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Edaravone (Radicava)

Section: Injections
Effective Date: August 01, 2019
Revised Date: July 29, 2019

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 of greater 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 diagnosis 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. 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, 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