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Prior Authorization Criteria for Nadofaragene Firadenovec-vncg (Adstiladrin) Effective February 1, 2024

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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.

Effective for dates of service on or after February 1, 2024, prior authorization criteria will be required for nadofaragene firadenovec-vncg (Adstiladrin), procedure code J9029.

Nadofaragene firadenovec-vncg (Adstiladrin) is an adenoviral vector-based gene therapy indicated to treat adult clients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Prior Authorization Criteria

Prior authorization requests for nadofaragene firadenovec-vncg (Adstiladrin) must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

Initial Therapy

Initial therapy for nadofaragene firadenovec-vncg (Adstiladrin) may be approved for a six-month duration for clients who meet the following criteria:

  • The client is 18 years of age or older.
  • The client has a confirmed diagnosis NMIBC with CIS with or without papillary tumors.
  • The client’s disease is high-risk and BCG unresponsive as defined as:
    • Persistent disease following adequate BCG therapy,
    • Disease recurrence after an initial tumor-free state following adequate BCG therapy, or
    • T1 disease following a single induction course of BCG.
  • The client does not have any metastatic urothelial carcinoma.
  • The client does not have a hypersensitivity to interferon alfa.
  • The client is not immunocompromised or immunodeficient.

Renewal or Continuation of Therapy

For renewal or continuation of therapy, the client must meet the following requirements:

  • The client continues to meet the requirements for initial therapy and has been treated with nadofaragene firadenovec-vncg (Adstiladrin) with no adverse reactions.
  • The client has no signs of unacceptable toxicity (such as risk of disseminated adenovirus infection) while on treatment with nadofaragene firadenovec-vncg (Adstiladrin).

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