverage determinations are subject to the member's evidence of coverage, certificate of coverage, policy, contract of insurance, and any applicable state or federal requirements. This clinical policy is a guide to medical necessity and does not supersede the specific terms, conditions, exclusions, and limitations of the member's coverage documents.

Patients who do not meet the strict eligibility criteria outlined in this policy (criteria modeled on the pivotal trials and the revised El Escorial/Airlie House diagnostic standards) are assumed unlikely to benefit from edaravone under this policy. Requests for such patients may be denied unless the provider provides convincing, case‑specific documentation supporting clinical benefit beyond the trial‑like criteria.

This clinical policy was developed by qualified health care professionals from a review of current evidence and practice standards and is intended to guide medical necessity determinations. It does not constitute a contract or guarantee of payment; coverage decisions remain subject to the member's benefit plan, applicable law, and Health Plan administrative policies. For Medicaid members, state Medicaid provisions take precedence where conflicts exist.

Coding and Billing References

Referenced drug HCPCS/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 Drug 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)

Percent predicted forced vital capacity (FVC) — clinical threshold requirement

Percent predicted forced vital capacity (FVC)% FVC ≥ 80%

Measurement contextRequired as part of initial and continued therapy eligibility for ALS (document baseline and ongoing values)

Impact on coverageRequests with % FVC below 80% do not meet the policy's stated pulmonary function requirement for approval

Disease duration — clinical threshold requirement

Maximum disease duration for initial approvalDisease duration ≤ 2 years

ApplicabilityRequired at time of initial approval for ALS; documented disease onset date must be provided

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for edaravone (Radicava, Radicava ORS). Approvals are time-limited and vary by line of business: Medicaid/HIM/ICHRA approvals are for 12 months; Commercial approvals are for 6 months or to the member's renewal date, whichever is longer.

PA required for edaravone (Radicava, Radicava ORS)
Approval duration — Medicaid/HIM/ICHRA: 12 months
Approval duration — Commercial: 6 months or to member renewal date, whichever is longer

Note

Policy Updates — formulation, redirection, and approval durations

Policy was updated to add the oral suspension (Radicava ORS) formulation and to add generic redirection for IV Radicava requests (members must use generic intravenous edaravone for brand IV Radicava requests unless contraindicated). Approval durations were revised (Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to renewal date).

Added edaravone oral suspension (Radicava ORS) to applicability

Background

Edaravone is a free‑radical scavenger approved for treatment of amyotrophic lateral sclerosis (ALS). The drug’s approval was informed by two pivotal phase III trials conducted in Japan: one trial showed no overall statistically significant delay in ALS progression, while a post‑hoc analysis identified a subset of patients who might benefit. A subsequent phase III trial using much stricter eligibility criteria demonstrated a statistically significant benefit in that narrowly defined population. As a result, this policy restricts coverage to patients whose clinical presentation and functional status align with the trial‑based eligibility (including revised El Escorial/Airlie House diagnostic criteria and baseline ALSFRS‑R requirements).

Definitions and Clinical Scales

Revised El Escorial/Airlie House diagnostic criteria — definition of diagnostic categories

Core requirementsRequires signs of lower motor neuron (LMN) degeneration, signs of upper motor neuron (UMN) degeneration, and progressive spread of symptoms or signs within a region or to other regions

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

Diagnostic categories definedClinically definite ALS: UMN and LMN signs in ≥ 3 regions; Clinically probable ALS: UMN and LMN signs in ≥ 2 regions with some UMN signs rostral to LMN signs; Probable lab‑supported and possible ALS categories also specified per criteria

ALSFRS-R — definition and scoring requirement (≥2 points per item)

Scale descriptionALSFRS‑R is a 12‑item, physician‑generated functional rating scale with each item scored 0–4 (total 0–48)

Policy Summary

Payermhn

PolicyEdaravone (Radicava, Radicava ORS) coverage

Policy CodePolicy CP.PHAR.343

Change TypeMaterial updates to approvals, formulations, and redirection of IV requests

Effective DateJul 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with supporting documentation showing the member meets all approval criteria, including diagnosis per revised El Escorial criteria and required baseline measures.

SourceLink

On This Page

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

Continued therapy noteContinued therapy requires ongoing positive response; initial duration requirement applies to initial approvals

Age — clinical threshold requirement

Minimum age for coverageAge ≥ 18 years

DocumentationMember age must be documented in the medical record at time of request

ApplicabilityApplies to both initial and continued therapy criteria

Generic redirection for IV Radicava: require generic IV edaravone unless contraindicated

Revised approval durations as noted

Step Therapy

Concomitant Therapy Requirement

Concomitant use of riluzole is required (at up to maximally indicated doses) unless contraindicated or clinically significant adverse effects occur. Providers should document rationale if riluzole is not used.

Concomitant riluzole required unless contraindicated or adverse effects present
Document contraindication or adverse effects if riluzole not used

Billing Rule

IV Radicava Generic Redirection

For brand intravenous Radicava requests, members must use generic intravenous edaravone unless contraindicated or clinically significant adverse effects are experienced. This redirection applies to both initial and continued therapy requests.

Generic IV edaravone required for brand IV Radicava requests unless contraindicated
Redirection applies to initial and continued criteria

Documentation Required

Required Supporting Documentation

Provider must submit supporting documentation (e.g., office chart notes, lab results, ALSFRS-R scores, %FVC, neurologist consult notes, documentation of independent living status, disease duration) to demonstrate the member meets all approval criteria.

Office notes, neurologist consultation documentation
Baseline and ongoing ALSFRS-R scores showing ≥2 points in each of 12 items
Percent predicted FVC (≥ 80%), disease duration, independent living status
Documentation of riluzole use or documented contraindication

Denial Risk

Missing Documentation or Unmet Criteria May Result in Denial

Requests missing required documentation or that do not meet the clinical criteria (for example: diagnosis not consistent with revised El Escorial/Airlie House criteria, absence of neurologist involvement, %FVC < 80%, ALSFRS-R not meeting thresholds, missing evidence of independent living status, or lack of documentation supporting generic redirection rationale) will be denied.

Missing or incomplete documentation = denial risk
Diagnosis must meet revised El Escorial/Airlie House criteria
Neurologist involvement required
Clinical thresholds (e.g., %FVC ≥ 80%, ALSFRS-R criteria) must be met

Note

Coding Does Not Guarantee Coverage

Codes listed in the policy are for information only and do not guarantee coverage. Providers should reference the most up-to-date professional coding guidance before submitting claims.

Inclusion/exclusion of codes does not guarantee coverage
Check latest coding guidance before claim submission

Note

Coding Guidance Reminder

Providers should reference the most current professional coding resources prior to claim submission to ensure accurate billing and reimbursement.

Verify CPT/HCPCS/NDC codes against current coding manuals and payer guidance
Use updated coding references at time of claim submission

Policy scoring requirementBaseline and continued therapy require ≥ 2 points in each of the 12 items

Use in eligibility assessmentScores document functional impairment across daily tasks and are required for initial and continued approval determinations

El Escorial — clarification of referenced criteria

Terminology clarification'El Escorial' in this policy refers to the revised El Escorial (Airlie House) diagnostic criteria

Location in policyClarification applied to initial criteria and Appendix D per 2Q 2025 update

Implication for documentationDiagnostic documentation should reference the revised El Escorial/Airlie House criteria when certifying ALS diagnosis