Pharmacy Prior Authorization Criteria

Ztalmy (ganaxolone)

Indications for Prior Authorization

Ztalmy (ganaxolone)

• For diagnosis of Seizures
  Indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.

Criteria

Ztalmy

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
AND
• Disease is confirmed by the presence of a mutation in the CDKL5 gene as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient is 2 years of age or older
AND
• Patient is experiencing motor seizures (e.g., bilateral tonic, generalized tonic-clonic, bilateral clonic, atonic, focal, or bilateral tonic-clonic)
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to two formulary anticonvulsants (e.g., valproic acid, levetiracetam, lamotrigine)
OR
• For continuation of prior therapy
AND
• Prescribed by or in consultation with a neurologist

P & T Revisions

2026-03-02, 2025-12-18, 2025-12-18, 2025-08-18, 2024-07-19, 2023-11-16, 2023-08-03, 2022-08-03

References

1. Ztalmy Prescribing Information. Marinus Pharmaceuticals, Inc. Radnor, PA. April 2024.

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Revision History

• 2026-03-02: Removed reauthorization requirement as part of extended reauthorization program.
• 2025-12-18: No criteria changes
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-08-18: 2025 Annual Review. Standardize genetic testing verbiage to "Disease is confirmed by the presence of a mutation in the CDKL5 gene as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)." Update reference.
• 2024-07-19: 2024 Annual Review. No changes.
• 2023-11-16: Program update to standard reauthorization language. No changes to clinical intent
• 2023-08-03: Annual review - no criteria changes
• 2022-08-03: New program for Ztalmy.

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