Pharmacy Prior Authorization Criteria

Papzimeos (zopapogene imadenovec-drba)

Indications for Prior Authorization

Papzimeos (zopapogene imadenovec-drba)

• For diagnosis of Recurrent Respiratory Papillomatosis
  Indicated for the treatment of adults with recurrent respiratory papillomatosis.

Criteria

Papzimeos

Prior Authorization

Length of Approval: 12 Weeks (One treatment course) [A]

• Diagnosis of recurrent respiratory papillomatosis [B]
AND
• Patient has had or plans to have removal or debulking procedure, to remove any visible laryngotracheal papillomas [B, 1]
AND
• Provider attests that patient has never received a treatment course with Papzimeos in their lifetime [A]
AND
• Patient is 18 years of age or older [2]
AND
• Prescribed by specialist knowledgeable in the treatment of recurrent respiratory papillomatosis (e.g., otolaryngologist, pulmonologist, oncologist)

P & T Revisions

2025-10-16

References

1. Papzimeos Prescribing Information. Precigen, Inc. Germantown, MD. August 2025.
2. ClinicalTrials.gov. Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis. Available at: https://www.clinicaltrials.gov/study/NCT04724980?cond=NCT04724980&rank=1. Accessed September 9, 2025.
3. National Organization for Rare Disorders - Recurrent Respiratory Papillomatosis. Available at: https://rarediseases.org/rare-diseases/recurrent-respiratory-papillomatosis/. Accessed September 9, 2025.

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End Notes

1. The recommended dose of Papzimeos is 5×1011 particle units (PU) per injection administered by subcutaneous injection four (4) times over a 12-week interval. [1]
2. The clinical trial inclusion criteria, specified that patient has had a history of at least 3 surgical interventions, within the previous 12 months, to remove visible laryngotracheal papillomas for the clinical diagnosis of RRP. [2]

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Revision History

• 2025-10-16: New UM PA Criteria

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