Vyondys 53 (golodirsen) intravenous therapy for Duchenne muscular dystrophy
Policy governs prior authorization, coverage criteria, dosing, renewal, allowable units, and billing codes for Vyondys 53 (golodirsen) for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island. Applies to outpatient intravenous administration with specific clinical and monitoring requirements.
Medicare members who previously received the medication within the past 365 days are not subject to step therapy requirements.
Coverage Summary
Vyondys 53 (golodirsen) is indicated for treatment of Duchenne muscular dystrophy in patients with a confirmed DMD gene mutation amenable to exon 53 skipping, consistent with FDA-approved labeling. Clinical studies demonstrate an increase in dystrophin production in muscle tissue, and the policy requires baseline and periodic laboratory and clinical monitoring per labeling and supplemental plan requirements to mitigate toxicity risk. Coverage is provided with specified prior authorization criteria and renewals; the policy applies to Medicaid, Commercial, and Medicare members and governs outpatient intravenous administration, dosing limits (e.g., 30 mg/kg IV once weekly) and billing/units (e.g., 1400 billable units every 28 days), and site-of-care requirements as set by the plan.
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