CurrentCignaPolicy N/A

Gene therapy prior authorization for Adstiladrin (nadofaragene firadenovec-vncg)

Form and requirements for prior authorization of the gene therapy product Adstiladrin for Cigna members; directed to prescribing providers (urologists/oncologists) and facilities administering the medication. Governs submission of clinical documentation to determine medical necessity.

Policy Summary

PayerCigna

PolicyGene therapy prior authorization for Adstiladrin (nadofaragene firadenovec-vncg)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the Gene Therapy Prior Authorization form with supporting clinical documentation to 833-910-1625.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

AdstiladrinProduct

18+Age

BCG-unresponsiveRequired Dx

J9029HCPCS

Coverage Criteria for Adstiladrin (nadofaragene firadenovec-vncg)

Initial therapy coverage criteria

Covered when ALL of the following are met:

Age: Patient is 18 years or older>=18 years

Must be documented on form

Diagnosis: Documented diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC)

Must be documented on form

BCG response: Documentation of Bacillus Calmette-Guerin (BCG)-unresponsive diseaseBCG-unresponsive

Must be documented on form

Policy Summary

PayerCigna

PolicyGene therapy prior authorization for Adstiladrin (nadofaragene firadenovec-vncg)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the Gene Therapy Prior Authorization form with supporting clinical documentation to 833-910-1625.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Requests that do not include documentation of the patient’s age (confirmation the patient is 18 years or older), a documented diagnosis of Non‑Muscle Invasive Bladder Cancer (NMIBC), documentation that the disease is BCG‑unresponsive, specification of the required tumor presentation (one of: carcinoma in situ (CIS) with or without high‑grade papillary Ta/T1 OR high‑grade papillary Ta/T1 without CIS), or evidence that the drug was prescribed by or in consultation with a urologist or oncologist may be determined not medically necessary or denied for insufficient information.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adstiladrin (nadofaragene firadenovec-vncg). Complete and fax the Gene Therapy Prior Authorization form to 833-910-1625. For questions, contact the Cigna Gene Therapy Program at 855-678-0051 or GeneTherapyProgram@Cigna.com.

Product: Adstiladrin (nadofaragene firadenovec-vncg)
Fax: 833-910-1625
Gene Therapy Program: 855-678-0051; GeneTherapyProgram@Cigna.com

Documentation Required

Required Supporting Documentation

Submit the completed prior authorization form with supporting clinical documentation including chart notes, genetic test results, recent history and physical, recent labs, disease stage, prior therapies, performance status, and names/doses/administration schedule of concurrent agents. Include documentation that patient is >=18 years old, has Non‑Muscle Invasive Bladder Cancer, BCG‑unresponsive disease, and meets the listed tumor-type criteria (CIS with/without high‑grade Ta/T1 or high‑grade Ta/T1 without CIS). If continuation request, provide documentation of beneficial response.

Supporting documentation: chart notes, genetic test results, H&P, labs, disease stage, prior therapy, performance status
Clinical criteria: age >=18, diagnosis of Non‑Muscle Invasive Bladder Cancer, BCG‑unresponsive disease, tumor-type documentation (CIS ± Ta/T1 or high‑grade Ta/T1 without CIS)
Therapy intent: indicate initial vs recurrent/persistent use; for continuation, provide evidence of benefit
Prescriber: prescribed by or in consultation with a urologist or oncologist

Denial Risk

Incomplete Submission May Lead to Denial

Failure to complete the prior authorization form in its entirety or to provide required supporting documentation may result in delayed processing or an adverse determination for insufficient information. Due to privacy regulations, Cigna cannot respond via fax with the outcome unless all asterisked (*) fields on the form are completed.

Incomplete submissions may be denied or delayed
Ensure all required fields (including asterisked fields) are completed on the form

Note

Provider Action

Providers should indicate any additional CPT/administration codes to be billed (e.g., J9029 Injection, nadofaragene firadenovec-vncg, per therapeutic dose) on the form and include clinical rationale if request does not meet listed criteria.

Suggested code to indicate: J9029 Injection, nadofaragene firadenovec-vncg, per therapeutic dose
If medically necessary despite unmet criteria, provide clinical justification and rationale

Key Definitions

BCG-unresponsive — definition and documentation expectations

DefinitionBCG-unresponsive disease: documentation that the patient’s non-muscle invasive bladder cancer (NMIBC) is unresponsive to Bacillus Calmette-Guérin (BCG) therapy (as queried on the prior authorization form).

Documentation required on formExplicit confirmation on the form that the patient has documentation of BCG-unresponsive disease (Yes/No).

Related clinical context to includeProvide additional pertinent information when submitting: recent history and physical, recent lab work, disease stage, prior therapy, performance status, and names/doses/administration schedule of concurrent agents.

Tumor presentation linkageForm requires documentation of ONE tumor presentation: carcinoma in situ (CIS) with/without high-grade papillary Ta/T1 OR high-grade papillary Ta/T1 without CIS.

Prescriber requirementAdstiladrin must be prescribed by, or in consultation with, a urologist or oncologist; this must be documented on the form.

OpenPayer

Gene therapy prior authorization for Adstiladrin (nadofaragene firadenovec-vncg)

Coverage Criteria for Adstiladrin (nadofaragene firadenovec-vncg)

Coding and Billing

Provider Actions and Prior Authorization

Background

Key Definitions