Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
The use of Vyondys 53 (golodirsen) 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 Vyondys 53 (golodirsen); 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; and
- Information has been provided to explain why Vyondys 53 (golodirsen) is needed over the preferred agents (Viltepso).
Initial Authorization: 8 weeks
Reauthorization Criteria:
Continuation of therapy with Vyondys 53 (golodirsen) 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 Vyondys 53 (golodirsen) for any other indication than listed above is considered experimental/investigational and therefore, not covered.
Procedure Codes
