Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of e
teplirsen (
Exondys 51
)
may be considered medically necessary when
ALL
of the following criteria are met:
-
The individual must be assigned male at birth between ages of four (4) and 19 years old;
and
-
Diagnosis must be confirmed by the documented presence of abnormal dystrophin or a confirmed mutation of the dystrophin gene;
and
-
E
teplirsen (
Exondys 51) must be prescribed by, or in consult with, a physician who specializes in the treatment of Duchenne Muscular Dystrophy (DMD) and/or neuromuscular disorders;
and
-
The individual has had an inadequate treatment response with standard corticosteroid therapy for a minimum of six (6) months with adherence, as evidenced by paid claims or pharmacy printouts;
and
-
Medical records must be provided confirming the member has:
-
A baseline six (6)-Minute Walk Time (6MWT) greater than or equal to (≥) 300 meters while walking independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.);
and
-
Stable respiratory function - FVC predicted greater than 50%, not requiring ventilatory assistance;
and
-
Stable cardiac function - LVEF greater than 40 % by ECHO;
and
-
Weight and calculated dose must be provided consistent with approved FDA dose;
and
- The individual must not be taking any other RNA antisense agent or any other gene therapy.
Initial Authorization: Eight (8) weeks
Reauthorization Criteria:
Continuation of therapy with e
teplirsen (
Exondys 51
)
may be considered medically necessary when
ALL
of the following are met:
- Medical records must be provided confirming the member has maintained:
-
A 6MWT greater than or equal to (≥) 300 meters while walking independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.);
and
-
Stable respiratory function - FVC predicted greater than 50%, not requiring ventilatory assistance;
and
- Stable cardiac function - LVEF greater than 40 % by ECHO.
The use of eteplirsen (Exondys 51) 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
