Skip to main content

You must have JavaScript enabled in order to access this part of the site. Please enable JavaScript and then reload this page in order to continue.

Prior Authorization Criteria for Zopapogene Imadenovec-drba (Papzimeos) Effective May 1, 2026

Last updated on

Effective for dates of service on or after May 1, 2026, providers must receive prior authorization for zopapogene imadenovec-drba (Papzimeos) (procedure code J3404).

Zopapogene imadenovec-drba (Papzimeos) is a nonreplicating adenoviral vector-based immunotherapy that is indicated to treat adults with recurrent respiratory papillomatosis.

Prior Authorization Criteria

Providers must submit prior authorization requests for zopapogene imadenovec-drba (Papzimeos) using the Special Medical Prior Authorization (SMPA) Request Form.

Requests for Initial Therapy

The Texas Medicaid & Healthcare Partnership (TMHP) may approve initial therapy with zopapogene imadenovec-drba (Papzimeos) for six months (one treatment of four doses) if all the following criteria are met:

  • The client is 18 years of age or older.
  • The client has a confirmed diagnosis of recurrent respiratory papillomatosis (diagnosis code D141).
  • The client has documented human papillomavirus (HPV) serotype 6 or 11.
  • The prescriber must perform a surgical debulking of visible papilloma before starting zopapogene imadenovec-drba (Papzimeos) treatment to establish minimal residual disease.
  • The prescriber attests that visible papilloma will be removed before the third and fourth zopapogene imadenovec-drba (Papzimeos) administrations to maintain minimal residual disease during treatment.

Required Monitoring Parameters

Providers must monitor clients who are treated with zopapogene imadenovec-drba (Papzimeos) for signs of thrombotic events, such as shortness of breath, chest pain, leg swelling, persistent abdominal pain, and neurological symptoms, including severe or persistent headaches or blurred vision.

For more information, call the TMHP Contact Center at 800-925-9126.

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.