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.

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) 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

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. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

*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

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date July 1, 2018

Internal Medical Policy Committee 5-19-2020 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.