Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
The use of casimersen (Amondys-45) may be considered medically necessary when ALL of the following criteria are met:
- The individual must be a male between ages of 4 and 19 years old; and
- The prescriber must be, or in consult with, a neurologist specializing in treatment of DMD (submit documentation of formal consultation with specialist); and
- The individual must have an FDA-approved diagnosis confirmed by genetic test as recommended by manufacturer; and
- The prescriber must submit medical records confirming the individual has:
- A baseline 6-Minute Walk Time (6MWT) ≥ 300 meters while walking independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.); and
- Stable respiratory function – FVC predicted > 50%, not requiring ventilatory assistance; and
- Stable cardiac function – LVEF > 40 % by ECHO; and
- Inadequate treatment response with standard corticosteroid therapy for a minimum of 6 months with adherence, as evidenced by paid claims or pharmacy printouts; and
- The individual must be currently taking corticosteroids, as evidenced by paid claims or pharmacy printouts, and will continue taking with casimersen (Amondys-45); and
- Weight and calculated dose must be provided consistent with approved FDA dose of 30 mg/kg infused once weekly; and
- The individual must not be taking any other RNA antisense agent or any other gene therapy.
Initial Authorization: 8 weeks
Reauthorization Criteria:
Continuation of therapy with casimersen (Amondys-45) may be considered medically necessary when ALL of the following are met:
- The prescriber must be, or in consult with, a neurologist specializing in treatment of DMD (submit documentation of formal consultation with specialist); and
- The prescriber must submit medical records confirming the individual has maintained:
- A 6MWT ≥ 300 meters while walking independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.); and
- Stable respiratory function – FVC predicted > 50%, not requiring ventilatory assistance; and
- Stable cardiac function – LVEF > 40 % by ECHO.
Continuation Authorization: 6 months
The use of casimersen (Amondys-45) for any other indication than listed above is considered experimental/investigational and therefore, not covered.
Procedure Codes
