Edaravone (Radicava) (Medicaid Expansion)

Policy ID: ME-I-173-006-05

Section: Injections

Effective Date: January 01, 2022

Revised Date: October 20, 2024

Revision Effective Date: December 01, 2024

Last Reviewed: November 19, 2024

Applies To: Medicaid Expansion Only

Description

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

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

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

The use of edaravone (Radicava) may be considered medically necessary when ALL of the following criteria are met:

The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
Edaravone (Radicava) must be prescribed by, or in consult with, a neurologist; and
The individual has had ALS symptoms present for less than two (2) years; and
Documentation has been submitted that the individual has a forced vital capacity (FVC) greater than 80 percent of predicted; and
Documentation of ONE (1) of the following has been submitted:
- ALS Function Rating Scale-Revised (ALSFRS-R) with a score of two (2) or greater on each individual item of the scale and
The individual must not have permanent invasive ventilation.

Reauthorization Criteria

Continuation of therapy with edaravone (Radicava) may be considered medically necessary when the following is met:

Documentation of Forced Vital Capacity (FVC) greater than 60 percent of predicted; and
Documentation of a therapeutic response as evidenced by stabilization or improvement (e.g., improved neurologic impairment, motor function, quality of life, slowing of disease progression, etc.) from baseline as evidenced by ONE of the following:
- ALS Function Rating Scale-Revised (ALSFRS-R).

The use of edaravone (Radicava) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J1301

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

Diagnosis Code

G12.21

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy effective 01-01-2022

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 1-26-2023 - Effective February 01, 2023

Updated initial criteria, and
Updated reauthorization criteria

Internal Medical Policy Committee 1-16-2024 Effective March 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 01, 2024

Updated initial criteria to remove 'Japanese ALS Severity Scale with a grade of 1 or 2' based on the DHHS PDL Version 2024.6
Updated reauthorization criteria to remove 'Japanese ALS Severity Scale with a grade of 1 or 2' based on the DHHS PDL Version 2024.6

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: ME-I-173-006-04

Section: Injections

Effective Date: January 01, 2022

Revised Date: January 15, 2024

Revision Effective Date: March 01, 2024

Last Reviewed: January 16, 2024

Archived Date: November 30, 2024

Applies To: Medicaid Expansion 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.

The use of edaravone (Radicava) may be considered medically necessary when ALL of the following criteria are met:

The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
Edaravone (Radicava) must be prescribed by, or in consult with, a neurologist; and
The individual has had ALS symptoms present for less than two (2) years; and
Documentation has been submitted that the individual has a forced vital capacity (FVC) greater than 80 percent of predicted; and
Documentation of ONE (1) of the following has been submitted:
- ALS Function Rating Scale-Revised (ALSFRS-R) with a score of two (2) or greater on each individual item of the scale; or
- Japanese ALS Severity Scale with a grade of 1 or 2; and
The individual must not have permanent invasive ventilation.

Reauthorization Criteria

Continuation of therapy with edaravone (Radicava) may be considered medically necessary when the following is met:

Documentation of Forced Vital Capacity (FVC) greater than 60 percent of predicted; and
Documentation of a therapeutic response as evidenced by stabilization or improvement (e.g., improved neurologic impairment, motor function, quality of life, slowing of disease progression, etc.) from baseline as evidenced by ONE of the following:
- ALS Function Rating Scale-Revised (ALSFRS-R); or
- Japanese ALS Severity Scale.

Procedure Code

J1301

Diagnosis Code

G12.21

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy effective 1-1-2022

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 1-26-2023 - Effective February 1, 2023

Updated initial criteria, and
Updated reauthorization criteria

Internal Medical Policy Committee 1-16-2024 Effective March 01, 2024

Annual review no clinical content change

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Edaravone (Radicava) (Medicaid Expansion)

Description

Policy Application

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer