CurrentAvMedPolicy N/A

Papzimeos (zopapogene imadenovec-drba) prior authorization for recurrent respiratory papilloma

Defines medical prior authorization and clinical criteria for coverage of Papzimeos (J3404) for treatment of recurrent respiratory papilloma in AvMed members, including required documentation and provider qualifications.

Policy Summary

PayerAvMed

PolicyPapzimeos (zopapogene imadenovec-drba) prior authorization for recurrent respiratory papilloma

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed medical prior authorization form with required documentation (chart history, procedure records, histology) to request approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4lifetime doses allowed

6 molength of authorization

>=18minimum age

3+required interventions (12 mo)

Coverage Criteria for Papzimeos

Initial Therapy

Covered when ALL of the following are met

Eligibility criteria

Age: Member is at least 18 years of age>=18 years
Provider qualification: Requesting provider is a specialist in otolaryngology, oncology, and/or knowledgeable in disease management of respiratory papillomas
Diagnosis confirmation: Confirmed diagnosis of recurrent respiratory papilloma (RRP) with documentation of laryngotracheal papillomas
Submit medical chart history and documentation of presence of laryngotracheal papillomas

Policy Summary

PayerAvMed

PolicyPapzimeos (zopapogene imadenovec-drba) prior authorization for recurrent respiratory papilloma

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed medical prior authorization form with required documentation (chart history, procedure records, histology) to request approval.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

HPV histology: Histological confirmation that papillomas are caused by human papillomavirus (HPV) serotype 6 or 11

Prior interventions: Member has required 3 or more interventions (e.g., surgery, systemic therapy, etc.) in the last 12 months for control of respiratory papilloma; procedure record must accompany request>=3 interventions in past 12 months

Surgical debulking plan: Provider attests to plans for surgical debulking of any present visible papilloma performed prior to the initial, third and fourth injections in accordance with present guidelines and product labeling

Administrative: Length of authorization: 6 months (180 days) for four doses total.

All supporting documentation (chart notes, procedure records, histology) must be provided or request may be denied.

Prior authorization for Papzimeos (zopapogene imadenovec-drba) may NOT be renewed. Additionally, use of samples to initiate therapy does not meet preauthorization criteria; previous therapies will be verified through pharmacy paid claims or submitted chart notes. Requests lacking required supporting documentation (chart history, procedure records, histology, etc.) may be delayed or denied.

Initial Dosing and Eligibility

Initial dosing

Dosing and quantity limits for initial course

Dose schedule: One dose (5 x 10^11 particle units) on day 1, then at week 2, week 6, and week 12 (4 doses total).

Each single-dose vial delivers a minimum extractable volume of 1 mL.

Per-dose volume: Each single-dose vial delivers a minimum extractable volume of 1 mL.

Quantity limit: Maximum 4 doses (4 vials) per lifetime.4 doses per lifetime

Length of authorization covers four doses over 6 months (180 days).

Reauthorization and Continuation Rules

Reauthorization

Reauthorization rules

Reauthorization: Prior authorization may NOT be renewed.

Coding and Quantity Limits

Covered HCPCSHCPCSCovered

J3404

Papzimeos (zopapogene imadenovec-drba)

Lifetime doses — summary

Lifetime doses allowed4 doses (4 vials) per lifetime

Length of authorization6 months (180 days) for four doses total

Minimum member age>=18 years

ReauthorizationPrior authorization may NOT be renewed

Papzimeos (zopapogene imadenovec-drba) — quantity limit

Quantity limit (per lifetime)4 vials total

Per-dose provisionSingle-dose vials — one vial per dose

Authorization period6 months (180 days) for the 4-vial course

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Papzimeos (J3404) requires prior authorization and a completed medical prior authorization form. Prescribing physician must sign and clearly print name on the request (preprinted stamps not valid). Fax completed form to 1-877-535-1391. For Medicare members, applicable NCDs/LCDs and Medicare Benefit Policy Manual requirements apply and must be followed.

Code: J3404
Fax: 1-877-535-1391
Prescriber signature required (no preprinted stamps)

Note

Samples Not Acceptable

Samples not acceptable — Use of samples to initiate therapy does not meet preauthorization or step-edit criteria. Prior therapies will be verified via pharmacy paid claims or submitted chart notes; provide documentation of prior interventions as required.

Samples cannot be used to meet prior authorization requirements
Plan will verify prior therapies through pharmacy claims or chart notes

Documentation Required

Required Supporting Documentation

Required supporting documentation — Submit complete medical chart history, procedure reports (including documentation of 3+ interventions in last 12 months when applicable), histology confirming HPV serotype 6 or 11, documentation of presence of laryngotracheal papillomas, weight (if applicable) with date, dosing schedule, diagnosis and ICD code, and any lab or diagnostic results referenced. Length of authorization: 6 months (180 days) for up to four doses (4 vials) per lifetime. Reauthorization is not permitted.

Medical chart history and procedure reports (must document 3+ interventions in last 12 months if applicable)
Histology confirming HPV serotype 6 or 11
Documentation of laryngotracheal papillomas
Lab results, diagnostics, and chart notes referenced
Weight and date (if applicable)
Dosing schedule, length of therapy, diagnosis, ICD code

Denial Risk

Incomplete Documentation Risk

Incomplete documentation risk — Incomplete, incorrect, or illegible information may delay review or result in denial. Ensure phone and fax numbers on the form are correct. For urgent reviews, contact AvMed Pre-Authorization Department per plan guidelines.

Ensure all fields on the prior authorization form are complete and legible
Provide valid phone and fax numbers to avoid delays
Call AvMed Pre-Authorization Department for urgent review requests

Dispensing Location

Note

Specify site of care: office or specialty pharmacy

Indicate whether the medication will be provided by the physician's office or by a specialty pharmacy by checking the applicable box on the prior authorization form.

Check the 'Physician's office' box OR the 'Specialty Pharmacy' box on the form.

Definitions and Dose Regimen

Dose regimen — vial volume and schedule

Extractable volume per vialEach single-dose vial delivers a minimum extractable volume of 1 mL

Per-dose potencyOne dose = 5 x 10^11 particle units (PU)

Dosing scheduleOne dose on day 1, then at week 2, week 6, and week 12 (4 total doses)

Vials required for full course4 single-dose vials (one vial per scheduled dose)

Step Therapy / Prior Treatment Verification

Requirement	Details
Previous therapy verification	Prior therapies will be verified through pharmacy paid claims or submitted chart notes.
Samples	Use of samples to initiate therapy does not meet step-edit/preauthorization criteria.

Background on Recurrent Respiratory Papilloma

Recurrent respiratory papilloma (RRP) is characterized by laryngotracheal papillomas that commonly require repeated interventions for airway control. These papillomas are typically caused by human papillomavirus (HPV) serotypes 6 or 11. Papzimeos is a gene therapy product administered as multiple single-dose vials on a defined schedule for treatment of RRP.