CurrentConnectiCarePolicy C11528-A

Amyotrophic Lateral Sclerosis (ALS): Edaravone Coverage Criteria

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This policy governs coverage and prior authorization for intravenous and oral edaravone products used to treat amyotrophic lateral sclerosis (ALS), including clinical eligibility, documentation, prescriber, dosing, continuation, and administration requirements.

Policy Summary

PayerConnectiCare

PolicyAmyotrophic Lateral Sclerosis (ALS): Edaravone Coverage Criteria

Policy CodePolicy C11528-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation supporting qualifying ALS, ALSFRS-R function, respiratory status, riluzole use, age, and specialist prescribing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ALSFDA-approved indication

18+Minimum member age

12 monthsAuthorization duration

13Initial treatment cycles

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CurrentConnectiCarePolicy C11528-A

Amyotrophic Lateral Sclerosis (ALS): Edaravone Coverage Criteria

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Sign up for ConnectiCare Policy C11528-A alerts

Get alerted when Policy C11528-A changes without checking for updates manually.

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Policy Summary

PayerConnectiCare

PolicyAmyotrophic Lateral Sclerosis (ALS): Edaravone Coverage Criteria

Policy CodePolicy C11528-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation supporting qualifying ALS, ALSFRS-R function, respiratory status, riluzole use, age, and specialist prescribing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ALSFDA-approved indication

18+Minimum member age

12 monthsAuthorization duration

13Initial treatment cycles

Continuation adherence

FVC >80%Respiratory threshold

Coverage Criteria

Initial Therapy Criteria

Initial therapy is covered when all of the following are met.

Initial therapy requirements

Qualifying ALS
- ALS diagnosis: Documentation supports a clinical diagnosis of definite ALS or probable ALS according to the revised El Escorial (Airlie House) diagnostic criteria.
Baseline function
- ALSFRS-R: Documentation shows a baseline ALSFRS-R score of at least 2 on each individual item of the 12-item scale.>=2 on each of 12 items
Respiratory function
- Forced Vital Capacity (FVC) is greater than 80%.FVC >80%
- A decline in respiratory function is better explained by a pulmonary disease process, such as COPD, asthma, or idiopathic pulmonary fibrosis.
  When baseline FVC is reduced, records documenting the pulmonary disease process may be requested.
Concomitant riluzole
- The member uses riluzole (Rilutek) up to the maximally indicated dose.50 mg twice daily
- The member has a labeled contraindication to riluzole or clinically significant adverse effects from riluzole.
Prescriber and age
- The member is at least 18 years of age.Age >=18
- Edaravone is prescribed by, or in consultation with, a board-certified neurologist, neuromuscular specialist, or physician experienced in the management or treatment of ALS.
  If prescribed in consultation, consultation notes must be submitted with the initial request.

Continuation Therapy Criteria

Continuation therapy is covered when all of the following are met.

Continuation therapy requirements

Adherence
- Adherence to therapy is at least 85%, as verified by the prescriber or the member's medication fill history.>=85%
- Adherence below 85% is due to surgery or treatment of an infection that caused temporary discontinuation.
Disease status
- The disease is stable or mildly progressing, indicating a slowing of decline.
- The member continues to have an ALSFRS-R score of at least 2 on each item.

Coverage is excluded for members with a history of hypersensitivity to edaravone or to any inactive ingredient in Radicava or Radicava ORS.

Use of Radicava or Radicava ORS for any indication other than treatment of amyotrophic lateral sclerosis (ALS) is considered experimental or investigational and is subject to the applicable off-label policy.

Coding and Clinical Thresholds

HCPCS CodeHCPCS

J1301

Injection, edaravone,1mg

Baseline ALSFRS-R

Minimum score per itemAt least 2 points on each ALSFRS-R item

Number of items12 individual items

Overall scale rangeMinimum 0 points; maximum 48 points

Respiratory Function

Required FVCGreater than 80%

ExceptionThe requirement may be met when respiratory decline is better explained by a pulmonary disease process

Examples of pulmonary disease

Prior Authorization and Documentation

Prior Authorization

Initial Authorization Required

Prior authorization is required for initial coverage of edaravone (Radicava or Radicava ORS). Submit documentation meeting all applicable ALS clinical eligibility requirements and the requested product, dose, and treatment schedule.

Initial authorization is approved for 12 months; 13 cycles (134 doses over 364 days).
Quantity limits: 60 mg/day IV or 105 mg/day (5 mL) oral suspension.
Initial cycle: daily dosing for 14 days followed by a 14-day drug-free period. Subsequent cycles: daily dosing for 10 days out of each 14-day period, followed by 14 drug-free days.

Prior Authorization

Continuation Authorization

For continuation authorization, submit evidence that the member remains adherent, has stable disease or only mild progression, and has no intolerable adverse effects or drug toxicity.

Continuation authorization is approved for 12 months; 13 cycles (130 doses over 364 days).
Document adherence of at least 85% by prescriber attestation or medication fill history, or explain adherence below 85% due to surgery or infection requiring temporary discontinuation.

Disease Background

Amyotrophic lateral sclerosis (ALS) is an adult-onset neurodegenerative disease characterized by progressive degeneration of upper and lower motor neurons. This progression causes muscle weakness and disability and may ultimately lead to respiratory failure. Diagnosis is based on upper and lower motor neuron findings, progressive spread of symptoms or signs, and exclusion of alternative causes. Edaravone is an FDA-approved therapy for ALS, available by intravenous infusion or oral suspension.

Clinical Definitions

Revised El Escorial (Airlie House) Criteria

Definite ALSUMN and LMN signs in the bulbar region and at least 2 spinal regions, or UMN and LMN signs in 3 spinal regions

Probable ALSUMN and LMN signs in at least 2 regions, with some UMN signs rostral to the LMN signs

Probable ALS, laboratory supportedClinical UMN and LMN dysfunction in 1 region, or UMN signs alone in 1 region, with EMG-defined LMN signs in at least 2 regions and exclusion of other causes

Diagnostic safeguardsOther disease processes that could explain the UMN or LMN degeneration must be excluded

ALSFRS-R

Assessment scopeA 12-question composite measure of fine motor, gross motor, bulbar, and respiratory function

Edaravone Initial Therapy

Initial edaravone therapy is covered when all of the following requirements are documented.

Edaravone initial therapy

Qualifying ALS diagnosis
- The member has definite ALS or probable ALS according to the revised El Escorial (Airlie House) diagnostic criteria.
Clinical function
- Baseline ALSFRS-R score is at least 2 on each individual item of the 12-item scale.>=2 on each of 12 items
Respiratory status

Edaravone Continuation

Edaravone continuation therapy is covered when all of the following requirements are met.

Edaravone continuation

Adherence
- Adherence to therapy is at least 85%, as verified by the prescriber or the member's medication fill history.>=85%
- Adherence below 85% is due to surgery or treatment of an infection causing temporary discontinuation.
Disease stability or mild progression
- The disease is stable or mildly progressing, indicating a slowing of decline.

Step Therapy Requirement

Step	Requirement	Exceptions
1	Use concomitant riluzole (Rilutek) up to the maximally indicated dose of 50 mg twice daily.	A labeled contraindication or clinically significant adverse effects may qualify for an exception.

Dosing and Quantity Limits

Edaravone Daily Quantity Limits

Intravenous maximum60 mg per day

Oral maximum105 mg per day, equivalent to 5 mL per day of oral suspension

Covered medicationEdaravone

Intravenous Dosing Cycle

Initial cycleDaily dosing for 14 days

Drug-free periodFollowed by a 14-day drug-free period

RouteIntravenous edaravone

Administration Site Requirements

Billing Rule

Use home administration for oral edaravone

Oral medications are recommended for pharmacy benefit coverage and patient self-administration at home.

Billing Rule

Route infused edaravone through the Site of Care program

Infused edaravone is recommended for pharmacy or medical benefit coverage through the Health Care Site of Care program and is administered by a healthcare professional.

The Site of Care Utilization Management Policy applies to intravenous Radicava.

Policy Summary

PayerConnectiCare

PolicyAmyotrophic Lateral Sclerosis (ALS): Edaravone Coverage Criteria

Policy CodePolicy C11528-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation supporting qualifying ALS, ALSFRS-R function, respiratory status, riluzole use, age, and specialist prescribing.

SourceLink

On This Page

The ALSFRS-R score has not decreased by more than 6 total points from the previous baseline or authorization.Decline <=6 total points

Safety

The prescriber attests to, or the clinical reviewer finds, no evidence of intolerable adverse effects or drug toxicity.

COPD, asthma, or idiopathic pulmonary fibrosis

Continuation ALSFRS-R

Minimum score per itemThe member continues to score at least 2 on each ALSFRS-R item

Maximum total declineNo more than 6 points below the previous baseline or authorization

Disease statusDisease stability or mild progression indicating a slowing of decline

Continuation Adherence

Minimum adherenceAt least 85% of the time

VerificationVerified by the prescriber or the member’s medication fill history

Temporary-discontinuation exceptionAdherence below 85% may qualify when surgery or treatment of an infection caused temporary discontinuation

Concomitant Riluzole

Maximum dose50 mg twice daily

Therapy requirementConcomitant riluzole use up to the maximally indicated dose

ExceptionThe dose requirement does not apply when the member has a labeled contraindication or clinically significant adverse effects

Document that the member continues to score at least 2 on each ALSFRS-R item and has not declined by more than 6 total points from the previous baseline or authorization.

Documentation Required

Specialist and Age Requirements

The member must be an adult, and edaravone must be prescribed by, or in consultation with, a qualified specialist experienced in ALS management.

Member must be 18 years of age or older.
Prescriber must be a board-certified neurologist, neuromuscular specialist, or physician experienced in the management or treatment of ALS.
If prescribed in consultation, submit consultation notes with the initial request and each reauthorization request.

Documentation Required

Document Qualifying ALS Diagnosis

Submit documentation supporting a diagnosis of definite or probable ALS under the revised El Escorial (Airlie House) diagnostic criteria.

Include clinical records supporting the qualifying ALS diagnosis.

Documentation Required

Baseline ALSFRS-R Documentation

Submit baseline ALS Functional Rating Scale-Revised (ALSFRS-R) results for all 12 scale items.

The member must score at least 2 on each individual item.
The ALSFRS-R has 12 items, with a minimum total of 0 and maximum total of 48 points.

Documentation Required

Respiratory Function Documentation

Submit documentation that the member has retained normal respiratory function or that the respiratory decline is better explained by a pulmonary disease process.

Document Forced Vital Capacity (FVC) greater than 80%, or provide records supporting an alternative pulmonary explanation such as COPD, asthma, or idiopathic pulmonary fibrosis.
For reduced baseline FVC, records may be requested documenting the pulmonary disease process responsible for the reduction.

Documentation Required

Concomitant Riluzole Required

Document concomitant riluzole (Rilutek) use at up to the maximally indicated dose unless the member has a labeled contraindication or clinically significant adverse effects.

Maximum indicated riluzole dose: 50 mg twice daily.
Explain and document any contraindication or clinically significant adverse effect that prevents concomitant use.

Documentation Required

Continuation Documentation

With each continuation request, submit documentation supporting ongoing adherence and disease status under the continuation criteria.

Verify adherence of at least 85%, or document a temporary interruption due to surgery or treatment of an infection.
Document ALSFRS-R results showing a score of at least 2 on every item and no more than a 6-point total decrease from the prior baseline or authorization.
Prescriber must attest, or clinical review must confirm, that there is no intolerable adverse effect or drug toxicity.

Documentation Required

Submit Consultation Notes

Include specialist consultation notes with both the initial authorization request and every reauthorization request when the medication is prescribed in consultation.

Consultation must be with a board-certified neurologist, neuromuscular specialist, or physician experienced in ALS management or treatment.

Documentation Required

Additional Supporting Records

The health plan may request additional records to complete coverage, medical-necessity, quality-improvement, or fraud, waste, and abuse reviews.

Additional documentation may include patient records, test results, provider credentials, and complete medical rationale for an exception.
The plan may deny reimbursement or take other appropriate action if records do not support medical necessity, non-investigational use, benefit eligibility, or appropriate billing practices.

Denial Risk

Non-ALS Use Not Covered

All other uses of Radicava (edaravone) and Radicava ORS (edaravone) are considered experimental or investigational and are handled under the plan's Off-Label policy.

Coverage is limited to the qualifying ALS indication described in this policy.

Denial Risk

Edaravone Hypersensitivity

A history of hypersensitivity to edaravone or any inactive ingredient in Radicava or Radicava ORS precludes coverage.

Review and document relevant hypersensitivity history before requesting authorization.

Denial Risk

Incomplete Clinical Eligibility

Missing or insufficient clinical-eligibility documentation may prevent approval of the initial request.

Submit qualifying definite or probable ALS diagnosis documentation.
Submit baseline ALSFRS-R results showing at least 2 on each of the 12 items.
Submit FVC greater than 80% or documentation of a pulmonary disease explanation for reduced respiratory function.
Submit concomitant riluzole use up to 50 mg twice daily, or documentation of a labeled contraindication or clinically significant adverse effects.

Denial Risk

Failure of Continuation Criteria

Continuation coverage may be denied when the member does not meet adherence, disease-status, or tolerability requirements.

Adherence below 85% without a qualifying temporary interruption may result in denial.
A score below 2 on any ALSFRS-R item or a decline of more than 6 total points from the prior baseline or authorization may result in denial.
Intolerable adverse effects or drug toxicity may result in denial or discontinuation.

Domains assessedSpeech, salivation, swallowing, handwriting, cutting food, dressing and hygiene, turning in bed, walking, climbing stairs, dyspnea, orthopnea, and respiratory insufficiency

ScoringEach item is scored from 0 to 4; higher scores represent greater functional ability

Definite or Probable ALS

Definite ALSUMN and LMN signs are present in the bulbar region and at least 2 spinal regions, or in 3 spinal regions

Probable ALSUMN and LMN signs are present in at least 2 regions, with some UMN signs necessarily rostral to the LMN signs

Required diagnostic foundationEvidence of LMN degeneration, evidence of UMN degeneration, and progressive spread of symptoms or signs within or to other regions

Exclusion requirementElectrophysiologic, pathologic, neuroimaging, and other evidence of alternative disease processes must be excluded

Forced Vital Capacity (FVC) is greater than 80%.FVC >80%

Reduced respiratory function is better explained by a pulmonary disease process, such as COPD, asthma, or idiopathic pulmonary fibrosis.

Records documenting the pulmonary disease process may be requested when baseline FVC is reduced.

Concomitant riluzole therapy

The member uses riluzole (Rilutek) up to the maximally indicated dose.50 mg twice daily
The member has a labeled contraindication to riluzole or clinically significant adverse effects.

Prescriber and age

The member is at least 18 years of age.Age >=18
The medication is prescribed by, or in consultation with, a board-certified neurologist, neuromuscular specialist, or physician experienced in managing or treating ALS.
If prescribed in consultation, consultation notes must be submitted with the initial request.

The member continues to have an ALSFRS-R score of at least 2 on each item.>=2 on each item

The ALSFRS-R score has not decreased by more than 6 total points from the previous baseline or authorization.Decline <=6 total points

Safety

The prescriber attests to, or the clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity.

Oral Dosing Cycle

Subsequent cycle dosingDaily dosing for 10 days out of each 14-day period

Drug-free periodFollowed by a 14-day drug-free period

RouteOral edaravone suspension

Initial Authorization Quantity

Authorization phaseInitial authorization

Treatment cycles13 cycles

Maximum doses134 doses over 364 days

Continuation Authorization Quantity

Authorization phaseContinuation of therapy

Treatment cycles13 cycles

Maximum doses130 doses over 364 days