Papzimeos (imadenovec-drba) — Coverage and Prior Authorization Criteria
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Defines prior authorization, coverage criteria, and limits for Papzimeos (imadenovec-drba) as a medical benefit for adults with recurrent respiratory papillomatosis (RRP) in the payer's Arkansas PASSE program.
New policy for Papzimeos created.
Coverage Criteria for Papzimeos (imadenovec-drba)
inv-01: Initial Therapy
Covered when ALL of the following are met:
If all requirements are met, approved for 12 weeks.
Papzimeos (imadenovec-drba) is not medically necessary for indications other than those explicitly listed in this policy. For any use not described here, refer to the payer's Off-Label policy for coverage determinations.
Requests for reauthorization of Papzimeos will not be approved; Papzimeos will not be reauthorized beyond the initial authorization period.
Initial Authorization Requirements and Dosing
inv-13: Initial therapy — Initial authorization requirements and dosing
Initial authorization requirements and dosing:
Quantity limit: 4 injections per 12 weeks; approval duration 12 weeks when criteria met.
Coding and Related Criteria
| No codes listed |
Provider Requirements, Prior Authorization, and Documentation
Prior authorization required; approval = 12 weeks
Papzimeos (imadenovec-drba) is a medical benefit that requires prior authorization for adults with recurrent respiratory papillomatosis (RRP) who meet the policy's initial authorization criteria. When all initial criteria are met, approval is granted for a 12-week course (four subcutaneous injections over 12 weeks).
No step therapy agents required; specialty prescriber and surgical debulking required
No formal step therapy agents or failures are required. The prescriber must be an otolaryngologist or pulmonologist or document consultation with one, and the provider must attest that surgical debulking will occur as required by the criteria.
- Prescriber requirement: prescribed by or in consultation with an otolaryngologist or pulmonologist
- Surgical debulking attestation required prior to initiation and, if papilloma present, prior to doses 3 and 4
Required documentation for initial prior authorization
Include the following with the initial prior authorization request: diagnosis of RRP confirmed by laryngotracheal papillomas, documentation of HPV serotype 6 or 11, and documentation that the member had three or more surgeries to remove laryngotracheal papillomas in the prior 12 months. Provider attestation that surgical debulking will occur as specified must also be submitted.
- Diagnosis: RRP confirmed by presence of laryngotracheal papillomas
- HPV serotype documentation: 6 or 11
- Surgical history: ≥3 surgeries to remove laryngotracheal papillomas in the previous 12 months
- Attestation that surgical debulking will occur prior to starting therapy and, if present, prior to the third and fourth dose
Reauthorization will be denied
Reauthorization requests for Papzimeos will be denied; the policy does not allow reauthorization of this therapy.
Clinical Background
Recurrent respiratory papillomatosis (RRP) is caused by chronic infection with human papillomavirus, most commonly HPV types 6 and 11, which leads to benign papillomatous tumors in the respiratory tract that frequently require repeated surgical removal.
Definitions
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | |
| Medication must be prescribed by or in consultation with an otolaryngologist or pulmonologist. |
Quantity Limits and Dosing Constraints
Site of Care and Administration
Office administration — subcutaneous injection per package insert
Administer each dose by subcutaneous injection per the package insert; the policy does not impose an additional site-of-care restriction (office setting listed).
- Dosage: 5 × 10^11 particle units per injection administered subcutaneously four times over a 12-week interval per package insert
- Site of care: office setting noted; no explicit restriction beyond subcutaneous administration
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