Pharmacy Prior Authorization Criteria

Duvyzat (givinostat)

Indications for Prior Authorization

Duvyzat (givinostat)

• For diagnosis of Duchenne muscular dystrophy (DMD)
  Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.

Criteria

Duvyzat

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of Duchenne muscular dystrophy (DMD)
AND
• One of the following:
• Patient has a confirmed mutation of the dystrophin gene
OR
• Muscle biopsy confirmed an absence of dystrophin protein
AND
• Patient is 6 years of age or older
AND
• Patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.) prior to initiating Duvyzat
AND
• Requested drug will be used concomitantly with a corticosteroid regimen (e.g., prednisone/prednisolone, Emflaza [deflazacort], Agamree)
AND
• Prescribed by or in consultation with a pediatric neurologist with expertise in treating DMD

Duvyzat

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient has experienced a benefit from therapy (e.g., improvement in preservation of muscle strength)
AND
• Patient is maintaining ambulatory status without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)
AND
• Patient continues to receive concomitant corticosteroid regimen (e.g., prednisone/prednisolone, Emflaza [deflazacort], Agamree)

P & T Revisions

2024-07-31

References

1. Duvyzat Prescribing Information. ITF Therapeutics, LLC. Concord, MA. March 2024.
2. Birnkrant DJ, Bushby K, Bann CM, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. The Lancet Neurology. 2018;17(3):251-267.
3. Gloss D, Moxley RT 3rd, Ashwal S, Oskoui M. Practice guideline update summary: Corticosteroid treatment of Duchenne muscular dystrophy: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(5):465-72.

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End Notes

1. Approximately 70% of individuals with DMD have a single-exon or multi-exon deletion or duplication in the dystrophin gene, dystrophin gene deletion, and duplication testing is usually the first confirmatory test. If genetic testing does not confirm a clinical diagnosis of DMD, then a muscle biopsy sample should be tested for the presence of dystrophin protein by immunohistochemistry of tissue cryosections or by western blot of a muscle protein extract. [2]
2. Prednisone 0.75 mg/kg/d should be considered the optimal prednisone dose in DMD. Over 12 months, prednisone 10 mg/kg/weekend is equally effective, although long term outcomes of this alternative regimens are unknown. [3]

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Revision History

• 2024-07-31: New Program

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