CurrentUnitedHealthcarePolicy CS2026D0141C

Papzimeos (Zopapogene Imadenovec-Drba) for recurrent respiratory papillomatosis

Defines UnitedHealthcare Medical Benefit Drug Policy coverage criteria for Papzimeos for adults with recurrent respiratory papillomatosis (RRP); excludes specific state applicability where noted.

Policy Summary

PayerUnitedHealthcare

PolicyPapzimeos (Zopapogene Imadenovec-Drba) for recurrent respiratory papillomatosis

Policy CodePolicy CS2026D0141C

Change TypeClarified — state applicability (Texas)

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain authorization for no more than one treatment course (four doses) per lifetime and document required surgical debulking and specialist involvement prior to dosing.

SourceLink

POLICY UPDATE CHANGES

Policy clarifies it does not apply to Texas and refers Texas members/providers to the Texas Medicaid Provider Procedures Manual drug-specific criteria.

1treatment course authorized per lifetime

4doses per treatment course

51%complete response rate at 5x10^11 PU dose in pivotal study

18+minimum patient age for coverage

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Medically Necessary

Papzimeos is proven and medically necessary for the treatment of recurrent respiratory papillomatosis when ALL of the following are met:

ALL of the following

Diagnosis of recurrent respiratory papillomatosis (RRP)
Patient is 18 years of age or older>= 18 years
Only adults are eligible per FDA indication
Patient has required surgery (e.g., surgical resection or laser ablation of papillomas) to remove laryngotracheal papillomas prior to treatment with Papzimeos
Surgical debulking of present visible papilloma will be performed prior to the initial, third, and fourth dose of Papzimeos
Debulking required before dose 1, dose 3 and dose 4
Prescribed by or in consultation with a specialist knowledgeable in treatment of recurrent respiratory papillomatosis (e.g., otolaryngologist, pulmonologist, oncologist)
Patient has not received a previous complete treatment course (i.e., four doses over a 12-week interval) with Papzimeos
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Authorization will be issued for no more than one treatment course (i.e., four doses) per lifetimeMaximum 1 course (4 doses) per lifetime
Maximum lifetime authorization = one 4-dose course

Authorization, Documentation & Denial Conditions

Prior Authorization

Authorization requirement and limits

Authorization is required for Papzimeos and will be issued for no more than one treatment course (four doses) per lifetime. Dosing must be in accordance with U.S. FDA-approved labeling.

J3404

Documentation Required

Surgical and specialist documentation required

Document that the patient underwent the required surgery to remove laryngotracheal papillomas and provide a plan showing surgical debulking will be performed prior to the initial, third, and fourth doses; include evidence of prescribing or consultation with a specialist knowledgeable in RRP (e.g., otolaryngologist, pulmonologist, or oncologist).

J3404

Denial Risk

Prior complete course exclusion

Requests will be denied if the patient has previously received a complete treatment course of Papzimeos (defined as four doses administered over a 12-week interval).

J3404

Clinical Background

Papzimeos is a non-replicating adenoviral vector–based immunotherapy engineered to express a fusion antigen derived from selected regions of human papillomavirus (HPV) proteins found in HPV 6 and HPV 11–infected cells. The product is designed to elicit an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis (RRP).

Papzimeos is FDA‑indicated for the treatment of adults with recurrent respiratory papillomatosis.

In a pivotal open‑label, single‑arm study, adults with RRP received Papzimeos on days 1, 15, 43 and 85. At the 5 x 10^11 particle units (PU) per injection dose level, 18 of 35 patients met the study definition of a complete response (no requirement for surgical intervention in the 12 months after treatment), corresponding to a complete response rate of 51% (18/35).

Policy Summary

PayerUnitedHealthcare

PolicyPapzimeos (Zopapogene Imadenovec-Drba) for recurrent respiratory papillomatosis

Policy CodePolicy CS2026D0141C

Change TypeClarified — state applicability (Texas)

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain authorization for no more than one treatment course (four doses) per lifetime and document required surgical debulking and specialist involvement prior to dosing.

SourceLink

On This Page

D14.1	Benign neoplasm of larynx
J38.7	Other diseases of larynx

OpenPayer

Papzimeos (Zopapogene Imadenovec-Drba) for recurrent respiratory papillomatosis

Medically Necessary Criteria for Papzimeos

Applicable Codes

Authorization, Documentation & Denial Conditions

Clinical Thresholds and Defined Terms

Clinical Background

Policy Changes