Edaravone (Radicava)

Policy ID: I-9173-002

Section: Injections

Effective Date: September 01, 2022

Last Reviewed: July 26, 2023

Applies To: Commercial Only

Description

Edaravone (Radicava^®) is a medication used in the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Edaravone (Radicava) intravenous infusion may be considered medically necessary when ALL of the following criteria are met:

Initial Authorization Criteria:

The individual has a diagnosis of amyotrophic lateral sclerosis (ALS); and
The individual has had the diagnosis of ALS for a duration of 2 years or less; and
The individual has a baseline percent forced vital capacity (FVC%) of 80% or greater; and
The individual is able to perform 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]; and
ONE of the following:
- The individual is currently being treated with riluzole; or
- The individual has tried and had an inadequate response to riluzole; or
- The individual has an intolerance or hypersensitivity to riluzole; or
- The individual has an FDA labeled contraindication to riluzole; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis.

Initial Approval: 6 months

Reauthorization Criteria:

The individual has been previously approved for edaravone (Radicava) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had documented clinical benefit with edaravone (Radicava); and
The individual is NOT dependent on invasive ventilation or tracheostomy; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis.

Reauthorization Approval: 12 months

The use of edaravone (Radicava) is considered experimental/investigational and therefore non-covered for any other indications. Scientific evidence does not support its use for any other indications.

Procedure Codes

J1301

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Note: Severe bulbar dysfunction is typically characterized by pharyngeal muscle weakness affecting swallowing, weak jaw and facial muscles, progressive loss of speech, and tongue muscle atrophy, rendering an individual incapable of accurate and reliable pulmonary function testing.

Note: Edaravone (Radicava ORS) may be covered on the pharmacy benefit.

Diagnosis Codes

G12.21

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-21-2022 - Effective September 01,2022,

Adopted new policy to replace I-173-006 edaravone (Radicava) new policy created to mirror pharmacy policy criteria for Radicava oral suspension.

Internal Medical Policy Committee 7-26-2023 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-173-006

Section: Injections

Effective Date: July 01, 2018

Revised Date: May 06, 2021

Revision Effective Date: July 01, 2021

Last Reviewed: May 24, 2022

Archived Date: August 30, 2022

Applies To: Commercial Only

Description

Edaravone (Radicava) is an injectable medication used in the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Edaravone (Radicava) may be considered medically necessary for the treatment of individuals with a diagnosis of ALS when ALL of the following criteria are met:

Initial Authorization Criteria:

Submission of the most recent, complete medical records (e.g., medical history, diagnostic testing) to substantiate ALL of the following:
- Diagnosis of “definite” or “probable” ALS, as noted in the revised EL Escorial and Airlie House diagnostic criteria, as determined by, or in consultation with, a neurologist with expertise in the diagnosis of ALS; and
- Individual is capable of conducting most activities of daily living independently defined by an ALS Functional Rating Scale-Revised (ALSFRS-R) score ofgreater than or equal to 2 in all items of the ALSFRS-R criteria at the initiation of treatment; and
- A percentage forced vital capacity (%FVC) equal to or greater than 80% at the initiation of treatment:
  - Individuals with documentation of severe bulbar dysfunction* who are incapable of performing FVC function test properly are not required to reach %FVC equal to or greater than 80%; and
- Individual is not dependent on invasive ventilation or tracheostomy; and
- Disease duration from onset of symptoms in individual is 2 years or less; and
- Initial authorization is valid for six (6) months.

Reauthorization Criteria:

Submission of the most recent, complete medical records (e.g., medical history, diagnosis testing) to substantiate ALL of the following:
- Diagnosis of "definite" or "probable" ALS, as noted in the revised EL Escorial and Airlie House diagnostic criteria, as determined by, or in consultation with, a neurologist with expertise in the diagnosis of ALS; and
- Individual is not dependent on invasive ventilation or tracheostomy; and
- Reauthorization is valid for one (1) year.

The use of edaravone (Radicava) is considered experimental/investigational and therefore non-covered for any other indications. Scientific evidence does not support its use for any other indications.

Procedure Codes

J1301

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

*Note: Severe bulbar dysfunction is typically characterized by pharyngeal muscle weakness affecting swallowing, weak jaw and facial muscles, progressive loss of speech, and tongue muscle atrophy, rendering an individual incapable of accurate and reliable pulmonary function testing.

Diagnosis Codes

G12.21

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-19-2020 Annual review, no clinical content change

Internal Medical Policy Committee 5-20-2021 Annual review, no clinical content change

Internal Medical Policy Committee 5-24-2022 Annual review, no clinical content change

Internal Medical Policy Committee 7-21-2022 Retire policy - Effective 8/31/22 and to be replaced with policy I-9173 (same title)

Links

References (PDF)

Disclaimer

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