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:
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The individual must be assigned male at birth between ages of four (4) and 19 years old;
and
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Diagnosis must be confirmed by the documented presence of abnormal dystrophin or a confirmed mutation of the dystrophin gene;
and
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Vyondys 53 (golodirsen) 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
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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
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Medical records must be provided confirming the individual has:
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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
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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
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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: Eight (8) weeks
Reauthorization Criteria:
Continuation of therapy with Vyondys 53 (golodirsen) 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 Vyondys 53 (golodirsen) 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
