Last Review Date: 10/02/2025

Date of Origin: 10/02/2024

Dates Reviewed: 10/2025

1. Length of Authorization

• Initial: Prior authorization validity will be provided for 6-months (180-days) for four doses total.
• Renewal: Prior authorization validity may NOT be renewed.

2. Dosing Limits

    Max Units (per dose and over time) [HCPCS Unit]:

• 1 dose (5x10¹¹ particle units (PU) per dose) on day 1, day 12, week 6, and week 12

3. Initial Approval Criteria ¹

Prior authorization validity is provided in the following conditions:

Respiratory Papillomatosis † Ф ^1-3

• Member is at least 18 years of age; AND
• Member has a confirmed histological diagnosis of recurrent respiratory papilloma; AND
• Surgical debulking of any present visible papilloma will be performed prior to the initial, third and fourth injections; AND
• Member has the presence of laryngotracheal papillomas; AND
• Member has required 3 or more interventions (e.g., surgery, systemic therapy, etc.) in the last 12 months for control of respiratory papilloma

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

• Duration of authorization has not been exceeded (refer to Section I)

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code(s):

• J3590 – Unclassified biologics
• C9399 – Unclassified drugs or biologicals (hospital outpatient use only)

NDC:

• Papzimeos single-dose vial of sterile frozen suspension, formulated to contain an extractable dose of 5×10¹¹ PU in a 1 mL suspension: 84768-0511-xx

7. References

1. Papzimeos [package insert]. Germantown, MD; Precigen, Inc; August 2025. Accessed August 2025.
2. ClinicalTrials.gov. NCT04724980. A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis. | ClinicalTrials.gov.
3. Norberg S, Gulley JL, Schlom J, et al. PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients. JCO 42, LBA6015-LBA6015(2024). DOI:10.1200/JCO.2024.42.17_suppl.LBA6015

Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Non-quantitative treatment limitations (NQTLs) refer to the methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan. These may include things like utilization review or prior authorization. The utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder (MH/SUD) Medical Benefit Prescription Drugs and medical/surgical (M/S) Medical Benefit Prescription Drugs. The table below lists the factors that were considered in designing and applying prior authorization to this drug/drug group, and a summary of the conclusions that Prime’s assessment led to for each.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A