Givinostat (Duvyzat) (PDF)
Defines medical necessity criteria, documentation, dosing limits, continuation criteria, exclusions, and administrative information for coverage of Duvyzat (givinostat) in commercial, HIM, and Medicaid lines of business for patients with Duchenne muscular dystrophy (DMD).
Added option for positive muscle biopsy for diagnosis of DMD if genetic studies negative.
Removed age restriction of < 18 years at therapy initiation; age now >= 6 years required.
Revised ambulatory criteria with removal of 4SC ≤ 8 seconds requirement and added documentation of baseline ambulatory function via motor function tests.
Removed QTcF, triglycerides and LVEF contraindications from criteria.
Added requirement that Duvyzat be prescribed concurrently with an oral corticosteroid unless contraindicated or adverse effects.
Updated dosing table and weight-based dosing; defined maximum daily dose 106.4 mg (12 mL) per day.
3Q 2025 annual review: no significant changes; references reviewed and updated.
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