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.
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 Codes
