Pharmacy Prior Authorization Criteria

Duvyzat (givinostat) - PA, NF

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), unless the patient has a contraindication or intolerance to corticosteroid therapy
AND
• Prescribed by or in consultation with a 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), unless the patient has a contraindication or intolerance to corticosteroid therapy

Duvyzat

Non Formulary (Initial Authorization)

Length of Approval: 6 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of Duchenne muscular dystrophy (DMD)
AND
• Submission of medical records (e.g., chart notes) confirming 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
• Submission of medical records (e.g., chart notes) confirming patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.) prior to initiating Duvyzat
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming requested drug will be used concomitantly with a corticosteroid regimen (e.g., prednisone/prednisolone, Emflaza [deflazacort], Agamree), unless the patient has a contraindication or intolerance to corticosteroid therapy
AND
• Prescribed by or in consultation with a neurologist with expertise in treating DMD

Duvyzat

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming patient has experienced a benefit from therapy (e.g., improvement in preservation of muscle strength)
AND
• Submission of medical records (e.g., chart notes) confirming patient is maintaining ambulatory status without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming patient continues to receive concomitant corticosteroid regimen (e.g., prednisone/prednisolone, Emflaza [deflazacort], Agamree), unless the patient has a contraindication or intolerance to corticosteroid therapy
AND
• Prescribed by or in consultation with a neurologist with expertise in treating DMD

P & T Revisions

2026-08-11, 2025-08-06, 2024-07-31

References

1. Duvyzat Prescribing Information. ITF Therapeutics, LLC. Concord, MA. November 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.

---

End Notes

1. Approximately 70% of individuals with DMD have a deletion or duplication in the DMD gene. Genetic testing is the preferred method of diagnosis and typically begins with deletion/duplication analysis followed by DMD gene sequencing if needed. In patients with a clinical presentation consistent with DMD in whom genetic testing is inconclusive, additional genetic evaluation and/or muscle biopsy with dystrophin protein analysis may be used to establish the diagnosis. [2]

---

Revision History

• 2026-08-11: Updated PA criteria. Added non-formulary criteria. Background updates.
• 2025-08-06: 2025 Annual Review - update to prescriber requirement
• 2024-07-31: New Program

---