CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Papzimeos

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Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPapzimeos

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 1, 2026

Last ReviewNov 10, 2025

Next Review Date

Key ActionRequests must document age, histologic confirmation of RRP from a CLIA-certified (or comparable) lab, HPV serotype 6 or 11, presence of laryngotracheal papillomas, documentation of >=3 interventions in prior 12 months, evidence that surgical debulking will be performed prior to doses 1, 3, and 4, and HPV vaccination history or rationale.

SourceLink

POLICY UPDATE CHANGES

No material changes

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CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Papzimeos

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Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPapzimeos

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 1, 2026

Last ReviewNov 10, 2025

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material changes

Coverage Summary

Policy governs coverage, dosing, authorization length, diagnostic eligibility, and billing codes for Papzimeos for Medicaid, Commercial, and Medicare members per Neighborhood Health Plan of Rhode Island. Coverage stance: Covered with criteria. Effective date: 02/01/2026; Last review date: 11/10/2025.

Initial and Treatment Criteria

Dose and Administration Criteria

Per-dose amount: Dose = 5 x 10^11 particle units (PU) per injection administered subcutaneously four times over a 12-week interval5 x 10^11 PU per injection; 4 doses over 12 weeks
Initial dose timing: Initial dose: Day 1Day 1
Second dose timing: Second dose: 2 weeks after initial administration but no less than 11 days after initial administration>=11 days and ~2 weeks after initial dose
Third dose timing: Third dose: 6 weeks after initial administrationWeek 6
Fourth dose timing: Fourth dose: 12 weeks after initial administrationWeek 12

Duration / Renewal

Authorization length: Coverage will be provided for 6 months for four doses total and may not be renewed6 months; 4 doses; not renewable
Lifetime limit: Max of one treatment cycle per lifetime1 treatment cycle per lifetime

Applicable Codes

HCPCS Codes (billing categories provided)HCPCS

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

NDCNDC

84768-0511-xx

Papzimeos single-dose vial of sterile frozen suspension, extractable dose 5×10^11 PU in 1 mL suspension

Covered Diagnosis Codes (Appendix 1)ICD-10Covered

D10.5	Benign neoplasm of other parts of oropharynx
D10.6	Benign neoplasm of nasopharynx
D10.9	Benign neoplasm of pharynx, unspecified
D14.0	Benign neoplasm of middle ear, nasal cavity and accessory sinuses
D14.1	Benign neoplasm of larynx
D14.2	Benign neoplasm of trachea
D14.30	Benign neoplasm of unspecified bronchus and lung
D14.31	Benign neoplasm of right bronchus and lung
D14.32	Benign neoplasm of left bronchus and lung
D14.4	Benign neoplasm of respiratory system, unspecified

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Prior Authorization, Documentation, and Billing Rules

Prior Authorization

Prior authorization required

Requests must document member age, histologic confirmation of RRP from a CLIA-certified (or comparable) laboratory report, HPV serotype 6 or 11, presence of laryngotracheal papillomas, documentation of at least three interventions in the prior 12 months, evidence that surgical debulking will be performed prior to the initial, third, and fourth Papzimeos injections, and HPV vaccination history or a rationale if vaccination was not appropriate.

ICD-10 codes listed in Appendix 1; HCPCS: J3590 or C9399

Billing Rule

Authorization length and unit limits

Coverage is provided for 6 months covering four doses total and may not be renewed; a maximum of one treatment cycle per lifetime is allowed. Each dose is 5 x 10^11 particle units (PU) per injection, and the product is supplied as a single-dose vial under NDC 84768-0511-xx.

Clinical Evidence

Injection site reactions, fatigue, chills, fever >60%Most common adverse reactions (incidence >60%)

Nausea 26%Adverse reaction incidence

Headache 11%Adverse reaction incidence

Papzimeos is a non-replicating adenoviral vector-based immunotherapy approved for adult patients with recurrent respiratory papillomatosis (RRP). Approval was based on the PRGN-2012-201 Phase 1/2 single-arm trial in 35 adults requiring at least three debulking procedures in the prior 12 months; the trial’s primary endpoint, complete response, was defined as remaining surgery-free for at least 12 months posttreatment, and 51% (18/35) of participants achieved this outcome (95% CI: 34% to 69%).

The most common adverse reactions reported were injection site reactions, fatigue, chills, and fever (incidence >60%); nausea occurred in 26% and headache in 11% of participants.

Definitions & Background

Complete response (in trial): Remaining surgery-free for at least 12 months posttreatment.

Revision History

2026-02-01Effective dateLatest

Policy effective date for Papzimeos (zopapogene imadenovec-drba) subcutaneous therapy.

2025-11-10Last review

Policy last reviewed.