Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual

Policy #:

2017026

Category:

Pharmacy

Initiated:

July 2017

Last Review:

August 2026

Edaravone (e.g., Radicava)

Description:

The policy applies to the following medication:Edaravone (e.g., Radicava).

Policy/
Coverage:

Prior approval is required for Edaravone (e.g., Radicava).

INITIAL AND CONTINUATION APPROVAL will be for duration of treatment course or 12 months (whichever comes first). Approval timeframes may differ for members/participants of Self-Insured plans.

Effective November 28, 2026

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Edaravone (e.g., Radicava) meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes or for members with contracts without Primary Coverage Criteria, is considered Medically Necessary and is covered when member receives a “recommended” determination from criteria review in InterQual® for Edaravone (e.g., Radicava) based on diagnosis and requested product.

Click the following link to view the specific criteria in InterQual®: https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc

Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria

Edaravone (e.g., Radicava) does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered for any indication or circumstance not described as covered.

For members with contracts without Primary Coverage Criteria, Edaravone (e.g., Radicava), is considered not Medically Necessary and is not covered or is investigational for any indication or circumstance not described as covered. Not Medically Necessary or Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Click the following link to view the specific criteria in InterQual®: https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc

Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Please refer to a separate policy on Maximum Dosage and Frequency (policy #2025031) for pharmacologic/biologic medications.

Effective August 6, 2025 to November 27, 2026

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The initial use of edaravone (e.g., Radicava) in the treatment of amyotrophic lateral sclerosis (ALS) meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL of the following criteria are met [FDA, 2021; Writing Group; Edaravone (MCI-186) ALS 19 Study Group]:

INITIAL APPROVAL

1. Individual has a diagnosis of definite or probable ALS according to the revised El Escorial criteria of signs of lower motor neuron degeneration and upper motor neuron degeneration in at least 2 topographical regions of the CNS based on the submission of medical records (chart notes, previous medical history, diagnostic testing including: imaging, nerve conduction studies, laboratory values) and seen either primarily or in consultation by a neurologist with expertise in the diagnosis and treatment of ALS; AND

2. Individual is age 18 to 75 years (ALS 19 Study Group 2017); AND

3. Functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised [ALSFRS-R; described below]) (ALS 19 Study Group, 2017); AND

4. Forced vital capacity greater than or equal to 80% (ALS 19 Study Group, 2017); AND

5. Disease duration of less than or equal to 2 years (ALS 19 Study Group, 2017).

CONTINUATION OF THERAPY

1. Individual continues to meet the initial approval criteria; AND

2. No evidence that the individual is dependent on invasive ventilation.

Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria

Edaravone (e.g., Radicava) for any indication or circumstance not described above in the treatment of ALS and for all other conditions (including but not limited to stroke, MI, other neurodegenerative disease) does not meet primary coverage criteria that there be evidence of effectiveness in improving health outcomes.

For individuals with contracts without primary coverage criteria, Edaravone (e.g., Radicava) for all other indications in the treatment of ALS and for all other conditions (including but not limited to stroke, MI, other neurodegenerative disease) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

POLICY GUIDELINES

There should be an absence of unacceptable toxicity such as hypersensitivity reactions or sulfite allergic reactions.

DOSAGE AND ADMINISTRATION

For FDA labeled indications, Edaravone (e.g., Radicava) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified below.

The recommended dose of edaravone is 60 mg daily for 14 days, followed by a 14 day drug-free period as the initial treatment cycle administered IV.

Then 60mg daily for 10 out of 14 days, followed by a 14 day-drug free period for all subsequent cycles administered IV.

Continuation of therapy will require evidence that the individual is not dependent on invasive ventilation.

Edaravone is available as 30 mg/100 mL in a single-dose polypropylene bag.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Effective August 2022 to August 5, 2025

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The initial use of edaravone in the treatment of amyotrophic lateral sclerosis (ALS) meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL of the following criteria are met [FDA, 2021; Writing Group; Edaravone (MCI-186) ALS 19 Study Group]:

Individual has a diagnosis of definite or probable ALS according to the revised El Escorial criteria of signs of lower motor neuron degeneration and upper motor neuron degeneration in at least 2 topographical regions of the CNS based on the submission of medical records (chart notes, previous medical history, diagnostic testing including: imaging, nerve conduction studies, laboratory values) and seen either primarily or in consultation by a neurologist with expertise in the diagnosis and treatment of ALS; AND
Indivdual is age 18 to 75 years; AND
Functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised [ALSFRS-R; described below]) (ALS 19 Study Group, 2017); AND
Forced vital capacity greater than or equal to 80% (ALS 19 Study Group, 2017); AND
Disease duration of less than or equal to 2 years (ALS 19 Study Group, 2017); AND
Must be dosed in accordance with the FDA label.

Dosage and Administration

Dosing per FDA Guidelines

The recommended dose of edaravone is 60 mg daily for 14 days, followed by a 14 day drug-free period as the initial treatment cycle administered IV.

Then 60mg daily for 10 out of 14 days, followed by a 14 day-drug free period for all subsequent cycles administered IV.

Initial authorization is for 180 days with a limit of <74 doses.

Continuation of therapy will require evidence that the individual is not dependent on invasive ventilation and will be for 180 days with a limit of 70 doses.

Edaravone is available as 30 mg/100 mL in a single-dose polypropylene bag.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of edaravone for any indication or circumstance not described above in the treatment of ALS and for all other conditions (including but not limited to stroke, MI, other neurodegenerative disease) does not meet primary coverage criteria that there be evidence of effectiveness in improving health outcomes.

For individuals with contracts without primary coverage criteria, the use of edaravone for all other indications in the treatment of ALS and for all other conditions (including but not limited to stoke, MI, other neurodegenerative disease) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective August 2019 to July 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The initial use of edaravone in the treatment of amyotrophic lateral sclerosis (ALS) meets primary coverage criteria and is covered for members with contracts without primary coverage criteria when all of the following criteria are met [FDA, 2021; Writing Group; Edaravone (MCI-186) ALS 19 Study Group]:

A diagnosis of definite or probable ALS according to the revised El Escorial criteria of signs of lower motor neuron degeneration and upper motor neuron degeneration in at least 2 topographical regions of the CNS based on the submission of medical records (chart notes, previous medical history, diagnostic testing including: imaging, nerve conduction studies, laboratory values) and seen either primarily or in consultation by a neurologist with expertise in the diagnosis and treatment of ALS, AND
Age 18 to 75, AND
Functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised [ALSFRS-R; described below]) (ALS 19 Study Group, 2017), AND
Forced vital capacity greater than or equal to 80% (ALS 19 Study Group, 2017), AND
Disease duration of less than or equal to 2 years, AND (ALS 19 Study Group, 2017)

Dosage and Administration (regimen is consistent with FDA labeling)

1. 60mg daily for 14 days, followed by a 14 day drug-free period as the initial treatment cycle administered IV.

2. Then 60mg daily for 10 out of 14 days, followed by a 14 day-drug free period for all subsequent cycles administered IV.

3. Initial authorization is for 180 days with a limit of <74 doses.

4. Continuation of therapy will require evidence that the member is not dependent on invasive ventilation and will be for 180 days with a limit of 70 doses.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of edaravone for all other indications in the treatment of ALS and for all other conditions (including but not limited to stroke, MI, other neurodegenerative disease) does not meet primary coverage criteria.

For members with contracts without primary coverage criteria, the use of edaravone for all other indications in the treatment of ALS and for all other conditions (including but not limited to stoke, MI, other neurodegenerative disease) is considered investigational.

Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective 7/12/2017 to July 2019

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

A diagnosis of definite or probable ALS according to the revised El Escorial criteria of signs of lower motor neuron degeneration and upper motor neuron degeneration in at least 2 topographical regions of the CNS based on the submission of medical records (chart notes, previous medical history, diagnostic testing including: imaging, nerve conduction studies, laboratory values) and seen either primarily or in consultation by a neurologist with expertise in the diagnosis and treatment of ALS, AND
Age 18 to 75, AND
Functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised [ALSFRS-R; described below]), AND
Forced vital capacity greater than or equal to 80%, AND
Disease duration of less than or equal to 2 years, AND
Dosing regimen is consistent with FDA labeling:

Initial authorization is for 180 days with a limit of <74 doses.

Continuation of therapy will require evidence that the member is not dependent on invasive ventilation and will be for 180 days with a limit of 70 doses.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of edaravone for all other indications in the treatment of ALS and for all other conditions (including but not limited to stoke, MI, other neurodegenerative disease) does not meet primary coverage criteria.

Rationale:

After full review and evaluation, the InterQual® Criteria has been adopted in full as Coverage Policy.

InterQual® Criteria are derived from the systematic, continuous review and critical appraisal of the most current evidence-based literature and include input from independent panel of clinical experts. To generate the most appropriate recommendations, a comprehensive literature review of the clinical evidence was conducted. Sources searched included PubMed, Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Reviews, AHRQ Technology Assessments, the Cochrane Library, Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations, FDA Drug Prescribing Information, and the National Institute of Health and Care Excellence (NICE). Other medical literature databases, medical content providers, data sources, regulatory body websites, and specialty society resources may also have been used. Relevant studies were assessed for risk of bias following principles described in the Cochrane Handbook. The resulting evidence was assessed for consistency, directness, precision, effect size, and publication bias. Observational trials were also evaluated for the presence of a dose-response gradient and the likely effect of plausible confounders.

CPT/HCPCS:

References:

See InterQual® for list of references.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants.