Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of eteplirsen ( 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
- Eteplirsen ( 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
