CurrentCentenePolicy CP PHAR.343

Edaravone (Radicava, Radicava ORS) for ALS — Coverage Criteria

Criteria and coverage guidance for initial and continued use of edaravone (intravenous and oral suspension) for treatment of amyotrophic lateral sclerosis (ALS) for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyEdaravone (Radicava, Radicava ORS) for ALS — Coverage Criteria

Policy CodePolicy CP PHAR.343

Change TypeMaterial updates and dosing/formulation additions

Effective Date07.01.17

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets initial or continued criteria (diagnosis per revised El Escorial, neurologist involvement, age ≥18, FVC ≥80%, ALSFRS‑R baseline/ongoing requirements).

SourceLink

POLICY UPDATE CHANGES

Added edaravone to the Policy/Criteria applicability section and added generic redirection for IV Radicava requests to initial and continued criteria; clarified that 'El Escorial' refers to revised El Escorial/Airlie House.

Added new oral suspension formulation (Radicava ORS) and aligned dosing/administration with FDA labeling.

Clarified percent predicted forced vital capacity (FVC) and lowered age limit from 20 to 18 years.

6 monthsApproval duration

FVC ≥ 80%Pulmonary function

≥ 18 yrsMinimum age

IV 60 mg; Oral 105 mg

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Coverage Criteria for Edaravone (Radicava, Radicava ORS)

Initial Approval Criteria

Covered when ALL of the following are met

Initial Approval for Edaravone: 1) Diagnosis of definite or probable ALS per the revised El Escorial/Airlie House diagnostic criteria; 2) Prescribed by or in consultation with a neurologist; 3) Age >= 18 years; 4) Independent living status (able to eat, excrete, and move oneself without assistance in everyday life); 5) Concomitant use of riluzole at up to maximally indicated doses unless contraindicated or intolerant; 6) Percent predicted forced vital capacity (FVC) >= 80%; 7) Baseline revised ALSFRS-R with >= 2 points in each of the 12 items; 8) Disease duration < 2 years; 9) For brand intravenous Radicava requests, member must use generic intravenous edaravone unless contraindicated or clinically significant adverse effects are experienced; 10) Dosing and cycle limits are met: IV dose limit 60 mg per treatment day with initial daily dosing for 14 days followed by a 14-day drug-free period; subsequent cycles daily dosing for 10 days out of 14 followed by 14-day drug-free periods; oral dose limit 105 mg per treatment day with same cycle structure.see text

Approval duration: 6 months

Continued Therapy Criteria

Covered when ALL of the following are met

Continued Therapy for Edaravone: 1) Member is currently receiving medication via the Centene benefit or previously met initial approval criteria; 2) Member is responding positively to therapy; 3) Member continues to meet: percent predicted FVC >= 80%; independent living status; revised ALSFRS-R with >= 2 points in each of the 12 items; 4) Dose and cycle do not exceed route-specific limits: IV 60 mg per treatment day and treatment consisting of daily dosing for 10 days out of 14 followed by 14-day drug-free periods; oral 105 mg per treatment day with same cycle structure; 5) For brand intravenous Radicava requests, member must use generic intravenous edaravone unless contraindicated or clinically significant adverse effects are experienced.see text

Approval duration: 6 months

Non‑FDA indications for edaravone that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety per the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless an evidence of coverage document permits the use.

Use of edaravone in patients who do not meet the strict eligibility criteria derived from the pivotal trials (that is, the trial‑defined population reflected in the revised El Escorial/Airlie House criteria and trial enrollment windows) is presumed to provide no benefit until further studies support effectiveness in broader ALS populations.

Coding, Dosing and Clinical Thresholds

HCPCS Codes referencedHCPCS

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

Forced vital capacity (FVC) — Percent predicted FVC ≥ 80%"

ThresholdPercent predicted forced vital capacity (FVC) ≥ 80%

ContextRequired for both initial approval and continued therapy; documented as percent predicted FVC

Assessment timingMeasured at baseline prior to initiation and reassessed for continuation of therapy

Approval impactFailure to meet FVC ≥ 80% renders the member ineligible per policy criteria

Dose limits — IV and Oral maximums

Intravenous maximum60 mg per treatment day (IV edaravone)

Provider Responsibilities and Authorization Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document that the member meets all initial or continued approval criteria and submit supporting clinical documentation (e.g., office chart notes, laboratory results, ALSFRS-R scores, pulmonary function testing) with the request.

Approval duration: 6 months

Billing Rule

Generic Redirection for IV Brand Product

For requests for brand intravenous Radicava, the member must use generic intravenous edaravone unless the provider documents a contraindication or clinically significant adverse effect to the generic formulation. This requirement applies to both initial and continued therapy requests.

Applies to initial and continuation approval requests

Background

Edaravone is a free‑radical scavenger approved for the treatment of amyotrophic lateral sclerosis (ALS). Approval was informed by two pivotal phase III trials conducted in Japan; a post‑hoc analysis of the initial trial identified a subgroup likely to benefit, which led to a second trial using much stricter eligibility criteria that demonstrated a statistically significant effect. Because benefit was seen only in this narrowly defined trial population, the policy requires adherence to those eligibility parameters when considering coverage.

The policy uses the revised El Escorial/Airlie House diagnostic criteria as the diagnostic framework for ALS (requiring clinical evidence of both upper and lower motor neuron degeneration and progressive spread of symptoms) and references the ALSFRS‑R, a 12‑item clinician‑rated functional scale (each item scored 0–4, total 48 points), for baseline and ongoing assessment.

Definitions and Clinical Scales

Revised El Escorial/Airlie House diagnostic criteria — Key points

Definition summaryDiagnostic framework requiring clinical signs of upper motor neuron (UMN) and lower motor neuron (LMN) degeneration and progressive spread of symptoms

Diagnostic categoriesIncludes clinically definite, probable, probable‑lab supported, and possible ALS based on regions involved and clinical/electrophysiological findings

Required elementsPresence of UMN and LMN signs and progressive spread, with exclusion of alternative explanations by electrophysiology or neuroimaging

Policy useMember must meet revised El Escorial/Airlie House criteria (definite or probable ALS) for initial approval

ALSFRS‑R — Revised ALS Functional Rating Scale (12 items, scored 0–4) used for baseline and continuation assessment