Modifiedsierra health and lifePolicy 2024D0062K

Radicava (Edaravone) IV for amyotrophic lateral sclerosis (ALS) — coverage criteria

This policy governs coverage and medical necessity criteria for intravenous Radicava (edaravone) administered by a healthcare professional for treatment of ALS under the UnitedHealthcare Commercial medical benefit.

Policy Summary

Payersierra health and life

PolicyRadicava (Edaravone) IV for ALS — coverage criteria

Policy CodePolicy 2024D0062K

Change TypeAuthorization duration revised

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization with medical records showing 'definite' or 'probable' ALS, ALSFRS-R ≥2 on all items, %FVC ≥80% at treatment start, and provider attestation that oral suspension cannot be administered.

SourceLink

POLICY UPDATE CHANGES

Changed duration for initial authorization from 'no more than 6 cycles (64 doses over 168 days)' to 'no more than 12 months'.

Changed duration for reauthorization from 'no more than 6 cycles (60 doses over 168 days)' to 'no more than 12 months'.

Updated References section to reflect the most current information.

Template update modified font style with no change to policy content.

2024D0062Kpolicy number

J1301HCPCS code

12 monthsmax auth period

≥80% FVCFVC threshold

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≥2 on all itemsALSFRS-R requirement

Definite/probable ALSDiagnostic requirement

Coverage and Medical Necessity Criteria

Initial Therapy

Radicava (edaravone) IV is covered when ALL of the following are met for initial therapy:

Initial therapy requirements: Submission of medical records (e.g., chart notes, prior medical history, diagnostic testing including imaging, nerve conduction studies, and laboratory values) supporting a diagnosis of 'definite' or 'probable' ALS per the El Escorial/revised Airlie House diagnostic criteria, prescribed by or in consultation with a neurologist with expertise in ALS;

Initial therapy requirements: Most recent ALSFRS-R score confirming the patient has scores ≥ 2 on all items of the ALSFRS-R at the start of treatment;

Initial therapy requirements: Documentation that percent forced vital capacity (%FVC) is ≥ 80% at the start of treatment;

Initial therapy requirements: Radicava dosing is in accordance with the United States Food and Drug Administration approved labeling;

Initial therapy requirements: 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;

Initial therapy requirements: Initial authorization will be for no more than 12 months;

Continuation Therapy

Continuation of therapy is covered when ALL of the following are met:

Continuation therapy requirements: Diagnosis of 'definite' or 'probable' ALS per the El Escorial/revised Airlie House diagnostic criteria, prescribed by or in consultation with a neurologist with expertise in ALS;

Continuation therapy requirements: Patient is currently receiving Radicava therapy;

Continuation therapy requirements: Patient is not dependent on invasive ventilation or tracheostomy;

Continuation therapy requirements: Radicava dosing is in accordance with the United States Food and Drug Administration approved labeling;

Use of edaravone IV is limited to patients who meet all required diagnostic, functional, and respiratory thresholds at treatment initiation. Specifically, coverage requires documentation of definite or probable ALS per the El Escorial/revised Airlie House diagnostic criteria, a baseline ALSFRS-R score with ≥2 on all 12 items, and a documented baseline %FVC ≥ 80%. Patients who do not meet these thresholds (for example, ALSFRS-R item scores <2 or %FVC <80% at the start of treatment) are not supported for initial approval under this policy.

Edaravone use outside the defined subpopulation characteristics is not supported by the clinical trial evidence cited in this policy. The randomized trial did not show a statistically significant benefit in the overall study population, and post-hoc analyses suggested potential efficacy only in select early-stage subgroups characterized by higher baseline function and respiratory capacity (e.g., ALSFRS-R ≥2 on all items and %FVC ≥80%, and shorter disease duration). Therefore, broader use of edaravone beyond these subpopulation parameters (longer disease duration, lower FVC, or ALSFRS-R item scores <2) is not demonstrated to be efficacious and is not supported by the policy.

Billing and Coding

Applicable HCPCS CodesHCPCS

J1301

Injection, edaravone, 1 mg

Applicable Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

Forced Vital Capacity (%FVC) — Thresholds for Therapy

Initial %FVC requirement%FVC ≥ 80% at the start of treatment for initial therapy (clinical trial entry required ≥70% with post‑hoc subgroups using ≥80%).

Continuation consideration%FVC measurement is part of ongoing assessment for continuation; authorization may be renewed up to 12 months if other criteria are met.

Source trial thresholdConfirmatory trial inclusion required FVC ≥70%; post‑hoc efficacy‑expected subpopulation used %FVC ≥80%.

ALSFRS‑R Item Score Requirements

Minimum item scores at baselineALSFRS‑R scores of ≥2 on all 12 items are required at the start of treatment for initial coverage.

Use for eligibility and monitoring

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit medical records demonstrating 'definite' or 'probable' ALS per the El Escorial/revised Airlie House diagnostic criteria and documentation that treatment was prescribed by, or in consultation with, a neurologist with expertise in ALS. Initial and continuation approvals are limited to no more than 12 months; check the member-specific benefit plan for any differing duration limits.

Required for initial and continuation therapy
Initial and reauthorization approvals limited to ≤ 12 months
Prescribed by or in consultation with a neurologist with ALS expertise

Documentation Required

Submit medical records including chart notes, prior medical history, and diagnostic testing to support the diagnosis and ongoing need for therapy. Lack of required documentation is a common trigger for denial.

Definitions and Assessment Tools

Diagnostic Criteria Required for Coverage

Required diagnostic criteriaDiagnosis of 'definite' or 'probable' ALS per the El Escorial / revised Airlie House diagnostic criteria is required for coverage.

Documentation to submitMedical records supporting El Escorial classification must be provided (chart notes, prior history, diagnostic testing) and prescribed by or in consultation with a neurologist experienced in ALS.

Trial diagnostic definitionsClinical trials used revised El Escorial World Federation of Neurology criteria (definite, probable, probable‑laboratory‑supported ALS) for eligibility.

ALSFRS‑R — Functional Assessment Tool

Full nameAmyotrophic Lateral Sclerosis Functional Rating Scale‑Revised (ALSFRS‑R).

Purpose

Clinical Background

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, fatal motor neuron disease that leads to progressive loss of voluntary muscle control and eventual respiratory failure, with typical survival of about 3–5 years from symptom onset. Edaravone is described as a free radical scavenger; its precise mechanism in ALS is unknown. Clinical trial evidence was mixed: the confirmatory trial failed to meet its primary endpoint in the overall population, but post-hoc subgroup analyses identified early-stage subpopulations (higher baseline ALSFRS-R and %FVC, and shorter disease duration) in which edaravone may demonstrate benefit.

Policy Revision History

2024-05-01policy_revision

Changed duration for initial authorization from 'no more than 6 cycles (64 doses over 168 days)' to 'no more than 12 months' and changed duration for reauthorization from 'no more than 6 cycles (60 doses over 168 days)' to 'no more than 12 months'.

2024-12-01formatting_updateLatest

Template update modified font style with no change to clinical policy content (formatting-only).

Policy Summary

Payersierra health and life

PolicyRadicava (Edaravone) IV for ALS — coverage criteria

Policy CodePolicy 2024D0062K

Change TypeAuthorization duration revised

Effective DateMay 1, 2024

Next Review DateN/A

SourceLink

On This Page

Continuation therapy requirements:

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;

Continuation therapy requirements: Authorization will be for no more than 12 months;

Most recent ALSFRS‑R must be submitted to support eligibility; changes in ALSFRS‑R were primary efficacy endpoint in trials.

Scale referenceALSFRS‑R is the Amyotrophic Lateral Sclerosis Functional Rating Scale‑Revised, which incorporates respiratory assessments.

Chart notes and prior medical history

Diagnostic testing (imaging, nerve conduction studies, labs)

Most recent ALSFRS-R score (all items ≥ 2 at treatment start)

%FVC measurement (≥ 80% at treatment start)

Medication administration records and dosing consistent with FDA labeling

Provider attestation regarding oral administration competency (see below)

Denial Risk

Denial Triggers

Denials may result if documentation does not confirm diagnostic criteria (El Escorial), required ALSFRS‑R scores, %FVC thresholds, provider attestation about oral administration competency, or if therapy is not prescribed/managed by an appropriate neurologist. Failure to provide requested medical records will also risk denial.

Missing or incomplete El Escorial diagnostic confirmation
Missing ALSFRS‑R scores or scores < required thresholds
%FVC < 80% at treatment start without justification
No provider attestation that patient/caregiver cannot competently administer Radicava ORS oral suspension
Therapy not prescribed by or in consultation with a neurologist with ALS expertise
Requested medical records not submitted

Note

Reference Member-Specific Plan

When applying this policy, always reference the member-specific benefit plan document and any applicable federal or state mandates. In the event of a conflict between this policy and the member-specific benefit plan, the member-specific benefit plan governs.

Member-specific benefit plan documents may differ from this standard policy
Applicable federal or state mandates may supersede policy statements
In conflicts, the member-specific benefit plan governs

Documentation Required

Oral Administration Competency Attestation

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 to qualify the member for the medical benefit (intravenous) route of Radicava. This attestation must be included in the submitted documentation.

Attestation required for inability of patient/caregiver to administer Radicava ORS orally or via feeding tube
Attestation must be part of the medical records submitted for prior authorization

Functional assessment tool used to determine eligibility and to measure treatment effect in clinical evaluation and trials.

Submission requirementThe most recent ALSFRS‑R score must be submitted with prior authorization to confirm item scores ≥2 at treatment start.

ALSFRS‑R — Definition and Clinical Role

DefinitionALSFRS‑R: Amyotrophic Lateral Sclerosis Functional Rating Scale ‑ Revised, a scale that incorporates respiratory assessments to track ALS progression.

Clinical useUsed in trials as the primary efficacy endpoint (change in ALSFRS‑R over treatment period) and for baseline eligibility criteria.

Reference literatureCited foundational references include Cedarbaum et al., J Neurol Sci. 1999 and subsequent validation and trial analyses.