Pharmacy Prior Authorization Criteria

Zycubo (copper histidinate)

Indications for Prior Authorization

Zycubo (copper histidinate)

• For diagnosis of Menkes disease
  Indicated for the treatment of Menkes disease in pediatric patients.

  Limitations of Use: Not indicated for the treatment of Occipital Horn Syndrome.

Criteria

Zycubo

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of Menkes disease
AND
• Molecular genetic testing confirms pathogenic variants of the ATP7A gene (copper-transporting ATPase) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Provider attests that the patient will be closely monitored for copper accumulation and related toxicity throughout therapy
AND
• Prescribed by or in consultation with one of the following:
• Pediatrician
• Neurologist
• Geneticist

Zycubo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy
AND
• Provider attests that the patient will continue to be monitored for copper accumulation and related toxicity throughout therapy
AND
• Patient has not exceeded 3 years duration of treatment with Zycubo
AND
• Prescribed by or in consultation with one of the following:
• Pediatrician
• Neurologist
• Geneticist

P & T Revisions

2026-04-10

References

1. Zycubo Prescribing Information. Sentynl Therapeutics, Inc. Solana Beach, CA. January 2026.
2. Clinical consult with geneticist. March 24, 2026.

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Revision History

• 2026-04-10: New Program.

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