Coverage of Adstiladrin (procedure code J9029) Begins January 2024; Prior Authorization Effective February 2024

Date: December 6, 2023

Attention: All Providers

Prior Authorization Effective Date: February 1, 2024

Call to action: Texas Children’s Health Plan (TCHP) would like to let providers know that effective February 1, 2024, Texas Health and Human Services (HHSC) will be implementing prior authorization criteria for Adstiladrin (procedure code J9029). Adstiladrin (nadofaragene firadenovec-vncg) 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.

Length of Authorization: 6 months

Prior Authorization Requirements

Criteria for Initial Approval:

1. Patient is at least 18 years of age; AND
2. Patient has a confirmed diagnosis for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors; AND
3. Patient has persistent disease following adequate BCG therapy also defined as high-risk and BCG-unresponsive confirming EITHER of the following:
   1. Disease recurrence after an initial tumor-free state following adequate BCG therapy; OR
   2. T1 disease following a single induction course of BCG.
4. Patient does not have any metastatic urothelial carcinoma; AND
5. Patient does not have a hypersensitivity to interferon alfa; AND
6. Patient is not immunocompromised or immunodeficient.

Criteria of Continuation of Therapy:

1. Patient has met all the initial approval criteria at the time of initial approval AND
2. Patient has been treated with Adstiladrin with no adverse reactions; AND
3. Patient does not have any signs of unacceptable toxicity (e.g., risk of disseminated adenovirus infection) while on treatment with Adstiladrin

Refer to the Outpatient Drug Services Handbook Chapter of the Texas Medicaid Provider Procedure Manual for more details on the clinical policy and prior authorization requirements.

Why is this important?

TCHP recognizes we may serve potentially impacted patients in our membership. We want to ensure that the member meets clinical evidence for treatment.

Next steps for providers: Prescribers should share this communication with their staff. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting member has met all approval criteria in support for Adstiladrin approval.

Note: If request is for a non-U.S. Food and Drug Administration (FDA) approved dose or indication, medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis.

If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.

For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.