Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of t
ofersen (Qalsody)
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
-
The requested medication must be prescribed by, or in consult with, a neurologist;
and
-
The individual has had amyotrophic lateral sclerosis (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 one (1) or two (2);
and
- The individual must not have permanent invasive ventilation.
Initial Authorization: Six (6) months
Reauthorization Criteria
Continuation of therapy with t
ofersen (Qalsody
) may be considered medically necessary when the following are met:
-
There is documentation of Forced Vital Capacity (FVC) greater than 60 percent of predicted;
and
-
There is 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.
Continuation Authorization: 12 months
The use of t
ofersen (Qalsody
) 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
