Policy (Criteria)

Papzimeos is considered MEDICALLY NECESSARY when all of the following criteria are met:

1. Diagnosis of recurrent respiratory papillomatosis (RRP) documentation required
2. Patient is 18 years of age or older;
3. Patient has required surgery (i.e., surgical resection of papillomas, laser ablation of papillomas) to remove laryngotracheal papillomas prior to treatment with Papzimeos;
4. Surgical debulking of present visible papilloma will be performed prior to the initial, third, and fourth dose of Papzimeos;
5. Prescribed by or in consultation with a specialist knowledgeable in the treatment of recurrent respiratory papillomatosis (e.g., otolaryngologist, pulmonologist, oncologist);
6. Patient has not received a previous complete treatment course (i.e., four doses over a 12-week interval) with Papzimeos;

The use of Papzimeos beyond four doses given over 12 weeks has not yet been established and is considered INVESTIGATIONAL by plan.

References

1. Papzimeos subcutaneous injection [prescribing information]. Germantown, MD:  Precigen; August 2026.
2. NCT04724980. Adjuvant PRGN-2012 in adult patients with recurrent respiratory papillomatosis. National Library of Medicine. National Center for Biotechnology Information.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2026 Forward