Pharmacy Prior Authorization Criteria

Agamree (vamorolone)

Indications for Prior Authorization

Agamree (vamorolone)

• For diagnosis of Duchenne muscular dystrophy (DMD)
  Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Criteria

Agamree

*This product may require prior authorization

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Duchenne muscular dystrophy (DMD)
AND
• Patient is 2 years of age or older
AND
• Patient has received genetic testing for a mutation of the dystrophin gene [A, 2]
AND
• One of the following: [A, 2]
• Presence of a confirmed mutation of the dystrophin gene
OR
• Muscle biopsy confirmed an absence of dystrophin protein
AND
• Trial and failure or intolerance to both of the following [2]:
• prednisone or prednisolone 0.75 mg/kg/day or 10 mg/kg/weekend [B, 3]
• generic deflazacort oral suspension*
AND
• Prescribed by or in consultation with a neurologist with expertise in the treatment of DMD
AND
• One of the following:
• For patients less than or equal to 50kg, dose will not exceed 6mg/kg of body weight once daily
OR
• For patients greater than 50kg, dose will not exceed 300mg/day

Agamree

*This product may require prior authorization

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
• One of the following:
• For patients less than or equal to 50kg, dose will not exceed 6mg/kg of body weight once daily
OR
• For patients greater than 50kg, dose will not exceed 300mg/day
AND
• Trial and failure or intolerance to both of the following: [2]
• prednisone or prednisolone 0.75 mg/kg/day or 10 mg/kg/weekend [B, 3]
• generic deflazacort oral suspension*

P & T Revisions

2025-03-05, 2024-06-07, 2024-03-21

References

1. Agamree Prescribing Information. Catalyst Pharmaceuticals, Inc. Coral Gables, FL. June 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

• 2025-03-05: Updated prescriber requirement and updated language for confirmed mutation criterion. Updated references.
• 2024-06-07: Update to T/F requirement
• 2024-03-21: New Program

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